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Signs of recovery Deals

Kai Pohlmeyer, CEO of Richter Biologics, on how biopharma service providers

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The West’s wake-up call to China’s biotech dominance

DR JEREMY M. LEVIN has held leadership roles in major pharmaceutical and biotechnology companies. He is currently Chairman and CEO of Ovid Therapeutics and Chairman of Opthea. Previously, he served as President and CEO of Teva Pharmaceutical Industries and was on Bristol-Myers Squibb’s Executive Committee. He has also been Global Head of Strategic Alliances at Novartis. Besides numerous board positions, Dr. Levin serves on the Board and Executive Committee of the Biotechnology Innovation Organization as Emeritus Chairman.

The U.S. House of Representatives recently passed the BIOSECURE Act, prohibiting U.S. biopharma companies from working with Chinese contractors due to national security concerns, including data leaks and intellectual property theft. The Act is expected to pass the Senate.

This legislation reflects shifting political, economic, and military forces. U.S. companies will need new suppliers, leading to immediate challenges in the biopharma supply chain. However, the broader impact involves rebalancing global biotech dominance, with longterm implications for competitiveness and supply chain sustainability.

China has invested in biotech for decades, positioning itself as a global leader. In contrast, the West was slow to prioritize biotech. The BIOSECURE Act may shift this, encouraging the U.S. and Europe to bring resources back home. Yet, in the short term, the consequences for manufacturing, clinical trials, and intellectual property are significant.

Western companies heavily rely on Chinese Contract Development and Manufacturing Organizations (CDMOs) for biotech productivity. A survey of U.S. biopharma companies revealed that 79% rely on at least one Chinese CDMO. China also supplies APIs and antibiotics to the U.S. and Europe, raising national security concerns. Shifting manufacturing out of China will be slow, taking years to establish new suppliers and affecting millions of patients. Geographic diversification of clinical trial sites also faces delays, increasing challenges in drug development.

China’s growing dominance in clinical trials may lead to data sharing restrictions under the BIOSECURE Act, affecting patient access and trial timelines. China’s share of global clinical trials grew by 57% in recent years, while Western Europe’s share dropped by 21%. Further tensions could slow innovation and limit access to treatments.

Biopharma executives must continue to carefully monitor China’s efforts to acquire Western biotech IP which threatens the industry’s competitive edge. The BIOSECURE Act also provides an opportunity. The West must respond with a comprehensive “BIOBUILD” strategy to maintain biotech leadership. This strategy should include tax incentives, regulatory reforms to accelerate drug development and approval, and investments in education of a biopharmaceutical workforce. It should also provide concrete support to ventures affected by BIOSECURE including providing incentives to those reliant on low-cost Chinese suppliers. China is committed to becoming the global biotech leader. If the West remains uncoordinated, it risks falling further behind a superpower that began its push decades ago. The BIOSECURE Act is a critical wake-up call. The West ignores it at its peril. We need a BIOBUILD plan.  You will find a detailed discussion after the publication of this issue at www. European-Biotechnology.com.

A new dawn for biopharma financing?

The first half of 2024 is history, and experts are divided on whether the financing nadir has been reached or even passed. There are very different figures for different types of treatments under development. ADCs and radioligands are on the rise, while cell and gene therapies are way down. Are larger financing rounds and a few IPOs a good sign for all? Some European companies hit the jackpot, but most still struggle. Amidst the positive news, one major uncertainty remains: interest rates.

INSIGHT EUROPE

6 Survey: Industry leaders adopt synbio and AI across eleven sectors

11 Alternative protein investments: Cell and plant-based down, fermentation up

12 Von der Leyen defines priorities for the European Commission’s next term

ECONOMY

14 M&A and IPOs –resurrection ahead?

20 Analyst commentary

21 European Biotech Stocks

24 SLAS Europe: Innovation in lab automation drives transformation in the biopharmaceutical industry

31 European Medicines Agency: Aplidin – a politically motivated scandal?

32 Update on clinical trials

38 Platform technologies: a ‘RNAaissance’ in drug development

REGIONAL NEWS

76 Northern Europe: Sweden, Denmark and Finland

78 Western Europe: France, Belgium, The Netherlands and the UK

80 Central Europe: Germany, Switzerland and Austria

82 Southern Europe: Italy, Spain, Cyprus and Portugal

84 Eastern Europe: Poland, Hungary, and the Czech Republic

SCIENCE & TECHNOLOGY

86 Bacterial cure for chemotherapy; Turning down immune response; Immune system-on-a-chip; Alcohol antidote; AdEs of obesity drugs

87 ‘Breaking Bad’ bugs

PICK & MIX

88 News from Biotech Austria, the Society for Laboratory Automation and Screening (SLAS) and the Young European Biotech Network (YEBN)

92 PharmaLab: Challenges with Bioassays

94 Innovate at Biofit in Lille

95 CPHI Milan: 2024 Dive into the heart of Pharma

96 Company index

97 Events

98 Encore

IMPRINT European Biotechnology (ISSN 2364-2351) is published quarterly by: BIOCOM Interrelations GmbH, Jacobsenweg 61, D-13509 Berlin, Germany, Tel.: +49-30-264921-0, Fax: +49-30-264921-11, Email: service@european-biotechnology.com, Internet: www.european-biotechnology.com; Publisher: Andreas Mietzsch; Editorial Team: Thomas Gabrielczyk (Editor in Chief), Derrick Williams (Co-editor), Dr. Georg Kääb, Uta Mommert, Maren Kühr; Advertising: Oliver Schnell, +49-30-264921-45, Christian Böhm, +49-30-264921-49, Andreas Macht, +49-30-264921-54; Distribution: Nancy Weinert +4930-264921-40; Graphic Design: Michaela Reblin; Production: Martina Willnow; Printed at: Königsdruck, Berlin; European Biotechnology Life Sciences & Industry Magazine is only regularly available through subscription with a BIOCOM CARD. Annual subscription BIOCOM CARD Europe: €80 for private individuals (students €40) incl. VAT, €120 plus VAT for corporates. Prices includes postage & packaging. Ordered subscriptions can be cancelled within two weeks directly at BIOCOM AG. The subscription is initially valid for one calendar year and is automatically renewed every year after. The subscription can be cancelled at any time and is valid until the end of that calendar month. Failures of delivery, which BIOCOM AG is not responsible for, do not entitle the subscriber to delivery or reimbursement of pre-paid fees. Seat of court is Berlin, Germany. As regards contents: individually named articles are published within the sole responsibility of their respective authors. All material published is protected by copyright. No article or part thereof may be reproduced in any way or processed, copied, and proliferated by electronic means without the prior written consent of the publisher. Cover Photo: © Ilugram - stock.adobe.com; ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

Playing catch-up

Ursula von der Leyen didn’t mention biotechnology a single time to the European Parliament in her election speech – likely because she wanted support from the Greens, whose members often have a general aversion to the industry. That makes binding political guidelines – including an extra budget for the financially ailing sector – all the more important.

RNA DRUGS

A second RNAissance

It took 20 years for RNA-based therapies to catch investor attention. Unlike small molecules or biologics, RNA drugs that can also target ‘dark matter’ in the human genome can be produced and screened fast, and easily scaled up.

SPECIAL

CROs & CDMOs

46 Impact of the BIOsecure Act

52 Interview: Dr. Kai Pohlmeyer, CEO, Richter Biologics

58 Your mRNA Partner in Europe

66 Interview: Dr. Samanta Cimitan, CEO, Celonic AG

70 Aequorin: Good choice for GPCR Calcium signalling

72 Interview: Dr. Benedikt von Braunmühl, CEO, Rentschler

Biopharma SE

EDITORIAL

A new hope

Ursula von der Leyen will not have an easy time of it in her second term as EU Commission President (see p. 12). Weakened by gains made by antiEuropean far right parties in the European Parliament and selfish moves by Member States, announced breakthroughs in biotechnology and the defence of democracy will grow more difficult to achieve. In a setting where the bloc is preoccupied with national sensitivities and fears about inflation, requested increases in budgets look less likely. Even if they’re vital – and not only to finally strengthen Europe’s competitiveness by cutting red tape.

A potential ally in those efforts is the US, which is trying to curb China’s growing supremacy in biomedicine and geopolitics. A new Biosecure Act (see pp. 3, 46). has already been approved by its House of Representatives. Will advancing biotechnology in terms of manufacturing and clinical trials in US-European research and production cooperations finally become more than just talk? After all, the world’s biggest dictatorship is no longer just breathing down the neck of the US in a range of fields, but increasingly in its face.

Whether EU heads of state and the next US President will support von der Leyen in promoting biologisation and digitisation in industry is rapidly becoming a broader geopolitical question.

Thomas Gabrielczyk Editor-in-Chief

Synbio is a key technology for eleven industrial sectors

SURVEY Two studies published in July see a mixture of AI and synthetic biotech at the centre of a future-proof economy. A white paper published by the World Economic Forum and an industry survey conducted by CapGemini send a clear message to EU policy makers: please don’t delay the biologisation of production!

Two studies published at the end of July by the Swiss World Economic Forum and the management consultancy CapGemini stand in harsh contrast to the silence of the re-elected EU Commission President Ursula von der Leyen (EPP) on biotechnology. In order to secure her re-election by green members of the European Parliament, the Christian Democrat failed to mention the importance of the future fields of biotechnology and synthetic biology for sustainable production.

Synbio across eleven sectors

In a survey, the management consultancy CapGemini obtained the opinions of 1,100 decision-makers from large com -

panies and 500 CEOs from SMEs on the current and future role of synthetic biology or engineering biotechnology for global product development. In addition, the team of analysts from the CapGemini Research Institute identified eleven fields of application in which the biologisation of production – called bio-solutions by CapGemini – is becoming increasingly established. A total of 72% of those surveyed worldwide were convinced that synthetic biotechnology would enable them to achieve their corporate sustainability goals significantly faster and also improve product performance. The Capgemini Research Institute´s research on the bioeconomy revealed that companies from eleven industries are using combined AI/Syn -

Bio tools to sustainably produce, for example, food with an optimised nutrient profile and carbon footprint, climateadapted plants, petroleum-free materials and improved cell therapies (see table p. 8). Sustainability and decarbonisation are therefore fueling the interest of large companies in ‘biosolutions’ developed by biotech SMEs.

Other motives include the potential for cost reduction through microbial, cell-based and cell-free production, the optimisation of product properties and – particularly in Germany – greater product and production process safety. However, the study points to challenges that need to be overcome in order to realise this potential: from market perception and acceptance on the consumer side, the high costs prior to scaling and a major shortage of qualified specialists.

Synbio across eleven sectors

The lack of optimal regulatory conditions for the development and commercialisation of biosolutions is also being discussed: While the USA and the UK have already identified engineering biology as a priority technology and corresponding measures to promote and deregulate the SynBio field are being implemented, it will be interesting to see whether Europe will continue to focus on bioconversions of agricultural residues or follow the biotech market leaders in the EU Commission’s announced new bioeconomy strategy and focus on bioreactor-supported largescale production. According to the

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study, the respondents all expect (99% internationally, 100% of the German companies surveyed) that Synbio will comprehensively change their industry in the next two to ten years. In Germany, more than one in two (58%) expect this to happen in the next two to five years.

About 68% of the analysed respondents attribute the greatest potential for transfomation to cell and gene therapy (see p. 46). However, bioplastics (59%), biotech fertilisers (57%), animal-free dairy products (56%), fragrances (70%), biotech dyes (63%), paints and varnishes (68%) and algae fuels (55%) are also classified by industry decision ­ makers as having a promising future. Techno -

logical advances in DNA synthesis, editing and sequencing have accelerated the implementation of metabolic engineering and synthetic biology in microbial and pharmacological production processes.

Life Sciences revolution

According to CapGemini‘s research, 96% of the industrial companies that answered the questions are already working on biosolutions: 40% in the exploration phase, 56% in research and pilot projects or on a commercial scale. More than two thirds (68% international, 74% national) intend to increase in -

Some examples of processes currently used by industrial companies with microorganisms that have been optimised with the help of synbio tools

Application Company Solution

› Cosmetic products Amyris Inc Until now, squalene has been extracted from shark liver and olive oil. A biosynthetically produced metabolic cycle in yeast enables the fermentation of the squalene precursor farnesene with a better yield. Sugar cane is used as carbon source

› Palm oil substitutes C16 Bioscience Inc C16 Bioscience Inc uses a CRISPR-engineered oil-producing yeast to produce a cost-effective palm oil substitute on an industrial scale by fermentation and thus counteract monocultures.

› Surfactants LanzaTech Inc Unilever uses Lanzatech‘s genetically optimised chassis archaea to produce the ethylene oxide required for the production of dishwasher tabs from CO2 waste streams by means of gas fermentation and subsequent chemical processing.

› Dyes Octarine BIO A/S The Danish company has reprogrammed the metabolism of yeasts so that they produce biodegradable textile dyes.

› Natural rubber Laastix SA The French start-up has incorporated the synthesis pathway from the rubber tree into E. coli bacteria and produces natural rubber in the fermenter.

› Material Sciences Amsilk GmbH Amsilk GmbH from Planegg is constantly finding new applications and partners for its recombinant BioSteel spider silk produced with engineered E. coli bacteria

› Essential pharma raw materials Antheia Inc Yeasts into which genetic circuits have been introduced, produce pharmaceutical ingredients (APIs) in the fermenter regardless of supply bottlenecks. According to the US company, 50% of the essential APIs can be produced in this way.

› Vaccines BioNTech NV, Moderna Inc

› Cultivated Food and Feed Mosameat NV, Formo GmbH, Every Inc, Novonesis A/S, Formay SAS

› Agriculture Bayer AG/Gingko Bioworks Inc, Greenlight Biosciences Inc

cGMP-manufactured COVID vaccines are the most primitive, but certainly the best-known achievement of synthetic biology.

In the case of synthetic foods from cell culture and precision fermentation, natural synthesis pathways or complex circuits are introduced into microbial production strains and As with beer brewing, milk, meat, egg and fish substitutes are produced in a closed system in an animal-free and CO2-saving manner. As the production strains excrete the product, it is GMO-free.

Through the use of optimised nitrogen-fixing bacteria Bayer and Gingko Bioworks want to replace artificial fertilisers. The company Greenlight, has launched RNA-based crop protection products on the market, while the French company Biotalys SA is trying to do the same with so-called agrobodies. There are also a handful of agronomically optimised plants using new breeding technologies.

vestment in biosolutions in the next two to five years.

Transformation has just begun

According to study leader Felizitas Graeber, Managing Director of Capgemini Invent in Germany, “the bioeconomy is moving into the focus of business leaders [...] in all industries – from energy and utilities to the automotive industry, healthcare and agriculture. Major investments are driving the momentum and are required to bring biosolutions to market. As generative AI increases precision, speed and cost efficiency in bioengineering, this technology field will drive significant momentum in the coming years, transforming companies and industries from the ground up.” Both established companies and biotech startups see scaling costs and the current lack of suitable infrastructure, such as large bioreactor volumes and a shortage of skilled workers, as the biggest hurdles to implementing biotech solutions in energy, transportation, materials development, nutrition, drug development, crop protection, chemistry and engineering. They are also concerned about a broad lack of knowledge and a dynamic, as yet unpredictable regulatory framework for synthetic biology. Nevertheless, the respondents agree that digital and engineering technologies are key factors for reducing costs, optimising bioprocesses, shortening the time to market for biosolutions and reducing ecological and social risks.

Recommendations

CapGemini‘s market specialists and management consultants also have some recommendations for the new EU Commission and its planned bioeconomy strategy up their sleeves:

› political measures must aim to prevent the use of fossil fuels and increase the economic attractiveness of biosolutions

› the creation of a clear and progressive legal framework, as promised in the political guidelines of the new

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SynBio: Biden’s legacy

In September 2022, the Biden Administration issued an “Executive Order to Promote Innovation in Biotechnology and Biomanufacturing for a Sustainable, Safe, and Secure American Bioeconomy” with the stated goal of finding “innovative solutions in the areas of health, climate change, energy, food safety, agriculture, supply chain resilience, and national and economic security. This order prompted the U.S. Department of Energy to develop highly ambitious climate change mitigation goals related to Engineering Biology (EngBio) (such as “harnessing more than 60 million metric tons

Commission, would also be expedient in order to promote the responsible use of synthetic biology and reduce legal uncertainty in the testing and use of SynBio processes.

› CapGemini also considers an increase in funding and money for the creation of corresponding production capacities for bioproduction to be conducive to innovation Above all, however, one thing is important: the proactive promotion of a fact-based public discourse on synthetic biology, i.e. educational campaigns that dispel unfounded fears of the technology and promote constructive dialog. Interest groups should also be heard in this process, the World Economic Forum warns.

World Economic Forum warns

The renowned World Economic Forum also published a bioeconomy white paper in July that makes people sit up and take notice, and right at the beginning of the paper the experts clear up a major misconception: In light of technological advances such as the precision gene scissors CRISPR, the integration of entire metabolic pathways into microbial production organisms and the increas -

of CO2 from waste gases suitable for conversion into fuels and products” by 2043). Such goals are among the priorities promoted by a new “Office of Critical and Emerging Technology”, which was established in December 2023. Recent US legislation also offers potential funding opportunities (such as tax credits in the Inflation Reduction Act for synthetic fuel producers and general support such as the creation of a National Engineering Biology Research and Development Initiative through the Chips and Science Act (2022). Similar patterns can be observed internationally. L

ing integration of AI tools into the development process, the bioeconomy is no longer a bioconversion of organic waste. This should no longer be understood as the bioconversion of organic waste, for example from agriculture and forestry, into products, but should also include the auxothrophic cell-based and cellfree production of food, silk protein, bioplastics, biofuels and non-fossil chemical base chemicals in fermenters, the bioprinting of tissues, etc. The new developments would already take into account the bioeconomy strategies of some countries.

For example, the USA – and subsequently the UK – had declared engineering biology a national priority and strategically important technology According to this definition, the bioeconomy offers “a realistic opportunity to reconcile economic growth with sustainability and environmental responsibility. By investing in the necessary infrastructure and promoting cross-sector collaboration, we can accelerate the transition to a sustainable economy and unleash the full potential of the bioeconomy, making it a cornerstone of a resilient and sustainable global economy,” according to the World Economic Forum. L

t.gabrielczyk@biocom.eu

Agri-shift

SDA EU subsidies only for needy farmers, and support for less and animalfriendly meat production as well as climate protection measures. These are the recommendations of the SDA (Strategic Dialogue on the Future of EU Agriculture) expert panel called on the future of EU agri-policy. At the beginning of September, following consultation with 30 lobby groups, the experts led by Angela Merkel’s former advisor Peter Strohschneider presented recommendations aimed at ending the current areabased agricultural EU subsidy system. The consensus paper must now be filled with concrete measures. Euroseeds chief Garlich von Essen hopes for a transition to more (bio)technologies in an “EU vision for agriculture”. L

CRISPR is safe

EFSA EU food safety watchdog EFSA has published a scientific opinion saying that microorganisms produced with new genomic techniques (NGT) such as CRISPR-Cas9 pose no more risk than strains produced conventionally by random mutagenesis. All foods produced using microorganisms should be assessed in the same way, according to the EFSA. Biotech associations celebrated the opinion. EuropaBio welcomed the assessment, “which notes a higher efficiency, specificity and predictability of genomic changes with NGT-produced microorganisms,” according to AnneGaëlle, Head of Industrial Biotechnology. It is also important that food cultures are not equated with so-called additives. In mid-June, the EFSA had already certified that plants produced using new genomic techniques were equivalent in terms of food safety to those produced conventionally by random mutagenesis. This was preceded by an inquiry with a contrary assessment by the French authority ANSES, which is riddled with genetic engineering sceptics. L

Alt protein investments: cell and plant-based down

MARKET ANALYSIS Fresh data from Net Zero Insights demonstrate that the alternative protein sector withstands the negative cross-sectoral investment trend of globally 38% less investment. Figures for the first half of 2024 show that investors currently bet on single cell fermentation, while cell and plant-based proteins saw less but higher investments.

A recent investment barometer sheds light on which technologies investors are focussing on when selecting developers in the European cultured food market. The data collected for Net Zero Insights shows that single cell and precision fermentation is experiencing an upswing, while investments in cell and plant-based protein really slumped in the first half of 2024.

However, when comparing growth in 2023 as a whole with the first half of 2024, it must be taken into account that

two major deals by the Swedish plant milk company Oatly AB (formerly Ceba Foods AB) totalling around €391m in 2023 distort the trend among plant protein producers. Adjusted for this, the picture is one in which investments in plant-based protein have been declining sharply since 2022 and those in cellbased protein have slumped to €45m for the first time in the first half of the year after stagnating at €120m in 2022 and 2023. Although the investment climate declined by around 38% in all sec-

tors in 2023, investments in the fermentation sector bucked the global market trend with highly significant growth. Investments of €164m in H1/2024 exceeded the full­year figure of around €100m by no less than 64%. Two thirds (€115m, 2023: €67m) went to companies that produce microbial or mycelial protein through biomass fermentation, while one third (€49m, previous year: €33m) went to precision fermentation specialists that produce ingredients such as the flavourgiving blood protein leghemoglobin.

Gold for fermentation

According to analyses by the industry association GFI Europe, the majority of single-cell protein manufacturers used side streams from agriculture and industry as a cheap source of carbon and reinvested the fresh capital in setting up a fermenter infrastructure for industrialscale production. GFI Europe used this result to lobby for public funding to address the lack of infrastructure.

Although the €79m raised by plant protein producers in the first half of 2024 seems small compared to the €553m (adjusted €162m) raised in 2023, successful companies are still receiving large investments, such as Spanish company Heura, according to GFI Europe. Although investments in European producers of cultured fish and meat alternatives declined compared to the previous year, they are well above the investment trend for the market as a whole when extrapolated to 2024 as a whole. L

t.gabrielczyk@biocom.eu

Von der Leyen defines priorities of next term

EC Ursula von der Leyen (EPP) faces a second term as EU head. After the old new President of the European Commission was confirmed by a majority of the 27 heads of states in the EU Council and re-elected with 401 out of 719 votes by the European Parliament, she has published her politically binding guidelines and received the member states’ proposals for 26 Commissioners.

The good news after Ursula von der Leyen’s re-election as EU head is: there is a 60.5% (454 out of 720 seats) democratic majority in the European Parliament to support her geopolitical and technological priorities. However, some of von der Leyen’s voters, particularly the Greens, might block some projects on her agenda laid down in her political guidelines (2024-2029). On paper, von der Leyen promised to make biotechnology one of the pillars – together with cleantech, AI, and digitisation – of a new Clean Industrial Deal that she plans to implement within the first 100 days of her term. On the other hand, she has no strong political and economic backing from EU payer states: Germany and France are in a budgetary crisis and its government heads are weakened by successes of the far right opposition. Thus it is likely that most promises von der Leyen made, which are based on an extra budget for biotechnology and innovation, cannot become true because there won’t be an extra budget. Furthermore, von der Leyen might face strong opposition from EU Member States in implementing her ambitious programme.

The Clean Industrial Deal replaces the Green Deal and puts more focus on successful implementation of circularity and competition. In her guidelines, von der Leyen writes: “I want Europe to make the most of the biotech revolution. Biotechnologies, supported by AI and digital tools, can help modernise entire parts of our economy, from farming and forestry, to energy and health. In order to make it easier to bring biotech from the laboratory to factory and then onto the

market we will propose a new European Biotech Act in 2025. This will be part of a broader Strategy for European Life Sciences to look at how we can support our green and digital transitions and develop high-value technologies. To lead on innovation, we need to create the conditions for researchers to thrive. This means providing the infrastructure and innovative laboratories they need to test and develop ideas through new public-private partnerships, such as joint undertakings It also means attracting new talents and retaining the best and brightest minds here in Europe. To do this, I want to strengthen the collaboration between research departments, higher education and business – notably by strengthening our University Alliances”.

Fresh money

The guidelines also promise a new European Competitiveness Fund designed to finance clean, strategic technologies and energy intensive industries. The implementation of this fund is not very probable, as EU countries struggle with inflation and investments to manage the energy crisis. However, von der Leyen proposes a new and reinforced budget in the next multiannual financial framework of the EU. The first trial to implement such a fund as a reaction to the US strategic commitment to engineering biology failed in 2023 due to the unwillingness of the member states to spend more money in order to give boost Europe’s competitiveness. However, von der Leyen insists on her demand to get an extra

budget because otherwise she won’t have the resources to boost strategic technologies and resources and manufacture them here in Europe. Von der Leyen also says she will reduce regulative and administrative burden for innovative SMEs, implement prevention programmes for neurological and heart diseases, and propose a Critical Medicines Act to reduce dependencies on critical medicines and ingredients. “In a world of adversity and uncertainty, I believe Europe must choose to stick together and dare to think and act big,” she hopes.

Candidate nomination

The second von der Leyen Commission will run through 2029. It will consist of one EU Commissioner from each EU member state – including von der Leyen. For the first time , she has nominated a Commissioner for Defense and Space, pro-Ukrainian MEP Andrius Kubilius (EEP) from Lithuania, together with a trio of Executive Vice-Presidents (VPs) who will lead her Clean Industrial Deal after confirmation by the European Parliament: Teresa Ribera (S&D, Spain) as the Executive VP for the Clean, Just and Competitive Transition will lead the Clean Industrial Deal together with former Dutch Commissioner for Climate Action, Wopke Hoekstra (EPP) who got the portfolio for Climate, Net-Zero and Clean Growth, and Dan Jørgensen (S&D, Denmark) who leads the Energy and Housing portfolio. The other Vice President jobs went to former Finnish Minister of Education and Transport, Henna

Virkkunen (EPP, who might get the job as Executive VP for Tech Sovereignty, Security and Democracy. After France’s most ambitious candidate, Thierry Breton (Renew), withdrew from his nomination at short notice in a dispute with von der Leyen, Stéphane Séjourné (Renew) will become VP for Prosperity and Industrial Strategy. As a reward for the last-minute nomination of a female candidate, Roxana Mînzatu (S&D, Romania) was appointed VP for People, Skills and Preparedness instead of the Romanian VP of the EU Parliament Victor Niegrescu (S&D). With Estonia’s outgoing head of government Kaja Kallas (Renew) as VP and High Representative for Foreign and Security Policy, von der Leyen is strengthening her pro-Ukranian position. In line with the distribution of seats in the European Parliament, von der Leyen also had to nominate candidates from the extreme right spectrum. Raffaele Fitto (ECR, Italy) was given the important position of VP for Cohesion and Reforms demanded by Italian Prime Minister Giorgia Meloni, who had not voted against von der Leyen’s re ­ election. He fills the post that Bulgaria would have preferred to fill with Ekaterina Zaharieva (Bulgaria). Fitto will have oversight of the European Regional Development Fund, which accounts for a third of the EU budget. Zaharieva got the post of Commissioner for Startups, Research and Innovation.

Von der Leyen allocated the further portfolios as follows: Von der Leyen nominated the incumbent Finance Minister Magnus Brunner (EPP, Austria) as Commissioner for Internal Affairs and Migration. Belgium’s former Foreign Minister Hadja Lahbib (Renew) will get the post as Commissioner for Preparedness, Crisis Management and Gender Equality. Croatia’s Dubravka Suika (EPP) has been selected as von der Leyen‘s Commissioner for Mediterranean. Cyprus’ biodiversity specialist Costas Cadis (no-party) could become Commissioner for Fisheries and Oceans. Czech Trade Minister Jozef Sikela (EPP) got the post as Commissioner for International Partnerships. The former President of the European Committee of the Regions, Apostolos

Tzitzikostas (EPP), will become Commissioner for Sustainable Transport and Tourism. Von der Leyen intends to award the important post of Commissioner for Health and Animal Welfare to Hungary’s right-winger Oliver Varhelyi (Patriots). Though Ireland voted against von der Leyen’s re-election, its Finance Minister, Michael McGrath (Renew) is nominated for Commissioner for Democracy, Justice and Rule of Law. Latvia’s EU Trade Commissioner Valdis Dombrovskis (EPP) was renominated but for the post as Commissioner for Economy and Productivity, Implementation and Simplification. As Commissioner for Agriculture and Food, von der Leyen’s EPP colleague Christophe Hansen (Luxembourg) is to implement the radical restructuring of EU agricultural subsidy policy (see p. 10). Malta’s Glenn Micallef (S&D) was nominated Commissioner for Intergenerational Fairness, Youth, Culture and Sport while Poland‘s Piotr Serafin might become Commissioner for Budget, Anti-fraud, Public Administrations and Portugal’s former Minister of State and Finance Maria Albuquerque (Portugal) got the post as Commissioner for Financial Services. Slovakia’s Maroš Šefcovic (S&D) was selected to become Commissioner for Trade and Economic Security, Interinstitutional Relations and Trans-

parency. Sweden’s Minister for European Union Affairs of Sweden, Jessika Roswall (EPP), will oversee the future and update of the bloc’s bio-economy as Commissioner for Environment, Water Resilience, Meanwhile, Slovenia at the last minute replaced the former president of the Court of Audit, Tomasz Vesel (no party), with Marta Kos (Renew), who will fill the post of Commissioner for Enlargement. L t.gabrielczyk@biocom.eu

Funding needed

AMR Antimicrobial resistance (AMR) poses a global public health threat, with urgent need for new drugs to prevent and treat infections. The AMR Accelerator, a public-private partnership, calls for longterm investments by governments and private actors to sustain European antibiotic R&D capabilities. This call, published in Nature r eviews Drug Discovery (DOI: 10.1038/d41573-024-00138-9), highlights the importance of coordinated action and risk-sharing to preserve expertise and infrastructure. Over the last five years, the AMR Accelerator has progressed 44 antibacterial programmes, to date resulting in two completed Phase I studies, and five ongoing Phase I and II studies. 

Ursula von der Leyen presented her priorities for the next five years to MEPs before she was re-elected as Leader of the European Commission.

