EB 2025 Spring

Alessandro Toniolo, CEO at Resalis Tx, on the first obesity antisense trial and the Sanofi deal.

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Knowledge-based bioeonomy – reloaded

DR MARTIN LANGER, is an Executive VP of BRAIN Biotech AG, and since Jan 2023, he has held the position of Managing Director Bioscience Operations Zwingenberg at BRAIN Biotech. The biochemist has been working for BRAIN Biotech in various positions for 30 years. In 2013, he was appointed Executive Vice President. In 2015, he led the IPO team at BRAIN, ending successfully in February 2016. After growing the business within the BU Industrial BioSolutions for two years, he took over the position of Head of Business Development in 2020.

To meet the goals of the European Clean Industrial Deal, we must quickly transform our energy-intensive, fossil industries. Biotechnology provides the necessary toolbox, ranging from energy-saving biocatalysts for the chemical industry to climate-friendly production of animal feed and food proteins for more resilience, microbial recovery of rare critical materials, to the production of pharmaceutically active ingredients. Biotech applications ensure that we will meet the Sustainable Development Goals of the 2019 EU Bioeconomy Strategy – food security, sustainable use of natural resources, growing independence from fossil resources, and limiting climate change. At the same time, we will strengthen Europe’s competitiveness and create new jobs.

However, why are we not really closer to the “biologisation” of industries? Well, from a global perspective, in the EU we are not the fastest region in the world when it comes to supporting industrial transformation but the USA, with its Inflation Reduction Act, China, with huge investements in fermentation capacity and biotech, Singapore, with its ultra-fast approval of novel foods, and Brazil, with a clear strategy on how to move forward in the bioeconomy.

What we can learn from them is that they significantly support innovators on their way to industrial-scale biomanufacturing. Why is this so important? It is about investment costs in demonstration or production plants (CAPEX). Many biological production processes today are price-competitive with their petrochemical counterparts. This price competitiveness ends at the point where investments in new production plants are needed. CAPEX costs have killed many sustainable business cases. Thus, forward thinking and time-limited strategic financing are needed. As Europe has not yet done so sufficiently, global players and start-ups are leaving Europe, taking advantage of funding opportunities abroad. An IPSEI (Important Project of Common European Interest) could be a tool for funding industrial transformation in the EU. However, we need more common financing tools to limit brain drain and keep value creation in Europe.

In addition, harmonisation of approval processes, such as for proteins from precision fermentation, is necessary in Europe. In Singapore and the USA, companies receive approval four times faster than in the EU, without compromising food safety.

The key is to recognise and implement the economic and sustainability potential that biotechnology offers to both industry and consumers. If we use biotechnology in a smart way, coupling it with new technologies such as AI and machine learning for process monitoring, development, and the prediction of molecular features, Europe will be at the forefront of the bioeconomy value creation. After all, it was in Europe, under the German EU Presidency in 2007, that bioeconomy was launched with the groundbreaking paper “En Route to the Knowledge-Based Bio-Economy.” Let us make the bioeconomy a reality now and here – a Knowledge-Based Bio-Economy – reloaded for Europe and our economy!■

The Deeptech

Bioeconomy battle

Faster, bolder, simpler – Ursula von der Leyen’s cabinet is charting a course with January’s Clean Industrial Deal. However, struggles between Commissioners over responsibilities and a lack of strategic investment in the EU bioeconomy to reduce CAPEX costs for green plants to produce fossil-free sustainable aviation fuels, chemicals, cultivated food, feed, ingredients and compostable materials that can replace plastics are currently jeopardising one of Europe’s biggest economic opportunities for a recovery – and for growing less dependent on China and the US.

INSIGHT EUROPE

6 Next German Chancellor wants the EU to work toward new strengths

10 Polish EU Council Presidency: Rapid agreement on EU NGT Regulation in sight

12 BioMed X launches new institute; European Medicines Agency reports record number of new drug authorisations; Foodtech industry disappointed over EU Vision for Food and Agriculture

ECONOMY

20 Analyst commentary

21 European Biotech Stocks

24 BioVersys goes public; Sofinnova goes bold with fund

25 Ryvu Therapeutics extends cashflow

26 Interview: Dr Sabrina Graf, COO, Tenthpin Group

32 Update on clinical trials

FOCUS LAB AUTOMATION

54 In focus: Technology and system integration

60 Interview: Enrico Grassilli, CEO, InSimili srl, Bologna

61 Novel sequencing technology

REGIONAL NEWS

62 Northern Europe: Sweden, Denmark, Norway and Finland

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

66 Central Europe: Germany, Switzerland and Austria

68 Southern Europe: Italy, Spain, Greece and Slovenia

70 Eastern Europe: Poland, Czech Republic and Hungary

SCIENCE & TECHNOLOGY

71 Golden Bullet: Oncologists identify cancer’s metabolic Achilles heel

72 Bioeconomy: Microbial gold recovery from e-waste is scaled-up; MS: How EBV reprogrammes B cells; GMOs: farmers out of control

73 Aspirin triggers metastasis resistance; UK biobank data analysed for disease prediction

PICK & MIX

74 Powtech preview

75 News from associations

79 Chemspec coming up

80 Company index

81 Events

82 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, Dr. Christian Kähler; Anette Mertens; Advertising: Oliver Schnell, +49-30-264921-45, Christian Böhm, +49-30-264921-49, Andreas Macht, +49-30-26492154; Distribution: Nancy Weinert +49-30-264921-40; 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: Create of God - stock.adobe.com; ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

ANTIBIOTIC RESISTANCE

The crossroads of the next pandemic

What do global pandemics and the growing crisis of antimicrobial resistance have in common? While EU member states prepare for the next viral pandemic and maintain vaccine production capacities, the ‘silent pandemic’ of AMR is mostly a fear only experts share. However, the current bird flu issues in the US demonstrate that the greatest risk of the next pandemic lies in animal farming – where 70% of all antibiotics are consumed.

Poland drives progress

The current Polish Presidency has tabled a draft modernising the EU’s GMO rules by differentiating GMOs from NGTs – breeds produced by new genomic techniques. At attachee level, the draft that harmonises IP on NGTs with farmers’ access to seeds was welcomed by roughly 80% of EU member states.

EDITORIAL

No will to grow

Peptides & Oligos

39 Megatrend oligo-based and peptide drugs

42 Interview: Alessandro Toniolo, CEO, Resalis Therapeutics srl

44 Enhancing macromolecule drug discovery with CDD

46 Interview: Jordan Turnbull, CEO, Fuse Vectors ApS 47 Precision Oligos for therapeutics

Swiss fruit grower Marco Messerli uses poison sprays up to 48 times a year. Too much, he says, even though the insecticides and fungicides are authorised for organic farming. Instead, Messerli would prefer breeding more robust varieties: “If you really want to produce organic apples sustainably, you also have to allow new breeding methods.” The Swiss Research Institute of Organic Agriculture is aware that breeders are working with CRISPR, but say “our customers don’t want that.” Because new genomic techniques (NGT), even to make old species high-yielding and therefore suitable for mass production, are not included in the definition of organic. Even if the techniques don’t leave detectable traces in genomes. That’s why out-of-the-box thinkers like Messerli have to give up or convert instead of realising market opportunities. The same applies to biotechnologists who see sustainability as an opportunity, and are trying to move beyond the EU definition of bio-based bioeconomy with precision fermentation, reprogramming microorganisms to produce cholesterol-free meat, milk for lactose intolerance, biofuel and plastics from atmospheric CO2 and recombinant silk. But EU subsidisers don’t seem interested, which is why the bloc’s economy is going downhill. A ray of hope comes from Italy and Poland. In February, the Italian parliament approved €2.2bn for new biorefineries. Meanwhile Poland’s draft to simplify NGT authorisation received 78% approval.

Thomas Gabrielczyk Editor-in-Chief

New German Chancellor wants to lead the EU

EU LEADERSHIP With a 7.7% lead, the incoming Christian Democrat Chancellor Friedrich Merz has put the radical right-wing AfD in its place. Before forming a government in Germany, Merz emphasised that Germany wants to strengthen the EU’s self-sufficiency, although at first sight the role of biotechnology seems to be of secondary importance to him.

With a majority of 28.5% ahead of the radical right-wing AfD (20.8%), 16.4% for the likely coalition partner SPD and the Greens (11.6%) and left-wing party Die Linke (8.8%), the Christian Democrat Friedrich Merz has been confirmed as Germany’s next Chancellor. He is in favour of a strong Europe that can act – at least militarily – independently of its former ally, the USA. “For me, it will be an absolute priority to strengthen Europe as quickly as possible, so that step by step, we can really achieve independence from the USA,” Merz said, noting that “the Americans, at least this administration, are largely indifferent to the fate of Europe.” His statement was initially clearly referring to military independence.

No priority for biotech yet

According to the election programme of Merz’s CDU/CSU parliamentary group, Merz wants to pause central regulations of the Green Deal such as sustainability reporting, CO2 tariffs on imported goods (CBAM) and ESG criteria for assessing the sustainability of companies for two years and boost Germany’s and the EU’s recently faltering economic growth by cutting red tape. On the same day that the EU Commission presented the targets and subsidies of the Clean Industrial Deal, it has already implemented Merz's targets. However, it has done so intelligently, as small companies in particular, which cause few CO2 emissions, are relieved of the burdensome reporting obligations, while large corporations with the corresponding administrative capac-

ity must continue to report. Germany’s Social Democrats are the preferred coalition partner of Merz. A coalition with the far-right AfD, which doubled its share of the vote compared to the last election in 2021 and is the strongest party in all federal states of the former GDR, was ruled out before the election.

It is still unclear how the Christian Democrats’ strong focus on rearmament, limiting uncontrolled migration and Germany’s economic recovery will affect biotechnology in the EU in concrete terms. However, Germany’s financial dominance as the world’s third strongest economy and Merz’s political influence on EU Commission President Ursula von der Leyen are likely to have a strong impact on the direction of EU policy – especially as Merz said after the election: “Europe is waiting for us, for Germany, to take on

a stronger leadership role again.” When it comes to biotechnology, it is striking that the Christian Democrats, who have always been open to technology, have not stated whether or not they see deeptech biotechnologies (AI + biotech) as a growth opportunity for the EU: In the programme, one searches in vain for the previously clear commitment to a simplified approval procedure for new genomic techniques (NGT) in plant breeding or to microbial and cell-based food production, for example to strengthen Europe’s independence from expensive soya imports and a sustainable production of meat and dairy products from single-cell cultures that complement agriculture. According to Christian-Democrat’s plans, climate laws are to be made less bureaucratic and the trading of standardised CO2 certificates, which are expected to start in

from left: The next German Chancellor Friedrich Merz, EPP head Manfred Weber, and EU Commission President Ursula von der Leyen at the European People‘s Party (EPP) Leader Retreat in Berlin

Europe in 2026, may help to achieve the target of a 90% reduction in greenhouse gases by 2045. According to experts, however, CO2 certificates only make sense when traded globally, but – following the USA’s withdrawal from the 2015 Paris Agreement and in view of China’s refusal to enter into concrete and binding agreements – global certificate trading is a distant prospect. Concerning NGTs, the Polish Presidency presented a third proposal, which balances the interests of farmers to have access to seeds with those of developers who want to have a certain degree of patent protection of their NGT breeds (see p. 10). It has good chances to go through, even if Germany and Belgium would reject it.

EPP shifts into reverse

Europe’s Christian Democratic parties, united in the European People’s Party (EPP), hailed the resolutions from the EPP Leader Retreat in mid-January as a success in reducing bureaucracy and fostering growth and job creation. The agreements made by EPP leaders, who dominate the European Parliament, in Berlin in mid-January also provide insight of the next Chancellor’s ambition to gain power over von der Leyen.

In a resolution document, the group –in the presence of and with the consent of EU Commission President Ursula von der Leyen – proposed a reversal of key regulations of her Green Deal. The sustainability reporting, introduced only in summer 2024 to disclose compliance with environmental and human rights standards in the supply and value chains of listed companies, is to be suspended. Additionally, the CO2 import duty on steel, cement, aluminum, fertilisers, hydrogen, and energy, which became mandatory in 2023 as part of the transition to sustainability, will also be temporarily suspended. Simultaneously, the EU taxonomy, which defines financial products and investments that contribute to environmental goals like climate protection, has been put on hold. Despite Merz’s prioritisation of industry above sustainability, major industry and bank executives

continue to view sustainability as a crucial economic driver besides technology.

Sustainable ≠ Growth?

However, as the new chancellor's party has an affinity for technology, it is expected to promote sustainable product developments that boost exports. According to new studies, this clearly includes cultivated food, which farmers see as competition. According to a new life cycle assessment of Finnish mycoprotein pet food producer Enifer, bio-based processes to produce protein alternatives might reduce the carbon footprint of meat production significantly. The cradle-to-gate total carbon footprint of its fermented product PEKILO ®Pet, covering fossil, biogenic, Land Use, Land-Use Change, and Forestry (LULUC) emissions, is 0.93 kgCO2eq per kilogram of product. In contrast, soy protein concentrate produces up to 6.7 kgCO2eq per kilogram. This means that PEKILO ® Pet has 86% lower carbon emissions. PEKILO ® Pet also performs better than insect protein powder (1.15 kg CO2eq) and produces five times fewer emissions than high-quality dry pet food ingredients like lamb (5.84 kg CO2eq). However next-gen biomanufacturing processes can do even more, according to two position papers published by German industrial biotechnologists and the innovation agency SPRIN-D.

The addition to the bio-based bioeconomy of the cross-sector integration of AI-supported biotech and biomanufacturing processes in industrial biotechnology called for by two expert groups before the German parliamentary elections remained uncommented on by European and German Christian Democrats. Instead, von der Leyen called young farmers new innovators in her “Vision for Agriculture and Food”, while the the potential double digit billion market for brewing microbially produced protein alternatives was ignored, suggesting that the EU Commission wants to stick to its low-tech bioeconomy approach. A brand new study published by the Nova Institute and promoted by the Bioindustry Consortium (BIC) concludes that biomass-centric processes can account only for a maximum of 20% of the current almost entirely petrochemical production of chemicals by 2050. In view of the presentation of an EU Bioeconomy Act planned for the end of November in Copenhagen, EU industry associations such as EuropaBio have recently pointed out the role of modern biotechnologies in a future-proof, growthoriented bioeconomy concept that will be realised in the USA, particularly in the states of Nebraska, Indiana, Maine, Michigan and Wyoming, as well as in the UK. Europe is now looking to Germany with excitement and hope.

■

t.gabrielczyk@biocom.eu

Access to genome profiling

POSITION PAPER In early March, the European Coalition for Comprehensive Genomic Profiling (ECGP) and the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) have called on to improve current funding and reimbursement frameworks to allow cancer patient to get access to routine testing for all relevant cancer mutations through comprehensive genomic profiling (CGP). The multistakeholder alliance, consisting of patients, clinicans, sequencing and pharmaceutical companies in their paper explain that AI-directed analyses of com-

plete genomes will allow for more personalised cancer treatments and thus should be more accessible for patients. However, it would need information campaigns to show the benefits of CGP-guided diagnosis and therapies for the health systems, standardisation of tests and data, harmonised rules for reimbursement and health technology assessment along with the addition of CGP to therapy guidelines. The ECGP also calls for EU funding if further evidence for patient benefit is needed regarding certain cancer indications (see eucope.org). ■

Rapid agreement on EU NGT Regulation in sight

EU COUNCIL A modified proposal by the Polish EU Council Presidency to exempt precision breeding with new genomic techniques from the strict EU GMO legislation has a good chance of being adopted by the EU Council. At a meeting of the national representations of the EU countries in mid-February, there were signs of broad agreement.

GMO opponents accuse the Polish Council Presidency of reversing its previous demand for full labelling and traceability and the protection of breeders and farmers from patented seeds, while GMO advocates rejoice.

After the Polish Council Presidency unsuccessfully presented two compromise regulations to exempt so-called NGT-1 crops from strict traceability and environmental compatibility tests for transgenic plants, which were vehemently rejected by both camps, a third seems to pave the way for a deregulated authorisation for crops that are genetically indistinguishable from conventional breeds and do not contain any foreign genes. NGT-1 crops are breeds that are genetically indistinguishable from conventionally produced seeds; they carry genetic alterations produced by targeted muta-

tion – up to 20 oligionucleotides within their own genes – instead of the random mutation by chemicals or radiation applied to produce conventional breeds.

Only 22% against

At a meeting of the attachés of the Permanent Representations of the Member States to the EU, a qualified majority was in favour of Poland’s proposal. However, the country representatives requested time for a detailed analysis before the text is passed on to the responsible ministers, the European Parliament and the European Commission for a political decision in the trilogue procedure. This would end two years of debate, which twice failed to achieve a qualified majority in the Council of Agriculture Ministers due to the rejection of Poland with its large population

and the abstention of Germany. A majority of member states had already supported the regulation at the time. However, the EU population share of 65% required for a qualified majority, which is represented by the necessary 55% of supporting states, was not achieved. The European Parliament had voted in favour twice at the time. Due to the approval of the ultra-right wing of the newly elected Parliament for the use of genetic engineering techniques in agriculture, a majority in favour of the NGT Regulation is considered certain, if the voting behaviour of the Christian Democratic EPP remains unchanged and the Commission will re-initiated the deregulation.

The present paper by Polish Agriculture Minister Czesław Siekierski, who called for exemptions from the Green Deal regulations for Poland's farmers from Commission President Ursula von der Leyen at the end of February, but did not yet name any specifics, provides for additions regarding the patentability of NGT seeds compared to the proposal submitted by the Spanish Council Presidency, which failed in the second half of 2024. Suppliers of genetically modified crops and seeds must therefore provide information on whether they are patented or have applied for a patent and whether they are prepared to grant licences for the use of their genetically modified plants.

No labelling

Demands by opponents of genetic engineering for labelling of food produced from genetically modified seeds, which

Polish Minister of Agriculture Czesław Siekierski in mid-December 2024 discussing breeding with new genomic techniques (NGT).

the trade perceives as a marketing obstacle and which therefore do not appear in the Commission proposal, as well as a mandatory risk assessment as for transgenic plants, are therefore not included in the Polish proposal.

Poland’s first draft contained two amendments, which were removed following negative feedback from the country representatives: A labelling requirement for NGT1 seeds if patents exist or have been applied for. In addition, the option for member states to prohibit the cultivation of NGT-1 plants on their territory under certain conditions was removed.

With the current obligation to provide information on the patent status of NGT seeds, which is a modification of seed labelling, Poland is striving to strike a balance between protecting inventions and safeguarding the use of seeds by farmers for breeding purposes.

According to the Council Presidency’s current draft, licences are to be grant-

ed under the same conditions in all EU member states.

U-turn by Poland

According to genetic engineering sceptics such as Franziska Achterberg from the Save our Seeds campaign, Poland recently called for “full labelling and traceability of genetically modified plants and that breeders and farmers should be spared patented seeds. Nothing has remained of this. In fact, even before the presidency, Poland had called for coexistence rules to protect organic farming from marketing bans resulting from the cultivation of NGT1 plants”. In organic farming, NGT1 cultivars are considered genetically modified.

Broad majority

According to reports, Bulgaria, Croatia, Romania, Slovenia, Slovakia and Greece,

i.e. 22% of the member states, have currently spoken out against Poland’s draft. The previously NGT-sceptical countries Austria, Hungary and Malta have not expressed an opinion. In the last vote in the EU Council of Agriculture Ministers, Spain’s proposal, which did not yet include Poland’s proposal, received 57.56% of member states in favour of the NGT Regulation. If Poland, which represents 8.37% of the EU population, votes in favour, there is a Council majority even if Germany (18.8%) and Belgium (2.6%) (%) continue to abstain or oppose the proposal.

Interestingly, the German Christian Democratic Union (CDU/CSU) had eliminated any pro-NGT positions from its programme before German elections. This might become interesting for the triloguedecision on the EU NGT Regulation, if the EPP majority in the European Parliament would surprisingly reject the EU ruling

BioMed X launches new institute

MEDICINE BioMed X Institute, in collaboration with the Government of Barbados and the European Commission, has launched BioMed X Barbados in February, a new research initiative focused on better treatment of cardiometabolic diseases in individuals of African descent.

The new initiative is supported by the European Commission’s PharmaNext programme. It will begin with a two-year pilot project focusing on molecular characterisation of patients in Barbados. The background is that native Africans face a significant burden of diseases such as type 2 diabetes, hypertension, obesity, and cardiovascular conditions, which rise globally. However, clinical trials rarely enrol this patient population, limiting the efficacy and safety of new therapies for these patients.