M&A and IPOs –resurrection ahead?

FINANCING The first half of 2024 is history and the experts are wavering as to whether the trough has been reached or even passed. Are things looking up again in terms of financing innovation? Is the slight upward trend stable enough to take a more positive view of the future? And are larger financing rounds and a few IPOs good signs for everyone? In the midst of positive news, one uncertain factor remains: interest rates.

Mergers and acquisitions (M&A) in the biopharmaceuticals industry rebounded even more in the first quarter of this year after a US$76.9bn increase in total deal value from 2022 to 2023. In the first quarter of 2024 alone, biopharma M&A reached a total deal value of US$43bn. There was also a 71% year-on-year increase in mega-deals totalling US$1bn or more compared to the first quarter of 2023, according to GlobalData.

Alison Labya, Business Fundamentals Analyst at the leading data and analytics company, commented earlier this year that “the recent uptick in biopharmaceutical M&A activity signals a return of dealmaking confidence, as Big Pharma companies are also looking to mitigate challenges such as the Inflation Reduction Act and upcoming patent expirations.”

GlobalData has also interviewed healthcare industry professionals who expect M&A mega-deals to be one of the factors that will have the greatest positive impact on the pharmaceutical industry in 2024.

Novo goes shopping

The largest M&A deal reported in Q1 2024 was Novo Nordisk holding and

investment company Novo Holdings’ $16.5bn acquisition of US-based contract development and manufacturing organisation (CDMO) Catalent, which was announced in February 2024. Another notable M&A deal was Gilead Sciences’ US$4.3bn acquisition of US-based CymaBay Therapeutics, completed in March 2024.

Outside the CDMO sector, companies developing antibody drug conjugates (ADCs) and radiopharmaceuticals attracted high levels of M&A investment. For example, Johnson&Johnson acquired US ADC company Ambrx Biopharma for US$2bn in March, and Anglo -Swedish AstraZeneca announced the acquisition of US radiopharmaceutical company Fusion Pharmaceuticals for US$2bn in the same month.

According to GlobalData and other sources, oncology was again the top therapy area for M&A deals in Q1/2024, with total deal values of US$29bn. However, immunology-focused M&A saw the largest increase in deal activity compared to Q1/2023, tripling with a 314% increase in deal value to US$14bn in Q1/2024 alone.

Labya concludes: “The rest of 2024 is poised for continued M&A investment by large biopharmaceutical companies, which could accelerate R&D and the launch of innovative drugs.”

Some of the billion-dollar acquisitions took place in the European space. Among them were the takeover of Cardior (Hannover, Germany) by Novo Holding for US$1bn, and the asset spinout of Numab (headquartered near Zurich, Switzerland) via Jersey Therapeutics to Johnson&Johnson for another US$ 1bn.

VC funding on the rise

GlobalData revealed in the early months of the year that private biotech rebounded in terms of venture funding in Q1/2024. The sector saw a 46% increase in the total value of VC deals in the first quarter of 2024 compared to the fourth quarter of 2023. The analytics company viewed this increase as a sign of progress towards a recovery in venture funding as investor confidence improves. Times have been tough before. In the face of macroeconomic challenges such as high interest rates and inflation, which led to increased investor caution, private biotech venture financing saw downturns in both 2022 and 2023. However, the trend appears to be reversing, as the area in Q1/2024 showed an increase in larger funding rounds compared to Q4/2023. This uptick could be interpreted as an improvement in venture capital sentiment from being more selective in smaller rounds

to investing more in larger ones. In line with this interpretation of sentiment, GlobalData’s Pharma Intelligence Center Deals Database reported a striking 109% increase in venture funding for Phase II and Phase III deals in Q1/2024 compared to Q4/2023.

A well-known behaviour in challenging times – that investor preference shifts towards late-stage clinical development in an effort to mitigate risk – has therefore not held true for 2024, at least so far. Whereas a turn to earlier investments in early-stage biotechs was really on display in 2021, with stronger-thanever Series B and C financing rounds, in the following years it beecame harder to get financing in any phase of development. According to a piece in Nature BiotechN ology from August, the scene has changed. The fewer but larger rounds can be found in Series A and D globally. There, the average round shows an increase of about 50% over 2023 in Series A and more than 100% in Series D (see Figs. 1 & 2).

First choice: ADCs and isotopes

The surge in investor interest in early 2024 was massive in antibody-drug conjugates (ADCs, see p. 46) and radiopharmaceuticals. ADCs saw a more than fivefold increase in venture funding, from US$98m in Q4/2023 to $568m in Q1/2024. German biotech Tubulis secured the largest venture deal in that period, raising US$139m in Series B2 funding for its next-generation ADC lead candidates. In addition, VC investment in innovative radiopharmaceuticals increased by over 330% in Q1/2024 compared to the same quarter last year, indicating continued growth prospects.

What is very noticeable is the clear downturn of any asset financing in the cell and gene therapy sector (see p. 18). Companies with AI or machine learning in their drug development toolbox, on the other hand, have already reached about the same milestones as last year, and may top those benchmarks handily.

While venture funding deals peaked in 2021, such deals have since declined.

Venture capitalists appear to have grown more cautious, and the caution from one reverberates throughout the group, dampening the appetite for investment as a whole. That means companies are taking longer to complete funding rounds, and many have returned to their syndicate of investors for additional funds, which reduces the capital available for new investment. While agreeing that the funding environment is challenging, many industry experts say that ultimately the strongest candidates – if properly

DR. KARL NÄGLER Newly appointed Partner with Sofinnova Partners, France/Germany

?Darkness or Dawn – in which direction is biotech trending?

!While it is still a challenging environment, there are positive trends. Experienced teams with high-value assets can raise substantial funding rounds, also in Europe. There is some concentration of capital – fewer companies attract larger rounds. VC financing volumes have gone up in H2 versus the previous year, and the likely lowering of interest rates will give an extra boost, first to public company performance and eventually also to the private sector. With regards to exits, we have seen good traction at Sofinnova. Amolyt was acquired by AstraZeneca, Shockwave acquired by Johnson & Johnson and Calliditas acquired by Asahi Kasei – all for over a billion dollars, as well as Mablink Bioscience’s acquisition by Eli Lilly.

managed – will survive regardless of the financial landscape.

Light at the end of the tunnel?

Every financing deal has been scrutinised with an eye to gauging whether the industry as a whole is ‘reawakening’, with select IPO windows opening, biotechs engaging in M&A deals and a small number of companies raising larger rounds to secure capital. But in this environment, investors continue to put their eggs in less risky baskets – which doesn’t appear to be cancer research.

Oncology is an area that waxes and wanes in popularity, but the current hurdle is the sheer number of oncology companies with robust preclinical data, which makes it hard to determine which candidates have the highest chance of success – or even which companies will find enough patients for clinical trials to generate enough data about their assets. Investor activity is heavily influenced by larger industry trends. For example, while current trends suggest that oncology is growing more difficult, and metabolic disorders are on the rise, in previous years the reverse was true. In the long run, investors are looking for novel candidates, and this is leading them away from the herd instincts to flock to PD-1 inhibitors and GLP-1 agonists, which are no longer groundbreaking.

Different behaviour for CMOs

While M&A activity in the biotech and pharma sectors increased, M&A activity in the contract manufacturing industry fell in 2023 compared to 2021-22. High inflation and interest rates, combined with an uncertain business environment, have discouraged investment. Despite fewer deals, the focus shifted to scaling up existing operations rather than acquiring specialist capabilities, according to further research by GlobalData.

Commenting on this particular behaviour, GlobalData Pharma Analyst Adam Bradbury said: “In 2023, the majority of acquired contract manufacturing and de-

Pictures:

© Magali

Delporte, Sofinnova Partners, Delporte

Source: DealForma Database

https://doi.org/10.1038/s41587-024-02357-2,

Pictures: © Nature Biotechnology 2024, Senior, M. Biotech financing: darkest before the dawn.

velopment organisations (CDMOs) had standard capabilities, whereas in previous years specialised and biologics acquisitions were higher. As borrowing and inflation have made investment more difficult and there has been an increased focus on solving drug shortages, manufacturers have shifted their focus to increased scale rather than higher-valuespecialised forms of production”.

Nevertheless, there were still very notable deals in the CMO industry in 2023. The largest by value was the acquisition of Baxter International Inc’s BioPharma Solutions business by Advent International and Warburg Pincus for US$4.3bn. In 2024, the acquisition of Catalent Inc. by Novo Holdings A/S for US$16.5bn shocked the industry. Mergers of that size can have potential anti-competitive effects and impact capacity in the CMO industry.

There is now a run on injectable capacity. Although demand for COVID-19 vaccines is no longer contributing to growth in injectable demand, demand for obesity treatments targeting GLP-1 is a key driver of growth in this segment. And as more and more products gain regulatory approval, the need for commercial production of biologics in general remains high. This is where the industry as a whole sees the trend rising: CDMOs with the right capabilities are winning new customers who need to bring newly-approved biologics to market. Mass and lifestyle product companies are investing heavily in production capacity and new sites around the world. The glass industry is getting a positive push to use pre ­ filled syringes. If a CDMO were able to step in and produce a ‘miracle’ syringe now, GLP­1 aficionados would beat down their doors (see Special Section on CRO & CDMO markets p. 45).

Q2/2024 remained on track

The positive sentiment and news from the beginning of the year continued to buoy business in the second quarter of 2024, with VC in the sector reaching US$9.2bn (in 215 deals), up

Fig. 1a: In 2024 up to August, the industry has seen fewer, larger biotech financing rounds. 1b: The average A round is worth US$80m – more than twice the average in 2019. The average D round in 2024 is skyrocketing. (YTD=year-to-date)

from US$7.4bn in the first quarter (in 196 deals). According to PitchBook’s Q2/2024 Biopharma Report, the last time funding reached that level in the same period was back in 2022.

PitchBook credited emerging technologies – such as advances in CRISPR and oncolytic virus therapies, as well as obesity treatments and AI-driven platforms – for attracting Q2 investments. Some mega-rounds made all the headlines: Formation Bio’s US$367m Series D in June brought its total funding to over US$618m. In April, Xaira secured one of the largest early-stage rounds in biopharma history with an astonishing US$1bn Series A round. Both companies use an AI-driven drug discovery platform.

Trends have pointed to an assetcentred focus, favouring advanced clinical programmes over platform investments. While investors recognise the potential of AI in pharma, investments

in the technology are seen as longterm, with slow adaptation for clinical development. “The slow adoption of AI in clinical development highlights the need for a long-term investment vision, as evidenced by leading AI therapeutic players such as Exscientia and InSilico Medicine, which are still in clinical trials despite being founded years ago,” the report said. Its top two therapeutic areas in Q2 were oncology, followed by immunology and infectious diseases. Oncology therapeutics saw 96 deals worth over US$3.3bn, while immunology and infectious disease saw 68 deals worth US$2.8bn.

The M&A cycle has slowed down after some large deals in previous quarters, which PitchBook attributes to depleted cash reserves, full pipelines and a trend towards nurturing startups rather than selling them. So what we saw in the first quarter does not automatically signal

a trend for the rest of the year. When it comes to public markets, news from the present is just one factor that affects the overall picture and the long-term choices investors make IPO activity reflected a preference for companies with mature clinical data, according to Pitchbook. Notable activity in the second quarter included the US$210m IPO of Alumis and the US$172m IPO of Rapport Therapeutics. Alumis’ listing on the Nasdaq in June followed closely on the heels of its US$259m Series C in March. The company released Phase II data shortly after the Series C, positioning its secondgeneration TYK2 inhibitor for plaque psoriasis as a rival to BMS’ Sotyktu. One area of potential concern, according to Pitchbook, is the passage of the

BIOSECURE Act in the US Congress. The bipartisan bill, which could be voted on in the US Senate by the end of the year, is expected to disrupt the biopharma industry by preventing companies from using equipment or services from Chinese “biotechnology companies of concern”.

While this legislation is expected to have a positive long-term impact on CDMOs outside of China, as companies have to transit by 2032, it could hurt the biopharma industry in the short term, potentially affecting current investment trends.

IPO window cracks open

We are now seeing IPOs such as Bicara Therapeutics (Boston) a Phase I biotech

Fig. 2: Different pictures for cell/gene therapy and AI. 2a: Venture funding for cell and gene therapy has plummeted in 2024. 2b: Companies using AI or machine learning for healthcare research and drug discovery are on track to raise more VC in 2024 than in any previous year apart from 2021. (YTD=year-to-date)

developing an antibody to target solid tumours. Or Zenas BioPharma (Waltham, US), a Phase III biotech developing therapies for autoimmune and inflammatory diseases. Both Massachusetts-based companies are developing “bifunctional” antibodies that can potentially fight a disease with two different mechanisms. Both deals are also being led by Morgan Stanley, and aim to raise US$200m+ by offering shares at US$16-$18. MBX Biosciences (Carmel, US) is also aiming for a deal size of US$128m on the Nasdaq. The Phase II biotech develops precision peptides for endocrine and metabolic diseases. Are these quite mixed IPOs opening the doors for more to come? Is there a mood upswing on stock exchanges? Perhaps. Antisense company Ionis Pharmaceuticals (Carmel, US) just used the momentum to nail down a second public offering of about US$500m. And investors have poured more than US$370m into Candid Therapeutics right from its start.

So if there’s a Big Takeaway, it’s this: overall venture funding is certainly up, and an IPO window may be opening, but whether core sentiments among investors are changing from ‘risk-averse’ to ‘feeling frisky’ remains up in the air. The overall mood, however, is becoming more positive in general, and the headline of Melanie Senior’s widely read and shared article in N ature B iotech N ology in August (‘Biotech financing: darkest before the dawn’) can be interpreted in two ways. One is that the last few years have unquestionably been dark ones for the industry when it comes to funding – but they’re not the first, and won’t be the last. The second is that even after the longest and darkest nights, the sun always rises. And right now there at least seems to be a glimmer of light on the horizon. Hopefully enough of a shift in mood to provide young companies with the momentum they need in upcoming partnering events and investor conferences, giving them confidence that their innovation also has the chance to be the next big thing. Still the truth is: pharma remains desperate. L georg.kaeaeb@biocom.eu

The stock exchanges trade the future – really?

BERNARDO GLAVO – EUROPEAN BIOTECHNOLOGY NETWORK Unfortunately, it has to be said that the biotech industry in Europe is developing less dynamically than in the USA or China.

This is despite the fact that biotechnological research here is still among the best in the world. Bureaucracy and regulation are certainly a factor, but so is the fragmented capital market.

In ecology, the more diverse a system is, the more stable it is considered to be. According to this, Europe’s stock exchange landscape should be a haven of stability, because in addition to a few multinational players, there are a huge number of small and medium-sized trading centres –most of which are digital these days anyway. It may be that this diversity provides a stable buffer against the odd insolvency, but for a potential growth sector such as biotechnology there is simply no adequate network of analysts, brokers, media and investors. Everything is small and scattered.

The sad consequence is that companies that really think big are aiming to go public in the USA. The best and saddest example of this was BioNTech dur-

ing the coronavirus crisis. You can see for yourself on the following pages of this magazine that there are nevertheless several hundred listed biotechs in Europe. However, in a global comparison, the European stock market landscape is fragmented when it comes to biotechnology and therefore not very effective. There are not even any biotech indices – 20 years ago we were further ahead in this respect.

Of course, investors can also do good business here, but the development of the sector is hampered by the lack of a financial ‘ecosystem’. Furthermore, there is quite simply no common capital market in the European Union. The fact that national pride is playing less and less of a role in this is shown by the recent grab of

News from the floor

At the European Cancer Conference ESMO, it was announced that a mRNA vaccination against COVID-19 can have a strong positive effect on ongoing immunotherapy at the same time. The share price of BioNTech SE (Germany) catapulted by 50%, while that of competitor Moderna Inc. remained stuck in the trough. BioNTech had announced a whole battery of news from its oncology pipeline at ESMO, particularly with regard to bispecific antibodies, which may have also boosted the share price.

The Austrian-French company Valneva SE is developing new vaccines against very different infectious diseases almost like on an assembly line. But so far, even a marketing authorisation such as the world’s first chikungunya vaccine has not really paid off. There are still candidates for Lyme, Zika and Shigella in the pipeline, but the stock market continues to wait and see. Waiting for what?

Lonza AG, a large CDMO from Visp in Switzerland, shows a strong performance of the share price over the year to date.

the Italian bank Unicredit for the proud Commerzbank in Germany. Nothing was heard of an outcry from the Germans. Apparently, agility is now growing at the corporate level.

What I don’t understand is why there is no specialisation anywhere in Europe. In a country with a strong biotech industry, it should be possible to develop a financial centre that specialises in life sciences and thus has a unique selling point. It’s probably a case of the wellknown chicken and egg principle: as long as it doesn’t smell like money, nobody wants to make an advance payment. It is quicker and more easy to go to the United States. As a result, the stock exchanges in Europe are unfortunately hardly trading this future. L

From CHF 347 at the start of the year to CHF 587 and currently around CHF 550. The downturn from early summer 2023 to the end of the year was a blip that appears to have been ironed out several months ago. Whether the US governmental legislation of BIOSECURE and the exclusion of Chinese CDMOs for all US businesses already play a role in this is hard to say. But if so, the strong investments of Lonza in expanding production capacities (also in the US) may pay off much earlier than expected. L

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The unique and most complete list of share price developments of biotech companies listed in Europe – exclusively in European Biotechnology Magazine.

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Physiomics plc 0.01 1,320k 

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Plant Advanced Technologies SA 15.60 16,410k 

PMD Device Solutions AB 0.34 7,250k 

PolyPeptide Group SF 34.58 1,140,000k 

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Poxel SA 0.63 26,060k 

Predilife SA 4.88 17,940k 

Probi AB 24.10 271,180k 

ProQR Therapeutics BV 1.72 140,540k 

Prostatype Genomics AB 0.00 1,980k 

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Pure Biologics SA 5.07 18,470k 

Qiagen NV 41.35 9,060,000k 

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Quantum Genomics SAS 0.10 5,380k 

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Skinbiotherapeutics

Spexis AG 0.06 4,000k 

tions

Biopharma transformation: growing impact automation

SLAS EUROPE New AI tools and drug screening based on human cells and organoids promise a quantum leap in the success rate of drug development and in the processing of data from high-throughput analyses as well as a revolution in diagnostics. The SLAS Europe 2024 conference in Barcelona highlighted the latest advances set to transform the entire biopharma sector.

The languages spoken by the 1,200 or so visitors to the 5th SLAS Europe organised by the Society for Laboratory Automation and Screening (SLAS) in Barcelona could not have been more different. However, this was not because the specialists came from 40 countries, but because they are rooted in different research cultures: AI nerds, bioengineers and robotic specialists as well as big pharma managers speak and think differently to biotech founders, biologists and medical serial entrepreneurs.

Bridging the gap between these groups to accelerate the current data-driven transformation in the increasingly personalised drug development is the mission of the 19,000-strong SLAS – also in Europe. It was not for nothing that SLAS CEO Vicki Loise called on the 1,185 registered visitors and 109 exhibitors at the start of SLAS Europe to join SLAS CONNECTED – an online network akin to LinkedIn that speeds up the confidential exchange of information, lab challenges, technology advice, and potentially technology transfer. Being the home for the European life sciences community to connect and collaborate with each other and colleagues across the globe is a declared goal of SLAS, Head of Communications Jill Hronek told europeaN BiotechNology in the run-up to SLAS.

Impressive market potential

The 5th edition of SLAS Europe featured a striking number of product innovations and launches in the current growth markets of microfluidics (CGAR 9.4%, glob -

al turnover in 2023: US$16.94bn, organon-chip (CGAR: 11%; US$9.6bn, 10% of which in China), AI/bioinformatics (CGAR: 15.1%, US$2bn) and human cell, spheroid and organoid model (CGAR; 25,.2%; US$1.5bn).

New drug delivery devices

In view of the lasting high failure rate of drug candidates (30%) due to adverse effects, mostly on the heart, drug developers are striving to develop drug candidates with less systemic effect, i.e. more precise local drug delivery and preclinically more predictable efficacy in humans, in addition to drug candidates that are as personalised as possible, i.e. tailored to patient groups.

Right at the beginning of SLAS Europe, Catalonia’s flagship scientist Louis Serrano from the Centre of Genomic Regulation (CRB) in Barcelona presented a cutting-edge drug delivery approach. Using synthetic biology tools, Serrano engineered bacteria that show a natural tropism for the therapeutically targeted regions in such a way that they deliver their therapeutic cargo locally to the drug target. This helps to minimise adverse drug effects (ADEs) – at least in theory.

Serrano is trying to do this in practice via his spin-out Pulmobiotics SL, founded in 2020, which uses engineered Mycoplasma pneumonia bacteria, which normally cause respiratory tract infections in infants, as an attenuated cell wall-free chassis organism to deliver an optimised version of the anti­inflammatory cytokine IL-10 or immunosuppressive nanobod -

ies directly to the lung epithelium of patients with severe lung inflammation. Preclinical in vivo success has already been achieved with antibiotic-resistant Staphylococcus aureus and Pseudomonas aeruginosa biofilms. Serrano’s 2022 spinout Orikine SL has the mission to design optimised anti­inflammatory cytokines. The approach of using bacteria as a targeted drug delivery device is not limited to infectious diseases as demonstrated by the latest investment by Boehringer Ingelheim Venture Fund in August in the Chinese cancer specialist Shenzen Synthetica Pioneering Ltd, which exploits the natural cancer tropism of engineered Salmonella strains to trigger their multiplication exclusively in the tumour microenvironment and in metastases and to eliminate them preclinically in animal and organoid models for skin, kidney and colon cancer.

Automated safety prediction

The Viennese IMBA spin-off HeartBeat. Bio AG and the US automation specialist Molecular Devices in 2022 entered into a collaboration to develop a different approach to eliminate severe side effects of drug candidates on cardiac function during drug screening. The collab now resulted in a first product launch at SLAS Europe 2024. According to Florian Fuchs, CTO at HeartBeat.Bio, the company licensed a platform from IMBA in 2021 to differentiate induced human induced pluripotent stem cells (hiPSCs) into socalled cardiods that faithfully reproduce the physiology, electrical signalling and function of human heart chambers – un-

like human cardiomyocyte-based cell or spheroid models. A miniature model of the automated cell, spheroid and organoid culture platform Cellexpress.ai, presented for the first time at SLAS ­ Europe by Molecular Devices LLC, now enables the reproducible and intervention-free culture of cardiods for drug screening.

In Barcelona, ModDev‘s Senior Manager of Assay Development Oksana Sirenko presented the automated system that seeds, feeds and passages the cardiods that are in-line monitored by AIguided image analysis.

The co-development enables not only modelling of drug-induced cardiomyopathies but also genetic cardiomyopathies as well as myocardial infarction and fibrosis. Maja Hoi, Sales Commercial Product Expert and Account manager Drug Discovery – Nordics at Molecular Devices, told europeaN BiotechNology that the fully automated system integrates Molecular Device’s first AI­supported optical cell recognition system to assure reproducible quality with a capacity for up to 154 plates at a time for 24h/7d cell or spheroid culture, standardised (stem) cell culture, from maintenance, monitoring, incubation through imaging, analysis and data processing to deliver unbiased results.

The system launched at SLAS demonstrates the general trend towards using generative AI for routine tasks in diagnostics or automated imaging in order to merge data for analysis. At SLAS Europe, Elyor Kodirov from modular liquid handling robot specialist Opentrons Labworks Inc. showed that this also works without special expertise. Generative AI tools can also be made available for protocol generation in plain language. They demonstrated that OpentronsAI is able to interpret language commands and to generate Python-based protocols such as PCR setup and on-deck thermocycling.

Organ on a chip

Microfluidic organ-on-chip systems are on the rise since the EMA and – thereafter – the FDA have created a regulatory framework that allows completely animal-free preclinical safety assessments.

At SLAS Europe, Asli Akidil from Bostonbased organ-on-a-chip market leader Emulate Inc pointed to the economic impact of the largest study conducted so far with organ-on-a-chip technology. Using 870 of their human Liver-Chips with a focus on drug-induced liver injury (DILI) prediction, the company assessed drug safety, toxicology, and efficacy of 27 small molecule drugs on liver cells of three donors with a sensitivity of 87% and a specificity of 100%. According to Akidil, compared to historical data from animal models and 3D spheroid cultures of primary human hepatocytes, the Liver-Chip performed significantly better. If widely adopted, she suggested an industry-wide $3bn increase in productivity. “This transformative approach ensures a more robust “fail early, fail fast” strategy, thereby increasing the likelihood of clinical success for candidate

drugs“, she said. Just after the end of SLAS Europe, a German group led by Peter Loskill from NMI Reutlingen reported another revolution to the breast oncology field based on organoids: a patient-derived breast cancer organ-on-a-chip for the individualised safety assessment of CAR-T-cell therapy. The channels in this system are perfused with T- or CAR-T cells while the Chamber, which builds an endotheliumlike barrier, contains the patient-derived breast cancer organoids in an extracellular matrix mimicking the tumour microenvironment. At the end of the chamber the researchers can measure the released cytokines and thus predict the strength of the immune response to be expected upon CAR-T cell therapy to inform individualised dosing. By addition of macrophages to the chamber, Loskill’s group next wants to add efficacy testing to the organ­ on­a­

Maja Hoi, Sales Expert for Commercial Products and Account Manager Drug Discovery – Nordics at Molecular Devices, presents a miniature model of the Cellexpress.ai, which Molecular Devices had specially made for SLAS-Europe.

chip. Another microfluidic device for early toxicity assessment was presented by Marie Pierron from EFPL spin out Nagi Bioscience SA’s at SLAS Europe. The company’s Organism-on-a-Chip technology, however, uses C. elegans nematodes as an alternative high-content screening method that bridges the gap between in vitro data and vertebrate testing in early pipeline stages. Nagi’s robotic platform SydLab™ One can autonomously test 64 independent conditions on 1.000 organisms (nematodes) in one run. SydLab™ One combines advanced microfluidic technology, robotics, biology, and AI-based algorithms to automate the entire process of C. elegans culture, treatment administration, high-content imaging, data extraction, and phenotypic analysis. SydLab™ One is able to execute multiple toxicity and aging assays, including the possibility of using the exist-ing wide collection of reporter strains thanks to its fluorescent imaging capability. When blindly assessing the effects of 20 chemicals on development and reproduction, a balanced accuracy of 87.5% was reached (sensitivity: 75%, specificity: 100%) according to ECHA database. Thus the platform is qualified for rapid identification of toxic compounds

and their mechanism of toxicity, effectively bridging the gap between in vitro and in vivo assays thanks to automation. According to Pierron, the platform allows not only endpoint measurements’ collection, but also the monitoring of biological responses’ dynamics.

Best teams in town

As every year, SLAS Europe honoured products and automation start-ups with the most impact on the sector. In Barcelona, Swiss Seed Biosciences SA (Epalinges) and UK-based CryoLogyx Ltd (Coventry) out of 13 applicants and six finalists won the SLAS Europe New Product Award 2024 for the development with “transformational potential” such as Seed Biosciences’ Dispen3D and CyroLogyx’ product PlateReady. According to SLAS CEO Vicki Loise at the award ceremony, the market opportunity, potential impact on the automation sector, originality of the product and the proof of concept of the products, which have been on the market for no more than a year, were assessed.

Dispen3D is a novel impedance-based single-cell dispensing and cell seeding

system designed to handle 3D cell models that are sensitive to shear stress including spheroids, organoids and tumoroids with pressures below 0.2 psi, comparable to manual pipetting in high throughput. The DISPENCELL-derived new product assures monoclonality in emerging applications such as spheroidbased lead optimisation, personalised and regenerative medicine. Currently, the industry standard for handling cells, organoids and spheroids involves manual processes that are cumbersome and not very efficient in throughput, hardly reproducible and slow. On the other hand, more complex, specialised equipment may not be readily accessible and is highly expensive.

CryoLogyx PlateReady is set to revolutionise biobank analyses. It uses cryoprotectants branded Cryoshield to speed up research with cryopreserved cells significantly. Today, cells are stored frozen in suspension and must be cultured for days or weeks before they can be used in an experiment. As a result, a cell biologist has to devote significant time to cell preparation and the routine maintenance of cell lines rather than other valuable operations. CryoLogyx’s PlateReady™ featuring cryopreserved cell cultures is designed to simplify the freeze–thaw process while maintaining high cell viability and functionality post-thaw. Plate Ready incorporates cryopreserved cells using Cryoshield™ that enable very high cell recoveries and cryopreservation of cells in non-standard formats. This approach ensures the cryopreserved cells work just as well as freshly cultured ones in terms of survival, function and response to drugs within 24 hours postthaw. “Our PlateReady products enable a major shift in how cell biology and cellbased assays are approached in the lab, Dr Tom Congdon co-founder and CEO of CryoLogyx told europea N BiotechNology in Barcelona.

Finalists

Among the finalists were German LPKF AG with its product Arralyze that uses nanowells in glass to allow

Jeroen Verheyen, CEO of Semarion Ltd, receives the US$5,000 Ignite Award for the most innovative automation start-up in Barcelona.

placing thousands of cells in a controlled manner onto a footprint of a microscope slide platform that physically immobilises cells, which is particularly beneficial for single ­ cell screening applications in the company’s CellShepard device. Further finalists included Italian CellDynamics isrl with its PL8 platform that allows accurate biophysical-based presorting of organoid subpopulations between 50µm and 500µm in diameter in terms of mass density, size and weight, and integrates label­free quantification of organoid structure with automated liquid handling processes, i.e. measurement of immune cell invasion into tumouroids; German CYTENA GmbH with the second generation of its product UP.SIGHT, a single-cell dispensing and imaging system with >97% single-cell dispensing efficiency >99.99% probability of clonal derivation, which eliminates the need for multiple devices, saving time and resources; and Yokogawa with its product CellVoyager CQ3000, a high-content analysis system that captures high ­ definition 3D microscopic images of live cell cultures at high speed over long periods, with minimal damage to cells.

Most innovative companies

Furthermore, UK-based Semarion Ltd (Cambridge) was was honoured with the Ignite Award for most innovative start-up company represented in the Innovation AveNEW section of the SLAS Europe exhibition. Not without reason, as the rush to the British company‘s stand, that has already a bunch of partners like AstraZeneca, continued unabated after cofounders Jeroen Verheyen (CEO) and Tarun Vemulkar (CTO) presented their Cavendish Lab’s spin-off‘s technology in Barcelona. The Semacyte platform enables adherent growing cells to be mobilised, magnetically aligned and tracked using microcarriers without losing the morphology and function of the cells, so that they can be handled and optically analysed using standard liquid handling tools used in drug development. According to Verheyen at the presentation of the finalists in Barcelona, this enables a

significantly faster data generation with high-throughput screening tools. “At the same time, around 100 times few er cells are required for screenings and these can be stored frozen.

“Our SemaCyte ® cell assay microcar riers function as ultra-miniaturised, mo bile, barcoded wells that carry small colonies of adherent cells. They can be moved with liquid handling tools, are magnetically steerable and can be fro zen as assay-ready cells,” According to Semarion, the barcodes are viewed us ing bright­field microscopy and digitally deconvoluted using Semalyse software. Multiplexing and combining different barcoded adherent cell types in one well enables pooled cell screening, which ac celerates discovery campaigns and re duces the resource burden of cell testing. After receiving the award Jeroen stated: “Receiving the SLAS Ignite Award is a tremendous honour. Our technology ad dresses fundamental bottlenecks in rapid data generation, offering a 10x increase in throughput and a 6x cost reduction to drug discovery workflows. We cently launched the early adopter pro gramme for our SemaCyte microcarrier platform and are already working on ex citing projects with pharma companies and CROs. As we prepare for a full com mercial rollout in the UK, EU, and aim to enter the US market, this award boosts our visibility and credibility among po tential customers and investors. We are eager to continue our mission to accel erate drug discovery and deliver ground breaking solutions to the biopharma in dustry.”

Together with Semarion, four com panies with highly interesting platforms had qualified for the final of the Ignite Awards and presented their technologies at SLAS Europe:

› Paris-based Oria Bioscience SA, led by CEO Alexandre Santinho, pre sented a microfluidic platform for the screening of whole organelles, which allows the testing of targets such as the lyso-resident protein for the treatment of lysosomal storage diseases in their native environment with a throughput of up to 50,000

CDMO for customized plasmid & minicircle DNA

DNA for GMP production of viral vectors, RNA & CAR-T cells

compounds per week. The company, which has been financed with €800,000 to date, is building up its own pipeline in addition to the licensing business.

› The Swedish company Lucero Bio A/S, which was founded in March 2020 through a matching programme of Chalmers E-School/Chalmers Ventures and is led by CEO Christopher Jacklin, presented a chip-based automated platform for cultivating, sorting and screening 3D spheroids/organoids. This promises to make the largely manual work involved in using human organoid models for lead optimisation and metabolic profiling more reproducible, cost-effective and manageable.

› German University Ulm spin-off Sensific GmbH, combines microfluidics with image-based analysis, cell sorting and microscopy to enable assay-driven cell sorting. According to CEO Daniel Geiger, the flagship product ODIN adds high-speed and highthroughput real-time image processing capabilities to microscopes or customised setups. You can analyse your experiment label-free in brightfield or simultaneously with up to 3 additional fluorescence imaging channels. ODIN automatically measures particles, cells, droplets, algae, bacteria and droplets in microfluidic systems.

Its intelligent algorithms provide more than 30 parameters of the object, including size, circumference, aspect ratio or brightness, and display them in a user-friendly interface.

Overcoming limits

› Spanish Loop Diagnostics SL addresses the unmet need of early sepsis diagnosis. CEO and CSO Enrique Hernandez has invented a method to accurately diagnose sepsis 10 times faster and 3 times more effective than today’s culture-based methods that work with serum biomarkers or are based on pathogen detection through PCR. To do this, the company is using a new type of lateral flow assay for point­ of­ care testing called Septiloop with 90% sensitivity. In brief: Blood is incubated and then the immune response is measured. SeptiLoop can diagnose bacteraemia as early as one to three hours after infection and throughout all stages of sepsis, enabling emergency specialists an early detection and timely treatment initiation. The prognostic test could reduce sepsis mortality by 10-25%, said Hernández, and is to be commercialised in the UK from 2025, thereafter in the EU, said Hernández.

Researchers from South-Korean Incheon National University presented another

rapid microfluidics ­ based culture method to detect sepsis-causing bacteria. It also can accelerate antibiotic susceptibility testing compared to standard blood culture, which takes 1-5 days depending on the pathogen but is not as fast as Loop Diagnostics‘ approach. While rapid DNA-based PCR tests (1-4 h detection time for microbes) can identify antibiotic resistance genes they do not allow to assess sensitivity for a specific antibiotic in sepsis patients. Using wide ­field microscopy, with the DropVIST system, Sunghyun Hi and colleagues were able to detect living bacteria (100 per ml compared to 100.000 per ml required for other culture-based methods) after only 6 hours of incubation time, accelerating antibiotic susceptibility testing significantly. In pilot tests, the group used chlorinated medium to selectively kill bacteria from blood and identified five surviving bacterial strains by subsequent widefield imaging and dFinder software-based image analysis in a microfluidic device with up to 99.1% sensitivity. Limit of detection (LOD) was at 10CFU/ml. The system can theoretically analyse 3,103,377 droplets in real-time. Thus the platform is a potential tool for antibiotic susceptibility testing.

In addition to the presentations, the international exhibition offered the opportunity to view new prototypes and exchange ideas – one more reason to fly to SLAS Europe‘s big brother, the SLAS2025 International Conference & Exhibition (25-29 January 2025) in San Diego – at least 7,500 visitors are expected. Before its EU and US launch in August, ThermoFisher Scientific’s Dr Andreas Koch presented prototype for cartridge-based plasmid preparation, which carries out a fully automated plasmid preparation in 75 minutes at SLAS Europe. All that is needed is the preculture, which is placed in a disposable cartridge which includes all required reagents. The system will be on display in full size in San Diego. Alternatively, SLAS Europe 2025 will take place in Hamburg from 20-22 May 2025. L t.gabrielczyk@biocom.eu

Focus on long-term protection

MS RESEARCH  Multiple sclerosis is currently an incurable, chronic autoimmune disease. While it is possible to effectively manage the feared relapses with existing therapies, novel approaches aim to provide important protection against long-term impairments.

Multiple sclerosis (MS) is often referred to as the “disease of a thousand faces.” The symptoms and course of the disease vary greatly, which is attributed to the autoimmune nature of the condition. In MS, the immune system attacks and damages the myelin sheaths, which is the coating that protects the nerves in the central nervous system. Since these damages can occur in any region of the brain and spinal cord, the symptoms are contingent upon the particular areas of the nervous system that are affected.

It is estimated that approximately 2.9 million people worldwide suffer from MS, with about 200,000 new cases diagnosed every year. This highlights the urgent need for improved therapies. "The biggest worry for MS patients tends to be the continuous worsening of disability, which is exactly where new, innovative treatments should be focused," says Dr. Daniel Vitt, CEO of Immunic.

The biotechnology company Immunic, headquartered in New York with its research and development centre in Graefelfing near Munich, currently has three small molecule products in development. Two of these, vidofludimus calcium and IMU-856, are in clinical development stage. The company’s lead asset, vidofludimus calcium, is currently being tested in two Phase 3 trials and a Phase 2 trial in relapsing and progressive MS, respectively.

Vidofludimus calcium is a selective immune-modulator that activates the transcription factor nuclear receptor related 1 (Nurr1), which is associat-

founder team:

ed with direct neuroprotective effects. Additionally, vidofludimus calcium inhibits dihydroorotate dehydrogenase (DHODH), a key enzyme in the metabolism of overactive immune cells and virus-infected cells, which is linked to anti-inflammatory and antiviral effects.

Immunic has published the results of the Phase 2 EMPhASIS trial with vidofludimus calcium in relapsing-remitting MS in “Neurology ® Neuroimmunology & Neuroinflammation” and “Annals of Clinical and Translational Neurology.”

For Dr. Vitt, the next major milestone will be reached next year: “We expect the readout of top-line data from our Phase 2 CALLIPER trial, with the focus on progressive MS, in April 2025.”

Unmet Medical Need

MS not only presents with a thousand faces, but also varies in its course from the

moment of disease onset. Approximately 85% of patients are diagnosed with the relapsing form of the disease, which primarily affects young adults and is more common in women then in men. This form of MS alternates between periods of low or no disease activity and severe symptoms. Relapses can vary in length and intensity and cause different symptoms, including vision problems, numbness or difficulty walking. In the relapsefree phases, the described symptoms can fully or partially regress, but will lead to accumulated disability over the years.

A very common, often underestimated symptom of MS is chronic fatigue, which exceeds ordinary tiredness and imposes significant limitations for patients. At least two-thirds of MS patients suffer from fatigue, with one-third citing it as the most burdensome symptom, especially concerning daily business and social life. Although the exact cause of

Immunic´s

Dr Hella Kohlhof, Dr Daniel Vitt, Dr Andreas Mühler

MS-fatigue is not fully understood, it is thought to be linked to constant viral reactivation, similar to post-viral infection fatigue, with Epstein-Barr Virus (EBV) being a suspected culprit. A key developmental objective would be to use medications to break the cycle of persistent immune reactions triggered by EBV, which could help alleviate chronic fatigue.

About 15% of MS patients experience a progressive worsening of their health from the onset of the disease, but without the usual relapses. This form of MS is called primary progressive MS (PPMS). The condition is more prevalent in males and typically manifests at a later age, which contributes to its severity. Since there are currently only few treatment options and the progression is almost uncontrollable, PPMS patients often face a poorer prognosis and a have a higher risk of significant impairments over time.

Many MS patients initially diagnosed with relapsing MS transition into a phase of steady, irreversible worsening of their health. The physical or cognitive impairments of these patients steadily increase, and their quality of life diminishes, even though they no longer or rarely experience relapses.

Some of these patients suffer from active secondary progressive MS, where disease activity is observed, but relapses continue to occur, although less frequently. Their overall physical and cognitive condition, however, continues to worsen.

Additionally, there is another group of patients who transition to a non-active secondary progressive form of MS. In this stage, there are no signs of inflammatory activity, and patients no longer experience relapses, but their health continues to worsen steadily and relentlessly. For this group of patients, the medical need is particularly high due to the severe and escalating disability worsening, further exacerbated by the absence of available treatment options.

Focus on PIRA

Recent studies have shown that, for all forms of MS whether a patient is

in the early, relapsing or the late, progressive phase of the disease there is a gradual, often invisible worsening of physical and cognitive abilities over time, known as progression independent of relapse activity (PIRA). This is also observed in patients treated with existing medications. While relapseassociated worsening (RAW) describes impairments that remain after a relapse and do not fully recover, PIRA is characterised by a slow but continuous decline in neurological and physical functions, independent of MS relapses. This subtle disease progression is not only seen in primary and secondary progressive forms of MS but also in patients with relapsing MS, often at a very early stage of the disease. Even the relapsing patient population experiences an increase in impairment over the course of their disease, despite the fact that relapses can be largely prevented by existing drug interventions. New data confirms that relapse-independent worsening accounts for about 50% of disability in the relapsing phase of MS and 100% in the progressive phase of MS. Currently, there is no therapy available for this continuous disability worsening.

Nurr1 as a new, emerging target

A promising novel target for developing innovative therapies against neurodegenerative diseases, including Alzheimer's, Parkinson's and MS, is the transcription factor Nurr1, which is thought to have neuroprotective effects. Dr. Vitt explains: “In microglia, resident im -

mune cells in the brain, activation of Nurr1 leads to a reduction of pro-inflammatory cytokines and blocks the production of direct neurotoxic substances. Increased Nurr1 activity in neurons can directly promote neuronal survival and differentiation as well as improve neurotransmission.” Nurr1's role in controlling these processes makes it an exciting target protein for therapeutic interventions.

A look into Immunic's future

Immunic expects top-line data from its two Phase 3 ENSURE trials in relapsing MS in 2026. In addition to the primary endpoint 'time to first relapse,' these studies examine the impact on disability worsening. With relapsing MS alone, Immunic could address a market worth several billion USD.

For CEO Dr. Vitt, there is further potential in the area of progressive MS: "If the data from our Phase 2 CALLIPER trial, expected in April 2025, are convincing, Immunic could discuss accelerated approval with regulatory authorities. Since there is currently only a single drug approved for the subset of primary progressive MS, this could open up an additional significant market."

Contact us: Jessica Breu VP Investor Relations & Communications Lochhamer Schlag 21 82166 Graefelfing, Germany jessica.breu@imux.com

Picture:

© Immunic/Alessandra

Schellnegger

Aplidin® – a politically motivated scandal?

IP Marketing authorisation for Aplidin® had been refused because the Scientific Advisory Group of the EMA denied safety and efficacy. Interestingly, one of the experts developed a rival product and had, thus, a severe conflict-of-interest. This casts a bad light on the EMA and its rules governing conflict-of-interest.

› Dr Ute Kilger, Boehmer t & Boehmert, Germany

What happened? PharmaMar, a Spanish biotech company, filed lawsuit in October 2018 before the General Court (GC) of the EU against the EC, seeking annulment of the EC’s decision to refuse MA for Aplidin® PharmaMar claimed conflict­ ofinterest of a Swedish expert appointed by the EMA and claimed correct scientific evidence provided by PharmaMar. In 2020 the General Court of the EU upheld PharmaMar’s claim in full. Surprisingly, Estonia and Germany appealed the decision of the GC although the EC did initially not. Then, the Netherlands and the EC followed. In 2023, the Court of Justice of the EU annulled the GC’s decision and referred the case back to the GC. In 2024, finally Adiplin® must be re-evaluated by the EMA. What a nightmare. What an odyssey. The damages are irreparable. First of all, for the patients who could have benefitted from Adiplin® over all these years. But also, for the PharmaMar who had invested enormously for many years into the development of Adiplin®. Taking away more than seven years of return-of-investment (ROI) makes it quite likely that PharmaMar suffers irreparable losses. When and if the market authorization will be granted by the EMA the window for reasonable ROI’s may be closed as competitive products may be meanwhile on or close to the market and/or relevant patents may be expired. More than seven years of fighting in courts instead of market entry with a promising drug is a disaster that some biotech companies wouldn’t even survive even if and when the courts will rule in fa-

vour of the innovator after all these years. So, the question arises who will be compensating these damages? And how could these damages be calculated at all? The damages are in particular hard to estimate in this case as PharmaMar furthermore claims that the refusal of market authorization also hindered Adiplin®’s development as an antiviral drug against Covid-19 since the MA refusal required a development from scratch. Thus, albeit prestigious journal “Science” published in 2022 that Adiplin® is one of the drugs with the most potential against Covid-19 the fromscratch-development was too slow and thus, too late. Being too late on the market quite often means that that development is no longer worthwhile at all. Another important question is how EMA will

ensure the objective impartiality of the experts involved in the approval process in the future? Experts and key opinion leaders are quite often associated with biotech and pharma companies. There is per so nothing wrong with this. The identification of unmet medical needs and the development of medicaments requires extensive consultation by leading experts in the field that are close to the patients. It seems, however, that EMA must ensure transparency about potential conflict­ ofinterests of experts and must adhere to strict guidelines that prevent such conflictof -interests in the future. Furthermore, looking at the number of oncology drugs submitted for approval in the last fifteen years it seems that the numbers are decreasing in Europe while the numbers are stable on a high level in the USA and are considerably increasing in China. So, what is happening with the EMA? Some voices are concerned that the requirements in Europe are too strict in comparison to other agencies as e.g. FDA, Swiss, Australian or Canadian agencies or that there is too much bureaucracy while on the other side so-called EU transparency guidelines require the companies to disclose their clinical data. Companies may think twice whether to approve their drugs in Europe. At least it doesn’t seem to be the first place to be with a new oncological drug. Last not least, the role of Germany, Netherlands, Sweden, Estonia in this case remains mysterious and it seems the political will leads to too many obstacles for innovative products in Europe. L

Dr Ute Kilger, Partner, Boehmert & Boehmert

Update of ongoing clinical trials NEWS

MPOX

Tailwind for tau-ists

Lausanne-headquartered AC Immune SA and Janssen Pharmaceuticals Inc/J&J have been grantes a FDA Fast Track Designation for its phospho-tau-targeting Alzheimer’s vaccine ACI-35.030/JNJ-2056. The ReTain Phase IIb proof of concept study, which may now become a pivotal trial through the FDA designation, has just started enrolment of 500 symptom-free patients and is expected to provide results in 2029. The cognitively normal, Tau-positive subjects, who will be randomised in a 1:1 ratio to a single dose level of JNJ-2056 or placebo and administered as intramuscular injections for a maximum of four years. The primary endpoint is cognitive decline as assessed by the PACC-5 score. Secondary efficacy endpointa include the assessment of the effect of JNJ-2056 on the propagation and/or accumulation of Tau pathology compared with placebo.

Unresectable cancer

Data from a Phase Ia dose escalation study with 20 pretreated cancer patients announced at the end of August showed that monotherapy with the salt-inducible kinase 3 inhibitor OMX-0407 from Munich-based iOmx Therapeutics AG in the dose range of 5 to 80 mg was safe and well tolerated. In addition, one patient showed a complete response. In the subsequent Phase Ib trial at sites in Madrid and Brussels, the company intends to investigate the effect of the epigenetic inhibitor of NF-KB signalling and death receptor inducer in up to 86 patients with previously treated kidney cancer or angiosarcoma.

ˆ

Following the global mpox warning from the WHO, Danish Bavarian Nordic A/S has applied for EU label extension of its smallpox and mpox vaccine Imvanex to include adolescents 12 to 17 years of age. Interim data from NIAID study enrolling 315 adolescents and 211 adults that showed non-inferiority of the immune responses as well as a similar safety profile in both study populations support the label extension application at the EMA. The EMA MAA follows an US FDA Emergency Use Authorisation for use in adolescents during the 2022 global mpox outbreak. Bavarian Nordic said it expects an EMA recommendation by Q4/2024.

SYNOVIAL SARCOMA

ˆ

The US Food & Drug Administration has conditionally approved the world’s first TCR-T cell-based therapy to treat a solid tumour: In an open-label Phase IIa study, British Adaptimmune plc’s afamitresgene autoleucel (ADP-A2M4, Tecelra) showed a response rate of 39% in MAGE-A4-positive patients with unrectable synovial sarcoma.

HEARING LOSS

ˆ

French Sensorion SA has reported new efficacy endpoints data from SENS ­ 401 in a Phase II study for the preservation of residual hearing loss. Following cochlear implantation, SENS-401 (arazasetron), a 5HT3R antagonist that blocks the CalN pathway, reduced sudden hearing loss as measured by the change of hearing threshold from baseline to the end of the treatment period in the implanted ear at several frequencies. Study entry criteria required patients to have a pure tone audiometry (PTA) threshold of 80 dB or better at 500 Hz, defined as indicating a minimal level of residual hearing. Six weeks post cochlear implantation, the mean hearing loss at 500 Hz was 19 dB for patients treated with SENS-401 (N=16) compared to 32 dB for the control group (N=8). A clinically meaningful difference was also observed for the mean of 250, 500 and 750 Hz with 16 dB in the SENS-

401-treated group compared to 31 dB in the control group. These results remained until the last study visit fourteen weeks after cochlear implantation. Back in March, Sensorion reported that it had successfully met the primary endpoint of the SENS401 study for the preservation of residual hearing in adult patients following cochlear implantation. Full final data later will be presented in Q3 2024.

OBESITY ˆ

Data from a Phase I trial published by Hoffmann-La Roche Ltd. in mid-July showed surprisingly clearly that the drug candidate CT-996 (RG6652), which was transferred to the Basel-based company following the US$2.7bn acquisition of the Australian company Carmot Therapeutics Ltd, is not only safe but also appears to be effective. Compared to patients in the placebo group, CT-996 resulted in a median weight loss of 6.1% after only 28 days in 118 obese or diabetic patients. The median weight loss after 104 weeks of weekly injections of semaglutide, the approved competitor product from Novo Nordisk, was -12.6%, that of Eli Lilly’s GLP1/GIP receptor agonist tirzepatide 21.1% after 36 weeks of injections. However, the weight loss curve is not linear nor the Roche study powered to demonstrate efficacy. In the following 52 weeks, the patients lost only 6.7% of their weight with continued administration. Further combination products in the late obesity pipeline are being followed with interest, such as Novos Cagrisema (GLP1/Amylin-RA), and Lilly’s Retatruide GLP1/GIP/GCC­ RA), whose first efficacy data are due next year.

NSCL/CRC ˆ Good or bad news for BioNTech SE? The open-label Phase I dosing study of the BNT326/YL202, an antibody drug conjugate (ADC) developed on MediLink Therapeutics (Suzhou) Co., Ltd ’s TMALIN ADC platform will continue. The FDA suspended the study in midJune due to three ADC-related out of 14

deaths. Together with the lift of the study suspension, the US regulatory authority defined a safety window: the drug concentration of BNT326/YL202 must not exceed 3mg/kg body weight. The ADC, which is directed against the human epidermal growth factor receptor 3 (HER3), is being developed by Chinese MediLink, while BioNTech SE aquired a licence option for the Asian mainland market in October 2023. Study sponsor MediLink had previously observed a dose-dependent trend in treatment-related neutropenia and mucositis for BNT326/ YL202, which increase the risk of developing serious infections. In view of three (2 in the 4 mg/kg, one in the 5.5 mg/kg group) treatment-related deaths in the single ascending dose-escalation trial, the FDA stopped the study in midJune due to potential dose-limiting toxicity. Data presented at the ASCO meeting 2024 showed a response rate of 54 patients (91%) enrolled by February 2024 and one complete response. In presentations, MediLink tells that the ADC constructed from an anti-HER3 antibody, a protease-sensitive linker and a camptothecin topoisomerase I blocker is cleaved extracellularly in the tumour microenvironment and thus the payload concentration is higher there because its release is independent from the uptake into lysosomes. Experts told e uropea N B iotech N ology that MediLink’s ADC

show differences concerning the payload strucure and the linker to Daiichi Sankyo‘s Phase III Her3-ADC patritumab deruxtecan. They said that it is not secure if the ADC will show efficacy in the given dose. If the toxicity is associated to the linker, the entire pipeline of the Chinese company would be at risk.

INFLUENZA/COVID-19 ˆ

Mixed Phase III data from Pfizer Inc and BioNTech SE put the brakes on their combined COVID flu vaccine candidate. Although it triggered an immune response against some of the virus species, it did not induce an immune response against influenza B. In contrast, competitor Moderna had presented an mRNA-based vaccine against COVID ­19 and three flu strains that triggered an immune response. The same appears to be the case with the combination mRNA vaccine against influenza/ COVID-19 developed jointly by Curevac and GlaxoSmithKline. In August, GSK secured the sole commercialisation rights with a new licensing agreement.

OVARIAN CANCER/NSCLC ˆ

ADC maker Tubulis GmbH has started dosing in a Phase I/IIa trial investigating its NaPi2b-targeting exatecan ADC Tub-040 in ovarian cancer and lung adenocarcinoma (NSCLC) patients. The NAPISTAR 1-01 (NCT06303505) multi-

centre study aims to investigate the safety, tolerability, pharmacokinetics, and efficacy of Tub ­ 040 as a monotherapy. Tub-040 links a humanised, Fc-silenced IgG1 antibody targeting NaPi2b via cysteine-bonds to eight exatecan-payloads, a topoisomerase-1 inhibitor.

BASAL CELL CARCINOMA ˆ Norway’s Lytix Biopharma A/S announced in mid-August that its Nasdaqlisted licensing partner Verrica Pharmaceuticals Inc reported positive top-line Phase II results from a study in patients with basal cell carcinoma (BCC) who received LTX-315. BCC is a skin cancer with a projected global market size of US$ 11.5bn in 2028 (CAGR 7.9%) and 3.6 million new cases in the US, annually. LTX-315 showed an 86% overall reduction of tumour size, 51% complete clearance rate of basal cell carcinoma and 71% average reduction in tumour size of patients with residual carcinoma. The preliminary efficacy results were retrieved from 93 patients and included a highly favourable safety profile with no severe adverse events. LTX­315 is a firstin-class, 9-mer membranolytic peptide that has shown potent immunomodulatory properties in preclinical models. By targeting the mitochondria, LTX-315 triggers the release of chemokines, danger signals and a broad repertoire of tumour antigens L

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Manual freezers have long been the backbone of ULT storage. While they will continue to have a crucial role in biobanking and drug development, relying on large numbers of manual freezers in “freezer farms” can have drawbacks – from labor-intensive management and inefficient space use to high running costs and environmental impact. And these limitations only become more apparent as storage needs grow.

ULT storage constraints

Freezer farms quickly consume available space, limiting the ability to store additional samples and drug products, which can ultimately hinder the expansion of research and development efforts. Moreover, sample retrieval can be slow and cumbersome, especially if freezers are spread out across a facility, which can lead to delays and increase project timelines. Sustainability concerns further complicate the picture. Many manual freezers in these farms

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IZB start-up

About the company

AATec Medical GmbH is developing innovative therapeutic solutions for respiratory inflammatory diseases, airway infections, and rare conditions. The company’s proprietary product platform is based on a novel recombinant version of alpha-1 antitrypsin (AAT) for inhalation, a human serine protease inhibitor with broadband anti-inflammatory, immunomodulatory and anti-infective properties. AATec Medical aims to unlock the full therapeutic potential of AAT for diseases with high medical need and limited or no available therapies. With proof-of-princi-

The IZB offers biotechnology start-ups a great home. The equipment and support provided by the IZB help build the company.

ple successfully demonstrated in various preclinical studies, AATec Medical is advancing toward a proof-of-concept clinical trial with the lead product candidate, ATL-105, in non-cystic fibrosis bronchiectasis (NCFB), a progressive lung condition affecting millions of patients globally. ATL105 uses cutting-edge nebulization technology for inhalation, enabling the delivery of the drug directly to the airways for optimal local effects.

What drives you?

Inflammatory respiratory diseases are globally on the rise due to lifestyle, en -

FOUNDED: 2022

NUMBER OF EMPLOYEES AT THE IZB: 5

BUSINESS SEGMENT:

Product Development

Protein biopharmaceuticals for inhalation

vironmental factors, climate change, and global migration. Conditions like COPD, bronchiectasis, asthma, acute respiratory distress syndrome (ARDS) or respiratory infections are creating significant challenges for healthcare systems worldwide. AATec Medical addresses the increasing demand for effective treatments for these diseases. The company has the aim to provide accessible and affordable therapeutics to meet these challenges, contributing to health and well-being globally.

CONTACT

AATec Medical GmbH Am Klopferspitz 19 82152 Planegg-Martinsried info@aatec-medical.com www.aatec-medical.com

Dr Rüdiger Jankowsky, CEO

Fördergesellschaft IZB mbH

Am Klopferspitz 19 82152 Planegg/Martinsried

Tel. + 49 (0)89.55 279 48-0

Fax + 49 (0)89.55 279 48-29 info@izb-online.de www.izb-online.de

YOU HAVE THE IDEA— WE HAVE THE LOCATION

 Site: 26,000 m2, S1 laboratories

 Real estate and facility management on site

 Faculty Club and conference rooms for up to 100 people

 Kindergarden (Bio Kids)

 Hotel CAMPUS AT HOME

 Restaurants SEVEN AND MORE, THE BOWL

 On the Martinsried Campus: over 40 start-ups in the IZB, two Max Planck Institutes, LMU Faculties and Institutes

 Clinical Center Grosshadern

WHERE FUTURE BECOMES REALITY

Small interfering RNA molecules binding to mRNA – a demonstration of the epigenetic mechanism of RNA interference in gene silencing.

A ‘RNAissance’ in drug development

NEW MODALITIES It took 20 years for RNA-based therapies to really catch investor attention. Initial action came in 2016 with Biogen’s US$1.7bn SMA antisense nucleotide blockbuster Spinraza and –two years later – the first approval of an siRNA drug (Onpattro). The pandemic boosted M&A activity dramatically, and pipelines began shifting from orphan to common diseases. It’s a revolution.

Unlike other biologics, RNA drugs can be produced fast, screened automatically and easily scaled up.

RNA medicines have been en vogue since mRNA vaccines during the COVID-19 pandemic showed that they are safe and effective, can be scaled easily, and be developed in record time. Between 2020 and 2021, the class of preventive mRNA vaccines alone triggered an 11-fold increase in M&A activity.

Together with four further non-proteincoding RNA drug classes, mRNA vaccines against cancer or infections can be easily adapted to tap into a target universe that appears ‘undruggable’ for other biologics. That’s the reason why Big Pharma companies such as Eli Lilly, Roche, Boehringer Ingelheim and Novo Nordisk are currently pumping billions into innovative SMEs that develop RNA drugs like:

› antisense oligonucleotides (ASOs), which block translation

› drugs that regulate the expression of proteins by RNA interference (RNAi)

› RNA aptamers that bind proteins and other targets, and finally

› RNA editing drugs such as CRISPR- and ADAR-based RNA editors.

“RNA therapeutics have gone from being a promising concept to one of the most exciting frontiers in healthcare and pharmaceuticals,” explains Mikael Dolsten, outgoing CSO and President at Pfizer Research & Development. The momentum in the field is being fueled

by huge advances in genetic engineering and delivery systems, which are allowing companies to take on more ambitious development efforts at an unprecedented pace.

The potential of all RNA medicines lies primarily in the fact that the approach differs from any previous drug strategy. Un-

MIKAEL DOLSTEN Pfizer’s outgoing CSO and President of Pfizer Research & Development

? What makes RNA therapeutics so interesting for drug developers?