The BioMed X Barbados project aims to tackle this disparity by employing artificial intelligence (AI) and deep molecular characterisation techniques. The initiative will conduct an epidemiological

study in Barbados, collecting samples and clinical history data from cardiometabolic patients and healthy individuals. The patient samples will be subjected to deep molecular profiling using cell sorting and omics technologies. The integration of these datasets with publicly available clinical and molecular data from age- and gender-matched Caucasian subjects will allow BioMed X to develop AI models designed to optimise available cardiometabolic treatment regimen for the black population. Based on the initial financial support from the Government of Barbados and the European Commission, BioMed X Barbados aims to attract additional funding from global pharmaceutical companies, development banks, and foundations.

The European Commission’s support through the PharmaNext program further reinforces the importance of international collaboration in tackling global health challenges. EU Commission President Ursula von der Leyen, acknowledged the importance of this milestone.■

Signing ceremony between BioMed X and the Government of Barbados. From left to right standing: Simone Rudder, Barbados’ Ambassador to the European Union, Dr. Ursula von der Leyen, President of the European Commission, Mia Amor Mottley, Prime Minister of Barbados, Małgorzata Wasilewska, EU Ambassador to Barbados. Sitting: Dr. Gerhard Ries, Co-Founder and Chairman of the Supervisory Board of BioMed X, Dr. Christian Tidona, Founder and Managing Director of BioMed X, Mark Hill, CEO of Export Barbados

Blurred vision

EC The protein alliance called for by 21 EU agriculture ministers in November 2024 under the leadership of the Danish government, which will remain in office until the end of March, is likely to turn into something less technological than expected. The geopolitically important goal of becoming less dependent on feed protein imports is apparently to be achieved more through the cultivation of domestic protein plants than through fast, spacesaving cell-based processes for the production of plant-identical proteins, which Denmark is driving forward with a threedigit million programme. At least that’s how it sounds in the strategy presented by EU Commission President Ursula von der Leyen at the end of February entitled “A Vision for Agriculture and Food. Shaping together an attractive farming and agri-food sector for future generations”. Sustainable (see p. 6) and climate-neutral fermentation processes are mentioned just once – on page 26 – in von der Leyen’s 28-page paper, which emphasises the priority of EU agriculture over all other sectors. EuropaBio however welcomed even the rare the mention of biotechnology in the EU paper. In the EU commission’s work programme biotechnology and an action plan greenlighted by the old European Parliament (see EuropE an Biot E chnology 3/2024) are mentioned as a priority and key enabling technology by the Commission. EU insiders described the Vision, praised by lobbyists such as Euroseeds and the Bio-based Industry Consortium (BIC), as embarrassing for Food and Agriculture Commissioner Christophe Hansen and the European bioeconomy. ■

2024 statistics

EMA The European Medicines Agency (EMA) recommended a record of 114 medicines for approval in 2024, including 46 new active substances, among them 28 cancer drugs and biosimilars. ■

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Reprogrammed immortal and infinitely proliferating stem cells are an inexhaustible resource for both cell therapies and deeptech bioeconomy applications.

Fighting for the EU’s crown jewels

DEEPTECH BIOECONOMY Faster, bolder, simpler: a course Ursula von der Leyen’s cabinet is seeking to chart with January’s Clean Industrial Deal. However, battles between Commissioners over responsibilities are jeopardising one of Europe’s strongest cards when it comes to getting the economic engine running again. Courage is also lacking when it comes to investment in scaling up the AI-driven deeptech bioeconomy, which could strengthen resilience against China and the US.

Almost three quarters of CEOs from companies from eleven sectors with an annual turnover of more than €1.5bn are convinced the use of AI-supported synthetic biology will be crucial to achieving sustainability goals and better products. 1,100 of them surveyed believe the deeptech bioeconomy will turn crucial in the next 5-10 years (see Fig. 1, p. 16). Cap Gemini reported these figures long before the new EU Commission took up its work in December. Despite the clear industry statement, however, the terms ‘biotechnology’, ‘bioeconomy’ or ‘synthetic biology’ were barely mentioned in the first hundred days of Ursula von der Leyen’s second term as EU Commission president. The silence on biotech was especially loud at the presentation of the Clean Industrial Deal – her cabinet’s central industrial policy project. The 2paper combines the CO2 reduction target of 90% by 2040 with a package of measures to revive stagnating economic growth and stop the outflow of investment from the EU. However, one piece of good news remains: the Commission’s binding work programme for 2025. It will update the 2020 EU strategy for the bioeconomy, which was never implemented through an action plan. The newly modernised bioeconomy strategy is slated to be presented in Copenhagen next December. However, the presentation of the EU Biotech

Act, which was also originally planned for Q4/2025, has now been postponed until 2026. EuropE an BiotEchnology learned why from circles close to the Commission: “Olivér Várhelyi, the Commissioner responsible for Health and Animal Protec-

?What does Europe need to foster the deeptech bioeconomy?

!With AI we are moving from describing biological systems to actively designing new ones, from protein design to precision fermentation. Europe needs to keep up, scale up processes, take risks and support creative synthetic biology projects across all Europe if we want to have a seat in the global arena.

tion, has strong reservations about crosssectional biotechnology applications in general.” In contrast, Christophe Hansen – who leads Agriculture and Food – and Jessika Roswall, who is responsible for the competitive circular economy, are probiotech. They favour the production of feed proteins in fermenters in a climateand space-friendly manner, which would make Europe’s agriculture more resilient to feed imports from the US and South America. “Várhelyi is also against the use of new genomic techniques (NGTs) for plant breeding,” according to sources who did not wish to be named. “Instead of solving problems together, the Commission is preoccupied with itself. That’s not good.” Meanwhile, the Polish Council Presidency’s latest proposals (see. p. 10) triggered a new, constructive discussion on simplifying NGT authorisation for health- and climate-optimised crops.

Silence aside, biotech will be key

The expansion of biotechnology as a key technology is inevitable though. That’s because the former European Parliament gave majority support to the biotech action plan contained in ‘Building the future with nature’, a communication issued in April 2024 by former Competition Commissioner Margarethe Vestager (see EuropEan BiotEchnology 3/2024). “The new Par-

DR GUILLERMO NEVOT is Chair of the European Synthetic Biology Society

Impact and commercialization timelines for engineering biology use cases – by industry

Commercialization timeline (in years)*

Timeframe within which the use case is likely to become commercially viable

Inner zone: 0–2 years

Middle zone: 2–5 years

Outer zone: 5–10+ years

Environmental use cases (common across industries)

Personalized medicine

Regenerative medicine and tissue engineering

Biosensors and monitoring

Bio-based synthetic rubberDisease and climate resilient crops

Bio-solvents, surfactants and lubricants

Bioplastics

Biocatalysts

Bioremediation

Diagnostics and detection

Cell and gene therapy

Drug discovery and vaccine development

Environmental sensing

Carbon capture

Waste management

Sustainable materials and packaging

Bio-based automotive materials (fabrics and paints and coatings)

Bio-cybersecurity

Biological defense

Biosolutions for space zexploration

Biopesticides

Biofertilizers

Nutritionally enriched crops

Potential impact of use case

Based on % of executives that rate the use case as high impact

Low (<30%)

Medium (30–50%)

High (>50%)

Food and beverages

Fortified foods and additives

Cultured meat/labgrown meat

Animalfree dairy proteins

Plant-based meat

Flavors and fragrances

Sustainable cosmetics and fragrances

Novel and highperformance skincare ingredients

Biofabricated textiles

Personalized skincare products

Sustainable and highperformance cleaning solutions

Sustainable leather alternatives

Sustainable dyes and pigments

Precision fermentation for sustainable biofuel production

Biomethane

Algal biofuels

Microbial biohydrogen

Bioengineering for oil refining

Biological solar cells

Water treatment and valorization

Biomining/bioleaching

Personal and household care products

Fig. 1: Applications of synthetic biology and bioengineering alternatives to fossil-resources based chemical engineering: Impact and commercialisation timelines by industry

*Commercialization timelines are based on the assessment of surveyed executives and Capgemini experts.

Source: Capgemini Research Institute analysis; Capgemini Research Institute, Engineering biology survey, April–May 2024, N=1,100 corporate organizations.

liament cannot and will not turn this back,” said one Brussels insider, mirorring a commonly held view.

However, companies and industry associations are concerned that behind closed doors “responsibility for the future of the bioeconomy is being passed on like a hot potato...while the next five years will be crucial for advancing the sector.” Officially, the agriculture-centred ‘Vision for Food and Agriculture’ presented in February is applauded as progress for the bio-based bioeconomy. Behind the scenes, however, the rumbling is growing louder: “It is

1Engineering biology (also known as synthetic biology) involves the application of principles from biology and engineering, in conjunction with AI and data-driven computational techniques, to create new or redesigned biological systems for valuable purposes. Products, materials, or processes driven by engineering biology are referred to as biosolutions in this report.

The CEOs surveyed by Cap Gemini, along with chairs of systemically relevant banks and industry associations, agree on one thing. Future economic growth will be determined by the three mega-trends sustainability, technology leadership and market volatility (due to a lack of resilience).

“Europe is a world leader in the R&D of biosolutions, but currently we are losing pace to the US, China and others when it comes to investments in and market access for these solutions,” says Sofie Carsten Nielsen, the Director of the European Biosolutions Coalition. Founded in Oc-

Organizations view engineering biology as transformative

a scandal that the Vision does not even mention cultivated protein feed and food and the scaling of its production.” The industry appears to have hopes Stéphane Séjourné will do something. The French Executive VP responsible for implementing the Clean Industrial Deal seems to have already recognised that the development of field-spanning biotechnology/ bioeconomy – which is split between the Health, Food & Agriculture and Circular Economy departments – is currently being slowed down by a lack of expertise and funding.

tober 2023, the young alliance currently made up of 11 industry associations is fighting for better framework conditions for the companies driving the biologisation of industrial production (see p. 3).

“We have what it takes to make Europe a place where biosolutions are not only born, but also grow up. However, this requires massive investment in testing and scaling up biosolutions, removing regulatory barriers that prevent them from reaching the market quickly, and a bold and broad European Biotech Act. A lot is at stake. If Europe does not take decisive action, we risk losing substantial growth, jobs and the opportunity for significant CO2-reductions,” Nielsen emphasises.

Others are leading tech transfer

While the US and UK added AI and synthetic biology to complement their bioeconomy strategies two years ago, the EU still focuses on the bio-based bioeconomy centered on agricultural residues.

Even though a new study by the Nova Institute for the Bio-based Industry Consortium (BIC), however, clearly shows that by 2050, there will only be enough wood and bio-based agricultural raw material available to replace 20% of the carbon produced by the chemicals industry.

This is why projects in pilot stage such as Rheticus from Siemens Energy and Evonik SE are needed. The pilot plant replicates the principle of photosynthesis in order to utilise CO2 and water as raw feedstocks. In it, CO2 and H2O first react in a co-electrolysis process fed with renewable electricity to form syn-gas. This is converted by chemolithotrophic Clostridia metabolically optimised for producing the chemical building blocks butanol and hexanol. Those in turn are used to make synthetic fibres, sustainable aviation fuels (SAF) and food supplements. That this works economically has already been demonstrated. Where exactly upscaling will take place depends on who makes the most attractive co-financing offer for a post-pilot plant. Al-

ternative processes in which chemolithotrophic bacteria convert hydrogen and CO2 into amino acids (Arkeon Biotechnologies), natural gas (Electrocaea GmbH, Krajete GmbH) and a range of other chemical building blocks have moved beyond pilot scale, and are now just waiting for investors. “There are already numerous sustainable, climate-neutral biotechnological drop-in processes that produce at the same price as their fossil counterparts,” explains Dr Martin Langer, Executive Vice President of BRAIN Biotech AG. It has co-developed a process with Südzucker AG similar to Evonik’s, but one that supplies other building blocks. “The high CAPEX costs of the production facilities are the problem. They mean that fossil fuels are not replaced by sustainable biotech processes,” says Langer. “No shareholder will accept a €100m investment without an increase in returns as long as a fossil- based process does the same. A solution could be public funding similar to that provided by the US In-

Meet experts from research and development in the field of Single-Use Technologies to discuss the topics:

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flation Reduction Act or as France and Italy do” (see p. 69).

“The fact that Europe is still ahead of China and the USA in scientific terms is a huge economic opportunity for Europe,” stresses Prof Dr Thomas Brück. The Chair of Synthetic Biotechnology at the Technical University of Munich has co-authored a position paper that calls for public funding to scale up biotechnological production processes for climate-neutral biomaterials, chemicals, feed and food, cosmetics, fuels and energy.

In February, Germany’s innovation agency SPRIND presented even more specific proposals on how production units for breakthrough innovations can be implemented quickly. It recommends mapping and coordinating existing bio(tech)-manufacturing capacities and retrofitting production capacities for selected suitable lighthouse projects that biotechnologically transform natural cells into self-renewing machines for the production of industrial goods. According to the agency, the deeptech bioeconomy – when supplemented by AI and automated bioprocesses – will significantly strengthen resilience, creating economic growth and jobs.

Commercialisation elsewhere

Germany and the EU were the first in the world to formulate the bioeconomy as a sustainable concept harnessing future technology and corresponding strategies back in 2011 and 2012 respectively (see p. 3). In

2025, there are no commercialised European products in competing North America and China. Instead, however, you can find a large number of biotechnological processes that were developed in Europe but didn’t found investors in Europe to transfer them to an industrial scale.

But lack of strategic funding is just one reason for Europe’s biotech exodus. Two years ago, German process developer The Cultivated B was the first company in the world to pre-register a hot dog for EU market authorisation made half from plant protein and half cultivated muscle cells. When

processes stalled at EU food watchdog EFSA, its parent company InFamily Foods took action. It outsourced production and R&D to Canada, where it found co-investment for the production facility, and benefited from approval times that are four times faster than in Europe. This year, Canadian spin-off n!Biomachines Inc reported its first successful milestone on the road to cost-effective commercial production: a significant improvement on the multiplication of muscle stem cells in bioreactors through the use of AI-controlled biosensors. In February, R&D at The Cultivated B followed suit, announcing a technological breakthrough set to drastically reduce the production price of cell-based meat made from muscle stem cells. Identified in a virtual screening, their TCB-32 molecule allows stem-cell cultures to grow almost as fast as those supplemented with costly bovine fibroblast growth factor derived from fetal calf serum. TCB-32 is thermostable and reduces the batch-to-batch variability associated with bFGF. Hamid Noori and his team have thus opened the door to climate-neutral, rapid and cheap industrial production of nature-identical food proteins in the US$1,730bn global meat market. A recent German survey of 2,100 North American consumers showed that

Fig. 3: Last year, German AMSilk and Danish 21st.BIO A/S forged an alliance to scale production of recombinant silk protein from kilograms to tonnes. Churning out large amounts of the biotech-produced silk-based fibres was made possible by an optimised bacterial strain. Commercial production is set to begin next year.

Fig. 2: Evonik Industry and Siemens Energy’s RHETICUS pilot plant in Germany. .

acceptance of meat substitutes depends mainly on cost. If there is price parity, the animal original is preferred. If prices fell by 10% compared to conventionally-produced meat, the sales of meat alternatives would increase by 17%. If prices continued to drop, acceptance would increase disproportionately, particularly among men. According to a recent study from Leaps by Bayer and the Boston Consulting Group, acceptance of cultured protein food and animal feed globally is still low (39%). However, with increasing health benefits, low-cost cholesterol-free meat and authentic milk and cheese for lactose-intolerant consumers are expected to turn into blockbusters.

Yet another little-known example of the commercialisation of German breakthrough innovations is in yet another environment that is more open to technology than Europe: “The mining of [the critical raw material, CRM] lithium, which is indispensable for rechargeable batteries for electric cars and e-bikes well as batteries, will increase eightfold by 2030,” explained Robert Kang, CEO of Blue Whale Materials LLC, two years ago at i ndustria B iot E c in Berlin. As natural deposits are limited, the US government recognised the strategic importance of lithium recycling in 2022 and is investing “huge sums’ to enable battery recycling. Together with German BRAIN Biotech AG, Bluewhale is co-commercialising BRAIN’a microbial process for the highly efficient recovery of lithium and other rare metals (see p. 72) from crushed spent batteries in the USA. BRAIN had optimised microorganisms from a screening that enrich lithium but also other CRMs. According to Kang, the US was “previously a “developing country” in terms of battery recycling” – 5 to 10 years behind Germany. Strategic investments can therefore help to close technological gaps.

Seizing a unique opportunity

While the EU Commissioners dither, France (with at least 20 biorefineries) and Italy are making things happen. At the end of February, the Italian parliament approved €2.2bn until 2027 for the conversion and construction of biorefineries that process classic bio-based residual streams. Lawmakers there have recognised that investing in the biologisation of industrial production not only strengthens raw material resilience and climate neutrality, but is also the market of the future (see SAF p. 69). According to synbio expert Thomas Brück, the first scaled applications will include food, cosmetics and chemicals. His hopeful spinoff, Global Sustainable Transformation (GST), produces palm oil alternatives from old bread. “Investors will go where the first lighthouses become visible,” he says – and others agree. The EU biotech production centres waiting for investment are also aware of this. In February, 14 production hubs came together to form the European Bioeconomy Clusters’ Alliance, aimed at accelerating commercialisation of sustainable biotech production processes. Deeptech bioeconomy is the EU‘s next trump. ■

t.gabrielczyk@biocom.eu

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European biotechs navigating a new financing environment

ULI KINZEL, PARTNER INVESTMENT

BANKING BRYAN GARNIER After the exuberance during the COVID -boost and the post- COVID hangover, 2024 was a rather calm year for the biotechnology sector. This provides an opportunity to take a step back and assess some emerging long-term financing trends as well as the recent events in the US, which may also impact the biotech industry.

There are two realities in biotechnology that have represented “ground truths” for decades. Firstly, developing drugs requires substantial amounts of cash and “regular stops at the super-charger”. Secondly, once you succeed in drug development, most of the payback is in the world’s largest and highest priced pharma market, the USA. How has the typically quite protracted financing journey of biotechnology companies changed in recent years?

Since 2023, with the IPO bottleneck extending and M&A activity resuming slowly, growth-stage as well as venture-stage companies are choosing to remain private for unprecedented periods of time. The good news is that the emergence of private equity continua-

tion funds, more sizeable series C and D-rounds – such as the US$350m Eikon Therapeutics funding or the extension of Numab’s series C to CHF180m – as well as cross-over financings are providing an opportunity for corporates and their longterm investors to bridge the time to an attractive M&A-exit or successful IPO. For impatient early investors, the rapidly growing market for secondaries also provides a potential exit opportunity along the road. The extension of the financing journey is driven by a higher bar for exits. Public market investors and strategic buyers have turned their focus on highquality, more mature assets positioned in attractive markets. For biotechs this generally means strong clinical data for nov-

News from the floor

At the turn of the year, German 4SC AG (Martinsried) remained optimistic. Although the European Medicines Agency (EMA) had raised questions in the final stages of the approval process for its cancer drug Resminostat, 4SC believed it had fully addressed them. However, the EMA has now issued another response, stating that the application is not approvable due to “serious objections.” As a result, 4SC’s share price has plummet-

ed. The presence of so-called Major Objections prevents a recommendation for market approval at this stage and leaves more questions to be answered.

PHARMAMAR GROUP from Spain (MSE: PHM) closed fiscal year 2024 with a total revenue of €174.9m, representing an 11% increase compared to the previous year. R&D investment in 2024 grew 4% compared to the previous year, reaching €103.5m.

el approaches targeting therapeutic areas of interest. However, in disease areas such as obesity or neuroscience, capital markets investors tolerate a higher level of development risk as they are attracted by the enormous market potential and high unmet medical need in the major chronic disease areas of our super-aging western societies. In addition, European biopharmas now also need to adapt to changes taking place across the Atlantic.