!

”RNA platforms are unlike those that have come before, as RNAencoding novel proteins can be quickly made at clinical scale and quality with few small modifications in automated, modular manufacturing units.”

like small molecules or biologics, which generally bind to active sites on proteins in order to therapeutically modulate their function, RNA-based therapeutics can target any site in the genome – including the non-protein-coding regulatory areas that are involved in many orphan and common diseases. And they can do so by simply changing the nucleotide sequence of the RNA involved – without having to change the manufacturing process, as is the case with biologics. Coding for proteins makes up only 1.5% of the human genome, and at most 14% of the proteins it generates have binding sites that are accessible to conventional drugs. RNA drugs can modulate any target encoded in the human genome, while AI can automatically screen it to exclude unsuitable hits.

Reshaping healthcare

Although they have clear benefits, RNAbased therapeutics also face several challenges. These include delivery issues (being addressed by providers like Acuitas Therapeutics, Capstan Therapeutics, Leon nanodrugs or Etherna), as well as off-target effects and immunogenicity issues. The young RNA therapeutics market stood at US$13.8bn last year. Companies such as Danaher, Thermo Fisher Scientific, Merck KGaA, LGC or Agilent

Modern Art of Making Antibodies

Fig. 1: RNA therapy pipelines: of the 1,150 RNA therapies being worked on as of Q2/2024, mRNA and RNAi continued to be the most common modalities.

Technologies that synthesise RNA oligonucleotides had revenues of US$8.8bn in 2023. According to forecasts by Markets&Markets, sales are expected to grow by 17.5% annually to US$19.7bn. In addition, there are the RNA modifications required due to the rapid enzymatic degradation of the molecule and its inherent toxicity, as well as the LNP delivery market, which Fortune Business Insights estimates at US$0.9bn. It’s expected to grow by 13.9% annually until 2032.

Improving the odds

According to Dolsten, there is already proof that RNA drugs can help reduce clinical failure – and thus significant -

› HAYA Therapeutics SA, Eli Lilly cardiometabolic diseases, i.e. obesity

› Genetic Leap, Eli Lilly & Company, AI-guided RNA drug discovery

› Bayer AG, NextRNA Therapeutics Inc Oncology

› Roche AG, Ascidian Therapeutics Neurology

› BioNTech SE, Triastek, Inc. drug delivery in oncology/infection

› Novo Nordisk, Cardior Pharma heart failure

› Orna Therapeutics, ReNAgade Therapeutics Inc, drug delivery

› GlaxoSmithKline, Curevac NV influenza vaccine

› Novartis AG, Argo Biopharmaceuticals Co.Ltd, cardiovascular diseases

ly improve productivity in pharmaceutical R&D. “There is already an industry precedent in RNA with Alynlam Pharmaceuticals Inc and their RNAi platform,” he explains. “By developing a repertoire of delivery vectors and referencing the data packets in each subsequent programme, Alynlam Pharmaceuticals was able to increase R&D capital efficiency and clinical success rate, resulting in a preclinical-to-Phase I transition rate of 62%... much higher than the industry standard of 10.3%.”

According to global advanced analytics and CRO leader IQVIA, the three most mature RNA platforms (siRNAs, ASOs and mRNAs) make up about 80% of RNA therapeutics pipelines (see Figs. 1 & 3).

Tab. 1: Most relevant RNA deals in H1/2024

IQVIA’s analysts also found that – in contrast to the currently 30 approved RNA drugs – only 19% of pipeline drugs have orphan drug designation. That indicates that larger patient populations might benefit from RNA therapeutics in the future. Pipeline analyses by Citeline, a company commissioned by the American Society for Gene & Cell Therapy, came to somewhat different conclusions (see Fig. 5). But there’s little doubt that more and more RNA therapies are targeting common diseases, not just rare ones.

Cardiometabolic promise

Figures from IQVIA suggest that cardiometabolic disorders such as diabetes, obesity and its cardiovascular/neurological co-morbidities account for nearly a third of the entire pipeline, with smallinterfering RNA (siRNA) as the leading class of RNA medicines in this therapeutic area. For instance, Eli Lilly’s Phase I siRNA candidate lepodisiran reduced lipoprotein(a) levels by up to 94% for nearly a year upon administration of a single dose. LP(a) is a well-recognised risk-factor for cardiovascular disease. After siRNAs, the next largest category is antisense oligonucleotides (ASOs) at 28% of the cardiometabolic RNA pipeline. While ASOs were the first RNA treatments to be marketed, innovation is certainly not slow -

Fig. 2: RNA drug classes: modified LNP-delivered mRNAs, currently with uses in cancer and infection vaccines, are the only protein-expressing RNA drug class. Antisense nucleotides (ASOs) block translation through hybridisation of complementary target RNA. miRNAs, siRNAs and others block or activate target RNAs. Aptamers form 3-D structures that bind to target protein pockets. RNA editors (not shown) modify single oligonucleotides in a target RNA, thereby modulating its activity.

ing down. Ligand-conjugated antisense (LICA) oligo nucleotides combine an ASO with a ligand, resulting in a more highly specific product and more precise delivery to target areas in the body. AstraZeneca/Ionis Pharmaceuticals Phase III LICA oligonucleotide eplon tersen is in the FDA pre-registration phase for trans thyretin-mediated amyloid cardiomyopathy. It is worth noting that almost a quarter of candidates in the cardiometabolic space are for hepatic diseases.

The liver is an appealing organ to target with RNA therapies, as medicine delivery is much easier than in other organs due to the liver’s function within the body and its high metabolism.

Recent deals and acquisitions prove that Big Pharma sees future value creation through RNA drugs outside the bounds of the rare diseases space. In March, Denmark’s Novo-Nordisk initiated the purchase of German RNA specialist Cardior Pharmaceuticals for €1.025bn. Cardior’s

RNA Oligonucleotide Therapeutics

product classification, environmental risk assessment and regulatory guidance for marketing applications

Phase II lead candidate CDR132L targets microRNA-132, which is responsible for remodelling the heart wall and is overexpressed in patients with heart failure.

Over 10 years’ experience with clinical trial and market authorization applications

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There have also recently been two transactions relating to RNA programmes aimed at permanent weight reduction in patients with obesity. In the first, Italybased Resalis Therapeutics Srl received €10m in Series A funding to advance its Phase I obesity programme RES-010 into Phase II. RES-010 is a non-coding, locked anti-miRNA22 ASO. In the conversion of white adipocytes to brown adipo cytes, deletion of miRNA-22 limited the expansion of the white fat layer and reduced the accumulation of fat mass induced by a high-fat diet in different disease models, with a more durable effect than incretin agonists. In the second deal in midSeptember, Swiss HAYA Therapeutics SA inked a US$1bn biobuck agreement with Eli Lilly to discover tissue-, disease- and cell­specific long non­ coding RNA (lncRNA) targets that recruit RNA-binding proteins (RBPs) to drive pathological processes and develop RNA-targeting therapies that reprogramme those disease-driving cell states in obesity and related metabolic conditions.

Fighting cancer

Oncology is the second most popular area for RNA therapeutics. It’s currently dominated by mRNA vaccines (32%

of pipelines) followed by ASOs (29%). The mRNA vaccines are often being trialled alongside a checkpoint inhibitor, such as Moderna’s mRNA-4157/V940, which when combined with pembrolizumab showed a 44% improvement in recurrence-free survival in melanoma patients. In addition to linear mRNAs, which require high doses, more stable viral-delivered self-amplifying RNA (saRNA) and hard-to-produce supercoiled circular RNA (circRNA) candidates have recently been added to clinical pipelines. One innovation in the mRNA cancer vaccine market – dominated by BioNTech and Moderna – is the attempt to deliver 3D-printed mRNA tablets. In July, China’s Triastek Inc and BioNTech SE entered into a US$1.2bn biobucks partnership to pursue the topic. CDMOs such as Wacker AG, which opened a €100m production facility for 200 million doses of mRNA vaccines per year in July, and Lonza AG, which entered into an alliance with Oxford Nanopore for RNA analysis, also see growth potential.

The third-largest therapy area for RNA therapies is CNS disorders. According to IQVIA analyses, ASOs dominate that area, representing 67% of the pipeline.

Neurological opportunities

The indications within CNS range from Alzheimer’s/dementia to muscular dystrophy to ultra-rare conditions such as An-

Fig. 3: Market-approved RNA therapeutics by class as of December 2023. In H1/2024, Citeline reported additional approvals for Rytelo (ASO, Geron) and Resvia (mRNA RSV vaccine, Moderna). In total, 30 products have been approved so far.

4: Distribution of preclinical and clinical drug candidates in the different classes of RNA-based drugs.

base, over the last five years (2019 ­2023), 59 strategic alliance deals were observed in Australia, China, Japan and South Korea. Among these, 28 were made for oligonucleotides, 20 for mRNA vaccines, and 11 for other molecule types (aptamers and gene therapy). Oligonucleotides accounted for 47.4% of all deals, mRNA vaccines 33.8%, and other molecule types contributed 18.6%.

China’s next move?

The Far East is revving up

Against this backdrop, biopharmaceutical companies based in the major APAC countries (Australia, China, Japan, and South Korea) entered into significant partnerships in the last five years to develop RNA-based therapies. In China alone, 40 developers are currently strategically expanding RNA pipelines, as was previously the case in the area of therapeutic antibody-drug conjugates (ADC). China has already overtaken the US in terms of clinical pipelines (see p. 46), one reason why the latter is currently planning disruptive legislation to suppress cooperation with Chinese companies (see p. 3). Among all the strategic alliance deals focused on RNA-based therapies, the majority of the deals are focused on oligonucleotides and mRNA vaccines, says GlobalData.

Back in 2021, China-based Hansoh Pharmaceutical Group Co Ltd and Silence Therapeutics plc inked a US$1.3bn deal under which the Brits will develop siRNA programmes against three undisclosed targets. In January, Argo Biopharma signed a US$4.165bn biobucks collabo -

5: List of indications addressed by RNA-based drugs gelman syndrome and Dravet syndrome. The pipeline for CNS disorders is heavily clustered around Phase II trials, with 64% of candidates in that stage of development. The latest approved product in the pipeline is Qalsody (tofersen) developed by Ionis and Biogen. It’s the first ASO approved to treat an ultra-rare inherited form of amyotrophic lateral sclerosis (ALS) in adults who carry a mutation in the SOD1 gene. According to GlobalData, a leading data and analytics company, oligonucleotides and mRNA vaccines dominate in strategic alliances for RNA-therapies in major Asia-Pacific countries (APACs).

ration with Novartis AG to develop multiple cardiovascular siRNA drugs. Furthermore, companies like Junshi Biosciences (siRNA), Synerk (siRNA), RNAi specialists Sanegene Bio, Ribo Life Science, ExoRNA Bio, Rona Therapeutics, Ribo Life Science, CSPC Pharmaceutical Group (mRNA), and Chia Tai Tianqing Pharmaceutical Group (siRNA) have clinical-stage medicines in pipelines.

“In the future, mRNA platforms will likely advance as a tool for more complex treatments, where the therapeutic outcome is not limited to expressing a missing protein but instead initiates a cascade of biological activities with the translated protein,” predicts Prof. Dr Erwei Song from Guangdong-Hong Kong Joint Laboratories for RNA Medicine. He may be right. L t.gabrielczyk@biocom.eu

According to the company’s Pharmaceutical Intelligence Center Deals Data-

Fig.

Fig.

CDMOs & CROs

Biosecure Act impacting CRO and CDMO business

CONTRACT RESEARCH & BIOMANUFACTURING

A draft US Biosecure Act being passed by the US House of Representatives and discussed by the US Senate could prohibit US biotech developers from collaborating with Chinese CROs, CDMOs and drug developers from 2032 by excluding the partners from federal contracts. US companies are unsettled, according to a survey. But how will the impending ban affect innovation, licences and the European sector in short term?

European biotechs often envy their US competitors for their wholehearted support of biotechnology, which is peppered with government statements. However, after China has been increasingly attacking the USA's leading role in future biopharmaceutical markets such as antibody drug conjugates (ADC) since 2010, the US House of Representatives and the US Senate are set to pass a bill – the US Biosecure Act – to push back China's in-

fluence, also for political reasons. Following the same model that was used to target Chinese telecommunications companies in the late 2010s, the Act would prohibit federal “executive agencies” from contracting with or extending loans or grants to any company that has certain commercial arrangements with a “biotechnology company of concern,” which includes a death list of specific Chinese biotechnology companies and a

procedure for identifying additional companies in the future.

Discussions in Senate were not expected to progress until after the US presidential elections in November 2024 at the earliest. However, companies such as the BGI Group, MGI, Complete Genomics, WuXi Apptec, WuXi Bio and their subsidiaries are already on the presumably growing death list, whereby, according to the news agency Reuters, the CDMO Wuxi alone has contributed to the development of a quarter of the drugs on the US market. As the leading ADC CDMO Wuxi generates 65% of its turnover in the USA. After the US biotech association BIO signalled support for the law this March, Wuxi withdrew from the US biotech industry interest group.

“Our adversaries abroad have stated that they intend to become the biotechnology centre of excellence in the world,” BIO CEO John Crowley previously stated. “America and our allies cannot let this happen. Securing and expanding our pre-eminence in bioproduction will be a key component of a multi-pronged approach to securing and advancing this

imperative in biotechnology.”

Race over leadership

A strategy paper published in 2023 by the think tank SCSP, founded by former Google CEO Eric Schmidt in 2021, fits in with this: its "National Action Plan for U.S. Leadership in Biotechnology" pro-

mRNA production & delivery

In-vitro models

Biomarker analysis

Protein production & purification

poses a biomanufacturing alliance of democratic states to counter China's state-subsidised biotech offensive.

As a reminder: in 2023, China accounted for 50% of the top 10 ADC drug developers, i.e. the one with the largest development pipeline. According to UBS Investment Bank, 42% of the ADC development pipeline, which Chinese authors in a first global ADC database (ADCdb) put at 6,572 projects, 346 of which were clinical, at the end of 2023 (doi:

10.1093/nar/gkad831), were Chinese. In addition, Chinese ADC developers are attracting more and more licensing income – US$19.79bn last year alone, excluding two companies that did not disclose financial details (see Table 1) – out of more than US$41bn raised by Chinese biotechs in 2023, according to China's largest CRO Tigermed (Hangzhou). The study situation in the field of cell and gene therapy and the rapidly growing market for CGT CDMOs (according

to data from RWD; 2022: US$2.048bn, 2028: US$4.13bn) and CROs (according to data from Markets&Markets, 2024: US$82bn; 2029: US$129.8bn) seem currently to go down, according to the reported deal activity.

Cell and gene therapies

DealForma identified a peak of US8.2bn invested in CGT developers in 2021, Nature reported, while in H1/2024 only

Fig. 2: Potential impact of the US Biosecure Act on current operations

Fig. 1: Perceived impact of the US Biosecure Act on partnering with Chinese companies

Top7 (*biologic) blockbuster drugs by 2030, according to Evaluate's World Pharma Report

US$0.5bn were invested. In contrast Evaluate’s "World Preview Report 2024" predicts a pharma growth boost in areas such as ADCs, multi-specific antibodies, RNA-based therapies, gene & cell therapies, and radiopharmaceuticals by 2030.

For 2023, figures of the Alliance for Regenerative Medicine (ARM) demonstrate that the USA (1101) is still ahead of China (765) and Europe (430) in terms of the number of CGT clinical trials and global licence deals of US$ 11.7 bn. In gene therapy trials for rare diseases, which fuels the business of most CROs and CDMOs, however, China (492) is already ahead of the US (478) and Europe

(199). "If the US Biosecure Act goes into effect, it will impact any company that wants to win US government contracts, like most global pharmaceutical companies, and prevent them from partnering with companies of concern, including certain Chinese CROs/CDMOs," L.E.K. Consulting said in June 2024 upon publishing a survey with a tremendous 66% response rate that examined the global impact of the Act on the biopharma industry. Respondents included investors (13%), biopharma executives, primarily business developers (54%, including 52%) from the US, but also from China (17%), CROs (4%) and CDMOs (6%).

According to the survey results and Jeremy Levin (see p. 3) – one of the 25 most influential CEOs in the US biotech sector –, the Act has the potential "to transform the entire industry". While about 50% of US-based biopharma developers said they have lost confidence in long-term relationships with Chinese CDMOs and 30% with Chinese CROs, about a third of respondents said they will maintain their partnerships for at least the next three years. While 26% of life sciences companies surveyed said they plan to move away from their current Chinese partners, 68% said they will adapt their approach. Despite the looming decoupling of biotechnology between the US and China, the majority of biopharma companies continue to show strong interest in partnering with Chinese companies for product commercialisation (see figures 1 and 2).

"The Biosecure Act is a threat,” says Thomas Heimann, analyst at the investment firm HBM Partners. “However, it is difficult to say to what extent it is a threat. The main problem at the moment is the uncertainty.” Non-Chinese CROs/ CDMOs could potentially benefit from the bill as pharmaceutical companies seek to diversify their production from these companies or even from China. Contract companies such as Evotec and Fujifilm Diosynth have reportedly already received an increasing number of enquiries and exploratory applications, according to the L.E.K. survey.

Federico Polano, VP Business Development at expanding CDMO Rentschler Biopharma SE (see p.72), said to e uropea N B iotech N ology: "As a global biopharma CDMO navigating the complexities of our industry, we recognise that legislation such as the Biosecure Act reflects genuine concerns about national security and the integrity of our supply chains. Having said that, we are also mindful of the potential impact on global collaborations and the broader biotech community. Realigning supply chains, for example, does not happen overnight, and this could lead to major adjustments for US biotechs, potentially increasing costs and timelines

Fig. 3: Sales of ADCs, which promise to replace chemotherapy, are expected to grow significantly by 2030.

for bringing drugs to patients. "Over the last 20 years, many Western-headquartered companies have become reliant on manufacturing and CDMOs in China, making agreements with Chinese companies central to the sector’s productivity. An A U.S. survey of 124 biopharma companies found that 79% have at least one contract or product with a China-based or Chinese-owned CDMO/ CMO. China is one of the largest suppliers of complex peptide, immunotherapy, and antibody drugs to US and European pharmaceutical companies. It is estimated that 13% of the world’s manufacturing facilities supplying APIs to the US are in China and China is a major global supplier of APIs for generic drugs. Additionally, China is responsible for approximately 42% of global export value of antibiotics. "Biotechs may need up to eight years to switch manufacturing partners, potentially affecting millions of patients. For preclinical and clinical work, chang-

ing vendors may require anywhere from six months to six years, depending on the service and availability of other providers," told Dr Jeremy Levin, Emeritus Chairman of US BIO and Chairman and CEO of Ovid Therapeutics and Chairman of Opthea, europea N BiotechNology after the US House of Representatives passed the Act on 9 th September. "The situation with clinical trials is similarly complicated," he said. "Many promising medicines currently in clinical trials in China could be impacted by the Biosecure Act, particularly if governments make it more difficult to share participant data across borders. While China’s share remains smaller than that of Western Europe or the US, it has been on the rise. If international relations continue to deteriorate, patients in all regions may suffer as trials take longer to recruit, and patients may be restricted from accessing investigational medicines," Levin outlines the short-term impact. He pro-

poses "Biosecure can serve as a call to action. The US and EU should implement a forward-looking BIOBUILD plan to maintain global leadership and pair divestment from China with strategic domestic investment.

Progress with novel drugs

According to Evaluate's World Report, in 2030, total pharma sales will top US$1.7tr, about 14% thereof will be made by the top-7 drugs, six out them biologics mostly in the areas of immuno-inflammation, oncology and obesity. Furthermore, new modalities and technologies continue to open up novel targets and targeting mechanisms: antibody drug conjugates (ADCs), multi-specific antibodies, RNA-based therapies, gene/cell therapies and radiopharmaceuticals are all expected to grow steeply until 2030. L

t.gabrielczyk@biocom.eu

Capacity tripled

MANUFACTURE After three and a half years of construction, the Richter BioLogics CDMO has inaugurated a new multipurpose production facility that triples its capacity for the bacterial production of pDNA, vaccines, nanobodies and recombinant proteins.

European Biotechnology spoke to CEO Kai Pohlmeyer about the background.

EuroBiotech _Dr Pohlmeyer, at the opening of the new P2 production facility at the Bovenau site, the first thing you noticed was that the company logo no longer says Richter-Helm BioLogics, but Richter BioLogics. Why?

Pohlmeyer Apart from the name and e-mail addresses, nothing will change for our customers. The new company name reflects the change in ownership of our company, which was founded by the current Gedeon Richter Chairman Eric Bogsch and Dieter Schnabel, the CEO of Helm AG, through the acquisition of Strathmann Biotec GmbH. Back in March, our Hungarian parent company Gedeon Richter announced that it was taking over the shares of Helm AG and increasing its stake in RichterHelm BioLogics to 30% and its stake in Richter-Helm BioTec to 50%. The name change concludes the process agreed in autumn 2023, in which Gedeon-Richter exercised its contractually agreed first right of refusal, and the company value was subsequently determined. As announced, Helm will focus on its chemicals business in future.

EuroBiotech _Richter BioLogics, together with its parent company Gedeon-Richter, has invested €100m to expand the capacity of its microbial biologics production at the Bovenau site, Germany. How did this decision come about in the midst of the coronavirus pandemic?

Pohlmeyer With the opening, we tripled our production capacity for recombinant proteins, antibody fragments, pDNA and vaccines and doubled our workforce. The reason for this was a very strong

Dr Kai Pohlmeyer is Managing Director at Richter BioLogics since 2018. He holds a PhD in cell biology and started his career at Richter BioLogics in 1999 as Head of Process Development. From 2001 onward he focussed on business development. Here he established the Business Development Department for the CDMO and until 2018 also took responsibility for Marketing&Sales and Project Management. He initiated and developed strategic partnerships and alliances.

demand from our existing customers at full capacity utilisation of our former single-line production in Bovenau. In 2019, we had three customers with products in clinical phase III who approached us and asked whether we could produce on a commercial scale in the event of approval. One big pharma company put the gun to our chest and said that the risk of working commercially with just one production line is too

high for us. We needed more backup capacity. So if we wanted to grow, we had to do something. One of the products has received market authorisation and its production will fully utilise the capacity of our new, large 1,500 litre line from next year. Thus, the capacity expansion in Bovenau was not a poker game, but was based on a solid business case. We also benefitted from our balanced project mix, where we are excited to fill our production pipeline with innovative products from the biotechnology sector. At the same time our long-standing customers from the pharmaceutical industry provide a reliable foundation. We are noticing the dip in the biotech sector in the number of new project enquiries, but we can more than compensate for this with existing customers. We will increase turnover again this year, for the 12th time in a row.

EuroBiotech_Scaling up from one production facility to another is always difficult. What specific challenges does Richter BioLogics face in the new production unit?

Pohlmeyer With the 1,500 line, we are lucky that the product from the Phase III trial was already at final scale, so we only have to manage the tech transfer to the new plant.

EuroBiotech_Due to the good capacity utilisation of the new production facility, a third production line is already under discussion, you said at the official opening of P2. What is planned?

Pohlmeyer With the new large 1,500 litre and the smaller 300 litre production line, we expect the output of the

Bovenau site to increase from 40 to 120 batches per year. Additional capacity is available at our Hannover facility. Our goal for the next two years is to fully utilise the new production lines. We are currently planning another 3,000 litre line, as we have several customers with antibody-products in Phase II and III who are considering commercial production at our site, which usually requires higher doses.

EuroBiotech _More than 60 skilled workers were hired as part of the production expansion in Bovenau. How is this possible in the midst of a global skills crisis in the CDMO sector?

Pohlmeyer We started the search well in advance – as early as last year – although this wasn’t great for the profit and loss account. We were also aware that rural Bovenau is not the centre of the world and would not automatically attract skilled workers. Today, we are in a better position than I would have expected. The fact that the German biotech sector is currently weakening and experienced engineers and scientists have been made redundant has helped us in recruiting staff – even in southern Germany, where we previously had no chance.

EuroBiotech_The expansion that has already taken place and is still planned

is considerable. What are the longterm plans of Richter BioLogics mentioned by Gedeon Richter's Chairman Erik Bogsch at the opening ceremony?

Pohlmeyer In the long term, we want to gain a better foothold in the US market, where we already generate the majority of our sales. I can't imagine any growth through M&A today, except in terms of breadth, i.e. in terms of strain development and processes upstream of production. Instead, we will continue to focus on organic growth. The 2024plus strategy envisaged a branch for Marketing & Sales in the USA. In view of the fact that the capacity of our

production expansion in Bovenau is already more than 50% utilised, we have postponed these plans by two to three years. With regard to the product mix, we will continue to focus on pDNA and antibody fragments. Although we find the currently rapidly growing market for antibody conjugates interesting, we will not address it because parallel production of such toxic products would neither be accepted by our customers nor can it be realised in-house. However, we do see great opportunities for growth in the area of nanobodies and antibody fragments. L t.gabrielczyk@biocom.eu

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Aerial view of Richter BioLogics' production facility with the new extension, which has space for a third line.

Celonic: A “Pure Play” Biologics Swiss-based CDMO

CDMO The biologics contract development and manufacturing (CDMO) market is experiencing rapid growth and is dominated by global players with investments in large scale stainless steel capacity. But is larger always better? Not necessarily says Celonic, a mid-sized, privately owned CDMO, who has been embracing next generation technologies to help small to large biotech customers bring their drugs reliably, effectively and efficiently to the market.

Celonic, Basel: New “Next Generation” Biologics Development Center (BDC) Laboratory. From left to right: Alex Villiger (CFO), Samanta Cimitan (CEO), Ricky Abbas (Strategy Advisor).

The Celonic Group is a fast rising, midsized biologics CDMO focusing uniquely on mammalian expressed drugs. It provides end to end drug substance development and manufacturing solutions for monoclonal antibodies, bispecifics and other complex molecules from development all the way to commercial supply. Celonic combines the expertise like larger CDMOs with the agility and a collaboration mindset of a family owned business. The Celonic Group is privately-owned and part of the independent German family business J. Rettenmaier & Söhne Group (JRS). Celonic’s history is a success story. Over 30 years, the company has

continuously expanded from research projects to GMP manufacturing.

Celonic’s roots trace back to the world renowned Max Planck Institute and the Jülich Research Institute in Cologne, Germany more than three decades ago. In 2011, the JRS Group acquired Celonic AG headquartered in Basel, Switzerland, followed by the acquisition of Glycotope in 2017 which provided the company its current GMP manufacturing site in Heidelberg, Germany. Today, Celonic has a state-ofthe-art Biologics Development and Innovation Center (BDC) in Basel, Switzerland, and clinical and commercial GMP manufacturing facilities in Heidel-

berg, Germany. At present, more than 500 highly qualified employees work at Celonic across the two locations.

Market trends

In the past decades, Biologics manufacturing has seen an advent of disposable single-use technology (SUT). The industry practice has been to utilize disposables for development and small scale clinical or launch supply, and then scale up to large scale stainless steel for market supply. One of the key benefits of integrated single-use solutions is its flexibility and minimizing lengthy changeover times between products or batches coupled with the reduced risk of cross-contamination which helps to avoid costly downtime and the risk for failed batches. Its main drawback is higher costs per gram of the pharmaceutical active ingredient driven by the smaller scales and the cost of consumables. However, a number of market factors are shifting, making it easier for bio-manufacturers and CDMOs to adopt single-use technologies and further broaden its appeal. First, is the trend towards increased protein titers. Historically companies developed blockbuster drugs with very low titers, often in the 0.5 to 1 g/L range. Today, with improvements in expression platforms, new processes routinely achieve titers in the 2 to 5 g/L range and sometimes even ti -

ters exceeding 8 to 10 g/L with process optimization. Higher titers means that commercial demand for these new molecules can be addressed with smaller size bioreactors.

Second, is the portfolio mix of new generation drugs. While historically the market was driven by large blockbuster standard monoclonal antibody (mAb) drugs, which required up to a ton of drug substance, newer molecules are more diverse, more complex, and in general require less volume with the possible exception of new large indications (e.g. Obesity, Alzheimer’s). With scaling out (e.g. multiplexing 2,000L reactors), it is estimated that single-use facilities can address nearly two thirds of all new mammalian molecules including some biosimilars, ranging from niche orphan indications all the way to hundreds of kilograms, providing flexibility and speed to market without the need for technology transfers between sites or assets.

Third, is increased scrutiny by pharma and biotech company shareholders and industry watchdogs on sustainability, demanding that bio-manufacturers and CDMOs adopt stricter sustainability practices, and explore how to adapt

manufacturing processes to minimize environmental impact. Stainless steelbioprocessing has significantly higher process mass intensity (PMI) versus single-use technology standard fedbatch processes. PMI is defined as the total mass of materials used (raw materials, consumables, water and ancillary products) to produce 1 kg of active drug substance. This is because the high amount of water and steam required by stainless steel-bioprocessing during cleaning- and steam-in-place (CIP and SIP) and its larger facility footprint relative to a disposable facility. With global warming, long term water scarcity is becoming increasingly a concern worldwide. The consequence is that some companies are starting to evaluate their decisions based on the combination of speed, flexibility, sustainability, and cost of goods per gram rather than cost of goods per gram alone, which provides additional momentum for single-use technology.

Next generation technologies

Georg Blaser, VP of the Celonic Biologics Development Center, is passionate about next generation technolo -

Georg Blaser, VP of the Celonic Biologics Development Center

gies. After a successful 13 year long career at a larger well-known CDMO, Georg joined Celonic to bring his vision of accelerating the adoption of next generation technologies in the biologics CDMO market. He states “Next generation technologies enable im -

proved bioprocessing productivity leveraging the flexibility of disposable technology with lower cost of goods per gram versus standard fed-batch processes. Simply put, it is about getting more for less”. Next generation technologies include process intensification which uses a perfusion-based cell culture process in the N-1 reactor as well as full perfusion which refers to perfusion in the N stage reactor. Separately, the downstream processes can also be intensified using latest generation resins as well as other optimisations.

Expression systems

Getting more for less starts with a robust expression platform to deliver solid base titers. Blaser explains “Celonic’s GS-CHOvolution ® offers a gene-edited Chinese Hamster Ovary (CHO) K1 cGMP-compliant cell line with Glutamine Synthetase genes (“GS”) knocked-out, combined with TnT transposon technology, which facilitates the

selection of high expressing clones during cell line development, resulting in higher titers”. The GS selection system is recognized by regulators as the industry standard for the manufacture of biologics, it offers accelerated cell line development timelines with high efficiency cell line screening, and is a robust and scalable platform with no glutamine supplementation required. Blaser is quick to point out that, Celonic’s GS-CHOvolution ® has a simplified milestone based licensing model without any royalties, which is attractive to many small to large biotech companies.

Process intensification

Intensified fed-batch, also known as N-1 perfusion, has been discussed in whitepapers and conferences for many years now. However, very few companies have actually adopted it in reality. Celonic is different. It recently inaugurated a new Biologics Devel-

opment Center with the aim of developing and optimizing processes using process intensification via perfusion technology. Perfusion bioprocessing involves exchanging fresh medium for spent medium within a bioreactor while retaining the cells, allowing for higher-cell densities and lower concentrations of waste product inside the bioreactor.

Extending the duration of the N-1 step and applying a perfusion cell culture process allows operating the N bioreactor such that it results in higher titers, a reduction in cycle time or both. Specifically, Celonic has developed a proprietary toolbox based on multiple molecules types, cell lines, media and feed systems which has demonstrated the doubling of titers, improvement in downstream capture step productivity by 50%, and a reduction of cost of goods per gram of up to 30 to 40% versus a traditional fed-batch process. At the same time these improvements significantly re -

State of the art: alternating tangential flow (ATF) cell retention devices from Repligen

duce process mass intensity (PMI) and thereby, improve sustainability.

Full perfusion

Celonic has been a pioneer in perfusion-based technologies for decades. The company has run GMP manufacturing for full perfusion up to 1,000L SUT scale and has produced over 50 batches above 50L using CHO and GEX cell lines. Celonic has run perfusion processes up to 40 days, handling up to 60,000L of bulk harvest. Celonic uses state of the art alternating tangential flow (ATF) cell retention devices from Repligen. A full perfusion process can increase total output by a factor of eight to tenfold and significantly reduce cost of goods per gram. This means a 1,000L SUT bioreactor perfusion process can compare itself to a 10,000L Stainless Steel Bioreactor in terms of output. Historically, full perfusion was reserved for hard to manufacture, so called labile molecules such as blood factors. Today, perfusion can be applied to even standard monoclonal antibodies and biosimilars that seek to get large scale volumes with the flexibility provided by disposable systems.

GMP manufacturing

Celonic has more than 20 years experience in GMP manufacturing. Whether a scale-up from a small scale or a straight technology transfer at scale from a third party, Celonic’s multifunctional expert team can help to bring customer’s products speedily and reliably into Celonic’s Heidelberg Site. Celonic’s small scale asset provides 200L SUT up 1,000L SUT scale bioreactors ideal for IND filings. Celonic’s new mid-scale 6 x 2,000L SUT asset offers opportunities to scale up and scale-out which minimizes inter-site technology transfer times and provides a faster pathway to PPQ and Marketing Authorization Approval. Both assets are equipped to handle process intensified processes as well as traditional fedbatch. The Celonic manufacturing as -

sets use Cytiva’s Xcellerex XDR singleuse bioreactor system.

Cytiva: the technology enabler

As an industry innovator, Cytiva understands the immense responsibility you have when it comes to advancing human health. That’s why Cytiva is Celonic’s ideal solutions provider and scientific thought collaborator. Their technologically advanced solutions offer flexibility, capacity, quality, and efficiency, helping you accelerate your clinical and commercial milestones.

The Cytiva Xcellerex™ XDR Bioreactor single-use system is designed to scale from process development to full-scale manufacturing. Its robust and flexible system integrates with the Xcellerex™ Automated Perfusion System (APS) to ensure consistent production during continuous manufacturing processes. The system’s automation capabilities include filter switching, liquid management and cell bleed which reduces risk for human error and increases process robustness.

ÄKTA ready™ XL single-use chromatography system is designed to meet the capacity demands from single-use upstream processes (2,000L high-titer feeds). ÄKTA ready XL operates large scale columns (up to 1200 mm), using the two flow kit sizes that cover a broad range of flow rates from 45 to 3,500 L/h. The single-use flow path minimizes the need for cleaning and cleaning validation, allowing for quick changeover between productions, while eliminating the risk of carryover. ÄKTA ready XL offers the accuracy and documentation required for use in a GMP-regulated environment.

Company Info:

If you would like more information about our services or company, please contact us: Eulerstrasse 55, 4051 Basel, Switzerland Elisa Witt Marketing and Communications Email: ceo.office@celonic.com www.celonic.com

Your mRNA Partner in Europe

MRNA PRODUCTION  Messenger RNA (mRNA) has gained significant attention since being used in the Pfizer-BioNTech and Moderna COVID-19 vaccines. mRNA holds potential for preventing and treating many difficult-to-treat or genetic diseases, including cancers. However, its production is complex and raises challenges for researchers developing new therapies: Discover Tebubio.

›

Flavien Carpentier, Contract Research Services Director, Tebubio SAS, Le Perray-en-Yvelines, France

Demand for mRNA has skyrocketed and researchers developing mRNA-based vaccines and therapies face the optimisation of stability, immunogenicity, translation efficiency, and delivery. EUbased Tebubio Contract Research Services provides mini-scale mRNA production to support proof of concept work. It produces μg to mg amounts of custom mRNA in Europe, to be used for screening purposes in preclinical research. This unique, personalised, mini-scale mRNA optimisation and production service guarantees support for researchers from start to finish, with successful transfer to scale-up with the end product in mind, from the outset.

Mini-scale production

Researchers no longer struggle to get a functional mRNA sequence. Having completed more than 300 projects in the last three years, Tebubio experts are skilled in optimising the template pDNA sequence to increase its stability, transcription efficiency, final mRNA and protein expression, and decrease immunogenicity. Once the sequence is optimised, research grade mRNA can be produced as of 100 μg at Tebubio’s dedicated, state-of-the-art mRNA laboratory in France.

Delivery

Intracellular delivery of mRNA represents a challenge, due, in part, to its large molecular weight and high negative charge density. Customised delivery

Accelerate your mRNA project from proof of concept to GMP

tools are required to suit the specific requirements of the final model (target, tissue, cells, disease). Tebubio employs either chemical delivery with a transfection reagent, or customised lipid nanoparticle formulations. With the knowledge and expertise to develop the best formulation, Tebubio streamlines production and provides mini-scale quantities of formulations, that are scale-up-ready.

Expression & analysis

Tebubio validates the expression of the mRNA in the chosen in vitro model, whether in cells, 2D and 3D culture, or on in vivo models. Further analysis can include protein expression, quantification and localisation, and the response of the in vitro models, such as: toxicity, inflammatory cytokine release, cytokine storm, phosphorylation, and secretome profiling. Once the encapsulated mRNA has been optimised, Tebubio provides seamless

handover to trusted partners to develop the in vivo models, with close support provided by a PhD-level Tebubio project manager throughout. All of the pre-clinical variants are validated in vitro, which reduces the number of candidates needed for in vivo testing, prior to clinical trials. Furthermore, Tebubio’s in-house biostatistics platform delivers complete biomarker analysis, with reports including robust proof of concept data that can be used in publications and grant/patent applications.

Upscale + GMP

At Tebubio, mRNA is designed with the final product in mind and every tool used is GMP-compatible. Support is provided for a smooth transition to larger manufacturing solutions.

To accelerate mRNA research projects, contact one of our local offices: www.tebubio.com/contact L

The mRNA workflow

MICROBIAL

CONTRACT DEVELOPMENT AND MANUFACTURING OF BIOPHARMACEUTICALS

Richter BioLogics is a Germany-based GMP manufacturer specialized in products derived from bacteria and yeasts, with a proven 35-year track record.

Count on us to flexibly provide a comprehensive range of services and customized solutions. Clients worldwide have already benefited from our commitment to good manufacturing practice and total transparency. Our work focuses on recombinant proteins, plasmid DNA, antibody-like sca olds (VHH/Nanobody), cell-free expression and vaccines.

Your product – our competence and dedication. Contact us +49 40 55290-801 www.richterbiologics.eu

LEARN MORE ABOUT OUR SERVICES AND CAPABILITIES

Well Prepared to Tackle New Pandemics

BIOMANUFACTURING  If you want to successfully guard against future pandemics, you’re going to need a good plan – and the right kind of vaccine producers. WACKER and CordenPharma have been commissioned by the German government to prepare their mRNA vaccine production lines for a new pandemic.

It pays to play safe. The Covid pandemic made that pretty clear. Better to be safe than sorry. A great many people took this advice to heart. Everyone was able to do something to stop the spread of the virus – such as wear a mask, keep their distance, or get tested. But the pandemic only became manageable once Covid vaccines - which were developed in record time - were made available, preventing further death and suffering. Innovative vaccines based on mRNA (messenger RiboNucleic Acid), in particular, were in high demand at the start. “The experience with scarce vaccines led to the German government’s decision secure production at home, so to speak,” explains Dr. Andreas Anton, head of Wacker Biotech’s pandemic-preparedness project in Halle (Saale). Phar -

maceutical producers with appropriate vaccine expertise and capacity were then invited to apply for pandemic-preparedness contracts. Having joined forces with CordenPharma, we did precisely that, because in combination, we cover the entire process chain for producing mRNA vaccines. Alongside four other companies, we were awarded a contract in April 2022.”

That was the go-ahead for these companies to start taking all the necessary steps to achieve pandemic preparedness. In particular, the managers that WACKER and CordenPharma put in charge of the project now faced a herculean task involving an ambitious schedule: both companies needed to create the relevant setup and capacities in just two years. “In the event of a new pandemic,

with Germany needing huge amounts of a particular vaccine for its population, the government would put our two companies in contact with the company that had developed the mRNA vaccine in question,” explains Dr. Alexander Radspieler, CordenPharma’s Global Project Manager, whose coordinating role is similar to that of his WACKER counterpart. CordenPharma has in-depth expertise in lipids and lipid nanoparticles and has many years of experience in terminal and aseptic filling. Wacker Biotech has become a specialist in therapeutic proteins, living biotherapeutic products, plasmid DNA and conventional vaccines based on microbial systems. It was one of the first companies to address the production of mRNA vaccines. Both companies jointly take on the vaccine’s complete production: from the bioengineering of the mRNA, starting out from plasmid DNA, through to formulation with lipid nanoparticles and the sterile filling of the final vaccine (see chart). “All the critical manufacturing steps must take place in Germany. That was specified by the German government to ensure the country’s vaccine supply. Equally, all the production steps must take place in the European Union,” explains Radspieler. “The idea is to stop being dependent on global supply chains. The importance of being independent in this respect was made patently clear by the Covid pandemic.” This was the reason for Wacker Biotech’s choosing the site in Halle, Germany. A major expansion project was taking

Dr Alexander Radspieler (left), Global Project Manager at CordenPharma, and Dr Andreas Anton, head of Pandemic Preparedness at Wacker Biotech

place at Halle’s Weinberg Campus Technology Park. CordenPharma decided to obtain pandemic-preparedness status for its production sites in Frankfurt am Main (Germany), Chenôve (France) and Caponago (Italy). All these sites were required to provide suitable production capacity by Q2 2024 to enable the annual production of 80 million vaccine units. “To meet this target, we mainly invested in Halle,” says Anton, who coordinates this large-scale project. “We have drawn up extensive schedules and project plans to achieve everything by the two-year deadline. After all, it was necessary to plan and erect a new building, obtain the requisite equipment, and take on and train considerably more staff.”

Bodyguards for the mRNA Active Ingredient

As the central process steps take place in Halle, the site plays a key part in the pandemic project. “Put simply, the first thing we do there is to use the pharmaceutical company’s specifications to make the plasmid DNA. That is the starting material for producing the mRNA active ingredient,” explains Anton. CordenPharma’s expert Radspieler adds: “The next stage involves our various lipids, as the vaccine is formulated in Halle, too.

This is almost the last process stage, in which the mRNA is combined with lipids to form lipid nanoparticles, or LNPs, and packed into a lipid envelope that protects the sensitive vaccine on its way into the muscle cells at the injection point. But first, the frozen vaccine is sent to our sterile filling center in Caponago, northern Italy, where the vaccine is put in prefilled syringes or vials.” As part of measures to combat pandemics, CordenPharma launched two major expansion projects. In one project, the size of the lipid production area was increased to make it possible to produce the neces-

sary quantities. This project also involved investing in supercritical liquid chromatography, which is an environmentally compatible purification strategy for lipids. In the other project, CordenPharma extended its existing sterile filling capacity so that it would be able to supply clinics, vaccination centers and doctor's surgeries with the necessary vaccine doses. After being successfully qualified and confirmed by the German government, WACKER and CordenPharma have been in a state of pandemic-readiness since June 1, 2024. To make it possible for mRNA vaccines to be produced in huge quantities, if need be, the new building in Halle includes four production lines for biopharmaceuticals – thus quadrupling Wacker Biotech’s capacity. Anton, as project manager, and his team have everything under control there: time management, adjustment of schedules, coordination of, and communication with, partners, service providers and Germany’s Center for Pandemic Vaccines and Therapeutics (ZEPAI). On 1 October 2021, the German Federal Ministry of Health (BMG) established ZEPAI at the PaulEhrlich-Institut (PEI) in an effort to better manage pandemic response in the field of medicinal products by establishing a framework for making pandemic vaccines available as fast as possible. Anton and Radspieler ensure that everything is good to go – first and foremost the necessary state-of-the-art equipment for

Four new production lines for biopharmaceuticals were installed in Halle (Saale), Germany.

Tried-and-tested LNP formulation & commercialization route

bio process engineering. “As we don’t know the name of the customer who will be approaching us with his vaccine on day X, we basically need to be prepared for everything,” explains Anton. “When we built the new facility, we adopted a modern model process and planned for as much flexibility as possible.”

Flexibility for Production Lines

Luckily, WACKER and CordenPharma are used to rapidly switching from one customer project to another: both are CDMOs, or contract development manufacturing organizations, so it’s standard procedure for them to switch to different production processes quickly and adeptly. “As CDMOs, we make our production lines available to a wide variety of customers from the chemical and pharmaceutical sectors so that their complex modalities can be manufactured, with WACKER taking on this role for biotech firms,” explains Radspieler. “Alongside our production sites, we provide additional customer support in the form of our many years of in-depth experience. We also make our expertise relating to process management and process engineering available.”

To ensure maximum flexibility, WACKER relies on what is known as the ball-

room concept in Halle. “This means that there are no permanent piping systems in our production facilities. Everything is designed to be as variable and modular as possible. It’s particularly easy to move equipment in or out of rooms. We are trying to represent a cross-section of technologies that are highly likely to be needed.” Wacker Biotech and CordenPharma have likewise adopted the notion of ‘warm base’: production facilities and staff can be deployed instantly. The necessary starting and auxiliary materials are on hand as well. The intersite logistics strategies, too, can be im-

plemented immediately. “If the German government gives the order to produce mRNA vaccines, we switch over to pandemic mode and can start the production process shortly after,” explains the WACKER expert. “The strategy put into effect here is one of permanent pandemic preparedness, which also benefits our customers. This makes us very flexible, enabling us, during normal customer business, to implement projects rapidly and with a high degree of supply security.”

So as not to run the risk of delays, both companies need sophisticated HR strategies, production planning and stockkeeping. Radspieler explains the reasons why: “During non-pandemic periods, our facilities are busy dealing with customer projects. As a result, we always keep production areas available for standby capacity, just like Wacker Biotech does. Or we can switch to other sites in the case of established customers - as would be the case with us when it comes to lipid production. This means that we must plan in great detail to avoid bottlenecks elsewhere,” explains Radspieler. Anton adds: “We use at least 50 percent of our capacity for customer projects, while the other half is reserved as standby capacity for vaccine production. The German government pays us compensation for doing so. Our production sites need a good mix of projects that make it easier for us to move

something from A to B. For this reason, we are setting up redundant production lines.” Stockkeeping is of equal importance for the pandemic project: all the raw materials required, such as chemicals, enzymes and single-use systems, i.e. filters or plastic bags, must be present. “That’s why we designed a special storage and monitoring system so that stocks can always be kept fresh, so to speak”, explains Anton.

Both WACKER and CordenPharma profit from the fact that they were directly involved with their own projects at the start of mRNA vaccine development, which allowed them to gain experience. “For instance, our expertise meant that we were the ones that produced the lipids for the Moderna vaccine. These lipids relate, on the one hand, to cholesterol and phospholipid – two standard products – and on the other hand, to two specialty lipids that Moderna developed,” says Radspieler. “The LNPs are important for mRNA vaccines in two respects: first, as a protective envelope, second, to enable bioavailability,” explains the CordenPharma expert. During the Covid pandemic, Wacker Biotech successfully produced a clinical mRNA candidate vaccine, thereby gathering invaluable experience. The process technology needed for industrial-scale mRNA vaccine production was scaled up at WACKER’s Amsterdam site and laid the groundwork – not only in terms of the pandemic-preparedness plan, but also as regards setting up the mRNA competence center in Halle. WACKER invested more than 100 million euros in this expansion project. Over the coming years, the Group intends to spend an annual average of some 80 million euros on its biotech operations. This is yet more proof of WACKER’s confidence in this future technology.

Successful Recruitment

“To join the top league, we had to take on a lot of staff in a very short period of time and we put a great deal of effort into recruiting highly talented personnel. As we cover the entire value-creation chain, we need to recruit employees

Aseptic filling equipment at CordenPharma in Caponago (Italy)

from different disciplines such as chemical and pharmaceutical technicians, IT specialists and quality managers,” says Anton. “We’ve been very successful here so far, thanks to an advertising campaign featuring influencer videos to tar-

get young people as well. It took us just one year to recruit more than 100 people,” he recounts proudly. An equally state-of-the-art approach was adopted when it came to familiarizing new staff. “On the one hand, we involved new employees in ongoing production at other corporate units. On the other, we set up dedicated training rooms so that new staff members could learn how to operate the various pieces of equipment needed for their work. If a particular piece of equipment wasn’t yet physically available, we used virtual reality modules to make the most of the familiarization phase,” explains Anton.

It’s All About Well-Laid Plans

The experts from Wacker Biotech and CordenPharma repeatedly stress that a huge number of aspects need to be taken into consideration. Pandemic preparedness depends on well-laid plans –and it’s essential to be in close contact with all the various parties involved in the project. After all, you want to play safe in the event of a new pandemic.

Partner for Innovative Biopharmaceuticals

The pandemic-preparedness project is not the only result of the very close cooperation between Wacker Biotech and CordenPharma. The two companies collaborate in other areas too: for instance, they started a development partnership in December 2021. Its focus is on creating an extensive pool of experience in terms of lipids and lipid nanoparticles (LNPs) so as to provide a broad portfolio for mRNA vaccines. The two companies are also working on the production processes and scale-up for industrial manufacturing of lipids to meet increasing market demand. Lipids are an essential part of advanced drugs because they safely convey the active pharmaceutical substances to their destination in the patient’s body. LNPs form a protective envelope around mRNA actives, antibody or protein replacement therapeutics. What’s more, the work performed by Wacker Biotech and CordenPharma on innovative lipids includes collaboration with two German universities: HumboldtUniversität in Berlin and Ludwig-Maximilians-Universität in Munich. The idea is to integrate the knowledge gained into an artificial intelligence model with the aim of issuing statements about suitable lipids more quickly in the future. www.wacker.com/biologics www.cordenpharma.com L

The key versus larger CMOs is agility and flexibility

BIOMANUFACTURING T he Celonic Group, a Swiss Based quality biologics Contract Development and Manufacturing Organization (CDMO) just opened its “Next Generation” Biologics Development Center and Pilot Plant in Basel, Switzerland. Another site is located in Heidelberg, Germany.

European Biotechnology spoke to CEO Samanta Cimitan about their strategy.

EuroBiotech _Huge growth rates are predicted for the contract manufacturing market. How can a smaller company like Celonic position itself for success?

Cimitan Celonic is a mid-sized “Pure Play” Biologics CDMO with over 500 employees. We focus uniquely on the Mammalian (CHO based) modality from development all the way to commercial manufacturing. Our target is primarily small to large Biotech customers and Biosimilar companies. We provide the technical expertise like larger CDMOs, but with the agility and collaboration mindset of a family owned business. We are also a trailblazer in adopting next generation technologies with the aim of reducing cost of goods per gram which is essential to make biologics more accessible to patients globally.

EuroBiotech_How important is the “D” in CDMO, i.e. involvement in project development, for the corporate strategy?

Cimitan_Development is crucial to deliver high titers and yields, with robust processes that can smoothly run during GMP manufacturing. We just inaugurated a new, state of the art Biologics Development Center in Basel, Switzerland where all development, process optimization and non-GMP manufacturing occurs. Celonic offers cell line development using GS-CHOvolution®, an expression platform based on a gene-edited Chinese Hamster Ovary (CHO-K1) cGMP-compliant cell line with Glutamine Synthetase (“GS”)

Samanta Cimitan CEO Celonic Group Dr. Samanta Cimitan is an expert in the CDMO industry, holding a deep and unique combination of scientific, commercial, and operational expertise. Prior to Celonic, she held several leadership positions at Lonza for almost 13 years including Vice President of Lonza Group Operations Strategy, developing and leading transformational programs across R&D, Operations, and Commercial functions.

genes knocked-out and the TnT transposon technology to accelerate cell line development timelines and to streamline the selection of high expressing clones.

Biopharma customers can also tech trans fer to us at any clinical phase for process optimisation and GMP manufacturing, including conversions to next generation technologies.

EuroBiotech What exactly is meant by “Next generation” bioprocessing?

Cimitan_“Next generation” bioprocessing includes process intensification (intensified fed-batch) and Full Perfusion (N reactor) with the aim of increasing productivity, reducing the cost of goods per gram, and improving sustainability. The Celonic Biologics Development Center is fully equipped with automation and equipment capable to support conversions from classical fed-batch to next generation technologies and is led by some of the brightest minds in the field with a wealth of expertise.

Celonic has more than two decades experience with GMP manufacturing using full perfusion processes up to 1,000L in its GMP facility in Heidelberg, Germany.

EuroBiotech_In order to keep costs under control for the smaller indications, there is a lot of innovation in the processes. Automation, continuous production, digitalisation ... Where do you see the biggest levers for successfully responding to specific demand even better than the competition?

Cimitan _Celonic works very closely with its supplier partners to leverage the latest technologies and is an early adopter of innovative solutions that address pain points in the development or manufacturing process.

The key for Celonic versus other larger CDMOs is agility and flexibility. Celonic has two manufacturing assets in its GMP facility in Heidelberg, Germany.

One for small scale (200L up to 1,000L) and one for mid-scale (6 x 2,000L). Both assets use disposable single-use technology (SUT) and are equipped with intensification and perfusion in mind, including the ability to handle high titer processes up to 8g per liter. Like this, whether by scaling up or out via multiplexing, Celonic can handle flexibly a range of molecules from small indications, all the way to commercial supply for mid-scale drugs requiring hundreds of kilograms.

EuroBiotech _Any other trend in the CDMO landscape that is keeping you very busy at the moment?

Cimitan_The political pressures to lower the cost of biological drugs will continue to accelerate, fueling growth in biosimilars over the next several years. In addition, geopolitics, in particular the US Biosecure Act, will impact the CDMO landscape and offer new opportunities for mid-scale players such as Celonic.

EuroBiotech_Does a smaller company inevitably only have the smaller indications and batch sizes, or should this not be seen so narrowly?

Cimitan_Small biotech customers are a key engine for innovation in the biologics world. They work on a range of disease areas from narrow orphan indications to broader high volume indications. At Celonic, we value all customers whatever their size.

EuroBiotech _Flexibility, agility and finding the right answer to customer requirements 24/7. That always sounds nice in theory, but how can you realize this in reality with the team?

Cimitan It traces, first and foremost, to mindset and culture. Many of our experts and leaders have left larger organizations, because of the bureaucracy, inertia, and politics. Celonic is a family owned business, and Celonic employees have a high affinity to entrepreneurship and genuinely thrive on collaborating to help our customers achieve their goals. We have a flat internal structure which enables responsiveness.

The other aspect is that, unlike some other CDMOs, Celonic does not work with rigid platforms. Instead we have toolboxes that can be flexed to meet specific customer needs, balancing customisation and cost efficiency.

EuroBiotech What is the division of labour between the Heidelberg and Basel sites?

Cimitan_In Basel, we have Celonic’s headquarters and the Biologics Development Center, including a Pilot plant of up to 200L non-GMP for the manufacturing of Tox material.

Heidelberg is the GMP manufacturing site in the heart of Europe, with small and mid-scale assets for clinical and commercial supply.

EuroBiotech At the Basel site in particular, people think that the competition must be huge and that any new player would have a very difficult time. How do you experience the reception in the local community?

Cimitan_The reception of the newly inaugurated Biologics Development Center has been very strong including from the Basel City/Canton and the Basel Area Business & Innovation organization. We also had several visits from customers and suppliers, who welcome Celonic’s expansion to the Basel biologics ecosystem.

EuroBiotech _The biotech companies have realis ed that there will probably hardly be any blockbusters. But then GLP-1 or something else comes along and everyone tries to conquer a market worth billions again. Is there a need for size in order to be able to play along, or can you survive well in a special niche?

Cimitan Celonic has a diversified portfolio of clients which includes some of these growing segments with larger volumes. We bring value through our development, process optimisation, scale up and manufacturing capabilities which are agnostic to size. On the contrary, some of these new indications have development risks and volume uncertainty. A flexible manufacturing asset such as Celonic’s mid-scale is ideal.

EuroBiotech_ What is it that attracted yourself to Celonic?

Cimitan Celonic is a smaller, entrepreneurial and agile organization. The bioprocessing industry is at a crossroads with several game changing innovations being available to transform the market. I believe Celonic is a thought leader and a rising star in the industry in adopting next generation technologies to make drugs more accessible and affordable worldwide. Additionally, Celonic has a young and dynamic culture with some of the brightest minds in the field. L g.kaeaeb@biocom.eu

Inauguration of Celonic Biologics Development Center (BDC) in Basel, Switzerland

Christof Klöpper, CEO Basel Area Business & Innovation, Samanta Cimitan, CEO Celonic Group, Samuel Hess, Head of Economic Affairs Canton Basel Stadt

Ensuring sustainability and continuity in biomanufacturing

CDMO  Biomanufacturers must balance the development of new therapeutic modalities and reduce manufacturing costs while maintaining environmental responsibility. Efforts are centered on improving process robustness and efficiency and creating more flexible manufacturing facilities that can accommodate diverse biopharmaceutical products.

›

Balu Guduri, Global Product Manager - Process Consumables, Tosoh Bioscience

The biopharmaceutical industry is entering an exciting and transformative phase. Increasing demand for treatments that address unmet medical needs while remaining affordable is driving significant changes. This is reflected in the rising number of FDA approvals for biologics each year. Biopharma manufacturers are expanding beyond monoclonal antibodies (mAbs) into new modalities, such as cell and gene therapies, without losing focus on the substantial market potential of mAbs.

Key strategies to improve development and manufacturing while aiming for sustainable operations include adopting single-use technologies, implementing process intensification and continuous manufacturing, enhancing process analytics, and developing digital capabilities to leverage AI.

Sustainable product development

At Tosoh Bioscience, we are committed to supporting biopharmaceutical manufacturers in achieving their goals of producing affordable, high-quality medicines. In addition, sustainability is a core value at Tosoh, integrated into every facet of our business. We are dedicated to implementing robust sustainability measures at the corporate level and incorporating eco-friendly practices into our product development to en-

SkillPak prepacked columns for biopurification

able more sustainable production processes in the biopharma industry. One of the ways the industry pursues sustainability is through process intensification and continuous manufacturing. Continuous manufacturing not only enables more sustainable manufacturing but also streamlines production and enhances the flexibility and scalability of biopharmaceutical operations, allowing for faster responses to market demands and regulatory changes.

Continuous manufacturing

To simplify continuous biomanufacturing, we have developed flexible and scalable Multi Column Chromatography (MCC) skids: Octave BIO for process development and OctaveTM PRO for GMP scale production, along with SkillPakTM Prepacked Chromatography Col-

umns. Through collaboration with Catalent Pharma/Novo, one of the largest global contract development and manufacturing organisations (CDMOs), we have optimised both the hardware and software for the Octave PRO skid to facilitate GMP operations. This partnership accelerated the implementation of multi-column chromatography (MCC) in the highly regulated clinical-materials production stage.

Partnering for future innovation

To further develop MCC instruments to anticipate future developments in the industry, we joined the ECOnti project to develop innovative technologies that enable smaller production facilities, reduce water and energy consumption, and help companies limit their CO2 emissions. This project, led by enGenes Biotech GmbH

and supported by the Austrian Research Funding Agency (FFG), aims to develop a fully integrated and automated continuous upstream and downstream process at up to 10L batch size, featuring the Octave BIO MCC Skid. The technology developed within the ECOnti project offers several key advantages, including smaller production facilities, reduced water consumption, lower energy consumption and CO2 emissions, end-to-end process control, full digitisation and automation, higher product yields, and enhanced process stability.