The new administration’s plan to slap tariffs across multiple sectors – including pharma – could affect valuations of the wider pharma sector which is already re-assessing its global supply chains; European biotechs are less affected, but developers with late-stage assets will consider possible trade barriers in their decision making in areas such as out-licensing and supply chain scale-up. ■

THOR MEDICAL ASA from Oslo, Norway, is preparing for a launch of radioligands in the alpha-emitter space. With NOK200m raised in a new equity, NOK90m (together around €24,8m) loan grants from Innovation Norway, and additional working capital arrangements, the AlphaOne project is fully funded through construction and ramp-up in 2026. First Thorium-228 product samples have been delivered to customers. ■

COMPANY QUOTE

4SC AG 3.02 33,810k 

AB Science SA 1.43 83,280k 

Abionyx Pharma SA 1.27 43,940k 

Abivax SA 7.39 480,450k 

Ablivia AB 0.03 50,130k 

AC Immune SA 2.35 228,770k 

Active Biotech AB 0.01 7,380k 

Adaptimmune Therapeutics plc 0.46 481,860k 

ADC Therapeutics SA 1.61 155,444k 

Addex Therapeutics Ltd 0.56 5,734k 

ADL Bionatur Solutions SA 0.25 16,590k 

Adocia SAS 4.68 85,990k 

Advicenne SA 1.78 21,670k 

Aelis Farma SAS 1.45 20,010k 

Affimed NV 0.97 14,830k 

Akari Therapeutics plc 0.85 20,650,000k  Alkermes plc 32.20 5,240,000k 

Allarity Therapeutics A/S 1.04 4,626k 

Altamira Therapeutics Ltd 0.11 410k 

Alvotech SAS 10.25 3,110,000k 

Alzinova AB 0.22 20,910k 

Annexin Pharmaceuticals AB 0.02 10,130k 

Aprea Therapeutics AB 2.08 13,320k 

Aqua Bio Technology ASA 0.12 13,660k 

Arctic Zymes Technologies ASA 1.60 81,610k 

Arecor Therapeutics plc 0.39 14,650k 

Argenx BV 565.40 34,600,000k 

Arocell AB 0.04 8,660k 

Arterra Bioscience SpA 2.06 13,700k 

Ascelia Pharma AB 0.20 21,050k 

Aton 0.01 7,680k 

Autolus Therapeutics plc 1.87 510,900k 

Avacta Group plc 0.43 155,000k 

Axichem AB 0.08 4,600k 

Basilea Pharmaceutica AG 47.92 580,551k 

Bavarian Nordic A/S 21.95 1,750,000k 

BB Biotech 37.95 2,080,000k 

Bergenbio ASA 0.13 5,370k 

BICO Group B 3.62 255,300k 

Bicycle Therapeutics plc 9.65 469,950k 

Bioarctic AB 19.43 1,430,000k 

Biocartis NV 0.26 24,300k 

Biofrontera AG 2.35 14,460k 

Biogaia AB 10.62 1,040,000k 

Bioinvent International AB 2.35 152,010k 

Biomed-Lublin SA 1.14 70,910k 

Biomérieux SA 114.10 13,580,000k 

BioNTech SE 100.80 24,960,000k 

Bioporto Diagnostics A/S 0.21 89,590k 

BioSenic SA 0.00 1,460k 

Biosergen AB 0.04 7,980k 

Biotage Sweden AB 9.44 755,670k 

Bioversys AG

Biovica International AB 0.16 14,120k 

Bioxxmed AG 0.84 1,070k 

Bivictrix Therapeutics plc 0.10 8,200k 

Brain AG 2.39 53,090k 

C4X Discovery Holdings plc 0.12 29,300k 

Camurus AB 55.30 3,270,000k  Cantargia

European Biotech Stocks

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

plc 15.50 1,990,000k 

Centogene NV 0.09 2,930k 

Circio Holding 0.05 4,280k 

CombiGene AB 0.23 4,750k 

Cosmo Pharmaceuticals NV 59.00

Evaxion Biotech A/S 1.72 9,932k 

Evgen Pharma plc 0.00 255k  Evolva N 1.33 9,563k 

COMPANY

Expres2ion Biotech Holding AB 2.26 6,000k 

Faron Pharmaceuticals Oy 2.13 237,700k 

Fermentalg SA 0.37 31,450k 

Flerie AB 4.01 313,050k 

Fluicell 0.00 1,920k 

Formycon AG 25.10 456,620k 

Fusion Antibodies plc 9.50 911,385k 

Gabather AB 0.00 5k 

Galapagos NV 23.92 1,580,000k 

Genedrive PLC 0.02 11,130k 

Geneuro SA 0.08 2,520k 

Genfit SA 3.42 169,490k 

Genflow Biosciences plc 0.02 6,120k 

GENinCode plc 0.03 8,750k 

Genmab A/S

14,080,720k 

Genovis AB 2.13 139,440k 

Genoway SA 3.38 31,770k 

Gensight Biologics SA 0.23 30,510k 

Gentian Diagnostics AS 3.98 60,460k 

Genus plc 22.20 1,450,000k 

Global Bioenergies SA 1.24 23,580k 

Glycorex Transplantation AB 0.23 17,279k 

Guard Therapeutics International AB 1.42 17,460k 

Hansa Biopharma AB 2.02 136,480k 

HBM Healthcare Investments AG 164.80 1,150,000k 

Heidelberg Pharma AG 2.68 123,490k 

Hemogenyx Pharmaceuticals plc 3.56 12,830k 

Herantis Pharma Oyj 1.32 31,560k 

Hofseth Biocare ASA 0.21 81,028k 

HOOKIPA Pharma 1.16 11,235k 

Idorsia Ltd 1.20 215,971k 

Immatics NV 4.14 494,610k 

Immunic AG 1.04 94,580k 

Immunovia AB 0.04 9,170k 

ImmuPharma plc 0.04 16,660k 

Infant Bacterial Therapeutics AB 3.13 40,754k 

InflaRx NV 1.12 66,070k 

Innate Pharma SA 1.97 164,810k 

Integragen SA 0.49 3,310k 

Intervacc AB 0.06 20,480k 

Inventiva SA 2.86 273,590k 

IO Biotech Inc. 0.82 53,968k 

IRLAB Therapeutics AB 0.48 24,860k 

Isofol Medical AB 0.13 21,740k 

ISR Holding AB 0.19 6,760k 

Kancera AB 0.10 9,760k 

Kuros Biosciences AG 19.27 726,969k 

Lipum AB 1.51 32,027k 

Lytix Biopharma AS 0.41 26,550k 

MaaT Pharma SA

Mabion

Mainz



Marinomed Biotech AG 13.40

MDxHealth

Medesis

Medigene AG 1.59 11,720k 

Medincell

Medivir AB 0.12 16,020k 

Mendus AB 0.63 33,490k 

Merus BV 42.80 2,960,000k 

Modus Therapeutics Holding AB 0.10 3,480k  Molecular Partners

Newron

Nextcell Pharma AB

Nicox SA

Nidhogg Resources Holding AB 0.38 3,390k 

Niox Group plc 0.72 286,550k 

NLS Pharmaceutics AG 1.55 1,815k 

Novacyt SA 0.57 40,610k 

Novozymes Biopharma DK A/S 54.92 22,280,000k 

NuCana ADR 0.86 47,030k 

Nykode Therapeutics ASA 0.15 52,380k 

Okyo Pharma Ltd 1.25 42,700k 

Oncimmune Holdings plc 0.01 1,840k 

Oncoarendi Therapeutics SA 1.97 40,710k 

Oncopeptides AB 0.14 12,250k 

OncoZenge AB 0.54 6,300k 

Open Orphan plc 0.19 127,910k 

Optibiotix Health plc 0.20 19,980k 

Orphazyme A/S 100.50 4,320k 

Oryzon Genomics SA 2.84 183,860k 

OSE Immuno SA 6.23 136,230k 

Ovoca Bio plc 0.01 1,280k 

Oxford Biodynamics plc 0.00 15,660k 

Oxford Biomedica plc 3.46 366,550k 

Oxurion NV 0.17 600k 

Pangaea Oncology SA 1.72 59,190k 

PCI Biotech Holding ASA 0.10 3,630k 

Pharma Mar SA 96.80 1,750,000k 

Pharming Group NV 0.78 521,650k 

Pharnext SA 0.00 1k 

Photocure ASA 4.17 112,010k 

Plant Advanced Technologies SA 10.10 11,140k 

PolyPeptide Group SF 19.82 653,822k 

Poolbeg Pharma plc 0.03 13,500k 

Poxel SA 0.18 9,070k 

Predilife SA 3.78 14,450k 

Probi AB 30.70 349,800k 

ProQR Therapeutics BV 1.83 186,180k 

Prostatype Genomics AB 0.30 1,540k 

Proteome Sciences plc 0.04 10,630k 

COMPANY QUOTE

Prothena Corporation plc 14.00 748,200k 

Pure Biologics SA 3.02 12,150k 

Qiagen NV 36.50 8,100,000k 

Q-Linea AB 0.00 24,390k 

Quantum Genomics SAS 0.07 5,020k 

Redx Pharma plc 0.17 66,130k 

Relief Therapeutics Holding AG 2.92 36,594k 

Reneuron Group plc 0.03 1,940k 

Ryvu Therapeutics SA 4.66 115,140k 

Saniona AB 0.63 71,570k 

Santhera Pharmaceuticals AG 15.73 190,430k 

Sareum Holdings plc 0.19 23,240k 

Sartorius AG 187.40 6,540,000k 

Scancell Holdings plc 0.07 68,430k 

Selvita SA 10.66 195,670k 

Sensorion SA 0.57 170,680k 

SenzaGen AB 0.51 15,050k 

Shield Therapeutics plc 0.03 32,290k 

Silence Therapeutics plc 4.40 615,910k 

Simris Group AB 0.01 2,990k 

Skinbiotherapeutics plc 0.22 50,050k 

Softox Solutions AS 0.00 5,850k 

Sophia Genetics SA 2.84 189,800k 

Spexis AG 9.70 656,350k 

Sprint Bioscience AB 0.12 8,740k 

Stayble

Tissue Regenix Group plc

Therapeutics

Verici Dx plc 0.03 6,670k 

Verona Pharma plc 61.50 39,930,000k

Bioversys goes public at SIX

AMR BioVersys AG, based in Basel, Switzerland, went public on the SIX Swiss Stock Exchange. The IPO with gross proceeds of approximately CHF80m was fully subscribed.

Dr Marc Gitzinger, CEO of BioVersys, expressed his pride in the success he had worked towards for many years: “This day marks an important milestone in our growth strategy. The strong demand and significant interest from investors in recent weeks motivate us to proceed with BV100 into the Phase III programme, advance alpibectir into additional Phase II studies in collaboration with GSK, and continue expanding our early-stage pipeline. I would like to thank everyone who has contributed to this success.”

BioVersys’ primary placement consisted of 2,083,333 newly issued shares, along with an option for a further 138,888 shares. The offer price was set at CHF36 per share. Only 30% of the options were exercised by mid-March, thus generating total gross proceeds of CHF77m. This corresponds to a market capitalisation of around CHF210m. Existing shareholders, including Glaxo Group Limited, invested CHF3.5m in the placement. The AMR Action Fund, L.P. and AMR Action Fund, SCSp committed to a total investment of around CHF22m. Industry experts widely regard the success-

ful IPO as a significant achievement in a field that has long been neglected by major pharmaceutical companies. However, analysts also caution that investors should not expect immediate price gains. This is particularly relevant for trading on a European stock exchange, where weaker investor activation and interest could quickly lead to a drop in share price, potentially overshadowing the success of the IPO in retrospect.

The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase III ready), and tuberculosis (alpibectir, Phase IIa, in collaboration with GlaxoSmithKline and a consortium of the University of Lille, France). BioVersys is a 2010-founded Swiss pharmaceutical company originating from the biotechnology lab of Martin Fussenegger at the Basel satellite research institute of ETH Zurich, Department of Biosystems Science and Engineering DBSSE.

Resistant Acinetobacter baumannii has surged in China, with rates rising from 32% in 2005 to over 75% in 2018. Perhaps a trigger why The Guangzhou Sino-Israel Bio-Industry Investment Fund (GIBF) has invested US$6m in BioVersys and supports the trials also in terms of regulatory demands. ■

Sofinnova goes bold with fund

VENTURE CAPITAL Sofinnova Partners, a leading European life sciences venture capital firm, has raised €1.2bn over the past year, including €1bn just in the last quarter, bringing its assets under management (AUM) to over €4bn. This reinforces its position as a key investor in healthcare and – less well known – sustainability.

“With the new funds raised, all of our seven investment strategies have the capital to support 50 to 60 new life sciences companies,” said Antoine Papiernik, Chairman and Managing Partner just a few days ago.

The firm’s latest funds have attracted strong commitments from institutional investors, sovereign wealth funds, and corporates. With a team of over 80 professionals across Paris, London, Milan, and a small group in Munich, Sofinnova remains committed to strengthening its presence in key European markets.

Coming back from the JPMorgan Health Conference in January, Dr Karl Nägler, Partner in Munich, shared his views on 2025: “After decades of rainy JPMs, the sunshine was a welcome change”, he commented. “Discussions focused on whether deal-making is picking up, the new US administration’s impact, potential policy shifts at the FTC, and the future of the China Newco model. The sentiment was one of cautious optimism, with a sense that the industry is moving in the right direction”, Nägler stated to EuropE an BiotEchnology. In light of the successfull fundraising, this positive disposition is likely to persist.

Although the focus of Sofinnova Partners on sustainability is less well known the firm has been investing in the field for over a decade and has already 24 companies in industrial biotechnology in its portfolio, from novel food to agritech and other sectors.

Founded in 1972, Sofinnova has backed over 500 companies, creating several market leaders worldwide. ■

Ringing the cowbell at Swiss Stock Exchange SIX opening after a successfull IPO: BioVersys extended management board: Nawaz Khan, Head of Research; Hernan Levett, CFO; Marc Gitzinger, CEO; Glenn Dale, CDO from left

Ryvu Tx extends cashflow

ADC In early March, Krakow-based oncology specialist Ryvu Therapeutics zoo announced a strategic reorganisation that will extend Ryvu’s cash runway to H2/2026 to focus on accelerating three ongoing RVU120 clinical programmes, and early pipeline small molecule and ADC assets to reach key data inflection points.

“We remain focused on advancing our first-in-class clinical blood cancer program RVU120, as well as promising early-stage assets”, Paweł Przewiezlikowskii, Chief Executive Officer of Ryvu, told Europ E an B iot E chnology. “Considering our cash position, revenue projections, cost structure and the demanding market environment, we decided to optimise expenses so that the company has sufficient cash runway to generate key data for RVU120 and the preclinical pipeline, expecting that our achievements over the next year will support future cash inflows.”

Cash runway will be extended from Q1 to H2 2026 to boost three clinical Phase II studies with its selective CDK8/ CDK19 kinase inhibitor RVU120. This will be achieved by reducing the staff by approximately 30% and stopping recruitment for the Phase II RIVER-52 study of

RVU120 monotherapy in patients with AML or HR-MDS. Cash runaway was approximately €46m in cash and other financial assets held by Ryvu. In addition, the company has secured approximately €22m in non-dilutive grant funding.

“We are also continuing two directions of our early pipeline – small molecules, including RVU305 and ADCs, but with a reduced headcount”, said Przewiezlikowskii.

Ryvu will continue to focus on efficient and profitable first-in-class and best-in-class therapeutics and accelerate Phase II development of its key asset RVU120 with three studies: RIVER-81 (plus venetoclax in patients with AML), POTAMI-61 (monotherapy/combination study with ruxolitinib in patients with myelofibrosis) and REMARK (monotherapy study in patients with LR-MDS).

The decision to progress RIVER-81 and suspend enrolment in RIVER-52 was based on data analysis and feedback from advisory boards in February 2025. The next data update for RVU120 is planned in Q2/2025. Furthermore, IND/ CTA-enabling studies for RVU305 are ongoing and planned to be completed in H2/ 2025. Ryvu will continue to develop ADCs with novel payloads. ■

Therapeutic antibody discovery & development

From Target to Lead

The tenth pin for quality management in life sciences

TECHNOLOGY INTEGRATION

The much-discussed digital transformation in the healthcare sector is in full swing. European Biotechnology spoke with Dr. Sabrina Graf, COO of the globally active Tenthpin Group, about how the right software can improve quality management, keep the system landscape lean, and safe both, time and money.

EuroBiotech _What are currently the most important challenges for globally active drug developers and how can AI and automation contribute to a productive solution?

Graf_Life sciences companies, as well as service providers for clinical trials and biomanufacturing, are facing a major transformation. The steadily increasing price pressure from the healthcare system, everhigher regulatory requirements for documenting the development process, more complex therapeutic modalities, the decentralised manufacturing of increasingly personalised therapies, and the coordination of biomarker and therapy development and global roll-outs require a growing reduction in errors and greater productivity from developers. The increasing use of AI tools promises not only a reduction in development times but also higher profits due to a lower error rate and better compliance rates in the highly regulated field of drug development, optimal utilisation of global supply chains, and the product development process. Corresponding AI applications are already being used for the automated recruitment of suitable participants for clinical trials and their design, the identification and validation of biomarkers that facilitate the right therapy choice, remote patient monitoring, and the automated GxP-compliant process optimisation and quality documentation. Many companies are still in the process of separating the AI signal from the noise. They are looking for reliable AI applications that offer fast implementation times, high returns, and immediate availability. Tenthpin’s expertise in life sciences, SAP

DR SABRINA GRAF is the Chief Operating Officer of Tenthpin Management Consulting and Solutions –a globally leading business and technology consultancy for the life sciences industry. With more than 15 years of leadership experience in consulting and finance, her career has focused on navigating complex organizational transformations.

software, and AI in-house developments helps to find the right and reliable application for a customer’s problem.

EuroBiotech _Where does Tenthpin see the digital journey going for life sciences companies?

Graf_The digital journey is accelerating rapidly, driven by AI to make processes faster, more accessible and more personalised. Our clients want to procure standard software built and operated GxP

compliantly and industry standards that make it easier for them to simplify their system landscape. Particularly, SAP customers are striving towards keeping their Core clean with minimal bespoke custom coding and enriching functionality by procuring standard solutions for instance in the quality management space. It is an approach to having a system that is flexible, extendable and easy to upgrade.

EuroBiotech _Can you please give us a brief portrait of Tenthpin’s goals and the resulting core business, as well as the response from the life sciences sector –from finding the company name, founding the company in 2017, until today?

Graf Let’s start with the name as it reflects our ambition for the market: 1841 Connecticut law banned ninepin bowling as it was deemed to promote gambling. Adding an extra pin (the famous Tenthpin) gave people a way to keep bowling. The tenth pin made the difference and paved the way for the success of the game. Some sources call this story a mere fable, while others confirm it. Today bowling is played by 120 million people in 90 countries. Our goal is to be the leading partner in life sciences for intelligence transformations to advance modern medicine – being the tenth pin for our clients. Being fully focused on one industry sector, the life sciences, we combine business process and technology know how to deliver true business value utilising state-of-the-art technology. We combine consulting as a partner for SAP-enabled business transformations in the life sciences industry with solution and software development. For our cli-

Adaptable to any type of needle

Low Density Polyethylene (LDPE)

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BRAZIL

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ents, we act as a partner for co-innovating new products that address significant industry gaps by leveraging state-of-the-art technology. Today, we are working for 16 out of the 20 largest life sciences players while many mid-size players like CDMOs rely on our services and products. We realise superior standard software solutions to create business value by leveraging latest technologies.

EuroBiotech _What consulting, software and AI services does Tenthpin offer to enable shorter time-to-market, compliance and profitability?

Graf_With our clear industry focus on the life sciences and our standard process models, specifically for biotech, pharma, medtech, diagnostics companies, CROs, and CDMOs, we make ERP transformations more efficient in terms of lead times, costs, business value created and keeping the core clean. We recognise that the life sciences industry sector is undergoing a rapid transformation into a data-driven deeptech industry. Leveraging our roots in consulting, along with our expertise in SAP and other technologies, we have a global team of highly experienced industry experts, software engineers, developers, and UX specialists, committed to delivering software solutions and closing the gap of missing standard software. For example, Tenthpin collaborated with SAP to develop new SAP standard software products such as the SAP Batch Release Hub, SAP Intelligent Clinical Supply Management, and SAP Cell & Gene Therapy Orchestration. Together with our clients and partners like AWS we identify industry gaps and develop software solutions that address fundamental shortcomings or efficiency needs supporting the ambition of

generating industry standards. We know how to combine agile approaches and compliance requirements like GxP and HIPAA with state-of-the-art technologies including AI and cloud platforms to create superior solutions.

EuroBiotech _What gap does Tenthpin close with its software compared to industry-standard QM functions in ERP systems?

Graf_Overall, we minimise compliance risk, cost and increase overall supply chain efficiency. With Tenthpin’s Intelligent Quality Suite we developed a portfolio of standard software called T/ICV, T/ ICG, T/QME to support quality processes and industry- wide collaboration.

› T/ICV (Tenthpin Intelligent Certificate VerificAItion): Tenthpin has developed a solution that uses AI and Large Language Models to extract all data from CoAs (Certificate of Analyis), CoCs (Certificate of Conformity), and CoSs (Certificate of Sterilisation) to automate the certificate comparison against corresponding specifications, and to handle the end-to-end approval process. The business case for this AI driven solution is overwhelming, as it reduces the time spent on manual checks by 90%, while ensuring unmatched accuracy.

› T/ICG is a flexible certificate generation solution to cover various regulatory industry requirements towards batch certificates (e.g. EU GMP Annex 16), which significantly reduces manual interaction times, at the same time increasing the quality.

› T/QME (Tenthpin Quality Management Evolved) enriches existing SAP S/4HANA processes in the QM do -

main. It is qualified to be GxP-ready and fully embedded into the production and supply chain processes. T/ QME enables the effective execution of quality control and quality assurance activities through automating back-end processes – from sample creation to batch release – with an enhanced and modern user interface.

EuroBiotech _Could you please give some examples/use cases of how Tenthpin has helped clients to automate and digitalise their processes?