Additionally, Tosoh Bioscience has announced a pioneering partnership with Prof D. Michael Wolff from the University of Applied Sciences Mittelhessen (THM) Gießen, Germany. This collaboration focuses on developing continuous purification processes for viruses and viral vectors. By financing a researcher position and supplying essential equipment, including an Octave BIO Multi-Column Chromatography system, Tosoh Bioscience is dedicated to advancing solutions that meet the critical needs of the cell and gene therapy (CGT) industry. This partnership exemplifies our commitment to innovation and industry-academic collaborations, aiming to make CGT manufacturing processes more cost-effective and accessible.

Single-use products

The commitment to provide advanced solutions extends to the design of singleuse consumables. A first example is our SkillPak Prepacked Chromatography Columns. By 2025, we will introduce columns for GMP production, with dedicated product lines for both batch and MCC applications. They will use significantly less plastic than traditional options and incorporate recycled glass fibers, further supporting sustainable practices.

More efficient mAb manufacturing

To enhance process robustness and flexibility, our brand new TOYOPEARL® Super A resin offers significant advantages for mAb manufacturers looking to

Reduced elution volume (-30%) and shorter process time for the capturing of an IgG1 through the novel TOYOPEARL Super A resin (vs. competitor).

implement a capturing platform to reduce their time-to-market. This highperformance protein A resin offers industry-leading critical performance parameters along with flexible operational parameters: high binding capacity at shorter retention times, robust alkaline stability, reduced pressure loss, and minimised aggregation with elution at pH 4.0. These attributes bring more process flexibility and robustness to antibody manufacturing, improving overall efficiency and product quality. TOYOPEARL® Super A resin is the ideal choice for small and large-scale bioprocessing. Its advanced features improve process economics and ensure high-quality, safe, and effective monoclonal antibody purification.

Business continuity

Post-COVID, the emphasis on business continuity has intensified, with manufacturers forging closer collaborations with suppliers of critical consumables to ensure supply chain resilience. To bolster business continuity, we are expanding our manufacturing capacities. This includes constructing Tosoh’s fifth manufacturing facility at the Yokkaichi Complex in Yokkaichi City, Mie Prefecture. This facility complements the fourth plant currently under construction in Nanyo, Yamaguchi Prefecture, which will be operational in 2025. Our fifth site for chromatography media is

tentatively expected to be operational by mid-2027. These expansions ensure that our customers can confidently plan for business continuity and have assured supply for their future expansion needs.

Future developments

The biopharmaceutical industry is navigating a period of rapid change and growth. The drive to address unmet medical needs with new and affordable treatments pushes manufacturers to innovate and adapt. Tosoh Bioscience is committed to supporting these efforts through our capacity expansions, process intensification initiatives, and unwavering commitment to sustainability. We are also engaged in numerous promising R&D projects at various stages of development aimed at supporting customers in their process development efforts for novel modalities like Oligonucleotides, AAVs and others. We view innovation and sustainability as an ongoing journey. Our approach includes continuous improvement, investing in research and development for more efficient and sustainable products, and partnering with stakeholders. By working closely with our partners and continually investing in research and development, we strive to help the biopharmaceutical industry meet its ambitious goals and improve patient outcomes worldwide. L

Aequorin: superior choice for GPCR calcium signalling

AEQUORIN TECHNOLOGY The study of G protein-coupled receptor (GPCR) signalling is crucial for understanding a wide range of physiological processes. Among the methods used to monitor calcium signalling, Aequorin stands out for its high sensitivity, specificity, and sub-cellular compartment targeting. While many CROs are still using fluorescent calcium dyes, EuroscreenFast is making use of Aequorin’s unique properties as an invaluable tool to delve into the complexities of cellular communication.

› Dr Laurent Meeus, Chief Scientist & General Manager, EuroscreenFast

In the realm of cellular signalling, GPCRs are pivotal in transmitting extracellular stimuli to intracellular responses, often involving calcium ions (Ca²⁺) as secondary messengers. To effectively study these intricate pathways, a precise reporter system is essential.

Aequorin, a photoprotein originally derived from the jellyfish Aequorea victoria, has emerged as a superior reporter for GPCR Ca² + signalling.

A primary advantage of Aequorin is its high sensitivity to Ca² + Upon binding with Ca² + , Aequorin undergoes a conformational change, leading to the oxidation of its coelenterazine substrate and the emission of blue light. This bioluminescent reaction is highly specific to Ca² + , ensuring minimal interference from other ions or cellular components. Because background noise is greatly reduced compared to other approaches that use fluorescent dyes, the use of Aequorin offers a larger assay window and allows for more accurate real-time monitoring of Ca² + fluxes within living cells, providing invaluable insights into GPCR-mediated signalling events.

Another critical benefit of Aequorin is its ability to be expressed in various subcellular compartments, such as mitochondria, using a dedicated signal peptide sequence. Ca 2+ fluxes are more intense in the mitochondria, upon cytosolic Ca2+ increase. This improves

the sensitivity of mitochondria-targeted Aequorin reporters. Moreover, progressive mutagenesis has allowed the generation of variants beyond wild-type Aequorin with improved stability, light emission, Ca2+ affinity.

Illuminating Cell Communication

Aequorin’s versatility in various experimental setups is noteworthy, including single-cell analyses, high-throughput screening, and even whole-organism studies. This adaptability makes Aequorin an ideal choice for a wide range of applications, from basic research to drug discovery. Furthermore, the bioluminescent signal generated by Aequorin is compatible with most standard laboratory equipment which allows EuroscreenFast to facilitate seamless integration into existing workflows.

The resolution offered by Aequorin is another advantage. GPCR signalling events occur on rapid timescales, necessitating reporters that can keep pace with these dynamic changes. Aequorin’s fast response to Ca2+ binding allows for the real-time tracking of transient Ca²⁺ signals, capturing the nuances of GPCR-mediated processes that might be missed by slower-responding indicators.

Aequorin’s bioluminescence is also advantageous in reducing background

noise, a common issue with fluorescence-based indicators. Since bioluminescence does not require external excitation light, it minimizes autofluorescence and photobleaching, thereby enhancing signal-to-noise ratio and improving the accuracy of measurements. This feature is especially beneficial in complex biological environments where autofluorescence can obscure subtle changes in Ca2+ levels.

The application of Aequorin in GPCR Ca2+ signalling has already yielded significant insights. For instance, it has been instrumental in elucidating the role of Ca2+ in neurotransmitter release, hormone secretion, and sensory perception. In EuroscreenFast’s hands, Aequorin has helped advance understanding of cellular communication and even led to the deorphanisation of a number of GPCRs.

The advantages of Aequorin as a reporter for GPCR Ca2+ signalling are manifold. High sensitivity, specificity, sub-cellular compartment targeting, versatility, and superior temporal resolution make it an invaluable tool. By illuminating the intricate dance of Ca2+ ions within cells, Aequorin paves the way for groundbreaking discoveries in cellular signalling and beyond. As EuroscreenFast continues to explore the depths of cellular communication, Aequorin will undoubtedly remain a beacon of clarity and precision in the study of GPCR Ca2+ signalling L

Empowering tomorrow’s therapies today

CDMO A specialist for complex biopharmaceuticals, the CDMO Rentschler Biopharma SE has once again reinvented itself: in 2021, the company set up a centre of excellence in the UK for manufacturing of cGMP-compliant viral vectors for gene therapies and more recently, it doubled its global production capacity with a new manufacturing line in the US. European Biotechnology spoke with CEO Benedikt von Braunmühl to explore the developments and future directions of the company.

EuroBiotech_Mr von Braunmühl, what is the strategy behind Rentschler’s expansion of its business and management?

von Braunmühl As a CDMO, being successful means being ready to evolve with the fast-moving market. In 1983, we were industry pioneers, with the world’s first market approval of a native interferon-b (fiblaferon). In 2023, we contributed to nearly 25% of all FDA-approved biologics alone. Our ability to respond to client needs has always been a driving force behind our decisions. The move to the UK was part of our effort to offer advanced therapies, the Stevenage Bioscience Catalyst, being an ideal location to grow in ATMPs and further evolve our business. With our Milford site in the US, we tapped into the country’s dynamic innovation landscape whilst moving closer to our clients. We transformed the site near the Boston biotech hub into a cutting-edge multi-product facility for biopharmaceuticals. Along with our expansion, we also evolved our leadership to reflect our new positioning as a global company.

EuroBiotech_How is Rentschler Biopharma positioned as a CDMO and where does it want to go in terms of clients, especially in the US market, and in molecule formats, sites and sales? von Braunmühl We are the experts for complex modalities from concept to market. We currently offer cGMP drug substance production for over 140 ther-

Benedikt von Braunmühl Chief Executive Officer of Rentschler Biopharma SE

apeutic modalities, more than 50% of which are advanced antibody formats and complex proteins. Our pledge is to find best-fit solutions for our clients’ endeavors. With our new state-of-theart production line in Milford, we have not only doubled our global cGMP capacities but are also strengthening our local presence for years to come, also welcoming new clients.

EuroBiotech The CDMO sector is rapidly growing – CAGR 11% by 2030 – and consolidating. Is it sensible for a CDMO of Rentschler’s size to continue to develop organically?

von Braunmühl _Consolidation for large-scale CDMOs will continue. But specialised CDMOs, like Rentschler Biopharma, will likely gain more importance. We add value by manufacturing therapeutics for rare and serious diseases that require substantial experience and expertise. Being free from capital market influences enables us to prioritise sustainable growth and long-term objectives over short-term profits. Moreover, we offer our clients full-service solutions across the biopharmaceutical value chain by building meaningful strategic alliances, like our collaborations with Vetter for fill & finish and Leukocare for formulation.

EuroBiotech _How do you envisage Rentschler’s business in five years’ time at the existing and possibly new locations? What role will the current growth areas like CGT play – especially in the early phase of clinical development?

von Braunmühl _Innovation is at the heart of what we do. We don’t limit our clients when it comes to exploring new possibilities. We give them space to test their ideas, especially in early phases of development projects. I firmly believe that this is how great results happen. We proved this during the global pandemic, when we rapidly adapted, becoming a manufacturer of about 2.5 million doses of the C OVID -19 vaccine. By combining the client perspective

with technological know-how, we drive innovation. Take CGTs: according to Global Data, about 5,000 CGTs are currently in preclinical phases. Many of which are working with viral vectors as gene ferries. We recently launched our new lentiviral vector manufacturing toolbox which complements our existing adeno-associated viral (AAV) vector services at our UK site.

EuroBiotech_What role do talent recruitment and site coordination play for Rentschler Biopharma? von Braunmühl_Today’s employers face many challenges. No company has the luxury of attracting talent and retaining them until their retirement. Rentschler is well-positioned, nevertheless, staying attractive for existing and future talent is vital. We actively invest in collaborations with universities and education initiatives, and partner with our peers in research clusters, strengthening the local biopharma regions our sites operate in. We also live by this spirit in our daily work and foster cross-site collaboration.

EuroBiotech _Which strengths of its team, logistics and client relations can Rentschler rely on and where do you see room for improvement? von Braunmühl_When I look at the work our employees do across sites, I am deeply impressed. Here are people working across three different countries, with many different nationalities and professional backgrounds. All share one vision: advancing medicine to save lives. Our two bio-pharmaceutical sites, for instance, are closely connected, not only when it comes to seamless technology transfer from Germany to the US, but also on a collaborative level. Our employees work in cross-site teams, regularly visit their counterparts, from production to business development or IT. The same is true for our site in the UK. This directly translates into our client relations: we believe that we achieve the best results when we work together as their partners. They place their trust in us when they commission us. So, their projects are our projects. No client is ever the same and we

learn with every project. The smaller ones may require more batches and consulting, while the larger ones are in need of specific processes. A client from the US may face different market challenges than one in Europe.

EuroBiotech_Cooperation with a CDMO is a matter of trust. In light of the shortage of qualified personnel, how do you address the fields of automation and AI in your services?

von Braunmühl_Trust is the key. Digitisation and automation play a central role in our short- and long-term strategy to ensure that we remain a reliable partner. Our roadmap is geared towards four areas of management, operations, clients and client business in a holistic strategy. We are in the process of digitising and networking our systems and processes end-to-end, also looking into AI solutions. Deloitte estimates that the adoption of AI in biopharma could reduce manufacturing costs by up to 20% and improve process efficiency by 30%. In the long run, this can translate into more efficient services, freed-up capacity, and increased transparency for clients along the entire value chain. These changes also pave the way for new professions in biopharma, like bio-data engineers

or oversight officers, who combine scientific expertise with data know-how.

EuroBiotech_How do you assess the increasing orphanisation of drug indications for your company’s business? von Braunmühl _Orphan drugs are part of our core business. At the same time, we are on the doorstep of the era of personalised medicine, with increased demand for new modalities, mainly driven by the growing need for new treatments for the rising incidence of cancers and other diseases globally. As modalities become increasingly complex, our expertise positions us well in both production and regulatory consultation. This allows us to effectively pave the path to clinic and market for therapeutic solutions.

EuroBiotech_Your next goals and priorities?

von Braunmühl_We have worked with clients from across the globe for five decades now. We know what it takes to adapt to local conditions and tailor our approaches. We will continue to build on this experience and are committed to empowering tomorrow’s therapies today, addressing unmet medical needs of patients worldwide. L

t.gabrielczyk@biocom.eu

With a new state-of-the-art manufacturing line in Milford, US, Rentschler Biopharma has recently doubled its global cGMP capacities

Pichia protein production

BIOPROCESS DEVELOPMENT Recombinant protein production in Pichia typically relies on AOX1 promoter-driven expression using methanol for induction. However, some companies avoid methanol due to safety concerns or operational demands. VALIDOGEN's unique AOX1 promoter variants enable methanol-free protein production at high space-time yields, offering advantages beyond safety. Latest case studies underscore the strength of this technology.

› Rosie Maddock, Evelyn Trummer-Gödl and Thomas Purkarthofer, VALIDOGEN GmbH

Methanol-induced protein expression in Pichia pastoris, leveraging the strong AOX1 promoter, is a highly efficient system for producing recombinant proteins. This approach is well-established and scalable, making it suitable for both laboratory and industrial-scale bioreactors. However, due to safety concerns and the operational challenges associated with methanol handling, recent advancements have focused on developing methanol-free alternatives.

Methanol-free expression

Validoge N develops high-performance MeOH-induced and MeOH-free Pichia protein production strains for various industries. Their MeOH-free system utilizes a specialized subset of their library of AOX1 promoter variants, eliminating the need for methanol while maintaining the beneficial characteristics of the original AOX1 promoter.

Unlike constitutive promoters, this system enables strong, time-controlled initiation of protein expression while reducing the metabolic burden from carbon source switching, as well as minimizing oxygen consumption and heat evolution. This technology is already in commercial use in bioreactors up to 100,000L.

Process Intensification

In collaboration with Boehringer Ingelheim, Validoge N has developed op -

timised MeOH-free bioreactor cultivation processes. A recent collaborative case study highlighted two of these approaches: one process in bacterial-like fermentation time (64 hours), and one in Validoge N standard process time of 111 hours, both applied for secreting a bivalent VHH.

The optimised MeOH-free short cultivation process achieved high product yields of 12 g/L and significantly increased space-time yield. The op -

timised 111-hour process, applying a specialised feeding strategy to maximise product titer, achieved a yield of 19 g/L, while maintaining high spacetime yield.

Validoge N's methanol-free processes provide a safe, efficient, and flexible alternative to conventional methanolbased or constitutive Pichia expression systems, offering enhanced safety and streamlined efficiency without compromising performance. L

UNLOCK PICHIA® protein production strain generation and process development at VALIDOGEN: high-yield expression strains and intensified processes considering safety, economic efficiency, and regulatory requirements. Serving industries including biopharma, food and feed, industrial biotechnology, and diagnostics

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ADC acquisition

M&A Danish company Adcendo ApS has acquired the global rights to commercialise Multitude Therapeutics Inc.’s first­in­class antibody­drug conjugate (ADC), ADCE-T02. Adcendo is paying the US biopharma up to US$1bn plus royalties for ADCE-T02, which targets tissue factor, a protein linked to various aggressive cancers. It is the first ADC with a topoisomerase I inhibitor-based linker/ payload, to enter into clinical development in Australia, US and Europe. The start of the Phase I study in Australia is anticipated in Q4 2024. With the acquisition, Adcendo is strengthening its ADC pipeline, already accelerated by a Series A funding worth €98m earlier this year. Investors include Novo Holdings and other major venture capital firms.

Waste to value

RESEARCH Researchers from Danmarks Tekniske Universitet (DTU) have succeeded in creating a genetically modified yeast cell that utilises the industry’s environmentally harmful wastewater and turns it into food, feed, and enzyme production.

The yeast D. hansenii thrives in highly saline environments and is thus wellsuited to process wastewater from industrial production. In collaboration with Arla Food and Novo Nordisk, the researchers combined two saline waste streams – one rich in lactose from cheese production, the other nitrogen-rich waste derived from perfusion mammalian cultivations. With the help of CRISPR/Cas9, the DTU researchers modified D.hansenii to also form a protein as it grew which can serve as the basis for a wide range of commercially viable products, such as milk substitutes, artificial meat, various protein-based pigments, and enzymes – or even sustainable fuels. The scientists, who published their findings in N ew B iotech N ology (DOI: 10.1016/j. nbt.2023.10.005), hope that their findings could prove to be an important step in the green transition, moving food production away from the fields and into steel tanks, DTU said in a statement. 

Last chance for cancer vaccine

ONCOLOGY No luck for Ultimovacs: the Norwegian biotech had to report yet another trial failure when its cancer vaccine UV1 failed to reach primary or secondary endpoints in a Phase II trial of a UV1-pembrolizumab combo in patients with head and neck cancer. This is the third failure for the company’s lead compound UV1, a therapeutic cancer vaccine designed to induce a specific T cell response against telomerase. Before, UV1 failed in melanoma and mesothelioma. There is one ongoing Phase II trial (DOVACC), in which UV1 will be

paired with durvalumab and olaparib for the treatment of ovarian cancer.

Earlier this year, Ultimovacs had laid off nearly half of its staff. “Earlier this year we implemented a cash preservation programme, enabling us to extend our runway to the fourth quarter of 2025 beyond the anticipated DOVACC Phase II topline readout in the first half of next year,” commented CEO Carlos de Sousa. The company plans to use that time to “actively developing a novel technology platform identified during the TET development”. 

Cosmetic seed

FINANCING In early summer, Danish industrial biotech start-up Cellugy A/S raised €4.9m in a seed financing round led by Germany’s ICIG Ventures and Denmark’s Unconventional Ventures. The company will use the funding to scale up its bio-fabricated dry cellulose production platform. According to Cellugy, the funding will accelerate the deployment and commercialisation of the company’s pilotscale fermentation platform from kilogram to ton-scale. Cellugy’s bio-based drop-in alternative to fossil-based petrochemical ingredients in personal care products could be a game changer for the multibillion dollar cosmetics market. 

Option exercise

ONCOLOGY Merck & Co is expanding its existing collaboration with Orion Corporation, committing over US$1.6bn to develop cancer therapies targeting CYP11A1, among them opevesostat (MK-5684/ODM-208), a CYP11A1 inhibitor discovered and developed by Orion. Opevesostat is being investigated for the treatment of hormone-dependent cancers. In 2023, two pivotal Phase III clinical trials were launched evaluating opevesostat in combination with hormone replacement therapy for the treatment of prostate cancer patients. Orion is eligible to receive development milestone payments up to US$30m, regulatory milestone payments up to US$625m and sales-based milestone payments up to US$975m as well as annually tiered royalty payments.

“The conversion of this collaboration into a license agreement allows Orion to focus our resources to progress our other promising development candidates while both remaining well positioned to benefit from the development and potential commercialisation of opevesostat and meeting our financial objectives,” said Liisa Hurme, President & CEO of Orion Corporation.

Banking on public preparedness

MPOX Will the recent mpox outbreak in Central Africa be the catalyser to propel vaccine specialist Bavarian Nordic out of its niche market? Investors, at least, are banking on it: Bavarian Nordic’s stock price surged by over 40% after the World Health Organization (WHO) upgraded the Mpox virus to an public health emergency of international concern in mid-August. The Danish pharmaceutical company is gaining attention for its advanced Modified Vaccinia Ankara (MVA) vaccine MVA-BN, the only mpox vaccine approved in the EU. A contract of 440,000 doses of MVABN to an undisclosed country, announced in August, brings the total value of secured contracts in the Public Preparedness business close to DKK3bn (€400m).

Bottleneck manufacturing

To ensure vaccine supply, Bavarian Nordic has announced plans to ramp up production. According to the company, it has the capacity to manufacture 10 million doses by the end of 2025, in addition to current orders. In addition, the company is also taking steps to make the vaccine availa-

ble to children and adolescents – after all, most of the mpox cases reported in Africa at the moment occur in those younger than 18, for whom no vaccine is currently available. It has already submitted clinical data to EMA to potentially support the use of the mpox vaccine in 12–17-year-olds, and will shortly initiate a clinical trial to assess the immunogenicity and safety of MVA-BN in children from 2-12 years of age.

“Bavarian Nordic is working closely with all stakeholders to ensure the equitable access to our mpox vaccine […].

Importantly, we have built a strong partnership with the Africa CDC, both on supply, but also expanding our manufacturing network to include Africa. We are also working with the WHO on a regulatory path to ensure access to all countries, while in parallel seeking approval for use in adolescents and conducting clinical studies in Africa to further expand the use to children,” said Paul Chaplin, President & CEO of Bavarian Nordic. In mid-September, the WHO added MVA­BN to its prequalification list and set up access schemes for badly-hit African countries.

NEWS

US partner

Gothenburg- and Stockholmbased biotech Oblique Therapeutics AB has announced a research collaboration with Eli Lilly and Company to use its proprietary AbiProt technology to generate antibodies for a high-value target. The partnership aims to accelerate innovative treatments, adding a second target to an an existing agreement between the two companies. Financial details were not disclosed.

Closing down

After an extensive search for a partner to advance its promising Tourette syndrome therapy, sepranolone, Solna-based Asarina Pharma AB has decided to liquidate. Despite showing a 28% reduction in tic severity compared to standard care in a Phase IIa study earlier this year and contacting more than 200 companies, no partnership or acquisition deal materialised, leading the Swedish company to fold.

Phase III setback

A Phase III trial evaluating AstraZeneca and Daiichi Sankyo’s potential “blockbuster” lung cancer drug datopotamab deruxtecan (DatoDXd), a specifically engineered TROP2-directed DXd antibody drug conjugate, showed no significant improvement over standard chemotherapy in the general study population. The results were published in the JourNal of cliNical oNcology (DOI: 10.1200/JCO-24-01544).

AstraZeneca’s share price dropped 5% following the announcement.

Money boost

FINANCING Belgian GPCR specialist Confo Therapeutics NV has raised €60m in a Series B financing round led by Ackermans & van Haaren to advance clinical development of two clinical programmes and preclinical candidates to treat rare endocrine diseases and obesity. “Our plans include potential new therapies for severe rare endocrine diseases, as well as next-generation obesity drugs which could be used in combination with, or as an alternative to, GLP1R agonists,” stated Cedric Ververken, CEO of Confo Therapeutics.

Besides lead investor Ackermans & van Haaren new investors and existing investors, BioGeneration Ventures (BGV), Capricorn Health-tech Fund (CHF), Fund+, MINTS (University of Michigan), Perceptive Advisors, Qbic, PMV, V-Bio Ventures, VIB and Wellington Partners participated in the financing.

The money will be used to finance Phase I testing of the AT2 receptor antagonist CFTX-1334 designed to treat peripheral pain together with Confo’s partner Eli Lilly as well as one of Confo’s proprietary GPCR agonists in lead optimisation stage, targeting SST receptor 4 (pain), MC1 receptor (fibrosis) or SST receptor 5 (hyperglycaemia). Furthermore, development of two programmes in discovery stage will be pushed forward through IND, a GPR75 antagonist to treat obesity and a PTH receptor 1 agonist to treat hyperparathyroidism. Also on the list: the discovery of novel Class B GPCRs modulators for rare endocrine disorders. L

First cultivated pet food approved

CELLULAR AGRICULTURE

British Good Dog Food Ltd (Meatly) has received regulatory clearance to sell its slaughter-free cultivated chicken as pet food in the UK. The company announced in mid-August that it has got Europe’s first market approval for a cellbased product from the Food Standards Authority and the Department for Environment, Food and Rural Affairs. Meatly said that its cultivated chicken will enter UK supermarkets this year.

The product is made from immortalised chicken stem cells obtained from chicken egg, which are cultivated in a in house serum-free medium costing less than £1 per litre, the company reported. This is a significant reduction in costs, making Meatly’s production at the industrial scale more economically. The Brits have prepared a robust safety dossier and performed extensive testing to demonstrate that its cultivated chicken is safe and healthy for pets to eat. The product has the same nutritious score than pet feeds containing meat. It is GMO, heavy metal and antibiotics free.

Meatly plans to continue its cost reduction work and start scaling production to reach industrial volumes within 3-5 years. Agronomics has invested £1.2m of £5.4 overall into Meatly since inception of the company two years ago.

The investor has an equity ownership of 38.7% on a fully diluted basis.

There are several pet food companies aiming for scaling and EU market approval. Hamburg-headquartered startup MicroHarvest offers a 100% vegan hypoallergenic alternative made from single cell bacterial protein. At the end of April, the company, which has a scalable plant in Lissabon, Portugal, teamed up with animalfree pet food producer VEGDOG to unveil first­of­its­kind microbial protein dog treat, which was presented at the 2024 Pet Food Forum during Interzoo (Nuremberg, Germany). Microharvest’s microbial protein is mixed with potato and apple pomace.

According to a survey 78% of dog owners would prefer microbial protein-based over poultry-based dog food.

At the end of last year, Czech startup Bene Meat Technologies claimed it was the first company in the world to receive EU Certification by Feed Materials Register for its mammalian cell-based meat for pet food. That is, the Czech company is the only company fulfilling the safety requirements so far to market its product. In August, the European Food watchdog EFSA has deemed Impossible Foods‘ fermentation-derived soy leghemoglobin, which mimics meat taste, as safe for consumption. L

Novel ADC payload

CELL THERAPY Danish Novo Holdings A/S and British Abingworth LLP have co-led the largest European Series A financing round in 2024 by August. Together with existing and new investors, they put £90m into cancer antibody-drug conjugate (ADC) specialist Myricx Bio Ltd, a spin-out founded by Professors Ed Tate and Roberto Solari. The assets will be used to build out Myricx Bio’s ADC platform and advance its pipeline through clinical proof of concept. The Brits have developed a novel payload class for cancer-targeted ADCs. These N-myristoyltransferase

inhibitors (NMTi) have overcome drug resistance of microtubule and topoisomerase blocking payloads. NMT is an enzyme that adds a myristic acid to a number of protein targets key to cancer cell survival. Catalysed by two N-myristoyltransferases, this modification can be co ­ or posttranslational. Myricx Bio has preclinically shown that NMTi-ADCs MYX2449 (Her2), MYX2468 (Trop2) and MYX2470 (B7-H3) achieved complete and durable tumour regressions, at well tolerated doses, in solid cancer models and organoids refractory to existing ADC payloads. L

TCR-T therapy hits solid tumours NEWS

CANCER Based on a response rate of 39% and increased tumour infiltration, the FDA has granted accelerated approval for the first TCR­T cell therapy designed to treat a solid tumour. British Adaptimmune plc celebrated the conditional market authorisation of afamitresgene autoleucel (ADP-A2M4, Tecelra) as a breakthrough for genetically engineered T cell cancer treatments.

So far, the success of CAR-T or TCR-T cell therapies was limited to blood cancers that make up only 10% of all cancers. Adaptimmune’s therapy, which

targets the MAGE-A4 antigen on tumours, is for patients with HLA-A*02positive, metastatic or unresectable synovial sarcoma and comes at a price of US$727,000 for one shot.

Following this FDA pre-approval, Adaptimmune must provide efficacy data in order to receive full approval. This April, Roche’s US subsidiary Genentech Inc terminated a collaboration with Adaptimmune inked in 2021 to develop five MAGE ­ A4 ­ based allogeneic TCR­T therapies based on induced pluripotent stem cells. L

Carbios set to expand

RECYCLING French enzymatic plastics recycling specialist Carbios SAS is set to export its very first PET recycling plant to the UK. In August, Carbios SAS and British recycling and waste management company FCC Environment plc announced they have inked a Letter of Intent (LOI) to establish a PET biorecycling facility in the UK.

Carbios’ enzymatic process for depolymerisiation of PET plastic and textile waste into virgin-like products yields over 95% monomer recovery rate, which would mean 20 recycling cycles for every ton of PET newly produced. The com-

pany will open a first recycling plant in Longlaville, France in 2025. The plant will have the capacity to process 50,000 tons of prepared PET waste per year (equivalent to 2 billion coloured bottles, 2.5 billion food trays or 300 million T-shirts).

Carbios’ CEO Emmanuel Ladent told europea N BiotechNology that the expansion of the company’s enzymatic PET recycling technology is only one pillar in the company’s business strategy. Another is PLA plastics and screening for enzymes that depolymerise other plastics that are resistant to biological decay such as PE or polyamides. L

No torture food

In August, three year old Paris-headquartered Gourmey SAS has submitted the very first EU authorisation application for a cell-based meat product, a duck liver pâté (Foie gras), to the European Food Safety Authority (EFSA). Once cultured foie gras is deemed safe and authorised for sale, consumers in the EU will have the opportunity to enjoy foie gras without the associated negative side effects on animal welfare and the environment. Gourmey states that they produce their product without animal ingredients such as foetal bovine serum and without antibiotics

Clear sight

AI specialist WhiteLab Genomics, the Vision Institute, an international research cent, and ADLIN Science SA have got €4m national funding to develop AAV vectors that allow gene therapy delivery to the outer retina.

Asian expansion

GCPR-screening specialist EuroscreenFast NV and South-Korean distributor GW Vitek inked a strategic collaboration in July. Under the agreement, GW Vitek will represent EuroscreenFast’s discovery and lead optimisation capabilities in the Republic of Korea. While EuroscreenFast has had some presence in EastAsia, this partnership will enable significant expansion of its commercial reach into the Korean market. EuroscreenFast aims to provide its GPCR cell-based assay services and a robust deorphanisation offering to a broader range of clients.

Model of Carbios’ French PET recycling facility in Longlaville

Viennese

Deal

ACQUISITION I Ligand Therapeutics paid US$100m to acquire Apeiron AG from Vienna, Austria. Ligand also commits to invest up to US$4m in Apeiron spin-off, invIOs which has taken the research pipeline from the mother company some years ago.

Apeiron shareholders are also entitled to additional consideration based on future commercial and regulatory events and up to US$28m if QARZIBA® royalties exceed certain pre-determined thresholds by either 2030 or 2034. The transaction finally closed in summer 2024.

The proceeds of the additional investment will be used by invIOs to fund the research and development of three innovative early-stage immuno-oncology assets. Apeiron is entitled to royalties and milestone payments on these assets. The company, known for its innovative approaches to immuno-oncology, received marketing approval from the European Medicines Agency in 2017 for APN311 (dinutuximab beta, QARZIBA®) for the treatment of high-risk neuroblastoma in patients aged twelve months and older.

Peter Llewellyn-Davies, CEO of Apeiron, said: “We have spent more than twenty years translating academic research into therapeutic products for diseases with high unmet need. This is an historic moment for Apeiron and its shareholders. We are delighted that Ligand has recognised the importance of our work. The sale also is an encouraging signal for the entire Austrian biotechnology industry”, Davies resumed. 

Fresh cheese without animal: Formo in supermarket shelf

NEWFOOD Formo made it through the back door into the shelfs of large German supermarket retailer REWE group, METRO and others in Germany and Austria. The Berlin-based laboratory cheese developer is using a protein from the koji mushroom, which has long been traditionally used in the preparation of soya sauce, for example. The clue: no extra authorisation under novel food legislation is required for the new cream cheese product. REWE also entered a €55m financing round bringing the total of investments in Formo to US$117m. The food start­up is now the world’s first manufac-

turer to launch animal-free cheese alternatives with proteins from the koji mushroom. Since the beginning of September, three types of fresh cheese and a Camembert alternative have been available in 2,000 REWE shops, at Billa in Austria and at Metro in Germany.

Formo, led by Raffael Wohlgensinger, use the proteins of koji mushroom through microfermentation. The protein further processed as a powder. A family cheese dairy in northern Germany produces the cheese for Formo in the traditional way: from the protein powder, vegetable fats, water, salt and ripening cultures.

First IPO in Germany for years

GOINGPUBLIC 2016 was the last biotech IPO in Germany. Eight years later the Berlin/Wurzburg located Pentixapharm Holding AG (Photo: CEO Hakim Bouterfa) is heading for an IPO at Frankfurt Stock Exchange later in this year. The topic of the company is 'theranostics', the combination of diagnostic measures (i.e. imaging) and therapeutic applications via the same molecular vector but with different radioligands for different options in the tissue. Pentixapharm is a daughter company of Eckert & Ziegler SE, producing isotopes in a wide range of applications and also medical engineering. The molecule in focus is CXCR4, a metastasis marker in cancer. L

GeneData goes Danaher

ACQUISITION II GeneData, the Swiss specialists for data analysis in life sciences laboratories, has agreed to be acquired by the US-based Danaher Corporation. Financial details have been kept under wraps.

The ‘global digital innovator’ (selfdescription) Genedata, based in Basel, Switzerland, has a history of 30 years of company development, and has positioned itself as a leading provider of software solutions for biopharmaceutical research and development.

In the founding year, founder Othmar Pfannes was able to recruit Hans Peter Fischer, a physicist from the University of Constance, as one of the first employees, with whom he has since worked together to develop in silico methods for analysing genomes, signalling pathways and promoters for a better understanding of the complex interrelationships in human biology. Genedata has delivered customisable solutions that have become the standard for the world’s top 25 leading biopharmaceutical companies. 

Nestlé buys in stool therapy

MICROBIOME The Swiss Nestlé Group has reached an agreement with the US company Seres Inc. (Cambridge, Massachusetts) to acquire the FDA-approved microbiome therapy VOWST. In return, Seres will receive around US$175m upfront and a high three-digit million amount if certain sales figures for the therapeutic are achieved.

Just a few weeks ago, it was only a non-binding memorandum of understanding between Nestlé S.A. and Seres Therapeutics Inc. regarding the acquisition of the only FDA-approved microbial therapy to date. Nestlé has now acquired the entire business unit and is taking a stake of approximately US$15m in Seres.

Interestingly, Seres moves forward with its owned pipeline. Just recently the company has announced promising but early results for a new experimental treatment. In a Phase Ib trial with data from 34 blood cancer patients receiving stem cell transplants, 10% of those given the drug developed bloodstream infections during the 100-day trial, compared with 43% of those given a placebo. And people on the drug, called SER-155, spent an average of nine days on antibacterial and antifungal drugs, compared with 21 days for placebo recipients, the company said. The ‘living drug’ is a consortium of bacterial species selected using Seres’ discovery MbTx platform. 

NEWS

CDMO expansion

Vetter Pharma Group is expanding its site for pharma fill solutions in Vorarlberg, Austria. Due to demand exceeding its own expectations, Vetter is expanding the Rankweil site in Austria. An additional floor of around 330 square metres is now being added to the existing two-storey building for further office use, as well as a technical building with additional 3,400sqm.

Subcutan from Roche

Roche Holding is celebrating a FDA approval. Its antibody against Multiple Sclerosis ocrelizumab & hyaluronidase-ocsq is now approved for the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) subcutaneously and can now be administered much more easily twice a year.

Animal health

German pharma company Boehringer Ingelheim buys Swiss animal health company. After three previous licensing deals, Boehringer Ingelheim has now topped it off: the pharmaceutical company is acquiring the Swiss animal health specialist Saiba Animal Health for an undisclosed purchase price. Saiba produces customised pet-vaccines against selected diseases. The vaccines consist of virus-shaped nanoparticles, also known as virus-like particles (VLPs), in which copies of any disease-causing molecule are chemically bound to the VLP surface and activating the host immune system.

Data quality and operability are key for any new KI-driven approach

New Fund

FINANCE Portugal’s leading VC investor, Biovance Capital Partners, announced in July the closing of the first dedicated early-stage biotech drug development fund in Portugal at €51m. Lead investors in the Biovance Capital Fund, which officially aims to provide seed financing of €1.5m to €6m in all unmet indications across Europe, include the European Investment Fund (EIF), Banco Português de Fomento (BPF), and the European Commission through the Portugal Tech and InvestEU programmes. Other investors include Caixa Capital, Ageas Pensions, EDP Pension Fund, and private investors from the USA and Europe. Within Portugal Tech, the EIF and BPF have already collaborated on a joint €100 million investment programme for Portuguese technology transfer projects, start-ups and SMEs.

Three experts make up the team of the new fund. Ricardo Perdigão Henriques, Managing Partner of the fund, said at the closing: “As the first ever biotech fund, Biovance Capital Fund I marks a significant milestone in the development of Portugal’s biomedical ecosystem.” João Incio is also involved as General Partner and André Albergaria as Principal. The composition of the team alone shows that the fund will focus its investments on Southern Europe, which started late in biotechnology but is booming. EIT CEO Marjut Falkstedt confirmed: “We are delighted to partner with Biovance Capital to close the financing gap for biotech companies in Southern Europe”. 

Authentic egg

PARTNERSHIP Spain’s largest producer of omlets, Grupo Empresarial Palacios Alimentación, has partnered with USbased cultivated egg manufacturer The Every Company to produce a liquid egg alternative not affected by avian flu. According to the Spanish food giant, Palacios will use the precision fermentation product in its flagship Spanish omelets and will use it as a base for the development of new products. Every’s product line is produced in the heterotrophic yeast Komagataella phaffii engineered to express egg proteins. Financial details of the deal were not disclosed. Palacios said that it selected The Every Company due to the “delicious taste and culinary versatility of the EVERY Egg.” The product was launched in December 2023 by a chef in New York City. 

Sector growth

ASEBIO REPORT Spanish biotech association AseBio has published 2023 growth figures of the flourishing Spanish biotech ecosystem, which is leading Europe in terms of the number of clinical trials conducted. According to the “AseBio Report 2023 “25 Years of Biotechnology”, investment in R&D by biotech companies grew by 17% compared to 2022 to €1,218m. After a decline in private funding for the sector in 2022, 2023 saw a 37% increase, reaching a historic high of more than €228m across 42 deals. In 2023, Asebio counted 974 biotechs mostly active in pharma biotech (52%). With 24.9% Catalonia has the highest number of biotechs, followed by the Madrid area (17.3%), Andalusia (12.9%), the Basque Country (9.45%), and Valencia (8.62%). 

Coloured seabass

CULTURED FISH

Researchers headed by Diana Marques and Afonso Gusmão from Instituto Superior Técnico at the University of Lisbon have 3D printed seabass filets from cultivated fish cells. Now they want to scale up production in bioreactors that use small electric shocks to align cell cultures, mimicking the fibrous texture and structure of the filet. Together with the Portuguese Institute of the Sea and Atmosphere they want to arrange tastings that compare the new product against conventional seabass. While overfishing is a problem, Marques said, “we need sustainable alternatives”. L

Picture:

Técnico

EMAgate: PharmaMar victorious

CONFLICT OF INTEREST The European Commission has fully upheld the complaint by Spanish PharmaMar SA due to conflicts of interest of leading EMA experts in the (non-)authorisation of Aplidin.

At the beginning of Juli, the European Commission has corrected its decision C(2018) 4831 from 2018 not to grant marketing authorisation for Aplidin (plitidepsin), a peptidic cell cycle blocker and apoptosis inducer for the treatment of the blood cancer multiple myeloma, because the EMA experts involved in the negative recommendation of the CHMP had a not disclosed conflict of interest that violated the principle of impartiality.

Unusual procedure

Prof. Dr José Maria Fernández Sousa-Faro, Chairman of PharmaMar’s Board of Directors, described the way to the EMA refusal as follows: Initially, “EMA’s rapporteur and co-rapporteur recommended the approval of plitidepsin with no outstanding issues. Then inexplicably, the CHMP summoned an oral explanation […] in which the Swedish and Danish CHMP members attacked the recommendation of the rapporteur and co-rapporteur leading to a negative vote. In Australia, the authorities with the same Phase III study we presented to the EMA concluded that the drug was safe and there was a positive benefit for the patients.”

After the European Court of Justice confirmed this view in 2020, the Commission reviewed the criteria for the involvement of experts in the administrative procedure for the authorisation of Aplidin and the relevant EMA rules on conflicts of interest to ensure the objective impartiality of these experts. But only four years later, the Commission noted that only one of the experts of the Scientific Advisory Group (SAG) involved as lead investigator in the Phase I tests of the competitor product Cellprotect, an autologous NK cell therapy, at the Karolinska Institute‘s hospital, developed by the Swedish XNK Therapeutics AB, which went bankrupt in April this year, should not

have been allowed to participate in the authorisation procedure for Aplidin.

Tip of the iceberg

In Spring 2023, Sousa-Faro told europeaN BiotechNology that all four members of the CHPM that bypassed the rapporteur’s and co-rapporteur’s recommendation for market approval of Aplidin, have had training at the Karolinska Institute: Tomas Salmonson, previous Chair of the EMA’s CHMP, Filip Josephson, Chair of the Scientific Advisory Group (SAG), Jonas Bergh, SAG’s multiple myeloma expert, and Hareth Nahi, Principle Investigator or the Phase I trial on CellProtect and previous Medical Advisor at XNK Therapeutics AB.

Coincidence or intent?

Furthermore, it remains unclear why Estonia and Germany appealed against the judgement of the 6th Chamber of the EU Court of Justice in 2020, while the European Commission did not, which must be understood as an implicit acceptance of the judgement. In 2023, the Court of Justice of the European Union subsequently set aside the General Court’s 2020 judgment and referred the case back to the General Court for it to rule again on the first ground for annulment raised by PharmaMar in its original action and, if it considers it necessary, on the second ground for annulment and, if it considers it necessary, on the other grounds for annulment of the action. That is, to rule not only on the conflict of interest and the breach of the principle of objective impartiality by the EMA, but also on the breach of the principle of sound administration, the breach of the principle of equal treatment and the incorrect analysis of the scientific evidence submitted by PharmaMar, the breach of the duty to state reasons and the breach of the rights of the defence. Should Aplidin be granted marketing authorisation, the exciting question remains as to who will have to pay what amount for the lost profit within the patent term of Aplidin (see comment p. 31). 

Pretty with exosomes

Naples-based Arterra Bioscience SpA and Siena-based Exosomics Inc have signed a strategic agreement at the end of July, to set up a joint venture in the space of plant exosomes. The plan is to formulate plant exosomes for topical application in regenerative aesthetic medicine and medical devices. Exosomes mediate wound repair, has anti-aging effects, inhibits hyperpigmentation and modulate collagen synthesis are thus a rising star in aesthetic medicine. The activities of the joint-venture will later be extended to applications in other fields such as nutraceuticals and biomedical products.

Money for protein

Pamplona-based alternative protein fermentation specialist MOA Foodtech has raised €3m in a Series A financing led by ICOS Capital Management BV with Clave, Viscofan, Sodena, and Banco Sabadell participating. The 15 headed team will use the proceeds to expand its product portfolio and advance its AI platform “Albatross” that selects the optimal microorganisms for costly and efficient conversion of a food sidestream, such as cereal and legume residues, into protein.

Smart foundress

Marianna Prokopi-Demetriades, founder and CEO of the Cypriot cancer biotech companies RSL Revolutionary Labs Ltd, Theramir Ltd and Promed Bioscience Ltd, was honoured with the Volkswagen Foundation’s Falling Walls Female Science Talents Award 2024 in August.

Pipeline update

PARTNERSHIP Sotio Biotech

AS signed a licence option agreement with antibody maker Biocytogen Co Ltd (Beijing) in August. Under the contract, Prague-based Sotio will pay up to US$325.5m biobucks to use Biocytogen’s RenLite antibody discovery platform to design bispecific antibody drug conjugates (ADC) that home in on selected different cancer targets. The companies did not specify the amount of the upfront payment. Biocytogen will be eligible to receive single-digit royalties on net sales on a product-by-product basis. Sotio will be responsible for preclinical and clinical development, manufacturing, and commercialisation of the ADC products. The contract also grants Sotio the option to license multiple fully human bispecific antibodies generated with Biocytogen’s proprietary RenLite platform, which Sotio will use to develop next-generation antibodydrug conjugates (ADCs) targeting solid tumours. The agreement also includes an option for Sotio to leverage Biocytogen’s proprietary ADC platform.

Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice (RenMab/ RenLite/RenNano/RenTCR-mimic) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCRmimic antibody discovery, and has established a sub-brand, RenBiologicsTM, to explore global partnerships for an off-theshelf library of >400,000 fully human antibody sequences against 1,000 targets. 

Scaling up cell-based food

NOVEL FOOD Poland, the country, which supported to restrict market access for cultured food this year together with a coalition of eight partners (see europea N BiotechN ology 1/2024), is investing €2m in cultivated meat. In August, Poland’s National Centre for Research and Development greenlighted a funding of PLN9m (€2m) in LabFarm Sp. zoo – the country’s first cultivated meat company. Originally, LabFarm applied for a grant of more than PLN16m. Financing started on 1 August this year.

LabFarm, which specialises in cultivated chicken, said they had previously relied on private funding but this grant will enable them to carry out the research needed to increase production capacity, optimise their processes and expand their workforce.

Government funding like this will play an essential role in supporting the growth of a flourishing ecosystem for

cultivated meat start-ups in Poland and beyond.

LabFarm is the only company in Poland that produces cellular meat, i.e. meat from cells that come from animals but are cultivated outside the animal. The main investor to date is Jarosław Krzynanowski, president and owner of the KPS Food meat group and the Foundation Fundacja Krzynanowski Partners. LabFarm currently produced cellbased poultry meat at 200 litre scale and presented a pilot product this June. The grant will be used to scale production and for optimisation of the culture medium. According to media reports, the company is in talks with a British pet food producer to launch a chicken-based pet food product in the European market.

By the end of last year, at least 174 companies were working on the manufacture of cell-based meat. L

Hungary thwarts NGT draft

AGRICULTURE After the Spanish and Belgian EU Presidencies failed to win an EU majority in favour of a law providing for relaxed rules for the authorisation of plants produced using new genomic technologies (NGT), the Hungarian Presidency now wants to put the law on hold until 2027. A 10-point plan to be discussed at working level at the first Council meeting under the sixmonth Hungarian EU Council Presidency, which began on 1 July, envisages waiting for the results of the two EU funding programmes Darwin and Detective on detection methods for NGTs, which run until 2027, and discussing contentious issues in the meantime. In Hungary’s view, this also includes the criteria used to differentiate between deregulated NGT1 and NGT2 breeds authorised under the current GMO legislation. Hungary does not want to apply the depth of genetic intervention, as provided for in the draft law,

but is in favour of risk assessment and authorisation on a case-by-case basis. Like Poland, Hungary also wants mandatory labelling for NGT-1 plants and legally binding coexistence rules to protect organic farming. Hungarian Agriculture Minister István Nagy also wants to clarify whether the draft law is compatible with the Cartagena Protocol on Biosafety. However, scientific opinions presented by the European Food watchdog EFSA in mid-June and at the end of July confirm the EU Commission’s view: plants and microorganisms produced using new genomic techniques such as CRISPR-Cas 9 are indistinguishable from their conventionally produced counterparts in terms of health and environmental impact, the EFSA reported. The authority emphasises that there is no scientific need for different regulations, but that these are purely political in nature. EuropaBio welcomed the EFSA statement.

No longer interim

FARON PHARMACEUTICALS Yrjö Wichmann, Faron’s interim Chief Financial Officer since mid ­ April, has now been appointed as permanent CFO of the Finnish biopharmaceutical company. He had already headed the finance division of Faron Pharmaceutical Ltd between 2014 and 2019. Most recently, he held the position of Senior Vice President, Financing & Investor Relations.

New CFO welcomed

OXFORD BIOMEDICA The cell and gene therapy CDMO, Oxford Biomedica plc, announced the appointment of Lucinda Crabtree

Ph.D. as Chief Financial Officer (CFO) and member of the Board of Directors in September. After nearly seven years of service, Stuart Paynter has stepped down as CFO and member of the Board of Directors. He will leave Oxford Biomedica after an appropriate handover period. Crabtree was previously CFO at MorphoSys AG. There she led a finance team in the US and Germany until the completion of the acquisition of the company by Novartis. Prior to joining MorphoSys, Crabtree was CFO at Autolus Therapeutics, a Nasdaq-listed clinical-stage biopharmaceutical company.

Prior to Autolus, she spent several years as an investment professional at Woodford Investment Management, Panmure Gordon, Goldman Sachs, J.P. Morgan (originally Bear Stearns) and Jefferies. She holds a Bachelor of Science in Physiology and Pharmacology from University College London and a PhD in Pharmacology from University College London. L

Experienced Support

AAX BIOTECH The Swedish biotech startup AAX Biotech AB has welcomed Patrik Stroemberg as a new member of the Board of Directors. He brings more than two decades of extensive experience in the pharmaceutical industry and a solid background in research and development, innovation management and business development to the Stockholm-based company. He gained this from key positions at pharmaceutical companies such as AstraZeneca and Biovitrum/Sobi. Stroemberg has been CEO of AnaCardio since 2021. He holds a PhD in biochemistry from Karolinska Institutet and an MBA from Stockholm University. L

New Managing Director

FONDAZIONE TELETHON Ilaria Villa has took over as Managing Director of the non ­ profit Fondazione Telethon in midSeptember. The Italian foundation aims to make innovative therapies available to people with rare diseases. Her predecessor Francesca Pasinelli will relin -

quish her operational duties. However, she will remain a member of the Board of Directors with special mandates. Villa has held management positions in various multinational pharmaceutical companies, including Roche, Zabon and UCB. There she was involved in the development and market launch of several innovative drugs in various therapeutic areas. Now she would like to contribute her extensive experience to support the work of the foundation. Founded in 1990, the non-profit Fondazione Telethon has set itself the goal of making innovative therapies accessible to people with rare diseases that are not always viable for companies. L

Management changes

DIOGENX In September, French Biotech Company DiogenX appointed Dr Eleanor L Ramos, MD, an Independent Board Member. She brings a wealth of clinical expertise in autoimmunity, inflammation, organ transplant rejection and the treatment of acute and chronic viral infections. Notably, she served as Chief Medical Officer at Provention Bio, an immunology-focused company acquired by Sanofi in 2023. Previously Dr Ramos held Chief Medical Officer positions in several biotechnology companies, including Global Blood Therapeutics, Theraclone Sciences, and ZymoGenetics. In this Summer the Marseille-based Company had also welcomed Hélène Sicard, PhD, as Chief Development Officer, Laetitia CohenTannoudji as Senior Director, CMC, and Joanna Fares as Director of Drug Development Sciences. In addition, Renaud Perret joins the team as Director of Administration and Finance. L

Lucinda Crabtree

Patrik Stroemberg

Yrjö Wichmann

Ilaria Villa

NEWS

Immune system-on-chip

Researchers at Institut Pasteur have developed an artificial “lymphoid organ-chip” that recreates much of the human immune system’s response to mRNA and protein booster vaccines against SARSCoV-2. The group headed by Lisa Chakrabarti suggest that the chip could be used to evaluate the likely effectiveness of new protein and mRNA-based booster vaccines for COVID-19 and other infectious diseases.

Alcohol antidote

An international consortium led by Raffaele Mezzenga from ETH Zürich has found an antidote for alcohol intoxication. Their orally administered biomimetic-nanozyme amyloid hydrogel was stable, safe in mice and converted 55% of alcohol within 300 min after intake into harmless acetic acid. It is made of single-site iron-anchored cheese byproduct beta-lactoglobulin and catalyses alcohol oxidation by mimicking the coordination structure of the natural enzyme horseradish peroxidase, which is responsible for the breakdown of alcohol in the body.

ADEs of obesity drugs

In a cohort study, Swedish scientists led by Peter Ueda from the Karolinska Institute in Stockholm have confirmed the FDA’s assessment that the use of obesity/diabetes drugs containing GLP-1 agonists does not increase the risk of suicide. In September, the scientists reported that in their study that enrolled patients with type 2 diabetes, they found no link to self-harm, depression or anxiety disorders.

Bacterial cure for chemotherapy

CANCER Cytotoxic chemotherapeutics have devastating side effects, particularly within the gastrointestinal tract. Nearly 80% of patients undergoing a chemotherapy face adverse effects such as nausea, diarrhoea, and painful inflammation limiting their quality of life. Now a team of microbiologists from Belgian VIB in Ghent, and the Universities of Luxembourg, Edinburgh, and Washington School of Medicine, have unveiled how communication between gut bacteria and mammalian cells hinders intestinal recovery after chemotherapy.

Microbiome affects recovery

Data of an multi-pronged analysis, indicate that gastrointestinal toxicity induces dysbiosis, caused by epithelial apoptosis and a resulting imbalance in the

intestinal microbiota, namely in the Enterobacteriaceae signaling axis fuels dysbiosis. Specifically, VIB group co ­leader Lars Vereecke and colleagues, who led the research, demonstrate that chemotherapy-induced epithelial cell apoptosis and purine-containing metabolites released from dying cells drive the interkingdom transcriptional re-wiring of the Enterobacteriaceae, including fundamental shifts in bacterial respiration and promotion of purine utilisation-dependent expansion, which in turn delays the recovery of the intestinal tract. When they blocked epithelial cell death or restricted Enterobacteriaceae to homeostatic levels, dybiosis was reverses. They conclude that maintaining homeostatic levels of E nterobacteriaceae may be useful in resolving chemotherapy-caused intestinal disease. L

Targeting immune switches

AUTOIMMUNITY Modulating the ability of T cells to change an pro ­inflammatory into an immune-dampening or tolerogenic phenotype has recently gained traction as a therapeutic approach to calm down autoimmune diseases and inflammatory (“hot”) cancers. Researchers at University Hospital Hamburg-Eppendorf have now laid the foundation to screen for molecules that shift Th17 cells from proinflammatory to immune-dampening mode.

CRISPR screen

Using an in vivo pooled scCRISPR droplet sequencing (iCROP-seq) screen, the team of Christian was able to identify the genes behind Th17 cell plasticity in mouse kidney and gut inflammation models. Subsequently, they ranked the resulting transcriptional perturbations, and polarisation biases into TH1 and regulatory T cells (Tregs) demonstrating that iCROPseq can facilitate the identification of therapeutic targets by efficient functional

stratification of genes and pathways in a disease ­ and tissue ­specific manner. The group also noted this plasticity in kidney biopsies of 11 patients with ANCA-associated glomerulonephritis. Their findings, based on single-cell (sc) T cell receptor analysis and scRNA velocity, demonstrate an approach to uncover molecules driving T cells to adopt either pro ­ or anti­inflammatory states. With further study, clinicians may be able to manipulate plasticity therapeutically in ACNA-glomerulonephritis and inflammatory conditions such as inflammatory bowel disease. “Allowing the screening of numerous therapeutic candidates in one experiment, iCROP-seq is a powerful tool to understand disease mechanisms at the molecular level,” said group leader Christian Krebs. “This could accelerate translational research and help to bridge the translational gap between the identification of transcriptional differences and clinical application by preselecting the most promising candidates for functional testing.” L

Breaking bad bugs

AMR A Dutch-German research team together with Evotec SE have presented a new class of antibiotic vancomycin derivatives with good safety profile that kill multiresistant, Gram-positive bugs.

Dutch and German drug discovery specialists report that their new series of semisynthetic vancomycin derivatives broadly neutralised methicillin-resistant Staphylococcus aureus (MRSA) and other antibioticresistant strains outperforming vancomycin in terms of safety and efficacy in challenged mice. the compounds may reduce the burden of antimicrobial resistance (AMR).

Vancomycin-resistant enterococci today make almost 30% of enterococcal infections in healthcare settings. However most semisynthetic vancomycin derivatives so far caused serious side effects. Now, Emma van Groesen and colleagues from Universities of Bonn and Leiden as well as the CRO Evotec SE report on guanidino lipoglycopeptides, which demonstrate strong antibacterial properties while having a favorable safety profile and a low propensity for resistance. When tested against a panel of Gram-positive bacteria such as MRSA, the glycopeptides neutralised the bacteria without damaging eukaryotic cells. Further stud-

ies showed that the compounds killed both wild-type and vancomycin-resistant bacteria by engaging with lipids on the bacterial cell wall with a higher affinity than vancomycin.

Guanidino lipoglycopeptides contain a positively charged guanidino moiety bearing a variable lipid group. Mechanistically, guanidino lipoglycopeptides engaged with bacterial cell wall precursor lipid II with a higher binding affinity than vancomycin. Binding to both wildtype d-Ala-d-Ala lipid II and the vancomycin-resistant d-Ala-d-Lac variant was confirmed, providing insight into the enhanced activity of guanidino lipoglycopeptides against vancomycin-resistant isolates.

One candidate named EVG7 was welltolerated and outperformed vancomycin in mice with S. aureus thigh infections and in a 7-day survival study in mice with sepsis. Van Groesen et al. did observe some minor signs of kidney toxicity in the sepsis study at supratherapeutic doses of EVG7, and call for work in more advanced in vivo models to establish the peptide’s safety profile before human testings.

KI diagnosis

CANCER Scientists led by Stefan Blankenberg from the University Medical Center Hamburg-Eppendorf (UKE) and Cardio-CARE in Davos have developed a new method that can rule out heart attacks after chest pain within minutes. At the Congress of the European Society of Cardiology (ESC) in London and in Lancet Digital Health, the team reported that twice as many heart attacks as before can be ruled out using a new singleuse POC troponin test in combination with the ARTMIS algorithm, that analyses eight clinical variables. The POC-Troponin/Artemis algorithm combination ruled out heart attacks with almost 100% certainty in 35% out of 75% of 2,500 patients included in the study, who definitely not had a heart attack. With the troponin laboratory tests recommended in the guidelines, this was achieved in 1415% of patients. In the long term, cardiologists hope that the new test option will relieve the burden on hospital emergency departments.

Troponin is a protein complex that only occurs in the heart muscle and is released into the blood when the muscle cells are damaged. International guidelines recommend laboratory-based troponin tests to diagnose a heart attack that take up to 60 minutes, in 20% of patients a second test is required two hours after initial measurement of the troponin blood level. The new troponin rapid test, presented in London together with ARTMIS analysis, enables a diagnosis of myocardial infarction within around eight minutes.

AI progressing

Further improvements in the diagnosis of acute coronary syndrome are hoped for thanks to an AI-Software developed by the Austria-based AI company RobotDreams GmbH, which is currently validated in a study with 2,700 blood samples at University Linz. Analysing blood parameters it differentiates different heart defect within seconds without the requirement for a troponin test. L

Words to actions

European Biotechnology

Austria: lifescienceaustria.at

United States: slas.org

biotechaustria.org

swissbiotech.org EuropE an BiotEchnology covers the biotechnology sector of the current 27 EU member states, Norway, Switzerland, and

If you would like to subscribe, please refer to european-biotechnology.com

FRANCE BIOTECH Pathological anatomy and cytology are essential for diagnosing certain cancers and rare diseases. With the growing demand for precise diagnoses, pathologists’ workload is increasing, both in terms of quantity and complexity. The French biotech association France Biotech has proposed 32 actions to promote the emergence of an anatomic pathology sector of excellence in the country. According to the association, the sector is at the dawn of a crucial digital transformation, which will require the support of public authorities to finance the associated investment costs. “With this very detailed study [...], we have now drawn up a precise inventory of the obstacles that need to be overcome if we are to turn the tide and begin the digital transformation of anatomopathology”, commented Frédéric Girard, President of France Biotech.