Graf For a globally acting CDMO, we accomplished a major SAP enabled business transformation based on S/4HANA. Given the client’s highly complex system and process landscape and reliance on manual processes for compliance, our goal was to pilot the implementation of SAP S/4HANA (RISE/PCE) across four manufacturing sites and the holding company. We integrated multiple systems (LIMS, SuccessFactors, DMS, etc.) and ensured that templates met the requirements of all sites. Leveraging our ready-to-use CDMO process template, we significantly enhanced process efficiency, provided full transparency on customer project margins, and successfully completed the pilot SAP S/4HANA (RISE/PCE) implementation within 15 months. Additionally, we ensured GxP-compliant processes and implemented our Tenthpin Quality Management Evolved (T/QME) as a standard software solution, achieving a rollout in just two weeks.

With one of the biggest global Pharma companies, we digitise the whole verification process for certificates of sterilisation (CoS). All incoming CoS are verified with our AI-powered Solution (T/ICV) that helps our client to reduce the time per certificate verification from 30 minutes to less than five minutes for more than 60.000 certificates per year. In a next step the same standardised platform, T/ICV, will be leveraged to streamline the verification process for Certificates of Analysis (CoA) and Certificates of Conformity (CoC), further enhancing efficiency and automation.

■ t.gabrielczyk@biocom.eu

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Moss Cell Line Finds Broader Application

ALLIANCES Freiburg-based Eleva relies on its moss-based platform for the development of new biologics both independently and with partners. A new alliance with Spanish CDMO

3PBIOVIAN now secures clinical production capacity for both activities.

EuroBiotech_Where does Eleva find its niche in the rapidly evolving therapeutic landscape?

Andreas Schaaf It is well known that a significant number of proteins cannot be produced in CHO cells at all or only with suboptimal outcomes. As a result, these CHO-incompatible biologics, even if they have great therapeutic potential, are simply avoided by our industry. Our mossbased platform can make such candidates "developable" again. That’s why, we are currently "alone in the field” with our Factor H (CPV-104) program, a natural regulator of the complement system.

EuroBiotech_CDMOs tend to trust only a few technology platforms. How did Eleva gain a foothold in this market?

Schaaf_First, it helps to be as close as possible to the industry’s "workhorse," the CHO platform. For example, we do not need greenhouses like other plant-based approaches. Our moss cell line grows in standard fermenters with an additional light source at this stage. In the long term, we aim to further refine the strengths of our own platform and address its remaining limitations. That is why technology development at our company remains a priority.

EuroBiotech_What does the 3PBIOVIAN partnership mean for Eleva?

Schaaf_We benefit in three ways. For our own pipeline, particularly CPV-104, we have secured the production capacity needed for mid-stage clinical studies. At the same time, we can offer these capaci-

Andreas Schaaf Chief

Scientific Officer

& Managing Director; he holds a PhD in plant biotechnology. Before joining Eleva in 2009, he held positions at the Universities of Münster and Freiburg, Germany. At Eleva, he played a key role in transforming the company’s mossbased expression technology into a fully viable biopharmaceutical platform. Since 2015, he has served as CSO and was appointed Managing Director in late 2019.

ties to partners who want to develop biologics with our platform. As a result of the alliance, we essentially triple our GMP production capacity for programs based on our technology platform. And as a third component, 3PBIOVIAN is now the first CDMO in the market actively promoting

our moss-based platform. Other CDMOs could follow.

EuroBiotech_How did the market react to this?

Schaaf_Very positive. We are, as always, engaged in numerous discussions with biopharma companies whose innovative drug classes could particularly benefit from moss-based expression—such as antibody-based therapeutics in all their modern forms, cytokines, and complex proteins in general. One key topic in these discussions is always securing capacity for clinical development, and we are beginning to address this through alliances like this one.

EuroBiotech_What are Eleva’s next steps?

Schaaf_From our own pipeline, initiating the clinical development of Factor H (CPV104) for a chronic kidney disease, C3G more specifically, is our main focus. We are also considering an indication expansion into dry age-related macular degeneration (dry AMD). Our second clinical program aGal (RPV-001) in Fabry Disease will move forward once we have secured a partnership for this compound. Furthermore, we are currently selecting entirely new molecules to expand our pipeline and are open to partner on such projects. ■ Contact us:

Eleva GmbH

Andreas Schaaf, CSO & Managing Director

aschaaf@elevabiologics.com https://elevabiologics.com

Update of ongoing clinical trials NEWS

Durable gene repair

Amsterdam-based uniQure NV completed enrolment in the first cohort of its Phase I/IIa trial of AMT191, a gene therapy approach for the treatment of Morbus Fabry. Following review of safety data from this patient population, the Independent Data Monitoring Committee (IDMC) recommended proceeding with enrolment in the second cohort. AMT191 is an investigational AAV5based gene therapy that delivers galactosidase alpha to liver cells. Patients with Fabry disease exhibit an alphaGAL-A enzyme deficiency, which in turn results in a progressive accumulation of lipids in multiple cell types including kidney and heart cells, eventually resulting in a multi-system disorder. AMT-191 may offer a novel one-time intravenously-administered approach to treating Fabry disease.

Endpoints met

Belgian J&J subsidiary Janssen-Cilag International NV has reported findings from its pivotal nipocalimab Phase III study in a broad antibody-positive (antiAChR+, anti-MuSK+, and anti-LRP4+) adults living with generalised myasthenia gravis in l anc E t n E urology. The Vivacity-MG3 study met its primary endpoint demonstrating statistically significant and clinically meaningful improvement (over 2 points) over 24 weeks in the MGADLb score. the multi-tyrosine kinase blocker had a tolerable safety profile, with adverse events leading to discontinuation in 5.1% of patients treated with nipocalimab (7.1% with placebo). J&J will file for approval now.

PARKINSON‘S DISEASE ˆ

BlueRock Therapeutics LP, the US gene therapy unit of Germany’s Bayer AG , has been authorised to test its bemdaneprocel gene therapy for the treatment of Parkinson’s disease in a pivotal Phase III trial in the US. In mid-January, the company announced that the study that will enrol patients with moderate Parkinson’s disease in H1/2025 is the first pivotal trial for a therapy derived from donor-derived (allogeneic) pluripotent stem cells and transplanted into the brain in this indication. The basis for the trial authorisation of the potentially curative therapy is the postoperative safety of the therapy, which was proven in a Phase I trial on 12 patients over a period of 24 months. On this basis the US FDA granted accelerated approval and progress into a pivotal Phase III trial. In addition, the companies reported ‘encouraging trends in motor impairment’. Approximately 102 Parkinson’s patients will be enrolled in the pivotal trial. The primary endpoint of the study is the change from baseline in time spent in the ‘ON’ state without disruptive dys-kinesia after 78 weeks. Data will be collected using a patient diary and adapted to a 16-hour waking day.

Bayer AG ’s second US gene therapy unit Asklepios Pharmaceuticals (AskBio) started enrolment of 87 Parkinson’s patients into Phase II testing of AskBio’s AAV-based GDNF gene therapy AB1005 in mid-January. The gene therapy will be injected directly into the brain of patients. Furthermore, in February, the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to AskBio after review of Phase Ib data of AB-1005. RMAT is granted if there is preliminary clinical evidence indicating that an advanced therapy may have the potential to address unmet medical needs.

RETINITIS PIGMENTOSA ˆ

Munich-based ViGeneron GmbH has provided two updates on its ongoing

Phase I study on its retinitis pigmentosa gene therapy VG901. An independent review committee gave the green light for a dose-finding study in early January and the FDA certified the experimental therapy for the treatment of the rare paediatric disease – this is a prerequisite for a Priority Review Voucher (PRV), which can end up in an accelerated market approval. In the course of VG901 therapy, the CNGA1 gene is administered intravitreally (IVT) to reach and repair the photo-receptor cells of the retina.

HIDREADENITIS SUPPURATIVA

ˆ Swiss MoonLake Immunotherapeutics AG (Zug) has started three clinical trials in which the anti-inflammatory nanobody sonelokimab is being clinically tested. According to data of Moonlake, sonelokimab inhibits IL-17A/A, IL-17A/F and IL-17F/F dimers and penetrates hardto-reach inflamed tissues. The Phase III trial VELA-TEEN, announced at the beginning of January, is designed to demonstrate efficacy in juvenile hidradenitis suppurativa (HS). It is a non-blinded, uncontrolled study with the primary endpoint of determining the pharmacokinetics, safety and tolerability of a subcutaneously administered 120 mg dose over 24 weeks in 30 to 40 adolescents aged 12 to 17 years with moderate to severe disease. The Phase II LEDA study is intended to demonstrate safety and initial indications of efficacy in palmoplantar pustulosis. The primary endpoint is the percentage change in the Palmoplantar Psoriasis Area and Severity Index (ppPASI) compared to baseline. The Phase II S-OLARIS study in 25 patients with axial spondyloarthritis (axSpA) is investigating the safety and preliminary efficacy of a 60 mg SC dose of sonelokimab in an unblinded fashion. The primary endpoint is the change from baseline at week 12 in the uptake of 18-F-NaF in the sacroiliac joints and spine using positron emission tomography (PET) in combination with MRI imaging.

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WHERE FUTURE BECOMES REALITY

HEPATOCELLULAR CARCINOMA

Stockholm-based Medivir AB reported final data from its Phase Ib/IIa study of a combo of its deoxycytidine analogue prodrug fostroxacitabine bralpamide (fostrox) and its anti-angiogenetic and anti-neoplastic multikinase inhibitor lentavinib in advanced liver cancer at the EASL Liver Cancer Summit (2/20/2025, Paris, France). The company reported a median overall survival of 13.7 months in second- or third line advanced liver cancer patients, while current therapies show only a 5% to 10% objective response rate and a median overall survival of 8 to 11 months. More than 75% of patients exhibited tumour shrinkage correlating with reduction in AFP biomarker levels from baseline to six weeks. Most common adverse events included temporary low neutrophil and platelet count, leading to dose adjustment (delay, reduction or discontinuation) in 11 patients.

TRAUMA ˆ

In late February, Belgian Novadip Biosciences SA shared positive 12-month data from its single-arm, open-label Phase Ib/IIa study with its allogenic stem-cell derived bone graft material NVDX3 in trauma. All participants with distal radius fractures treated with NVDX3 showed durable bone union. According to Novadip, no adverse events related to NVDX3 were observed. A Phase IIb/III trial in two-level cervical spine fusion is expected to start enrolment this November. NVDX3 was created from human osteogenic adipose tissue-derived mesenchymal stem cells (ASCs). Novadip is also investigating the safety and preliminary efficacy of NVDX3 as a bone graft to achieve spine fusion in the lumbar spine in its NVDX3-CL02 (NCT05961956) trial. One-year results are expected in March 2025.

PAH ˆ

Tiakis Biotech AG , the Kiel-based specialist for pulmonary and cardiovascular diseases, has received approval from the US Food and Drug Administration

(FDA) for a Phase II trial for the treatment of pulmonary arterial hypertension (PAH). In the ATHENA study announced in early January, 90 patients will receive recombinant human Elafin (tiprelestat). The primary endpoint is pulmonary vascular resistance, the secondary endpoint is 6-minute walk distance. The study design provides for a four-week waiting period to investigate the disease-modifying potential of tiprelestat. Elafin is an anti-inflammatory protein and a reversible inhibitor of human neutrophil elastase and proteinase 3 and an inhibitor of neutrophil exosome and extracellular neutrophil trap formation. In animal models, tiprelestat has contributed to vascular remodelling. In PAH patient cohorts, a significant mechanistic imbalance between neutrophil elastase and relative elafin deficiency was observed.

CHRONIC KIDNEY DISEASE ˆ

At the end of January, the US FDA has approved Novo Nordisk A/S ’ obesity blockbuster med semaglutide for patients with chronic kidney disease who suffer from type 2 diabetes. In addition to its use for type 2 diabetes, Ozempic may now also be used to reduce the risk of worsening kidney disease, kidney failure and death from cardiovascular disease in patients with chronic kidney disease and diabetes. According to Novo Nordisk, about 40 percent of patients with type 2 diabetes also suffer from kidney disease. The approval is based on results from FLOW study, which found that Ozempic reduced the risk of severe kidney damage by 24% compared to placebo.

B-CELL MALIGNANCIES

US-based Interius BioTherapeutics Inc. has received approval from the Paul Ehrlich Institute for Phase I dose-finding testing of its INT2104 gene therapy for the treatment of B-cell malignancies. The INVISE trial, announced in January, will evaluate the safety of the in vivo CAR-T and CAR-NK cell therapy INT2104 targeting the CD-20 cancer antigen. Interim results are expected in the second half of 2025. INT2104 is a

proprietary gene therapy candidate that specifically targets CD7-positive T and NK cells and delivers a CAR transgene to generate in vivo effector CAR T and CAR NK cells. The CAR cells target CD20-positive B cells for the treatment of B-cell malignancies. Unlike ex vivo CAR-T therapies, INT2104 is a commercially available single-dose treatment administered systemically via intravenous infusion without the need for lymphatic drainage, specialised equipment or training

CONGESTIVE HEART FAILURE

At the end of February, Bayer AG’s subsidiary AskBio Inc. has started enrolment of 90 to 150 adults into the adaptive GenePHIT Phase II study of AB-1002, a gene therapy for the treatment of congestive heart failure. The trial evaluates the safety and efficacy of a single intracoronary infusion of AB1002 in treatment-refractive adults with non-ischemic cardiomyopathy and New York Heart Association (NYHA) Class III heart failure symptoms such as a reduced ejection fraction of 15%-35%, who have been medically stable for at least four weeks.

RENAL CELL CARCINOMA

Ipsen SA reported final results from its Phase III CheckMate -9ER trial of cabozantinib plus BMS’ PD1 blocker nivolumab versus sunitinib treatmentnaive patients with advanced renal cell carcinoma after 67.6 months follow-up. Ipsen reported a median overall survival gain of 11.0 months, 46.5 months in total, versus sunitinib, the longest for a kinase inhibitor and immunotherapy combo ever seen. Additionally, the combination demonstrated a 42% reduction in the risk of disease progression or death, with median progression-free survival nearly double that for the combination versus sunitinib, at 16.4 vs 8.3 months respectively.

Treatment-related adverse events occurred in 98% vs 93% of patients for the combination versus sunitinib respectively. No new safety signals were reported.

■

Boosting Start-up Ecosystems

INNOVATION HUB The Technologiepark Heidelberg has been shaping Heidelberg‘s startup ecosystem with 100,000 sqm of lab and office spaces, individual startup support, and top events for over 40 years – offering ideal conditions for established companys and startups in the fields of life sciences, biotech, industry tech, and AI.

The city of Heidelberg has been ranked first in the latest ranking by the Startup Association and startupdetector as the city with the most new startups in Germany. This top position highlights Heidelberg's innovative strength and the excellent support available to founders. The Technologiepark Heidelberg plays a crucial role in this success, significantly contributing to the city's dynamic startup culture with its diverse offerings.

Providing Lab and Office Space

A prime example of modern infrastructure provision is the new LAB22 building and shared labs facility by BioLabs. It offers young and established companies unfurnished, state-of-the-art office and laboratory spaces as well as fully equipped lab workstations and co-working spaces. Rental units start at 160 sqm and can be

customized. The passive house has central air supply, exhaust systems and continuous air quality monitoring, LAB22 sets new standards in energy efficiency and the working environment.

Another key project is the Business Development Center (BDC), for startups and young companies. It offers flexible office and laboratory spaces that can be individually tailored, along with modern technical infrastructure. The BDC supports companies in transforming their ideas into market-ready products and promotes the exchange between science and business.

Support and Technology Transfer

The Technologiepark Heidelberg places great emphasis on fostering startups and technology transfer via the Heidelberg Startup Partners e.V. Programs such as the Life Science Accelerator Baden-Würt-

temberg support entrepreneurs in the pre or seed phase. The 12-month program provides high-quality workshops and an excellent network of industry experts and mentors to strategically advance startups and prepare them for investment.

Accelerators and Events

The accelerators at the Technologiepark Heidelberg play a crucial role in supporting startups. A major highlight is the annual Life Science Investors' Day, which will take place on September 25, 2025, at the Business Development Center Heidelberg. This event brings together life science investors, startup projects, and founders from around the world, fostering continuous exchange between investors and entrepreneurs. The Life Science Investors' Day is organized by the Life Science Accelerator Baden-Württemberg, BioRN, BioLabs Heidelberg, and Heidelberg Startup Partners e.V.

The Technologiepark Heidelberg is thus setting standards in infrastructure provision, startup support, and technology transfer, making a significant contribution to the innovative strength of the city of Heidelberg. ■

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Oligonucleotides and Peptides

Megatrend oligo-based and peptide drugs

BIOMANUFACTURING Peptide drugs such as the glucagon-like peptide-1 (GLP-1) receptor agonists semaglutide and tirzepatide alone recorded global sales of US$25.3bn in 2024, US$9.62bn of which in Europe. The market for gene and cell therapy contract manufacturing, oligonucleotide synthesis (US$9.1bn) and the production of viral vectors and plasmids (US$3.3bn), which is currently growing at an annual rate of 27%, is also expanding considerably. But there is still plenty of room for technological improvement.

Production capacities for GLP-1 receptor agonists are currently barely able to keep up with demand. That‘s reason enough for the manufacturers of appetite suppressants, diabetes drugs and potential drugs for currently 27 co-morbidities to scale up their production on a large scale, as there are hardly any manufacturing problems. Rather, the Big 20 are struggling to divide up the market with ever new combination approaches to make the peptide drugs more effective (see EuropE an BiotEchnology 3/2024).

However, while these first generation of blockbusters reduces muscle mass as well as fat and must be taken for a lifetime to avoid a rebound effect, new approaches that are still in the early stages

of development promise lasting resistance to weight gain by not targeting appetite, but instead transforming energy-

storing white fat cells, which interfere with the hormone balance, into energyconsuming brown fat cells. One exam -

Fig. 1: Comparison of the properties of common gene therapy vectors with the HSV-1 vectors of the French start-up EG 427 SA

Plasmid & Minicircle DNA

From Research to GMP grade

ple is Resalis Therapeutics srl, a spin-off from the Italian gene therapy forge San Raffale Institute for Gene Therapy (see interview on p. 42).

Oligos instead of peptides

At the beginning of the year, following a €10m Series A financing round, it was able to spring a surprise: even before the start of clinical trials of its LNA antisense oligonucleotide (LNA-Aso) RES-10, the French pharmaceutical giant Sanofi SA secured the option for one of the world's first gene therapies in a blockbuster indication with an equity investment. RES-10 targets the inhibition of the regulatory microRNA-22, which converts white fat cells into brown fat cells and thus counteracts obesity.

capsulated in lipid nanoparticles (LNPs) or other nanocarriers, vector-based single-use gene therapies are also attracting a great deal of attention from investors. All gene therapies approved to date are still authorised for the treatment of rare diseases. Both, gene therapies and CAR-T or TCR-T cell therapies, which use viral vectors constructed from plamids to equip immune cells with synthetic recombinant receptors (CARs), suffer from high production costs. These are partly due to the low degree of automation in production, laborious engineering but especially because they work with autologous cells. Biomanufacturing is the cost driver here. Due to the high costs involved, healthcare systems are extremely reluctant to reimburse the costs, if at all.

Another example of an antisense nucleotide with blockbuster potential is the aso inhibitor CDR132L of the regulatory miRNA-132, clinically developed by the German company Cardior Pharmaceuticals, which reversed cardiac hypertrophy, the fibrotic thickening of the heart wall that causes heart failure, in a Phase II trial. Cardior was acquired by Novo Nordisk last year.

Recent figures from IQVIA suggest that antisense oligonucleotides (ASOs) make up 28% of the cardiometabolic RNA drug pipeline including disorders such as diabetes, obesity and its cardiovascular/neurological co-morbidities.

Vector optimisation

Nevertheless, Big Pharma continues to invest heavily in the production of viral vectors (see Fig. 1), which transport the synthetic gene constructs ex vivo into target cells (CAR/TCR-T and NK cells) or in vivo to the target cells.

As RNA drugs such as Asos, siRNAs or CRISPR-based gene therapies can modulate any target encoded in the human genome, while AI can automatically exclude unsuitable hits, the corresponding market and pipelines are currently growing very rapidly, especially in Asia. In comparison, proteins as classical targets make up only 1.5% of the human genome, and at most 14% of them have binding sites that are accessible to biologics and small molecules.

Developers are increasingly focussing on indications with blockbuster potential. Roche AG, which has invested €90m in a production facility for adeno-associated virus (AAV) vectors at its German site in Penzberg, is targeting neurological diseases, for example. Nevertheless, the production of AAV vectors often still suffers from suboptimal efficiency, i.e. poor yields of functional virus capsids. In their recent US$1bn collaboration with Dyno Therapeutics, their AAV capsid platform is being used to optimise vectors for in vivo gene therapies against neurological diseases.