Ideas to market

ASEBIO AseBio and the Spanish National Research Council CSIC have signed a framework agreement with the aim of facilitating the development of biotech research projects between CSIC researchers and AseBio’s member companies. The mission of the agreement is to promote collaboration in R&D&I and tech transfer, deepening the collaboration between the two entities. Back in 2000, CSIC, Spain’s largest public research organisation, was one of the founding partners of AseBio. ‘With the agreement, we take a significant step forward in addressing the challenges of management, transfer and cooperation between the public and private sectors in biotechnological innovation,’ said Eloísa del Pino, president of the CSIC. “Together, we will be able to advance further in research and development, creating a more promising future for the sector in Spain.”

A promising semester for YEBN

EVENTS & NEWS The Young European Biotech Network (YEBN) is preparing for a busy semester, with a variety of events and initiatives planned through the end of 2024. From launching a new community platform to hosting key events, YEBN aims to support innovation, facilitate collaboration, and address the evolving needs of the biotech community.

One of the key events on the calendar is the return of our BioHorizons series on October 1st. These sessions are designed to explore different career paths in biotech and life sciences, offering a combination of scientific insights and practical applications from our guests. Attendees will hear from experts in the field and take part in discussions that can help inform future directions and career aspirations.

Empowering emerging talent

Another notable event is the YEBN RoadShow, scheduled for October 16th in Barcelona. This event, held in partnership with the European Institute of Innovation and Technology (EIT) Health Innovators Community, will focus on showcasing emerging talent and fostering connections among young professionals, researchers, and entrepreneurs. It will feature interactive sessions and networking opportunities, making it a key moment in the semester’s activities.

Moreover, the YEBN Symposium on November 6th will be a members-only event, offering a deeper look into critical biotech topics and the management of biotech associations. It provides a space for detailed discussions and shared learning, with plenty of opportunities to connect with others in the biotech community. Attendees can expect valuable insights and the chance to contribute to ongoing conversations about the future of the sector.

Additionally, the Scientific Dissemination on December 4th event will bring a new angle to the familiar BioHorizons format, focusing on the exciting and versatile field of scientific communication. This will provide a fresh perspective on how biotech professionals can better communicate their work.

To keep engagement going throughout the year, YEBN is also launching a new Slack community. This platform will enable members to continue discussing

bio tech-related topics, share insights, and connect with peers and industry experts. It offers an ongoing space for conversation and collaboration, beyond the confines of scheduled events.

Commitment to the community

These activities underscore YEBN’s ongoing commitment to supporting the biotech community by encouraging innovation, building connections, and offering platforms for knowledge exchange.

With a range of events and a new digital community, YEBN is certain to contribute meaningfully to the European biotech landscape. Offering opportunities for learning, networking, and collaboration, YEBN continues to play a key role in shaping the future of the biotech sector. If you’re interested in our work or would like to collaborate, reach out to us at contact@yebn.eu.

FIND OUT MORE!

For more details about the association and upcoming activities, visit our website at yebn.eu

Austria welcomes first biotech fund

VENGA VENTURES Two seasoned biotech entrepreneurs are introducing Venga Ventures, Austria’s first fund dedicated to biotech financing.

Supported by global biotech leaders and prominent Austrian expatriates, Venga Ventures aims to support the most promising startups across DACH and CEE.

For startups, particularly in knowledgeintensive sectors like biotechnology, securing institutional funding can be one of the toughest hurdles. Recognizing this challenge, Austrian biotech veterans Florian Schuster and Christopher Trummer are stepping in with a solution: Venga Ventures, a new fund focused on nurturing high-potential biotech companies in the DACH and CEE regions.

Noticeable lack of investment

While early-stage startups often rely on business angels and public grants, there is a noticeable lack of biotech-specific private investments in the Pre-Series A and Series A phases. Schuster and Trummer see this gap as particularly pro -

nounced in their target markets, particularly in Austria, which have strong pre-seed and seed funding ecosystems but lack biotech-focused funds – until now. The duo believes the timing is ideal, with tremendous growth potential in the field. In recent years, biotech startups have gained significant traction, increasing the demand for financial backing. In Austria, for example, only three biotech firms – YGION, invIOs and Ribbon Biolabs – have managed to secure substantial Series A funding in the last three years. This highlights a market inefficiency that, if addressed, could unleash considerable growth in the Austrian biotech sector.

Trummer has experienced this challenge firsthand; despite strong interna -

UPCOMING EVENTS

› October 10-11, 2024, Innsbruck

2. BIOTECH SUMMIT AUSTRIA

› November 13, 2024, Vienna

16. CEO Lunch

tional interest in his own biotech startup, Celeris, which pioneers degrader modality technologies, he had to look to U.S. investors to secure critical funding. Venga Ventures aims to bridge this funding gap by creating a strong international network, connecting with successful Austrian expatriates based in key biotech hubs such as Boston, Cambridge (UK), and Silicon Valley.

Opening doors to foreign funds

This global reach will not only bring international attention to Austria but also open doors to foreign investment. The advisory board at Venga Ventures boasts industry leaders such as Norbert Bischofberger (formerly of Gilead and Bayer), Isabella Gräf (formerly of Eidos Therapeutics), Patrick Trojer (formerly of Constellation Pharma), and Mark Kotter (bit.bio). These seasoned professionals, all of Austrian origin but now working abroad, bring a wealth of global biotech expertise. Their mission is to help earlystage biotech startups navigate the critical stages of validation and proof-ofconcept, thus enabling them to attract international investors.

One of BIOTECH AUSTRIA’s main goals is to support the provision of growth financing for Austrian biotech and therefore increase the volume and number of equity investments. Given the under-representation in Austria, the foundation of this fund is at the right moment to promote innovation and growth in our sector. 

The Founders of Venga Ventures – Christopher Trummer und Florian Schuster

Transforming research

LAB AUTOMATION The Society for Laboratory Automation and Screening (SLAS) is transforming the global life sciences community by uniting interdisciplinary researchers and technology providers to drive innovation in laboratory automation and research.

Our commitment to advancing life sciences extends globally, with a significant focus on supporting and empowering the European scientific community. Our Society’s collaborative platform catalyzes more than 20,000 researchers from academia, industry and government alongside developers and providers of progressive laboratory automation tools. Together, we pursue advancements in pre-clinical drug discovery and life sciences research to create change.

SLAS embeds itself in the European life sciences landscape. We offer several engaging events throughout the continent to serve as the meeting place for the life sciences community, such as our Regional SLAS Meet-Ups, our topical symposia and our annual SLAS Europe Conference and Exhibition.

Next year, we’ll gather in Hamburg, Germany, 20-22 May, for SLAS Europe 2025: Interconnecting Lab Automation. This premier event will offer unparalleled opportunities for professional development, networking and exposure to the latest innovations, making it an essential gathering for European life sciences professionals. If you’re eager to see the latest laboratory automation, discover and embrace new developments and leave inspired to propel research forward, save the date for Hamburg! We offer Student Poster Awards and generous travel grants

to selected podium and poster presenters. Start-ups can gain valuable exposure through our Innovation Ave NEW initiative.

Before our 2025 Europe conference, we’ll be in Toulouse, France, for the SLAS 2024 Sample Management Symposium on 16-17 October at Evotec’s Campus Curie. Sample and compound management experts will converge to explore the field’s latest best practices, challenges and innovations. Key sessions will focus on bio-sample management, highlighting experiences handling biological samples alongside traditional small molecules and the added value of effective compound management in scientific projects. Each session will offer insights into the evolving demands of research facilities and the role of digital innovation in meeting these challenges.

We Reward Academic Excellence

We bestow Student Poster Awards to up to three students, and at our annual international conference in the U.S., we present the $10,000 Innovation Award recognizing the work behind one cutting-edge podium presentation. For our technology providers, we honor the best New Products, and celebrate the most promising start-up companies with the Ignite Award.

UPCOMING EVENTS

› October 15, 2024, Oss, Netherlands Netherlands Community Meet-Up

› October 16-17, 2024, Toulouse SLAS 2024 Sample Management Symposium

The Society’s SLAS Ignite Program underscores the Society’s foundational commitment to collaboration, enabling scientists, academic researchers and business development professionals to build relationships as potential strategic partners. The program includes: › academic collaboration presentations showcasing the latest research partnerships between academia and industry, › panel discussions and online discussions focused on entrepreneurship, › Innovation Ave NEW – a designated area of our exhibition floor for start­up companies fully funded by SLAS, and › the SLAS Ignite Award given to the most promising start-up company featured on Innovation AveNEW

To Innovation and Beyond

We aim to empower our members to lead the industry rather than follow. At SLAS2025, we are introducing NexusXp, a new interactive pavilion at SLAS2025 in San Diego, to showcase collaborative and integrated lab automation scenarios around the Design – Make – Test – Analyze cycle for drug discovery. 

FIND OUT MORE! slas.org Sign up for Pointto-point, our weekly e-newsletter, to stay in touch.

Bioassay challenges

EVENT Bioassays are used to determine the critical quality attribute (CQA) bioactivity/ potency of biopharmaceutical products. They shall reflect the mechanism of action (MoA), therefore bioassays are individual for each product but still need to fulfil all regulatory requirements.

› Dr Ulrike Herbrand, Scientific Director Global in vitro Bioassays, Charles River Laboratories

Risk assessment tools and life cycle approaches are becoming increasingly important for developing and maintaining phase-appropriate biological activity tests. Statistics are also gaining importance beyond the actual evaluation of relative activity, e.g. in the form of design of experiments and trending. The aim is to have a validated method that is robust, feasible and provides trustworthy results.

To meet expectations, the optimal control of critical reagents and the cells used in the assay, the use of automation and the inclusion of quality by design (QbD) and, if appropriate, artificial intelligence are essential. Automation improves reproducibility and reduces the risk of human error, while the use of assay ready cells, for example, significantly reduces the variability in the process caused by continuous cell culture.

In addition, a comprehensive understanding of the underlying biology is es-

sential and still gains importance for development, as the mechanistic principles and therefore requirements for classic protein therapeutics, cell and gene therapy products and vaccines can be very different.

The regulatory requirements also pose a challenge, as both the strict specifications of general guidelines, such as those for the development and validation of analytical procedures and the statistics for the evaluation, must be met, as well as specific local guidelines, such as those for cell and gene therapy products. At the same time, due to the very individual nature of the mechanisms of action, there are very few monographs and, if at all, only very limited international reference and control materials.

Particularly for cell and gene therapy products, some of which are even produced autologously, a matrix approach over the life cycle with selection of suitable test procedures to ensure maxi -

mum patient safety, but without unnecessarily complicating the release of individual batches and meeting all regulatory requirements, is gaining acceptance. The inclusion of orthogonal methods to guarantee the requirements for reproducibility, accuracy and robustness is also often useful. The acceptance criteria should be selected in such a way that a minimum level of efficacy and a maximum level of safety is achieved. Both, FDA and EMA now require compliance with 3Rs for release assays. While in vitro assays are often more practical and cost-effective, they do not always reflect the complex interactions that occur in a living organism. It is therefore a challenge to develop in vitro potency assays that accurately reflect in vivo conditions and effects.

In the context of protein therapeutics, the assessment of biosimilarity still involves several challenges, especially for bioassays. On the one hand, similarity must be established with often more than one MoA ­ reflecting bioassay, and on the other hand, regulatory guidelines for assessing biosimilarity are limited.

The two-day track “Biossays/Potency Assays – Regulatory Requirements, Development and Routine Use” at PharmaLab 2024 addresses all these challenges with experienced international speakers from industry, regulatory agencies, service providers and suppliers. There will also be enough time for further discussion and exchanging experiences with the speakers and other participants. L

For all information, please visit www. pharmalab-congress.com/bioassays

Developments in Modern Pharmaceutical and Biopharmaceutical Laboratories

Highlights

 NEW: Analytical Instrument Qualification and System Validation

 GMP Compliance Trends in Analytical Laboratories

 Laboratory Optimisation and Automation

 Modern and Alternative Microbiological Methods

 Cell and Gene Therapies/ATMPs - Quality and Safety

 Endotoxin and Pyrogen Testing

 Mycoplasma Detection Outsourcing in Pharmaceutical Laboratories

 NEW: Bioassays/Potency Assays

Premium Sponsor 2024

Innovate at BioFIT

EVENT BioFIT 2024 gathers industry experts, investors and innovators to drive collaboration and innovation in Life Sciences, creating opportunities for early-stage deals and advancing science for human and animal health.

BioFIT is Europe’s leading partnering event for early-stage deals, innovation partnerships and investment rounds in Life Sciences. On December 3rd and 4th in Lille, BioFIT will bring together 1,000 key players from more than 35 countries to catalyse growth in the biotech and pharma sectors.

Participants will have opportunities for one-on-one partnering sessions, giving them the chance to connect with potential collaborators, investors, and experts. Whether you’re a start-up seeking seed or Series A funding, a TTO, a research insti-

Come to Lille

GREETING It is with great pleasure that we welcome you to BioFIT 2024, where innovation meets collaboration.

Over the years, BioFIT has become a vital platform that brings together the brightest minds in Life Sciences. This year, we are thrilled to expand our reach even further with the inclusion of MedFIT

tute, or an industry leader, the BioFIT platform enables discussions that could shape the future of healthcare innovation.

The event will also feature an engaging conference programme with insights into the latest trends in academia-industry R&D collaborations, early-stage assets, earlystage investment as well as animal health. Key highlights include the pitch sessions as well, featuring the much-anticipated Startup Slams, Collaborative and Licensing Opportunity Presentations and Animal Health Presentations. These sessions offer a val-

and MEDigIT, creating a truly comprehensive ecosystem for healthcare innovation.

At BioFIT, we don’t just come together to talk about the future, we actively shape it. Whether you're seeking earlystage investment, exploring collaboration opportunities or simply connecting with the world's leading Life Sciences experts, BioFIT provides the tools, network, and platform to help you make it happen.

Etienne Vervaecke General Manager, Eurasanté & Clubster NHL

December 3rd & 4th, 2024

Lille, France

December 11th & 12th, 2024 for online meetings

uable platform for start-ups, companies, TTOs, and universities to present their innovations to top-tier investors and potential partners. For those who can’t attend in person, online meetings will be available on December 11th and 12th, ensuring full access to the BioFIT’s partnering platform.

This year’s event is set to offer even greater value with its distinctive multi-sector approach. Alongside the biotech focus, BioFIT will be held together with MedFIT, which zeroes in on MedTech and Diagnostics, and for the first time, MEDigIT, dedicated to Digital Health. This expanded format creates a comprehensive ecosystem for healthcare innovation.

BioFIT is a unique marketplace for collaboration, fostering cutting-edge innovation and connecting the best in Life Sciences. Don’t miss the opportunity to be part of this ground-breaking event that continues to drive the future of healthcare innovation. Register today to secure your spot with the coupon code EBMAGAZINE_PASS20. L

QUICK FACTS

2024 Figures

1,000+ delegates

35+ countries represented 60+ speakers ∙ 100 exhibitors

Programme Highlights

One-on-one meetings ∙ Conferences Pitch competition ∙ Exhibition

Project – CEO matchmaking https://www.biofit-event.com/

Dive into the heart of pharma at CPHI Milan 2024

EVENT Join us at CPHI Milan 2024, the largest event for global pharma professionals to meet and grow their business at Fiera Milano from October 8 th to 10 th , 2024. The event promises unparalleled opportunities for networking, innovation, and professional growth. With over 62,000 attendees and 2,500 exhibitors, it’s the biggest ever, and you can expect insightful seminars, cutting-edge exhibitions, and plenty of evening events.

› Tara Dougal, Brand & Content Director at Informa Markets

As CPHI Milan marks its 35th year, it continues to serve as the premier event for pharma professionals worldwide. This year’s gathering is more than an event –it’s a global celebration of pharmaceutical advancements, highlighted by the Walk of Pharma, showcasing 35 groundbreaking champions who have transformed the industry.

CPHI promises to unite the world’s largest pharma network for three days of inspiration, collaboration, and growth. With an agenda packed with thoughtprovoking seminars and cutting-edge exhibitions, it provides an immersive experience for professionals looking to stay ahead of industry trends.

There will also be a series of evening events, inspired by the city’s La Dolce Vita, offering unique opportunities for networking in a relaxed and festive atmosphere. The awards night CPHI Celebration will be back with two new categories introduced this year – Woman of the Year and Future Leader.

“It will be the largest event in our history, and we are continuing to innovate with new awards categories and improved bioproduction zones and content for our biopharma audience. There has never been a better time to attend CPHI, especially as we return to Lombardy – a region home to one of the most vibrant hubs for pharmaceutical manufacturing and API production. I look forward to welcoming the global pharma supply chain, its partners, and drug innovators to Italy. The partnerships made this week will empower future drug development and ultimately improve patient access and treatments,” added Tara Dougal, Brand and Content Director – Pharma at Informa Markets.

Conference program highlights

The CPHI Milan 2024 conference features over 150 expert speakers across five content tracks, designed to inspire and inform. Thought leaders will address critical

topics like regulatory trends, technological innovations, and sustainability. From visionary R&D keynotes to panel discussions on emerging therapies and market dynamics, it offers a wealth of learning opportunities.

To connect with industry leaders yearround, attendees can also leverage CPHI Online to maximise their experience at CPHI Milan.

For the live agenda, please visit: https://www.cphi.com/europe/en/ agenda/conference-agenda.html

Join us

CPHI Milan 2024 is more than an exhibition – it’s a catalyst for change and advancement within the pharmaceutical industry. With a renewed focus on supply chain resilience, attendees will gain actionable insights into navigating challenges, optimising operations, and ensuring continuity in supply. By embracing these trends and focusing on strategic imperatives, the pharmaceutical industry can achieve greater efficiency, resilience, and success in the years to come. The future of pharmaceutical outsourcing is increasingly shaped by the need for strategic, integrated, and collaborative partnerships.

Join us at the heart of pharma at Fiera Milano, Italy, and immerse yourself in a dynamic environment where ideas flourish and partnerships thrive. Together, let’s shape the future of pharma. Visit CPHI Milan 2024 to learn more and register today. L

AATec Medical GmbH (DE) 36

AAX Biotech (SE) 85

Abingworth LLP (GB) 78

AC Immune SA (CH) 32

Ackermans & van Haaren (NL) 78

Acuitas Therapeutics (CA) 39

Adaptimmune Ltd. (GB) 32, 79

Adcendo ApS (DK) 46, 76

ADLIN Science SA (FR) 79

Advent Life Sciences LLP (GB) 17

AGC Biologics (USA) 65

Agilent Technologies (USA) 40

Alnylam Pharmaceuticals Inc. (USA) 40

Alumis (USA) 18

Ambrx Biopharma (USA) 15

Amsilk GmbH (DE) 8

Amyris Inc. (USA) 8

Antheia Inc (USA) 8

Apeiron Biologics (AT) 80

Argo Biopharmaceuticals Co. Ltd. (GB) 40, 44

Arla Food (DK) 76

Arterra Bioscience SpA (IT) 83

ARTES Biotechnology GmbH (DE) 19

Asarina Pharma AB (SE) 77

AstraZeneca (GB/SE) 15, 27, 46, 77

Azenta (GB) 35

Bavarian Nordic A/S (DK) 32, 77

Baxter International (USA) 17

Bayer AG (DE) 8, 40

Bene Meat Technologies (CZ) 78

BGI Group (CN) 46

Bicara Therapeutics (USA) 18

BILLA (AT) 80

BIOCOM AG (DE) 23, 43, 75

Biocytogen Co. Ltd. (CN) 84

Biogen Idec (USA) 39, 44

BioGeneration Ventures (NL) 78

BioNTech SE (DE) 8, 20, 32, 34, 40, 42, 46

Biovance Capital Partners (PT) 82

Boehmert & Boehmert (DE) 31

Boehringer Ingelheim (DE) 24, 39, 81

Bristol Myers Squibb (USA) 18, 46

C16 Bioscience Inc. (USA) 8

Caixa Capital Biomed (ES) 82

Candid Therapeutics (USA) 18

Capricorn Ventures (BE) 78

Capstan Therapeutics (USA) 39

Carbios SAS (FR) 79

Cardior Pharmaceuticals GmbH (DE) 15, 40, 41

Catalent (USA) 17

CellDynamics srl (IT) 27

Cellug A/S (DK) 76

Celonic AG (CH) 54 –57, 66, 67

Chia Tai Tianqing Pharmaceutical Group (CN) 44

Citeline (USA) 41

Commerzbank AG (DE) 20

Complete Genomics (USA) 46

Concept Heidelberg/PharmaLabCongress (DE) 93, 94

Confo Therapeutics NV (BE) 78

CryoLogyx Ltd. (GB) 26

CSPC Pharmaceutical Group (HK) 44, 46

Curevac N.V. (DE) 34, 40

CymBay Therapeutics (USA) 15

Cytena GmbH (DE) 27

CZ Vaccines (Zendal Group) (ES) CP4

Daiichi Sankyo (JP) 50, 77

Danaher Group (USA) 39, 81

DASGIP an Eppendorf Company (DE) 7

DiogenX (FR) 85

Duality Bio (CN) 46

Eisai Ltd. (JP) 46

Eli Lilly (USA) 32, 39, 41, 50, 77

Emulate Inc. (USA) 25

EtheRNA immunotherapies NV (BE) 39

Eurasanté GIE | BioFit 2024 (FR) 92, CP3

European Investment Fund (BE) 82

Euroscreen S.A. (BE) 49, 70

Every Inc. (USA) 8

Evotec SE (DE) 87

ExoRNA Bio (CN) 44

Exosomics Siena (IT) 83

Faron Pharmaceuticals Ltd. (FI) 85

FCC Environment plc (GB) 79

FGK Clinical Research GmbH (DE) 41

Fördergesellschaft IZB (DE) 37

Formation Bio (USA) 17

Formo Bio GmbH (DE) 8, 80

Fund+ (BE) 78

Fusion Pharmaceuticals (USA) 15

Genedata AG (CH) 81

Genentech Inc. (USA) 79

GeneticLeap (USA) 40

Gilead Ltd. (USA) 15

Ginkgo Bioworks (USA) 8

GlaxoSmithKline (GB) 34, 40, 46

Gourmey SAS (FR) 79

Greenlight Biosciences Inc (USA) 8

Grupo Empresarial Palacios Alimentacion (ES) 82

GW Vitek (KR) 79

Hansoh Pharmaceutical Group Co. Ltd. (CN) 44, 46 Haya Therapeutics SA (CH) 40,

Lanzatech Inc. (USA)

Nanodrug GmbH (DE)

(UK) Ltd.

Ligand Pharmaceuticals Inc. (USA)

AG (CH)

BPSA’s Roundtable

10.–11.10.2024 MILAN Attendees at BPSA’s European Roundtable – (Bio-Process Systems Alliance) – will have the opportunity to engage with industry experts on the trends, and innovations shaping single-use bioprocessing. https://bpsalliance.org

3.-4.10.24

International Forum on Industrial Biotechnology and Bioeconomy – IFIB, Bologna (IT)

Info: SPRING – Italian Circular for Bioeconomy Cluster/ ASSOBIOTEC https://ifibwebsite.com/

8.-10.10.24

CPhI Milan 2024, Milan (IT) Info: CPhI Global Office, https://www.cphi.com

10.-11.10.24

2 nd BIOTECH SUMMIT AUSTRIA, Innsbruck (AT) Info: BIOTECH AUSTRIA/Human.technology Styria www.biotech-summit-austria.com

20.–24.10.2024

HUPO 2024, Dresden (DE) Info: Human Proteome Organization https://2024.hupo.org

23.-24.10.24

Global Bioeconomy Summit 2024, Nairobi (Kenya) Info: International Advisory Council on Global Bioeconomy/icipe/BioInnovate Africa www.gbs2024.org

23.-24.10.24

Future of Biofuels 2024, Copenhagen (DK)

Info: Fortesmedia https://fortesmedia.com/future-of-biofuels-2024

4.-5.11.24

European Forum for Industrial Biotechnology & the Bioeconomy – EFIB, Marseille (F) Info: EuropaBio https://efibforum.com

7.11.24

Bioscience, Stockholm (SE)

Info: Maria Eriksson, Life Science Sweden www.bioscienceevent.com

12.-13.11.24

BIO-Europe 2024, Digital Partnering, online Info: EBD Group https://informaconnect.com

11.-14.11.24

esib – European Summit of Industrial Biotechnology, Graz (AT)

Info: acib – austrian center of industrial biotechnology www.esib.at

14.-15.11.24

ICPO Virtual Theranostics Summit 2024, +++ online +++

Info: International Centers for Precision Oncology Foundation – ICPO Foundation www.icpo.foundation

27.-29.11.24

CellMAT 2024 – International Conference on Cellular Materials, Magdeburg (DE)/ +++ online +++ Info: Deutsche Gesellschaft für Materialkunde www.dgm.de/cellmat

3.-4.12.24

8 th MedFIT, Lille (F) Info: Eurosante www.medfit-event.com

3.-4.12.24

BioFIT 2024, Lille (F) Info: Margaux Satola, Eurosante www.biofit-event.com

15.-18.1.25

Global Forum for Food and Agriculture, Berlin (DE) Info: Federal Ministry of Food and Agriculture https://www.gffa-berlin.de

BIO-Europe 2024

4.–6.11.2024 STOCKHOLM Europe’s leading conference for biotech connects the global biopharma community. In November, it will celebrate its 30 th anniversary. BIO-Europe brings together over 5,500 delegates from biotech, pharma and finance, to participate in 30,000+ one-to-one meetings. https://informaconnect.com

25.-29.1.25

SLAS2025, San Diego (USA)

Info: Society for Lab Automation and Screening – SLAS https://www.slas.org

17.-19.3.25

BIO-Europe Spring 2025, Milan (IT)

Info: Olivia Guiliana, EBD Group https://informaconnect.com/bioeurope-spring/

PEGS Europe 2024

5.–7.11.2024 BARCELONA More than 1,500 protein and antibody experts will meet to exchange ideas at this year’s PEGS Europe. New this year is the expanded coverage of AI/ML, multispecific antibodies, antibody-drug conjugates and an entire section dedicated to oncology. www.pegsummit.com

18.-20.3.25

Bioprocessing Summit Europe, Barcelona (ES)/+++ online +++ Info: Cambridge Healthtec Institute www.bioprocessingeurope.com/

28.–29.4.25

BioVaria 2025, Munich (DE) Info: Rebecca Engels, Ascenion GmbH www.biovaria.org

12-14.5.25

BioEquity Europe 2025, Bruges (BE) Info: EBD Group/Biocentury https://conferences.biocentury.com/ bioequity-europe

14-15.5.25

8 th European Symposium on Biomaterials and Related Areas – BioMAT 2025 Weimar (DE)/+++ online +++

Info: Deutsche Gesellschaftfür Materialkunde https://dgm.de

Winners & losers

THE HEAT is on, is a song by Agnetha Fältskog as a soloist and without ABBA or by Glen Frey, depending on your taste in music. But also summer of 2024 was the hottest in the world since records began.

EU CLIMATE recovery fund has lost the plot. The European Court of Auditors (ECA) has given the EU’s ambitious climate protection programme a poor report card in terms of implementation. Much is based on estimates, not all measures can really be described as ‘green’, and overall there is a lack of overview of all climate policy expenditure in the European countries. This may involve overestimated expenditure in the order of €34.5bn, 12% of the ‘Green Deal’. 

I’m in biotechnology because

HUGO FRY, CEO,Topas Therapeutics, Germany

“While at pharma I in-licensed an innovative product from an exciting biotech. Then the FDA stated that 75% of future product approvals would come from biotech. I wanted to be part of this fast-moving world.”

Theranostic is growing

According to Global Market Estimates Research & Consultants (GME), the global theranostics market is projected to grow at a CAGR of 5.41% from 2024 to 2029 and will reach around US$5bn globally. The analysis assesses various factors including market size and growth potential, regulatory environment, technological advancements, and consumer trends and can be purchased at a special discount for our readers by sending a request on sales@globalmarketestimates.com 

The really very last word

The current main cause for concern in the countries of the European Union is socalled irregular migration. Nothing new really, one is tempted to say, as the problem has been around for a long time. In fact, it has been around for a very long time: Since the years between 375 and 568, when the prosperity, better climate and state-of-theart infrastructure of the Roman Empire attracted all kinds of travelling peoples. The

Barbarian Invasions could actually have been a nice deterrent example for today. Poverty, war and climate change are likely to cause even more dramatic waves of migration in the near future. The fundamental problem is often ignored today. Half a century ago, a well-known zoologist stamped his letters with ‘Ceterum censeo

progeniem hominum esse deminuendam.’ – ‘Incidentally, I am of the opinion that the growth of humanity must be reduced.’ 

B ernardo Glavo

AI helps climate

AI A brand-new AI analysis of 1,500 climate policies across 41 countries between 1998 and 2022 reveals that only 4% achieved significant emission reductions. The new machine learning analysis of climate policies – concerning electricity (see Sweden for huge emission reduction), transport (Hungary), buildings (Denmark), and industry (France) – developed by Annika Stechemesser at Potsdam Institute of Climate Research has identified 1,437 ineffective out of 1,500 implemented climate policies over the last two decades. The authors have published an interactive dashboard that clearly demonstrates that combination of policies such as a carbon tax plus the introduction of energy efficiency labels were more successful than single measures. To reach Paris Agreement’s targets, it is essential to choose climate policies that work effectively at scale. 

Next issue 2024

WINTER EDITION BioFIT appears on the horizon shortly before our next issue will be published. Novel Drugs, New Drug Formats and our BioFairs Compass are topics. Players in these fields are invited to present their offering in e uropea N BiotechNology. Want to participate? Just contact Christian Böhm (+49-30-26492149), Oliver Schnell (-45), Andreas Macht (-54) or please mail: marketing@biocom. de . Publishing date is 5 Dec. 2024; deadline for ads is 22 Nov. 2024. 

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