Vector-based gene therapies

In addition to the 18 approved, scalable and multi-administered oligonucleotidebased gene therapies to date, which are usually delivered to the target site en-

The Danish start-up Fuse Vectors A/S, which recently closed a US$5.2m preseed financing round to advance its proprietary enzymatic virus-free AV capsid assembly technology, is also committed to optimising the yield of functional AAV capsids (see interview, p 46).

Meanwhile, competitors such as French company EG 427 SA, which raised €27m in Series B funding in February, have developed HSV1 vectors with a loading capacity of more than 30kB as an alternative to

the existing lentiviral, adenoviral and AAV vectors (see Fig. 39)

The optimisation and automation of the production of AAV, adenoviral, lentiviral and other vectors, which deliver the gene sequences to the target site for expression, is currently on the upswing again, according to Dr Martin Schleef, Managing Director of Plasmid Factory GmbH in Bielefeld, Germany, which specialises in the production of plasmids and minicircle DNA.

Non-viral vectors

“The market is currently being driven primarily by the success of CAR-T cell therapies. However, these are expensive and harbour safety risks due to the use of lentiviral vectors, which preferentially integrate into active genes and can therefore induce cancer instead of curing it,” says Schleef. “A cost-effective and scalable solution that has already been clinically validated is the patent-protected approach pursued by T-CurX of transfecting CAR gene constructs directly into the T cell in a virus-free manner using transposons” (doi: 10.3390/ijms252413685).

The cost savings are indeed immense, as the costly co-transfection with three to four plasmids to generate a lentivirus is no longer necessary. Instead, T-CurX utilises two so-called minicircle DNAsone for transporting the target DNA into

Minicircle DNA

Minicircle DNA are small circular plasmid derivatives without origin of replication and slection marker that have been freed from all prokaryotic vector parts. They have been applied as transgene carriers for the genetic modification of mammalian cells, with the advantage that, since they contain no bacterial DNA sequences and less CpG motifs, they are less immunogenic than plasmids. The smaller size of minicircles also extends their cloning capacity and facilitates their delivery into cells. Their preparation usually follows a two-step procedure: Production of a parental plasmid with eukaryotic

the cell and one that encodes the transposase. These show no toxicity compared to plasmids, says Schleef, and transfect T cells with comparable efficiency as viral vectors transduce them. In addition, the T-CurX Sleeping Beauty transposons only integrate statistically into genes, which is an advantage over lentiviruses. According to T-CurX founder Michael Hudecek, who want to democratise cancer research by providing cost-effective CAR-T similars to approved CAR-T cell therapies, transfection efficacy of minicircle DNA in CAR-T

inserts) in E. coli. Induction of a sitespecific recombinase at the end of this process but still in bacteria followed by the excision of prokaryotic vector parts via two recombinase-target sequences at both ends of the insert and recovery of the resulting minicircles e.g. by affinity chromatography.

The purified minicircle can be transferred into the recipient cell by transfection or lipofection. The smaller size of minicircles compared with standard plasmid vectors makes for greater transfection and expression efficiency, while the gene of interest is more stable expressed. ■

cell development is near 60%. According to Schleef, they can even be designed in such a way that they no longer do so. The international competition, which focuses on optimising AAV vector yield, is still sceptical. However, Schleef can see from the incoming orders that they are testing the minicircles: “Those who have tried it are fascinated,” says Schleef, “we are in the final stages of qualifying and certifying our GMP system after ArchiMed 2022´s investment.”

■

t.gabrielczyk@biocom.eu

Towards a LNA-ASO-based obesity gene therapy

OBESITY Just before going into Phase I testing, Italian Resalis Therapeutics srl has secured €10m in a Series A financing and an equity investment of Sanofi SA. European Biotechnology spoke with Alessandro Toniolo, CEO of Resalis, about the challenges to commercialise an obesity gene therapy targeting miRNA 22.

EuroBiotech_The results of inhibiting the regulatory microRNA 22(-3p) with a complementary LNA antisense nucleotide codenamed RES-10 in mouse models of obesity are impressive. Would you please briefly describe these and explain what processes in the human body miRNA-22 regulates?

Alessandro Toniolo_miR-22 plays a key role in lipid metabolism, mitochondrial function, and adipose tissue regulation. Preclinical studies conducted by our co-founder and Chief Scientific Officer, Riccardo Panella and his team, have shown that inhibiting miR-22 leads to significant metabolic improvements. This includes restored lipid biosynthesis, enhanced mitochondrial biogenesis, and the transformation of fat-storing white adipose tissue into energy-consuming brown adipose tissue. These combined effects reduce fat accumulation and increase energy expenditure, making weight reduction independent of food intake. RES-010 is designed to target miR-22, which could then modulate these pathways to support metabolic health. The promising preclinical findings support RES-010’s ongoing clinical evaluation.

EuroBiotech_What are Resalis’ preclinical toxicity, immunogenicity, and druggability data of RES-10?

Toniolo_Preclinical toxicology package studies demonstrated a favourable safety and tolerability profile supporting the further clinical development. Moreover, RES010 specifically showed no signs of triggering an immune response.

EuroBiotech_How is RES-10 transported to the site of action?

Alessandro Toniolo joined Resalis Therapeutics srl as CEO in October 2022 after 20 years in positions with increasing responsibility in the pharma industry. He worked in commercial roles at Italian, European and global companies including Merck, Pfizer, Shire and Novartis. Prior to joining Resalis, Alessandro was Novartis’ Head of Immunology as well as Head of Respiratory and Allergy franchises in Italy. He is also a business angel supporting multiple oncology startup companies on behalf of Italian Angels for Growth.

Toniolo_RES-010 is formulated for systemic administration as a weekly subcutanous injection of the naked ASO. It is designed to efficiently reach its target tissues, ensuring selective engagement with its target.

EuroBiotech_What gap could Resalis’ gene therapy fill in the treatment of obesity if RES-10 successfully completes clinical trials?

Toniolo_RES-010 is not a gene therapy as it does not alter gene sequences. It is an antisense oligonucleotide (ASO) that can modulate mRNA expression by targeting a microRNA, miR-22. MicroRNAs (miRNAs) are small non-coding RNAs that are approximately 21-25 nucleotides in length and function by regulating gene expression. They bind to messenger RNAs (mRNAs) and inhibit their translation into a protein, reducing the target protein’s presence in cells. By inhibiting miR-22, we aim to restore the metabolic balance disrupted by obesity. RES010’s mechanism is distinct from current treatment options focusing on appetite suppression. Based on our preclinical results, we also believe that our candidate has the potential to be combined with treatments targeting GLP-1 RAs (GLP-1 receptor agonists) to provide more sustainable long-term metabolic improvements, filling a critical gap in current obesity treatment.

EuroBiotech_Resalis has received financial support from Sanofi surprisingly early after a Series A financing. How long will the money last and how is the risk distributed until the completion of Phase II development? Toniolo_Our financial position allows us to advance RES-010 through key clinical milestones. We are focused on efficient resource allocation and leveraging strategic partnerships to support long-term development.

EuroBiotech_What competing approaches are you aware of, what are their strengths and weaknesses and how high do Resalis and Sanofi estimate the market potential for RES-10 on this basis?

Toniolo_Most anti-obesity therapies do not directly target the underlying metabolic dysfunctions of obesity. RES-010 takes a different approach by modulating multiple interconnected metabolic pathways, positioning it within the new generation of multi-target therapies. As a miRNA-based intervention, it offers a novel and more comprehensive alternative to receptor-targeting drugs, with the potential to reshape obesity treatment by addressing its root metabolic causes.

EuroBiotech_How long will the follow-up period of your 48-patient Phase I safety and dose escalation study be, and when will you publish the first results?

Toniolo_The study is progressing as planned, and data will be disclosed in a timely manner, following rigorous analysis.

EuroBiotech_Is the study sufficiently powered to proceed directly to a pivotal study after first efficacy signals and an acceptable safety profile have been shown?

Administation of RES-010 led to a 20% reduction in fat after 100 days in mice models.

Toniolo_The Phase I trial is designed to assess safety, tolerability, and pharmacokinetics. We are confident that these data will provide a strong foundation for the next steps in clinical development, including a potential pivotal study.

EuroBiotech_What are the next relevant steps for Resalis?

Toniolo_We are focused on advancing the clinical development of RES-010 in obesity. In parallel, we are exploring additional indications where miR-22 modulation could offer therapeutic benefits. With RES-010’s unique MoA, we are pursuing a multiple-indications strategy to expand its therapeutic potential.

■

t.gabrielczyk@biocom.eu

Enhancing macromolecule drug discovery with CDD

DATA MANAGEMENT The landscape of macromolecule drug discovery is evolving rapidly, with oligonucleotides and peptides leading the way in innovative therapeutic applications. CDD Vault, a leading scientific data management system, significantly improves the way researchers manage macromolecule data by introducing a dedicated Macromolecule mode that seamlessly integrates with modern workflows.

› Mariana

Vaschetto, PhD, Head of Operations EMEA, Collaborative Drug Discovery

From a data perspective, macromolecules are difficult to manage due to their inherent complexity. To accelerate research, CDD Vault introduces a more efficient approach to registering macromolecules.

Simplified registration workflow

Researchers can now register individual molecules directly or upload bulk datasets using an easy-to-use interface. Whether working with linear or cyclic peptides, single-stranded RNA, or double-stranded DNA, sequences can be input using standard or custom codes. These sequences are automatically converted into structured molecular files, ensuring seamless integration with existing data. Metadata and experimental information are captured alongside molecular structures, making data management more comprehensive and efficient.

Intuitive structure editing

Building on CDD Vault’s strong chemistry and biology foundation, the new Structure Editor Macromolecule Mode enhances how DNA, RNA, and peptide sequences are composed, edited, and visualised. Researchers can view sequences as letter codes or as molecular components, making it easier to analyse their structures. A built-in RNA builder allows for precise customisation of nucleotides, including sugar, base, and phosphate modifications. Users can also

Visualising structures of monomers from macromolecules registered in CDD Vault

browse a growing library of unnatural amino acids and effortlessly upload or draw sequences using intuitive tools like Ketcher. Additionally, the ability to toggle between monomeric and full atomistic views provides greater flexibility in understanding complex macromolecular architectures.

Enhanced visualisation

Understanding macromolecular structures is critical for effective drug development. With CDD Vault, researchers can now explore molecular structures with greater interactivity. By simply hovering over a monomer, they can reveal detailed chemical structures and attachment points. The software intelligently orients molecular previews, making it easier to analyse modifications and interactions at a glance. This dynamic visualisation en-

sures that scientists, even those unfamiliar with CDD Vault, can quickly grasp key structural insights.

A commitment to innovation

This release is part of CDD Vault’s ongoing commitment to improving the registration and analysis of modified bioconjugates. With continuous updates driven by expert user feedback, CDD Vault is poised to remain at the forefront of macromolecule drug discovery informatics. Researchers can now register, manage, and visualise complex biomolecular entities with ease, accelerating the path to groundbreaking therapeutics.

For further details, please visit www.collaborativedrug.com, or contact info@collaborativedrug.com ■

Tailored Solutions for Drug Discovery & Preclinical Development

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Making AAV gene therapy faster and better

ADENO-ASSOCIATED VIRUS VECTORS AAVs Danish start-up Fuse Vectors ApS bagged pre-seed financing to advance its breakthrough cell-free technology for a faster, safer and more scalable gene therapy.

EuropEan BiotEchnology spoke with Jordan Turnbull, Co-CEO, CSO and co-founder of Fuse Vectors.

EuroBiotech_High production costs of gene therapies hinder their reimbursement and profitability. How does Fuse Vectors intend to change this?

Jordan Turnbull_For decades, gene therapy’s potential has been limited by development processes first developed in the 1980s, which often result in inefficient products that drive up cost and increase toxicity risks in patients. Fuse Vectors is making gene therapy faster, better, and more affordable. Our novel process takes just hours per batch, significantly accelerating drug development, and ensures that more than 99% of the AAV capsids carry the target product, reducing unnecessary waste and inefficiencies that drive up costs. With the reduced time, expense, and risks associated with the novel process, we hope to incentivise more drug developers to enter the gene therapy space, expanding treatment options for diseases that currently have no cure.

EuroBiotech_Could you please describe exactly what differentiates your platform from other production methods for AAV vectors for gene therapies?

Turnbull_The key differentiator of our platform is the removal of the cell from the AAV gene therapy production equation. Because we work outside the cellular environment, we can cut development times from months to years to hours. Additionally, our system optimizes for >99% AAV capsids filling with the target gene to increase drug product quality, improve outcomes and decrease patient risks. Our technology is also modular and adaptable, meaning it can be used across different diseases and gene therapy

Jordan Turnbull, Henrik Stage and Benjamin Blaha co-founded Fuse Vectors ApS in 2022. Jordan (right) serves as co-CEO and CSO, previously leading viral vector development teams in Boeh-ringer Ingelheim and Novo Nordisk. Henrik is Executive Chair, bringing huge experience in M&As and financing. Benjamin is serving as CoCEO and CTO with huge process development expertise from his many years in the gene therapy industry.

programmes without the need for major reengineering. We see the technology as more than just an innovation, but rather a quantum leap that will reshape the future of gene therapies.

EuroBiotech_... and how exactly it works, please?

Turnbull_Fuse Vectors’ process breaks free from the constraints of cell biology. Thus, we can control and optimise the filling mechanism, the process by which the therapeutic

gene is loaded into the AAV delivery vehicle, beyond what is feasible in living cells, allowing us to produce AAV gene therapy at the speed and quality not achievable with current technology. This also potentially allows us to fill novel capsid designs that were previously unmanufacturable resuscitating previously cancelled novel capsid projects. With this redefined AAV production process, Fuse Vectors is poised to become the universal solution for gene therapy needs.

EuroBiotech_Finally, what are the most important next steps to make your dual business plan work?

Turnbull_ Our first avenue involves collaborating with pharma and biotech companies as well as academic institutions. Simultaneously, we are committed to developing our own pipeline. While we are currently in the early stages of commercialisation and prerevenue, we have proactively engaged in discussions with over a dozen partners set to trial our technology in the coming weeks, and we hope to convert these collaborations into revenue-generating relationships by the end of the year. The recent US$5.2m preseed funding, led by HCVC and supported by the BioInnovation Institute, EIFO, and Innovation Fund Denmark, is instrumental in accelerating the development of our Fuse Technology. This investment also enables us to mature current partnerships and advance our internal therapeutic pipeline. Looking ahead, we are actively seeking collaborations to develop new gene therapies, aiming to expand our impact and bring innovative treatments to patients worldwide. ■

t.gabrielczyk@biocom.eu

Precision oligonucleotides for therapeutics

MANUFACTURING Therapeutic oligonucleotides are rapidly transforming drug development by enabling precise gene modulation strategies. Microsynth empowers biotech, pharmaceutical, and academic researchers with high-quality therapeutic oligonucleotides, supporting every stage from sequence design to preclinical development. With tailored solutions, advanced automation, and expert design support, we accelerate your therapeutic programmes with precision and speed.

› Elges Lardi, Business Development Therapeutic Oligonucleotides, Microsynth AG

Antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs) play key roles in gene modulation strategies. ASOs are single-stranded oligonucleotides that hybridise with target RNA sequences via complementary base pairing, inducing RNase H-mediated degradation or steric blocking of translation. In contrast, siRNAs are double-stranded molecules that integrate into the RNA-induced silencing complex (RISC) to degrade complementary mRNA sequences. Both approaches offer targeted gene silencing, making them promising tools for treating genetic disorders, viral infections, and oncological indications. The therapeutic potential of these novel long-lasting or even curative treatment approaches is underscored by the market approval of eleven ASOs and six siRNAs as drugs to date.

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certifications, ensuring reliability and reproducibility.

› Rapid turnaround times: As short as three to four working days for screening oligos and five to six days for scaleup batches, accelerating timelines without compromising quality.

Trusted Partner in Therapeutics

At Microsynth, we recognise that success is built on more than just delivering high-quality oligonucleotides – it’s about fostering strong partnerships with our customers. Our philosophy goes beyond transactions; we are committed to understanding your unique challenges and providing tailored support at every stage of development. By prioritising collaboration, flexibility, and scientific excellence, we ensure that our solutions align with customer goals, helping them turn innovation into real therapeutic impact. ■

Contact

Contact Microsynth today to discover how our team can accelerate custom therapeutic oligonucleotide development with precision and reliability.

Microsynth AG Schützenstrasse 15 9436 Balgach

info@microsynth.ch +41 71 722 83 33

At the crossroads of a new pandemic

PANDEMIC PREPARDENESS Europe received a slap-in-the-face wake-up call with COVID-19, and the EU’s response to the infectious disease has impacted its relationships across the world. In the future, we may have to act swiftly, because the next challenge is beginning more silently –as an antibiotic crisis. It may end up affecting animal and human health in ways similar to a viral spillover event, but have an even bigger effect on our coexistence with other farmed species.

We are still far from conquering many infectious diseases, and even very old foes that seemed to be overcome still regularly pose new challenges. On the virus side, for instance, hundreds of measles cases have been reported in the border region between Texas and New Mexico in the US. Meanwhile polio has been detected in the German capital Berlin. Among other infectious microbes, the growing threat of antibiotic resistance looms ever larger. And battlefields in the Ukraine are giving rise to lethal pathogens that don’t respond to our most effective treatments

Preparedness in theory...

How are these headline-grabbing events in the world of infectious diseases connected? And post-COVID-19, is Europe better prepared for such challenges than it was before the most recent pandemic?

Recurring local outbreaks of infectious diseases were common long before SARS-CoV-2 hit the world. Studies kicked off in the early 2000s examined Europe’s preparations for potential pandemics. At the time, for historical reasons, influenza viruses were considered the most likely candidates for triggering the next ‘big one’. However, most such studies received little attention, and

when they did, they failed to establish a common understanding of the challenges involved or of appropriate measures for addressing them

Now largely forgotten, the so-called swine flu – a combination of pig, avian, and human viruses – became the first H1N1 pandemic in 2009. In the years that followed it, however, a rising number of studies began questioning whether we were really prepared for a much larger outbreak. Individual European countries developed a range of pandemic response initiatives (e.g.: UK Influenza Pandemic Preparedness Strategy 2011, Beredskapsplanering för pandemisk influensa, Sweden 2012; Swiss Influenza Pandemic Plan 2013, among others), but these plans were gradually buried deep in the archives of health authorities. Even right before the COVID-19 era arrived, a Scandinavian comparative study conducted from 2016-2018 (“Framing postpandemic preparedness: Comparing eight European plans”, Martin Holmberg & Britta Lundgren in gloBal puBlic hEalth) found that a fundamental problem was that officials did not seem to be speaking about the same issues – even when they were using the same terminology.

The shock and collective awakening were therefore all the greater when SARS-CoV-2 began spreading rapidly. It wasn’t an influenza virus, true...

but shouldn’t recommendations for action have been transferable and applicable? Apparently not. Europe’s scramble to address the disease resembled a henhouse raided by a fox. There was havoc in some areas, while others were left seemingly untouched. The initial reaction across Europe was not one of collective, cross-border action, but rather a desperate and ultimately futile attempt to isolate outbreaks, contain the virus within local and regional clusters, and shield those areas that had initially been spared from infiltration by infected individuals and carriers.

...did not work in emergency

Eventually, Europe’s institutions converged on a more unified COVID strategy. While it may not have been perfect in every respect – nor entirely transparent and comprehensible – it nonetheless played a crucial role in bringing the virus under control through a coordinated vaccination approach. Efforts in therapeutics for treating COVID infections, on the other hand, remained scarce. Remdesivir, Paxlovid and Ibuprofen were and still are the treatments of choice when patients are hospitalised.

Numerous experts and committees have examined the lessons to be learned from the most recent pandemic and con-

tinue to mainly focus on vaccine responses. There the European Union continues to strengthen measures like expanding capacity for the rapid production of future vaccines and maintaining necessary production capabilities. At the end of January, for instance, new pandemic preparedness facilities were inaugurated under HERA’s EUFab network.

Production capacity is king

Bilthoven Biologicals (BBio), a member of the EUFab network in The Netherlands, officially inaugurated its new pandemic preparedness manufacturing facilities at Bilthoven Science Park on January 30. Completed in just twelve months, the facilities are aimed at enhancing Europe’s strategic health autonomy by expanding vaccine manufacturing capacity and supporting EU-wide pandemic response efforts. The EUFab network is made up of vaccine manufacturers from Belgium, Ireland, the Netherlands and Spain. The initiative’s goal is to bridge the gap between vaccine production and rapid scale-up, while ensuring the industry retains the capacity to produce life-saving medicines at short notice.

The new facilities are equipped with state-of-the-art drug substance (bulk antigen) purification and advanced fill/ finish isolator technologies that enable efficient, rapid production of crit-

ical vector-based vaccines. Designed for multi-product manufacturing, the site has the capability to produce up to 300 million doses a year of various vaccine types, including mRNA-based, vector-based and protein-based vaccines. Other EU members, like Germany, have anchored their own prepardeness capacities in deals with different CDMOs.

At the inauguration event, HERA Director-General Laurent Muschel hailed the initiative as a model of public-private collaboration that reinforces Europe’s resilience in the face of future pandemics: “Investments like these are essential to maintaining Europe’s leadership in vaccine innovation and manufacturing. By opening this new facility with the support of EUFab, Bilthoven Biologicals is making a key contribution to strengthening our collective preparedness.”

Bilthoven Biologicals is part of the Serum Institute of India (SII) group, so the event was also attended by its CEO, as well as India’s ambassador to the Netherlands. The new facility was promoted as “part of the European Commission’s broader efforts to strengthen pharmaceutical resilience across Europe.” But it will also further reflect the EU’s partnership with India on health security and supply chain cooperation under the EU-India Trade and Technology Council (TTC), underscoring the growing importance of international partnerships and resilient

All is in place for vaccine production at Bilthoven Biologicals. Why is Europe’s preparedness strategy not addressing AMR with infrastructure in the same way?

supply chains, particularly in light of recent medicine shortages across Europe.

EU capacity on several pillars

How does EUFab work? The EUFab network is mandated and financially equipped to reserve manufacturing capacity to produce vaccines for the EU in case of public health emergencies. The structure of the network operates in two key phases:

› Preparedness phase

EUFab ensures continuous readiness by keeping manufacturing facilities up to date, training staff, and monitoring supply chains, including stockpiling where necessary.

› Crisis phase

Once a public health emergency is recognised, the European Commission will decide to procure vaccines and activate EUFab. Manufacturing sites will then rapidly commence production and deliver vaccines according to the agreed timelines.

Bird flu – the next pandemic?

Preparedness goes hand-in-hand with prediction. What pathogen might set off the next pandemic? The H5N1 bird flu virus is one likely candidate, since it may only need a few mutations to become more transmissible in humans. A recent study in s ciEncE found that a single amino acid change could enable the virus to bind to human receptors – an essential step for human-to-human transmission.

Researchers at the Scripps Research Institute analysed modified variants of the haemagglutinin (HA) protein and discovered that the Glu226Leu mutation increased binding to human receptors. A second mutation (Asn224Lys) strengthened this effect. These receptors are abundant in the upper respiratory tract, raising concerns even higher.

US healthcare authorities have struggled to contain H5N1 outbreaks in dairy farms since spring of 2024. The virus has so far been detected on over 700 farms, with dozens of confirmed human infections, most linked to cows or poultry. So far, no human-to-human transmission

of Serum Institute of India

Data source: PNAS, Nov 18 2024, Eili Y.Klein et al., Global trends in antibiotic consumption, https://doi.org/10.1073/pnas.241191912

has been reported. However, experts warn that the virus’s continued spread in livestock poses significant risks.

On January 6 of 2025, the US reported its first fatal case of H5N1. The victim – over 65 with underlying conditions –was apparently infected through contact with backyard poultry. Although it was the first confirmed H5N1 death in North America, scientists there continue to stress that additional factors are required for bird flu to fully adapt to humans, including changes to the N1 neuraminidase protein and adjustments to the pH level needed for transmission. Containment remains nevertheless critical, and experts back swift control measures in livestock to prevent further spillover to humans.

Vaccination preparations

The UK government has secured five million doses of bird flu vaccine in preparation for a potential outbreak. Finland is also set to vaccinate high-risk groups, such as fur-farm workers. In the US, the Biden administration allocated US$306m for preparedness and surveillance before leaving office. Vaccine company Moderna received a US$600m grant for preparing next-step combinations of vaccines. Both of those big programmes are now under review from the Trump administration, and may be withdrawn.

Why does preparation and vaccination matter? Scientists warn that if H5N1 were to mix with seasonal flu, it could spark a deadly pandemic similar to those that oc-

curred in 1918 and 2009. Five of the six viral pandemics in the last hundred years were caused by respiratory viruses. Four of them by influenza A viruses, a statistic that highlights their high pandemic risk. A common theme from these pandemics is evident: All four influenza pandemics had zoonotic origins, often transmitted from birds via intermediate hosts like pigs. The current H5N1 virus poses significant pandemic potential as it spreads among migratory birds, encounters little human immunity, and has begun infecting mammals, including humans.

Animal link to ‘silent pandemic’

There’s an obvious link between viral pathogens – and fear of their pandemic spread – and the long-overlooked ‘silent pandemic’ of antibiotic resistance. In both scenarios, animals play key roles, whether as livestock, pets, or as sources of agricultural products like meat or milk. Viruses that have evolved alongside humans ensure their survival by adapting to animals we interact with as well. So as intermediate hosts, animals must be more strongly integrated into prevention strategies. This is where the concept of “One Health” comes in. It aims to connect human and veterinary medicine, aligning actions and treatments. After all, farming is still the biggest of consumer of antibiotics worldwide. Around 70% of the drugs are given to animals.

It remains unclear whether antibiotics use in animals is falling on a global scale. The 4th European JIACRA report published

in early 2024 revealed that 10 out of 20 European countries investigated significantly reduced consumption (-44%) in both animals and humans from 2014 to 2021, and have seen a subsequent reduction in antibiotic-resistant bacteria. That’s a good start, although the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) are all calling for even less use.

But looking at the wider picture, the drop in antibiotics usage may also be connected to the drastic general downturn in activity during the COVID-19 pandemic years. According to a study in PNAS GLOBAL, antibiotic consumption continues to rise despite a brief decrease during the COVID-19 pandemic. Authors Eili Klein, Arindam Nandi and their colleagues used pharmaceutical sales data to estimate trends in antibiotic consumption in 67 high-income (HIC) and middle-income countries (MIC, see graphic above) and projected future global antibiotic consumption through 2030. From 2016-2023, they determined that total estimated antibiotic consumption in the examined countries increased by 16.3% to 34.3 billion defined daily doses (DDDs) dispensed in 2023. Other studies have suggested a global decrease of antibiotics usage in animals to be about 13%, (World Organization for Animal Health, WOAH) but the data basis used is not comparable to that used in the PNAS study. In lowincome countries (LIC) like India in particular, it is common to use the same antibiotics in farming and human healthcare. The resistance of microbes follows evenly across species.

Antibiotics in humans

There’s no question that antibiotic use leads to antimicrobial resistance (AMR), which has become a growing global threat. A frequently quoted l ancEt article in 2024 estimated that multidrug-resistant pathogens caused over 1.2 million deaths in 2021 and perhaps 4.5 million more were associated with bacterial AMR. Projections suggest AMR could surpass cancer as a second-leading cause of

death worldwide by 2050, killing around 10 million people globally every year. According to recent ECDC estimates, there are now more than four million healthcare-associated infections each year leading to more than 40,000 deaths in the European Union alone. Over half of those deaths have been attributed to hospitalacquired bacterial pneumonia and hospital-acquired bloodstream infections (bacteremia).

Infections caused by multidrug-resistant bacteria are associated with high morbidity and mortality, so the discovery of innovative agents with potent activity against these pathogens should be top priority for research teams looking to find therapies with new mechanisms of action.

One particularly common bacterial pathogen is methicillin-resistant Staphylococcus aureus (MRSA). Patients with MRSA infections are more than twice as likely to die from an infection with the bacteria as patients who acquire the methicillin-susceptible form (MSSA). MRSA rates in the US have now been reported in the range of 50%.

Staphylococcus aureus bacteremia (SAB) is associated with significant morbidity and reported mortality rates of about 20%. It can result in infective endo carditis, an inflammation of the heart associated with poor patient outcomes. Only a few antibiotics that cover both MSSA and MRSA are also approved for the treatment of SAB. Hence there is an urgent need for new effective antibiotics in this indication.

Tuberculosis remains the most common infectious disease globally, with 10.6 million new cases and 1.3 million deaths in 2022. “New, effective drugs (against it) are urgently needed due to rising antibiotic resistance,” says Dr Julia Dreisbach. She and Prof Dr Michael Hoelscher from the University of Munich (LMU) have headed up efforts to develop a new drug dubbed BTZ-043. It’s the first antibiotic developed solely by the academic community. Discovered at Leibniz-HKI Jena and developed in collaboration with LMU University Hospital, it inhibits an enzyme essen -

tial for tuberculosis bacteria to build cell walls.

Initiatives tackling AMR

In tandem with more academic research groups, industry has accepted the AMR challenge. There is the AMR Action Fund (see interview next page), Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), as well as the AMR Accelerator, which is part of the Innovative Medicines Initiative. With investments of €479m into antibiotic research, addressing pipeline shortages and strengthening research infrastructures, all of those organisations have appeared in different issues of E uro p E an Biot E chnology at some point in the last few years. For example, since its inception in 2016, CARB-X has supported 113 R&D projects across 14 countries, leading to 18 projects advancing into or completing clinical trials. 12 of those remain in active clinical development – including late-stage trials. Two CARB-X-supported diagnostic products have already reached the market, and at least nine product developers have secured advanced development partnerships to continue clinical progress after leaving the CARB-X portfolio.

Collaborative efforts are necessary to sustain expertise and funding in novel antibiotic development, but frustration about reactions to the obvious challenge of AMR is rising. CEO of the AMR Action Fund Henry Skinner complains that “awareness of the AMR threat is growing, but translating it into effective actions is largely missing.” Other experts from CARB-X and companies in the field expressed similar sentiments in feedback to EuropE an BiotEchnology

Spotlight on Bioversys IPO

The successful IPO of BioVersys AG on the Swiss stock exchange (see p. 24) –raising CHF 77m for antibacterial R&D – is a positive exception under the current market circumstances. BioVersys has benefited from funding and support from public-private partnerships such as the

AMR Action Fund, CARB-X and the Innovative Medicines Initiative

The reality for many antibacterial product developers, though, continues to be that attracting sustained investment is very difficult given market failures when it comes to the commercialisation of innovative antibiotics. While the news from Switzerland therefore represents an encouraging step, ongoing efforts are needed to create sustainable economic models – such as pull incentives and novel funding mechanisms – to ensure that innovation in the field remains viable in the long term. “The BioVersys IPO is a spotlight moment, but lasting impact will depend on maintaining and expanding this momentum,” according to a spokesperson from CARB-X.

One Health, not two crossroads

Pandemics show that only international collaboration can provide long-term solutions to the problems posed by infectious diseases. Virology and microbiology research must be globally coordinated to detect new pathogens, contain their spread, and develop vaccines and treatments that tackle the antibiotic crisis. It is important to understand that preventing viral infections is also linked to AMR because vaccination can reduce the incidence of bacterial infections, ultimately lowering the need for antibiotic use and slowing the spread of resistance. Expanding access to existing vaccines and developing new ones targeting resistant pathogens will be critical to mitigating the AMR crisis and future pandemics alike, and that approach is also part of strategy for initiatives like CARB-X.

Understanding the One Health concept – the overlap of animal and human health and the impact of using antibiotics across species barriers – is crucial for pandemic preparedness. Efforts there remain out of balance, mainly targeting viral infections and vaccination readiness. Similar efforts at building infrastructure to prepare against AMR are rare. But we’ll need both to conquer infectious disease. ■ georg.kaeaeb@biocom.eu

Innovation in AMR needs a viable market

The AMR Action Fund, backed with approximately US$1bn from the pharmaceutical industry, the Wellcome Trust, European Investment bank, and others is investing in small biotechnology companies around the world in hopes of rekindling antimicrobial innovation and bringing 2-4 new antibiotics to patients by 2030. EuropE an BiotEchnology talked to CEO Henry Skinner about the ongoing challenge.

EuroBiotech _How much has the overall situation in respect to awareness of the antibiotics crisis changed?

Henry Skinner_Awareness of the AMR threat is growing, but it isn’t necessarily translating into effective actions nor do most people appreciate the effects AMR has on the most vulnerable, such as patients with cancer. It is imperative that policymakers take steps to fix the broken market for antimicrobials, a market that is so dysfunctional that numerous companies who have successfully developed new antimicrobials have gone bankrupt within a few months after earning regulatory approval. Not because they couldn’t raise the hundreds of millions of dollars needed to develop a new drug, but because they could not afford the few million dollars a month needed to bring these drugs to patients. That cannot remain the status quo for a global health challenge that already contributes to more than 4.5 million deaths each year and could kill as many as 10 million people annually by 2050.

acted meaningful policies in this regard and that’s problematic. If other countries don’t step up and meet their moral obligation to address one of the greatest health challenges of our time, the situation will deteriorate rapidly.

AMR is an intergenerational challenge; it often takes more than a decade to develop a new antibiotic, and we are already far behind in terms of having a robust pipeline of potential new therapies. Our grandparents gave us the Golden Age of antibiotics and effective treatments for what were the greatest killers of their time, yet we have trifled away this gift. If policymakers fail to act with urgency, we will doom our grandchildren to a dark, unforgiving future. That’s a dismal legacy to leave behind and one that we must avoid.

EuroBiotech _How is Europe doing in AMR in general from your perspective? How advanced are other regions?

well the commercial challenges associated with antimicrobials and so they have abandoned the field, instead focusing their capital in other areas like cancer, obesity, and inflammation, where they can earn a generous return. To build the type of innovation ecosystem needed for a problem like AMR, governments need to reattract private investors with policies that assure them that the market will reward innovation. If Europe can get the right pull incentives in place, I think it would send a strong message to investors and give an advantage to the small antimicrobial companies that are doing very good work and leading innovation across Europe.

EuroBiotech_There are a number of European initiatives actively and globally connected with CARB-X, the WHO and others. Are all these initiatives coordinated enough to make the most out of a synergised approach to tackle AMR/the next pandemic?

EuroBiotech _Is the challenge still not seen at the political level?

Henry Skinner_It is encouraging that the G7 in recent years has issued numerous communiqués calling on their members to enact pull incentives, which would go a long way toward stabilizing the market, reinvigorating financing of the most promising innovation, and rewarding small companies that are successful in developing new antimicrobials. But the UK is the only G7 member that has en-

Henry Skinner_There are pockets of antimicrobial innovation in Europe, just as there are pockets of innovation in the U.S. and Asia. But to be frank: There is not enough innovation occurring anywhere in the world and the pipeline of antimicrobials is horrifically insufficient for a public health threat of this magnitude. The World Health Organization recently released an analysis showing that only 32 antibiotics are in development against high-priority bacteria. Of those 32, only 12 can be considered innovative. And as we know, most of those candidates will fail in clinical testing. I want to emphasize that the lack of innovation isn’t a scientific problem, it is primarily an economics problem. Investors know all too

Henry Skinner_The spectrum of drug development is long, costly, and incredibly complex. What really concerns me is that in the absence of a viable market, all of the early-stage grant funding and R&D will be for naught. There is an adage that “you can’t push a rope,” and this applies to financing innovation to address the issues of antimicrobial resistance. It’s sort of like building a bridge across a river but only having enough concrete and steel to get twothirds the way across. That is a pier, not a bridge. We need governments to enact pull incentives in order to complete the bridge. Only then we will be able to consistently get new antimicrobials to the other side and to patients need. ■

SLAS 2025: New tools set to improve screening

CONFERENCE The world’s most important conference for laboratory automation and drug screening, SLAS 2025 International, saw a record of 409 exhibitors, 7,100 visitors and 99 market launches of products. The most relevant developments came from Systemic Bio that won the US$10,000 SLAS Innovation Award 2025 and the New Product Award winners Semarion Ltd and US start-ups n6Tec Inc and Portal Biotechnologies Inc. But there is much more to come.

At the 2025 Annual International Conference of the Society for Laboratory Automation and Screening (SLAS), it became clear that personalised medicine, as a first step towards P4 (preventive, predictive, personalised, participatory) medicine, is getting closer.

A dominant topic at SLAS 2025 was again how to integrate artificial intelligence (AI) into automated iterative workflows of the Design-Make-Test-Analyse

(DMTA) cycle to improve the costly, low success rate (5%-15%) of preclinical to clinical development. A striking number of companies exhibited systems that sort, cultivate and analyse cells, human spheroids and 3D organoids using AI-supported image recognition. For the first time, SLAS presented the interactive NexusXp Pavilion to showcase successful examples of automation integration and collaboration scenarios improving R&D

Welcome to SLAS Europe 2025

DR PHILIP GRIBBON, President in 2025 of the Society for Laboratory Automation & Screening in 2025 (Fraunhofer Institute for Translational Medicine and Pharmacology, Hamburg)

I’m very excited to invite the European Biotechnology community to Hamburg for the SLAS Europe 2025 Conference & Exhibition. This conference is an excellent platform for technology providers and users to exchange ideas and make connections, all under one roof in a collaborative atmosphere.

We have a strong SLAS community in Hamburg but our conference at-

tracts researchers and tech providers from around the world, to transform the work being done in life sciences research. We’re especially proud to be able to showcase our local expertise on 20 May by hosting technology provider tours and scientific discussions at a few of our industry leaders’ locations – AcCELLerate, Evotec, and Fraunhofer ITMP / Revvity – in addition to our two-day scientific program and exhibition.

Hamburg has worldclass academic institutions, and it is also a great place to enjoy culture, music, nature, or rent and ride bikes around the beautiful Alster Lakes! Come and enjoy the Science City with us! ■

productivity in a “lab of the future”. An important question was how a lab can integrate various technology providers’ automation solutions to work in unison through the four pillars of the DMTA cycle to decrease the current up to 30% of the expenditure on a new drug discovery programme. Stef van Grieken, co-founder and CEO of Cradle Ltd, told Europ Ean Biot E chnology that though challenges remain, embedding automation and AI into customers’ discovery workflows is key to optimising experimental design, accelerating iteration cycles, and unlock the full potential of AI-guided protein engineering. “As automation and machine learning converge, the future of drug discovery will be faster, more scalable, and increasingly driven by data,” he stated. While AI-based image analyses are increasingly finding their way into automated cell cultivation, sorting and high-content screening (HCS) systems, the sector is still in the testing phase for AI solutions that analyse the binding and aggregation behaviour, toxicity and other aspects of the druggability of biologics. The algorithms do not yet work as well for complex new drug formats filling drug pipelines such as bispecific antibodies, PROTAC s or multispecific ADCs as they do for small molecules or monoclonal antibodies. Nevertheless, Dr Romelia Salomon from the Alphabet spin-out SandboxAQ Inc (Palo Alto, market capitalisation US$5.6bn) presented the opportunities identified in collaborations for using the company’s proprietary numerical Large Quantitative Models (LQM) to pre-

dict the toxicity, solubility, synthesisability and efficacy of drug candidates. With the LQM AI alternative to Large Language Models (Deepseek, ChatGPT), SandboxAQ and partners have so far produced 22 preclinical candidates, ten completed Phase IIa programmes and 54 papers, Salomon reported in a SLAS Ignite Collaboration lecture.

Automation expanding

According to Markets & Markets, the global market for lab automation remains set for significant growth. The market research experts estimate that the market will grow from US$5.85bn in 2024 to US$7.71bn in 2029 along with the global market for drug discovery services that is expected to double by 2028, from the current US$20.7bn to US$41.4bn. At SLAS 2025 International, which featured more than 150 lectures in eight thematic streams, groundbreaking product in -

Taci Pereira, CEO of Houston-based Systemic Bio Inc, presented the latest organ-onchip technology predictive for liver toxicity.

novations were shown at the exhibition, particularly from the 27 finalists of the SLAS New Product, Ignite and Innovation Awards. This year’s winning team of the SLAS Ignite Award for the most innovative

automation start-up presented an innovation that promises to significantly facilitate the search for life-prolonging cancer drugs. Until now, the success rate of drug screening in oncology has been extreme-

Bridging Innovation and Validation

MagStrep® Strep-Tactin®XT Beads close the gap between computational protein design and experimental proof. Optimized for automation and scalability, they transform protein purification from a bottleneck into a streamlined process.

ly poor. Despite implementing hundreds of strategies, cancer drug development suffers from a 95% failure rate over 30 years, with only 30% of approved cancer drugs extending patient survival beyond 2.5 months. One reason is the complexity of solid tumours, another is the lack of test systems for preclinical drug screening that realistically simulate the physiological conditions in the tumour (TME). But this could now change. InSimili srl from Bologna has developed a microtitre plate that sets the exact oxygen concentration – or gradient – in the well that prevails in the TME. The company’s Oxygen Control Plates, which contain a hydrogel mimic the hypoxic and acidic milieu and glucose concentration found in tumours, are designed to de-risk preclinical development in cancer, according to CEO Enrico Grassilli.

Innovation at its best

At the end of January, an innovation aimed at reducing animal testing through more realistic in-vitro disease models received the US$10,000 Innovation Award. Taci Pereira, CEO of Systemic Bio from Houston prevailed against nine finalists in San Diego. Despite advancements with models such

as spheroids, organoids, and organ-onchips, and in silico strategies, a persistent challenge during the past two decades has been the generation of human-relevant, reproducible preclinical data at scale, she said. Traditional animal models yield a preclinical failure of 85-95% due to intrinsic differences from human pathophysiology, while overly simplistic in vitro models struggle to capture the complexity of human biological processes crucial for assessing therapeutic safety and efficacy. In her presentation “h-VIOS: A human-relevant drug discovery and development platform using bioprinted human tissues”, Pereira explained how h-VIOS organ-on-chip technology from Texas-based Systemic Bio Inc improves preclinical safety and toxicity assessment. Systemic Bio Inc, a subsidiary of 3D printing specialist 3D Systems Inc, has succeeded in using 3D printing to produce vascularised hydrogels at scale that are compatible with numerous cell types such as healthy and diseased cells, stem cells and human primary cells (hepatocytes). “The h-VIOS™ platform delivers bioprinted organ-chips that enable therapeutic delivery through endothelialised vasculatures into complex, three-dimensional tissues,” Pereira stressed. “This modular and customisa-

ble system enables the generation of multimodal data, ranging from high-content imaging to transcriptomics.”

Pereira showed data demonstrating that parallelised h-VIOS organ-on-chips can be used to determine drug-induced vascular injury (DIVI) and drug-induced liver injury (DILI) as the organ-on-chips mimic essential functions of a human liver. In an ISO-7 clean room facility in Houston, which is subject to a quality management system, Systemic Bio can produce thousands of tissue models that replicate human organ systems with high precision. Thus, the platform represents a significant advance in preclinical testing and supports collaboration with leading pharmaceutical companies.

HT analysis of adherent cells

A total of ten product developments, which the SLAS jury believes will significantly advance drug screening, qualified for the final of the SLAS New Product Awards. In the end, there were three winners: British Semarion Ltd as well as the US companies n6Tec and Portal Biotechnologies shared the prize for the breakthrough product, set to have the most impact on drug discovery.

Winners of the SLAS New Product Award (from left): Jury member, Semarion co-founders Jeroen Verheyen and Tarun Vemulkar; Armon Sharei, Ph.D. Founder and CEO, Andrew Larocque, Engineer, and Crystal Tsui, Scientific Partner at Portal Biotechnologies Inc; (background) Yann Jouvenot, PhD, MBA, Sr Director of Product, Yassine Kabouzi, PhD, Co-Founder and CTO of n6Tec Inc with his co-founder Pranav Patel, PhD, MBA, CEO

The Semacyte platform developed by Semarion, who had won the last Ignite Award at SLAS Europe 2024 in Barcelona, 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 with wide-field microscopy using standard liquid handling tools used in drug development. “Receiving the SLAS 2025 New Product Award for our SemaCyte Microcarrier Platform is an important validation of our approach to revolutionising adherent cell assays,” Jeroen Verheyen, co-founder and CEO of the University of Cambridge spin-out Semarion Ltd, told EuropE an BiotEchnology. “SemaCytes push the boundaries of traditional workflows by converting adherent cells into barcoded reagents that can be frozen, multiplexed and seamlessly integrated into microplate-based assays, enabling assay miniaturisation, higher through -

put and better data generation,” he said. “The recognition by SLAS and the enthusiasm of pharma and biotech companies at our booth demonstrate the transformative potential of our technology,” added Tarun Vemulkar, Co-Founder and Chief Technology Officer of Semarion. Verheyen stated: “Winning this award is an exciting step forward in our expansion into the US market and we look forward to seeing how SemaCytes will continue to reshape the future of cell-based assays.” The company’s platform addresses fundamental bottlenecks in rapid data generation, offering an up to a tenfold increase in throughput and a sixfold reduction in costs for drug discovery workflows. Last year, the company established several partnerships through an early adopter programme with pharma companies and CROs, followed by commercial launches in the UK and EU.

Two-year-old Portal Biotechnologies Inc was also awarded for its Galaxy plat-

form for high throughput intracellular delivery of virtually any molecular cargo into any cell type, enabling unique applications across drug screening and cell therapies. Galaxy mechanoporates cells in a high-volume fashion through a silicon membrane at low pressure, inducing holes in the cellular membrane temporarily. It integrates with all liquid handlers to enable high-throughput assays and screens by dispensing mechanoporated cells. The Boston-based start-up, which emerged from obscurity in 2023, has faced rapid adoption of its Galaxy platform.

In December, Portal Bio announced that it had already secured 50 partners, including seven of the top ten pharma companies, as well as US$7m in seed funding led by IA Ventures with participation from Pear VC, which had already led US$5m in pre-seed funding. “We look forward to further expanding our footprint by bringing new opportunities to our biopharma part-

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ners and joining forces with additional innovative technology partners,” said Crystal Tsui, Scientific Partner at Portal Biotechnologies Inc. Portal is a member of the Bayer Co.Lab, a cell and gene therapy accelerator co-located with the Bayer Research and Innovation Center (BRIC) in Kendall Square. “We are delighted to receive the New Product Award in recognition of our potential to support a new generation of cell engineering and drug discovery capabilities,” added Tsui. “We are especially grateful to our early partners, including Eppendorf and Promega, for supporting our rapid development and early adoption by our customers,” she added.

California-based n6Tec Inc presented a solution to current limitations of PCR, i.e. suboptimal cycling conditions often undermining its efficacy, generation of chimeric products, exacerbation of PCR duplication rates, and species misrepresentation in metabarcoding experiments due to the preferential amplification of

dominant populations. The inventor of semiconductor-based iconPCR unveiled the world’s first real-time thermal cycler with 96 individually controlled wells at AGBT 2024 and now presented it to a wider audience at SLAS 2025. By setting a predefined fluorescence threshold, iconPCR ensures that all SBS-based Next Generation Sequencing (NGS) libraries are amplified to equivalent levels, thereby eliminating the risks of over- or underamplification through a process known as “Auto-Normalisation.” “We thank the judges and the SLAS organising committee for awarding iconPCR the New Product Award at SLAS 2025,” Yann Jouvenot, Head of Product at n6Tec Inc, told EuropE an BiotEchnology. “We hope this is seen as an illustration that no technology is too established to be improved upon. We wish that iconPCR can continue to improve data quality and streamline NGS workflows for genomics users across the world.” You should also keep

an eye on the seven non-award-winning product innovations and eight runnersup in the SLAS Ignite Awards.

› NanoTemper Technologies (Dianthus uHTS) presented an ultra-high throughput system that measures binding events in a mass-independent manner based on the change in the spectrum of a fluorophore bound to the target or drug compound.

› ThinkCyte Inc. (VisionCyte) has unveiled the first cell sorter that combines label-free and morphometric cell sorting with the analytical capabilities of FACS.

› Ramona Optics Inc (Vireo™) has developed the world’s fastest live-cell imaging system. Ramona’s synchronised array is twelve times faster than any high-content imager. The system can differentiate cytotoxic from cytostatic compounds, analyse growth dynamics of 3D tumour organoids,

and quantify morphological features across thousands of conditions.

› Partillion Bioscience Corp‘s Nanovial Multicell Assay Kits allow high throughput studies of cell-to-cell interactions such as antibody-antigen binding, immune cell activation, and cell-to-cell signalling in their natural context by co-localising multiple cell types within microscopic compartments.

› Last year’s SLAS New Product Award winner CytoTronics Inc (Pixel™ Octo) presented a benchtop plate reader for its electric field impedance-based semiconductor Pixel plates within an incubator that increases the scale at which researchers can functionally characterise live cells without any limitations of spatial resolution or throughput seen in common CMOS multielectrode arrays. Pixel plates also overcome a limitation of high-content imaging systems, which only allow endpoint images of fixed cells. Using 4,096 electrodes at 25 µm spatial resolution per well to measure 20 different morphological properties of cells including cell barrier, attachment, flatness, and motility every 15 min, Pixel Octo can acquire data from up to eight 96 or 384 well Pixel microplates. Additionally, it can monitor electrophysiological signals from cardiomyocytes and neurons, and the oxidative state of cultures in a single assay and is set to yield more impressive results in compound screening than its smaller predecessor.

› Hamilton Company unveiled Microlab PuriFY, its latest innovation in magnetic bead-based nucleic acid purification for NGS and PCR applications.

› Automata Ltd launched an AI-enhanced update of its vertically integrated automation platform LINQ that connects existing hardware using a robotic arm and a transport layer, both of which handle labware and consumables throughout the workflow, without compromising instrument accessibility or lab space. Instruments and data are digitally linked via a Python-based software.

The advancement and integration of European start-ups’ systems into the automation landscapes of pharmaceutical, laboratory and service companies will be the subject of SLAS Europe 2025 in Hamburg in May (20-22-5-2025).

Next stop: Hamburg

The laboratory automation and life sciences research communities will meet at the SLAS Europe 2025 at the Congress Center Hamburg (CCH), 20-22 May. Hamburg’s world-class academic institutions will be well-represented with Jan Baumbach, Ph.D., delivering the opening keynote address on 21 May. On 20 May, three local companies – AcCELLerate, Fraunhofer ITMP/Revvity, and Evotec – will open their doors for half-day scientific discovery sessions. This year’s conference includes three scientific tracks:

› Advances in Drug Discovery

› Advances in Lab Automation, and

› Screening Applications & Diagnostics

Poster presentations are still being accepted until 28 April. ■ t.gabrielczyk@biocom.eu

ISBN 978-3-928383-95-0

+49 (0)30/26 49 21-0 service@biocom.eu www.biocom.eu

Modelling human oxygen levels in drug screening

CANCER Italian InSimili Srl has been awarded the Ignite Award at SLAS 2025 in San Diego for the most innovative start-up company in the lab automation sector. European Biotechnology, partner of the Society for Laboratory Automation and Screening (SLAS), spoke with Enrico Grassilli, CEO of InSimili, about technology applications and future plans of the University of Bologna spin out.

EuroBiotech _Congratulations on winning the SLAS Ignite Award! Can you please briefly explain what your invention looks like and where you see its application?

Enrico Grassilli _Thank you! Winning the SLAS Ignite Award is a great recognition of our team and mission at InSimili. Our invention is an advanced cell culture plate with a patented biocoating that accurately controls oxygen levels directly inside the wells of standard culture plates. This enables us to provide ready-to-use plates with different levels of hypoxia and 3D oxygen gradients. Researchers can use our technology to easily recreate physiological and pathological conditions – such as tumour microenvironments, ischemiareperfusion injury, and neurodegenerative disease models – directly in vitro. Thanks to the accessibility and scalability of this technology, we believe that physiopathological models made with our plates can provide more predictive results early in the preclinical stages of drug development, derisking clinical trials.

EuroBiotech _How exactly does Insimili manage to adjust the oxygen and glucose concentration in the well? Grassilli _Our technology is based on an active biomaterial coating that contains enzymes and proteins that regulate the concentration of oxygen and nutrients in the culture media. As long as the media are replaced, the coating reaction continues, maintaining stable

ENRICO GRASSILLI is the CEO of InSimili Srl in Bologna, Italy. He holds a Master of Science in Mechanical Engineering from the University of Illinois at Chicago and Polytechnic Institute of Turin. Prior to joining InSimili he lead micro fluidics engineering at the biotech startup Chronus Health in Silicon Valley.

oxygen levels for several days. This is achieved without the need for external tubing, gas control chambers, or perfusion systems. Researchers can simply use our plates like any standard cell culture consumable, making it easy to integrate into existing workflows

EuroBiotech _Does the system also takes into account that tumours at different development stages show different oxygen concentrations? If so, how does this work?

Grassilli _Absolutely, we are working with several research groups and companies on oncology applications. One of the biggest challenges in cancer research is replicating the dynamic oxygen gradients found in tumours. Early-stage tumours may have higher oxygen levels, while aggressive, hypoxic tumours are more resistant to therapy. We can apply our coating to the wells with distinct configurations that recreate these gradients. Then, we can include multiple configurations within a single plate by adjusting the oxygen levels well by well. This means that we can effectively model different tumour stages in a single 96-well plate and study how therapies respond under realistic conditions.

EuroBiotech _Keyword: system integration – how can your system be integrated into automated environments, and how are signals read out and analysed?

Grassilli_Our plates are designed to be fully compatible with standard lab automation, including high-throughput screening (HTS) platforms, liquid handlers, and imaging systems. Since there’s no need for external gas control, they can be used seamlessly in automated workflows. They are compatible with most of the standard imaging readouts, including bright-field and fluorescence. However, the most interesting applica-

tions are the ones involving high-content imaging, since it can fully exploit the complex insights coming from cells growing under the oxygen gradient we recreate.

EuroBiotech _Do you already have partnerships and what are your goals in this regard?

Grassilli_We have ongoing pilot studies with contract research organisations (CROs), pharmaceutical and biotech companies, as well as collaborations with leading academic institutions. We are currently working with early adopters to validate our technology in oncology, and cardiovascular research. In the next months, we expect to announce longterm collaborations with some of these partners to develop specific applications and assays.

EuroBiotech _As far as we can tell, just one month after SLAS 2025: What has Insimili gained from participating in the award?

Grassilli_Winning the SLAS Ignite Award has been an honour and a blessing. It has significantly increased our visibility in the life sciences industry, leading to new partnership discussions and pilot studies with top pharma and biotech companies. But most importantly, it gave us access to the great network of experts and leaders in the lab automation and life sciences industry, which will be crucial to support our growth.

EuroBiotech _What are Insimili’s next goals?

Grassilli_Our immediate focus is publishing relevant application notes, posters, and papers on our technology with partners. Also, scaling up manufacturing to prepare for future growing demand. To do this, we are securing investments, and recently entered the acceleration programme Ready2Scale for promising Deep-Tech Startups in Europe. In the long term, we want to develop assay kits that include oxygen monitoring and target specific applications in oncology research.

■ t.gabrielczyk@biocom.eu

Novel sequencing approach

Nanopore-Sequencing Researchers at Roche have introduced a greatly improved nanopore sequencing method that has the potential to revolutionise nextgeneration sequencing . The scalable and flexible “Sequencing by Expansion” (SBX) promises to speed up genome sequencing enormously which might contribute to multiple biomedical applications as called for in a position paper “The untapped potential of Comprehensive Genomic Profiling” published the European Coalition for Comprehensive Genomic Profiling (ECGP) and the pharma federation EUCOPE in March. both interest groups lobby to widen the still limited access to comprehensive genomic profiling in Europe, that is “blocking routine testing for relevant cancer mutations and the rapid adoption of personalised medicine in Europe,” they say.

In contrast to Illumina’s sequencing standard Sequencing by Synthesis (SBS), Roche’s new chemical process is based on the expansion of target nucleic acids passing through a nanopore (10.1101/2025.02.19.639056v1). The individual bases are expanded into surrogate polymers, so-called Xpandomers. These reporter molecules are many times longer than the original nucleic acid sequence and therefore generate particularly strong signals with minimal background noise –the biggest problem with other nanopore sequencing approaches to date.

Two key new developments

According to Matt Sause, CEO of Roche Diagnostics, the technology is suitable for a wide range of genome, exome and RNA sequencing applications. It can sequence up to seven complete genomes per hour at 30x coverage, which equates to 5 billion duplex reads per hour – in both strands of DNA sequenced simultaneously.

The first innovation is the SBX expansion approach developed by Mark Kokoris and Robert McRuer at Stratos Genomics, which Roche acquired in 2020. The

aim was to overcome the limitations of previous methods, which lie in the dense packing of nucleic acid sequences and lead to a poor signal-to-noise ratio. “Thanks to this capability, we can work flexibly with one and the same sequencing system across different throughput levels, which offers users a significant advantage,” says Kokoris, now head of SBX technology at Roche.

Challenging SBX sequencing

The basis for Xpandomers are expandable nucleoside triphosphates, the X-NTPs, which contain reporter codes. A specially developed XP synthase incorporates the X-NTP molecules into the growing Xpandomer enabling >99.3% mean raw read accuracy, uniform GC coverage, and longer read lengths. The extending molecule is stabilised by special polymerase enhancers (PEMs). After synthesis, the bonds in the Xpandomer are cleaved, resulting in a long molecule that is around 50 times longer than the original sequence.

The second major innovation concerns the read-out of the sequences. After synthesis, the Xpandomer is routed through a biological nanopore where voltage pulses control its movement and the reporter codes are read out with high precision. This is done using a high-throughput sensor module developed by Genia Technologies, which is based on complementary metal oxide semiconductor (CMOS)-based array, which combines electrodes, detection circuits, and analogto-digital conversion and is designed to enable ultra-fast and parallel processing. Because the CMOS array contains roughly eight million microwells (each containing a nanopore), measurement occurs in a massively parallel, highly controlled manner without the convolution issues of traditional nanopore sequencing. The result is the cost-effective measurement of hundreds of millions of bases per second, bypassing the traditional approach of cyclical incorporation and measurement of a single base at a time. ■

Ziccum folds

BANKRUPTCY After a string of financial setbacks, Lund-based biotech Ziccum has filed for bankruptcy. The company’s board of directors made the decision in January, citing insufficient funds to meet outstanding obligations and continue operations. After a disappointing rights issue in late 2024 and unsuccessful attempts to secure other funding, Ziccum’s key investor, Global Corporate Finance, also declined to provide further financing. This ultimately led to the bankruptcy filing. Ziccum was known for its innovative LaminarPace technology for drying biopharmaceuticals and vaccines. In the twelve months leading up to the bankruptcy announcement, the company’s share price had already fallen by over 96 percent, reflecting its mounting financial difficulties.

US buyout

RARE DISEASES Immedica Pharma AB has announced the acquisition of Marinus Pharmaceuticals for US$151m, a move that significantly enhances its global rare disease business. The deal brings seizure medication ZTALMY (ganaxolone), a neuroactive steroid and GABA-A receptor positive modulator, under Immedica’s umbrella. The acquisition aligns with Immedica’s strategy to expand its presence in the U.S. rare disease market while adding an immediate revenue-generating asset to its portfolio. ■

Arctic funding

APPLIED GENOMICS Icelandic drug discovery and development company Arctic Therapeutics has secured €26.5m in an oversubscribed Series A financing. This influx of capital will help accelerate the development of two promising treatments: AT-001 for several forms of dementia, and AT-004 for inflammatory skin diseases. The investor lineup includes the EIC Fund, Kaldbakur, Sanos Group, Cerebrum DAO, and The Lurie Family Foundation.

The European Medicines Agency has given the green light for a pivotal Phase IIb/III trial of AT-001, targeting Hereditary Cystatin C Amyloid Angiopathy. Data from previous trials demonstrated AT-001’s potential in preventing the rapid accumulation of amyloid proteins in the brain, thereby reducing the risk of stroke and early dementia. ■

Phase II boost

IMMUNOTHERAPY Cancer Research UK, Bergen-based biotech Cytovation, and the Norwegian Cancer Society have announced a collaboration to progress Cytovation’s leading compound, CY-101, into a multi-national Phase II clinical trial for patients battling adrenocortical carcinoma (ACC).

The upcoming Phase II trial is built upon promising results from Cytovation’s Phase I CICILIA trial. Under the agreement, Cancer Research UK’s Centre for Drug Development will lead the design and execution of the Phase II trial, while Cancer Research Horizons, Cancer Research UK’s innovation arm, will manage the commercial relationship between the organisations. The Norwegian Cancer Society’s support will help secure additional resources, patients, and sites required for the study. ■

Danish expansion plans

INVESTMENT A state-of-the-art finished production facility and warehouse spanning more than 40,000 m 2 : Novo Nordisk is building a production facility in Odense, Denmark. The Danish company is investing DKK8.5bn (approximately €1.14bn) in the site, with plans to hire 400 permanent staff members. The Odense site will be equipped with cutting-edge technology and handle a variety of rare disease treatments, including those for haemophilia. Construction is already underway and is expected to wrap up by 2027. ■

LEO Pharma strikes gold

DERMATOLOGY Danish dermatology specialist LEO Pharma has inked a deal worth up to US$1.7bn with US biotech giant Gilead Sciences, setting the stage for a new chapter in inflammatory disease treatment. The partnership centers on LEO Pharma’s oral STAT6 programme, a promising contender in the fight against conditions like atopic dermatitis, asthma, and COPD.

LEO Pharma is handing over its preclinical oral STAT6 small molecule inhibitors and targeted protein degraders to Gilead. The California-based compa-

ny will take the lead on developing these oral treatments, while LEO Pharma focuses on potential topical formulations. The deal could be worth a whopping US$1.7bn for LEO Pharma, including a US$250m upfront payment. LEO Pharma also stands to receive tiered royalties on oral STAT6 product sales, ranging from high single-digit to mid-teens percentages. The company will have the option to co-commercialise oral programmes for dermatology outside the U.S. and retains exclusive global rights to STAT6 topical formulations in dermatology. ■

Dutch deal for Abliva

RARE DISEASES Abliva AB, a Lund-based clinical-stage company developing treatments for rare and severe primary mitochondrial diseases, is set to be acquired by Dutch biopharmaceutical company Pharming Group N.V. in a deal valued at approximately US$66m (around €60.8m). Pharming’s offer of SEK0.45 in cash per share was taken up by the majority of Abliva’s shareholders.

The deal centers around Abliva’s lead product KL1333, currently in a pivotal clinical trial for mitochondrial DNAdriven primary mitochondrial diseases. Pharming believes KL1333 has blockbuster potential, targeting a market of around 30,000 patients in key regions including

the U.S. and major European countries. KL1333 is currently being evaluated in a global, potentially registrational, Phase 2 study (the FALCON study) and has received orphan drug designation in both the USA and Europe as well as Fast Track designation in the USA. Just a week before the takeover offer, Abliva published results from its Phase 1a/b study for KL1333 in scientific journal Brain (DOI: 10.1093/brain/awae308). The study not only demonstrated KL1333’s safety and tolerability but also showed promising early signs of efficacy.

As a result of the acquisition, Abliva has applied for delisting from Nasdaq Stockholm.

■

NEWS

Funding for Orbis

Orbis Medicines, a player in oral macrocycle drug discovery, has secured €90m in a Series A funding round, bringing its total financing to €116m. Led by New Enterprise Associates (NEA) with participation from Eli Lilly and Company, Cormorant, the Export and Investment Fund of Denmark, and founding investors Novo Holdings and Forbion, the funding will support the development of Orbis’ next-generation oral macrocycle drugs, known as ‘nCycles.’

Approval for vaccine

Bavarian Nordic A/S is set to launch its Chikungunya vaccine Vimkunya on both the US and the European markets. In February, the company gained FDA approval for Vimkunya, followed shortly after by marketing authorisation in Europe. The virus-like particle (VLP) single-dose vaccine is the first chikungunya vaccine approved in Europe or the US for persons as young as 12 years old.

Power-to-food

Finnish microbial food startup Solar Foods OY has secured a €10m grant from Business Finland, related to the company’s IPCEI (Important Projects of Common European Interest) notification approved by the European Commission. The funding will support Solar Foods in scaling up production of its gas-fermented protein, Solein. The company’s demo factory has been in operation since 2023 and currently manufactures 160 tons of Solein per year.

Good fat

MARKET In parallel with an almost oversubscribed €3.8m equity crowd funding round from private investors, Dutch food tech pioneer Mosa Meat NV, with the support of Bell Switzerland, has submitted a marketing authorisation application for its cell-cultured beef fat in Switzerland. The well-financed (more than €120m raised) inventor of the first cellbased burger sees its cell-based beef fat as an entry point into the mass market for hybrid meat substitutes made from plant protein, as it gives them an authentic meat flavour.

In mid-January, Mosa Meat had submitted an application for EU market authorisation for its cell-based ingredient, making it the second company to do so after French foie gras producer Gourmey SAS. Gourmey SAS applied for authorisation from the EU food watchdog EFSA in July 2024, a process that typically takes up to four times longer than in the US, Singapore, and Israel – ranging from 18 to 48 months.

In contrast to Mosa Meat’s assumption that authentic meat taste will drive market adoption of hybrid meat alternatives, a recent survey shows that it is not the similarity to meat that is the deciding factor when buying protein alternatives, but the price alone: A price reduction of 10% would increase sales of plant-based meat alternatives by 14%. With the discovery of synthetic compounds that can replace the need for fetal bovine serum in culture media, culture based meat substitutes are ready to to enter the mass market. ■

Money for sustainability

FINANCING Dutch venture capital firm Forbion (Naarden) revealed that its BioEconomy Fund I has amassed €164.5m. This surpasses the fund’s initial target of €150m, highlighting the increasing interest from investors in the commercial viability of bio-based and biotech solutions that tackle the climate and economic crisis. The BioEconomy Fund I is a global health fund that focuses on business-to-business (B2B) alternatives that substitute unsustainable products with scalable, cost-efficient options. It is backed by high-caliber institutional investors such as KfW Capital, Novo

Holdings, Rentenbank, and Aurae Impact, along with new supporters ABN AMRO Bank and EIFO. The BioEconomy Fund I expects to reach an ambitious final close anticipated near its €200m hard cap. Sander Slootweg, Managing Partner and co-founder of Forbion, stated, “Exceeding €150m in just over a year reflects the strength of our team and strategy and the confidence our investors have in our ability to execute. Their support for BioEconomy Fund I demonstrates the growing demand for scalable, cost-competitive biotech solutions which deliver both sustainability and strong returns.” ■

Chinese pipeline in British cloak

OBESITY London-headquartered Verdiva Bio Ltd has raised US$410m in what CEO Khurem Farooq calls “the largest Series A round ever seen from a British biotech company”. Fueled by investments from co-leaders Forbion and General Atlantic and participation from RA Capital Management, OrbiMed, Logos Capital, Lilly AsiaVentures, and LYFE Capital, the Brits target the multibillion-dollar market of obesity and resulting co-morbidities type II diabetes, NASH and cardiovascular diseases.

The pipeline of the company has been filled by a US$70m upfront plus a US$2.33bn biobucks licence agreement with Hangzhou Sciwind Biosciences

Co., Ltd that licenced its Phase I synthetic oral GLP1 receptor agonist Ecnoglutide (XW004, now VRB-101), and both, an oral and an injectible amylin receptor agonist (Amylin RA, now VRB-102 + VRB-103) IND stage for commercialisation outside China and South Korea.

Verdiva Bio Ltd announced it will initiate a Phase II study for its once weekly GLP-1 agonist later this year. Additionally, Verdiva aims to explore the potential of a co-formulated tablet combining the oral amylin agonist with the GLP-1 agonist, as well as a combination of the subcutaneous amylin agonist with a proprietary GLP-1 peptide. “Our vision is to build a cardio-metabolic company for the long term,” said Farooq. ■

New gene therapy vectors NEWS

DRUG DELIVERY French targeted DNA gene therapy specialist EG 427 SA has closed a €27m Series B financing coled by VC investor Andera Partners and Bpifrance. The financing, which was announced in February, will be used to initiate Phase I testing of a Herpes Simplex Virus 1 (nrHSV-1) vector that specifically targets type C neurons to suppress dysfunctions of the bladder in people with spinal injury.

Besides lead investors Andera Partners and Bpifrance, British SCI Ventures, as well as existing investors Stephane Boissel and David Lamond participated in the €27m Series B round of EG 427 SA. The Paris-headquartered company said the funds will be used to finance Phase Ib/IIa trials of its lead candidate EG110A conducted at four study sites in the USA. A DNA-encoded study drug that blocks type C neurons near th e spinal cord will be administered to adult patients with neurogenic detrusor overactivity (NDO) who had a spinal cord injury at least 12 months prior to administration in order to reduce the number and time of bladder leakages (uninary incontinence). Safety and first hints to efficacy will be followed initially for 12 months. After that, responders will be asked to enter a Five-year follow-up observational period to assess long-term safety and efficacy.

EG110A is a genetic medicine utilising a non-replicating HSV-1 vector, which has been designed to selectively silence

the signals of key bladder sensory neurons, which are responsible for bladder muscle overactivity, whilst preserving bladder voiding function. Neurogenic detrusor overactivity is a common urinary bladder dysfunction caused by neurodegenerative diseases, such as Alzheimers’ and Parkinsons’ disease.

Results of preclinical tests seem promising. In a non-clinical pharmacology study in an OAB model, EG110A showed similar efficacy and a strong safety profile compared to botulinum toxin A, notably without the increase in post-void residual urine volume, a known adverse reaction in NDO and OAB with botulinum toxin A. In a long-term non-clinical kinetic study, EG110A demonstrated persistent transgene expression in the dorsal root ganglia in animals of at least six months. It is the first human study of such a vector, targeting sensory neuronbased diseases.

In addition to the first-in-man study, EG 427 plans to use some money to support the company’s earlier-stage pipeline based on its proprietary HERMES vector technology platform, that delivers large DNA pieces to specific neurons of the peripheral and autonous nerve system with help of a non-replicating HSV1 vector that „promises affordable production costs compared to mostly used AAV-based vectors,“ according to Benoît Barteau, Investment Director at B pifrance‘s InnoBio funds. ■

Viral combat

Antivirals specialist Synairgen plc has raised £18m by way of a subscription from TFG Asset Management. The company said it will use the proceeds to fund external and internal trial costs to the interim analysis, and drug manufacturing and stability testing for Synairgen’s Phase II INVENT trial (SG021). The company expects the study of its interferon beta blocker SNG001 in mechanically ventilated patients with confirmed respiratory viral infections to begin in the coming months.

Manufacture partner

In late February, Brusselsheadquartered Syensqo BV announced a strategic partnership with US consumer goods CDMO Bota Bioscience Inc in order to scale up its speciality ingredients portfolio. According to the contract, Syensqo will leverage Bota Bio’s performance protein technology to drive the protein-mimetic hair repair and hair growth product portfolio.

Golden ticket

British Sygnature Discovery plc spin-out Melio Bioscience, which was co-created last year with Molecule to Medicine, was awarded the 2025 Golden Ticket by Pioneer Group and Novo Nordisk in February. The company is working on a GPR75 inverse agonist, a pleitropic GPCR blocker implicated in cardiometabolic, neurodegenerative and autoimmune disease. The price includes one year of rent-free incubation space at Pioneer’s Victoria House and drug discovery mentorship.

Approved

COVID-19 In mid-January, InflaRx NV from Jena, Germany, received market approval from the European Commission for GOHIBIC® to treat COVID19-induced acute respiratory distress syndrome (ARDS). This approval was granted under “exceptional circumstances” as the first therapy in the EU for the treatment of SARS-CoV-2-induced ARDS. The EMA approval for the active ingredient Vilobelimab, which controls the complement factor C5a, is a significant achievement for Inflarx but extends far beyond the clinical indication of COVID-19. With its target molecule from the complement system, part of the evolutionarily older innate immune system in humans, further indications are possible where dysregulation or dysfunction of this defence mechanism plays a role. ■

Merger talks stopped

#NOMERGER Viennese Hookipa ends merger talks with Poolberg plc from London. In a brief statement filed as an 8-K form with the US Securities and Exchange Commission (SEC), the Nasdaq listed Hookipa NV announced that merger discussions with Poolberg Ltd will not be continued. No further details have been provided, and the British company expressed surprise and disappointment at the development. ■

It’s the ADC, stupid!

ACQUISITION Glycotope GmbH from Berlin finds its million-dollar exit with Japanese Daiichi Sankyo Pharma.

Daiichi Sankyo, Glycotope’s licensing partner since 2018, has acquired the Berlin-based biotech company for US$132.5m, including the full acquisition of the antibody developed through their collaboration. Major shareholders, the Strüngmann billionair brothers (46% stake) and entrepreneur Andreas Eckert (17.6% stake), will decide how to proceed with the remaining assets.

This acquisition marks the end of Glycotope GmbH’s operations in its current form which previously was a biotechnology company with around 30 employees,

developing monoclonal antibodies targeting tumour-specific glycoepitopes. Their innovative approach led to the creation of highly specific antibody-based therapeutics, including antibody-drug conjugates (ADCs), which attracted Daiichi Sankyo’s interest. The antibody GT-00A, developed as an ADC and currently in Phase I/IIa trials, was central to the acquisition. Founded in 2000 by medical technology entrepreneur Andreas Eckert, Glycotope was part of the Strüngmann brothers’ portfolio since 2007. The company is now history, as CEO Henner Kollenberg said. This exit includes milestone payments and revenue shares from the 2018 collaboration agreement. ■

mRNA-building blocks

CANCER Researchers from Jülich, Germany, have developed the principle of mRNA as a reading code for a protein to a selectively expressed RNA (seRNA, published in n atur E). Using a modular approach, the team has threaded different functional units onto a single mRNA strand, which is made up of several components. An important component is a highly specific sensor: it recognises a biomarker RNA within the target cell and provides the sequence of an antisense RNA that binds to form a double-stranded RNA. This RNA double strand is recognised by the cell as a potential viral attack and triggers a degradation mechanism, which also affects part of the seRNA. However, all of this is intentional. The antisense RNA serves no other purpose than to ensure the high cell specificity of the entire construct. Only if the cell produces the corresponding biomarker, i.e. a tumour marker which does not occur in healthy cells, will the sense and antisense partners bind. Through the partial degradation of the introduced “Lego”-mRNA, an activator hidden in the 3D structure of the mRNA strand becomes accessible, which in turn leads to the translation of another component and production of an enzyme that causes the cancer cell to self-destruct. ■

Switzerland: Basel remains biotech capital

LOCATION The Swiss Venture Capital Report annually describes the investment climate for start-ups. For the past year, it recorded a total investment sum across all sectors of around CHF 2.37bn, slightly more than in 2019 (prior to the pandemic’s special effect-driven investment years of 2021 to 2023). The biotechnology sector accounted for around CHF 740m, approximately a third of the total sum, and grew by an impressive 50% compared to the previous year.

No other sector in Switzerland receives as much venture capital as biotechnology. Around CHF 739m flowed into Swiss biotech start-ups last year, marking a 50% increase compared to the previous year. Biotech companies from the Basel region secured nearly 44% of the total investment in the Swiss biotech sector, leading the country by quite a margin.

Zurich or Basel – the eternal debate among the Swiss. Which city holds the title of Switzerland’s innovation capital? Zurich positioned itself as the startup capital last year. Basel asserts itself as the capital of biotechnology, maintaining its lead as Switzerland’s premier biotech hub.

In the cantons of Basel-City and BaselLand, around CHF328 million was invested in biotech companies in 2024 – significantly more than in any other region. Two of the three largest funding rounds in Switzerland went to start-ups located at the main campus of the Switzerland Innovation Park Basel Area. This is according to the Swiss Venture Capital Report 2025.

The largest funding round by far went to Alentis Therapeutics. The biotech start-up based in Allschwil raised CHF 160m in a Series D funding round, despite the fact that clinical trials with a standard antibody and an antibody-drug conjugate targeting the molecule Claudin-1 have only just begun. Also located at the Innovation Park in Allschwil, Bright Peak Therapeutics secured the third-largest funding round of the past year, raising CHF 80m. The second-largest funding round went to French-speaking Switzerland in Lausanne, where Ascneuron raised CHF89.5m.

According to the survey, investors have a positive outlook for the current year: approximately 76% of respondents expect an increase in funding. ■

NEWS

Stop-codon suppressor

Recombinant protein specialist CDMO enGenes Biotech (Vienna) presented their precision protein engineering using non-canonical amino acid incorporation in a whitepaper. It introduces the enGenes-expand technology, the site-specific incorporation of noncanonical amino acids (NCAAs) by amber-stop codon suppression. This technology has vast applications in fields like protein engineering, drug discovery, and biotechnology, by enabling the synthesis of modified proteins with tailored properties, as well as the cost-effective incorporation of NCAAs into proteins for bioconjugation through click-chemistry.

USA orders vaccine

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) announced a new contract with the U.S. Government for the supply of its Japanese encephalitis (JE) vaccine, IXIARO ® Under this new one-year contract, the Department of Defense will buy a minimum of US$32.8m worth of IXIARO ® vaccines and has the possibility to purchase additional doses during the coming twelve months. Deliveries of IXIARO ® doses have continued in 2024 under the supply contract signed in September 2023.

Austrian antibiotics

Sandoz is investing €12m to expand its production facility in Kundl, Austria, for the introduction of a new antibiotic. This strengthens Sandoz’s position as a leading European antibiotic manufacturer.

Basel´s skyline dominated by the Roche Towers, but there is a lot more going on.

Catching up

LICENSING Prior to AseBio’s BioSpain event to be held in Barcelona from 7–9 October 2025, Spain’s largest life sciences region Catalonia has reported record investment in biotech start-ups and scale-ups. According to the 2024 BioRegion Report published in mid-February, investments in healthcare companies climbed to the all-time record of €350m, 80% thereof invested by venture capital specialists. However, three large operations got nearly 70% of all investment: Impress, with a second megaround of €110m; INBRAIN Neuroelectronics with €46.2m, and foodtech firm Heura, which baged €40m. The second source of funding were competitive grants of €55m, 16.25% of all healthcare investments.

Life sciences made up 7.6% of Catalonia’s GDP in 2024 with more than 1,500 companies contributing, 90% of which being SMEs. Furthermore, Catalonia exported more than 40% and imported more than 32% of Spain’s life sciences and healthcare products, making it the second largest foreign trade volume in this arena of any autonomous community. With 280,000 life sciences employees (7.3%) and nearly half of all Spanish pharma companies, Catalonia has consolidated as one of the most important healthcare innovation hubs in Europe, stresses the report. With 75 drugs in clinical trials, the region is ranked fifth in Europe and eighth globally concerning the number of clinical studies, surpassed only by France, Italy, Spain (Catalonia representing 78% of trials) and the UK. ■

Hope for WAS patients

NEPHROLOGY Milan-based orphan disease charity Fondazione Telethon has submitted an EU marketing authorisation application (MAA) for the gene therapy etuvetidigene autotemcel as a treatment for the familiar immune system disorder Wiskott-Aldrich Syndrome (WAS). Etuvetidigene autotemcel stems from research carried out by the San Raffaele-Telethon Institute for Gene Therapy (SR-TIGET, Milan), a leader in the field of advanced therapies. “This submission marks a crucial step. Not only that, we are also working on the submission to the Food and Drug Administration (FDA), to make the therapy available also in the USA. We are proud to fulfil our promises to the patient community and donors and reinforce our commitment to accessible and sustainable thera-

pies for rare and ultra-rare diseases”, said Foundation Director General Ilaria Villa. Wiskott-Aldrich Syndrome (WAS) is a rare immunodeficiency which manifests itself from early childhood with recurrent and relapsing infections, bleeding, eczema, increased risk of developing autoimmune diseases and lymphomas. It almost exclusively affects males, with an incidence of 1/250,000 male live births. The current treatment options of affected children consist of supportive treatments managing and preventing clinical manifestations. The potentially curative treatment is a CD34-positive hematopoietic stem cell transplant expressing the defect WAS gene, which is, however, only feasible in the presence of an adequate donor and still carries potential complications. ■

Votum.World with new partner

FINANCING Through a partnership with StartupXplore, the Spanish developer of non-psychoactive endocannabinoids Votum.World will increase its capital from €432,000 to €730,000 to expand its staff, R&D as part of the threeyear BIORCAN-EU project and the start-up’s product pipeline. In addition to its OTC medicines for mental health, the start-up wants to develop effective and safe solutions for the relief of skin and muscle complaints. Company founders Alejandro M. Martí and Borja Vera welcomed the partnership and emphasised that they see its value above all in access to the expertise of strategic investors. ■

Enilive’s sustainable SAF facility is an example for how industry is working to met the Green Deal‘s goals.

SAF production takes off

SAF In mid-January, the Italian company Enilive srl began producing sustainable hydrogenated vegetable oil (HVO) as sustainable aviation fuel (SAF) from biomass at its biorefinery in Gela (Sicily). The biorefinery was converted to refine 763 million tonnes of waste and residual materials such as used cooking oils, animal fats and by-products from vegetable oil processing into SAF. Enilive’s first biorefinery will start with an annual capacity of 400,000 tonnes per year and is expected to more than double its output by 2026.

Currently, the Gela biorefinery can provide 25% of Europe’s expected demand of 2% SAF admixture to kerosin that will grow according to the ReFuel EU aviation regulation to 70% admixture by 2050. Enilive plans to boost its HVO biorefining capacity to more than 5 million tonnes annually by 2030. “By 2026, the SAF plant in Porto Marghera, in the Venice biorefinery, will also be operational, and by 2030 other plants will be commissioned in Italy and abroad,” said Stefano Ballista, Enilive’s Chief Executive Officer. ■

Neuronal symbiosis

COLLABORATION CNS specialist

Neuraxpharm Group GmbH and Greek specialist for long-acting injectibles Pharmathen SA have formed a strategic alliance to co-develop new injectable therapies under Pharmathen’s long-acting therapeutic technologies (LATT) programme. Financial details were not disclosed. However, under the agreement, Neuraxpharm will have exclusive rights to commercialise the resulting therapeu-

NEWS

Greening transport

Finnish hydrated vegetable oil (HVO) producer Neste Oy has started distribution of Neste’s renewable diesel HVO100 in Italy thanks to a partnership with Italian fuel distributor Firmin srl. HVO100 comes at a price premium of 10% with the aim to reduce greenhouse gas emissions, from diesel in the transport sector. “This partnership is a step towards more sustainable road transportation and will offer companies the opportunity to switch from fossil to renewable diesel,” stressed Nicola Minzocchi and Manuel Minzocchi, CEOs of Firmin. Depending on the raw material used to make HVO100, its use can reduce greenhouse gas emissions by between 40% and 90%.

Gene therapy hub

Novartis LLC has opened a €40m viral vector facility, VIFA One in Mengeš, Slovenia. The new site brings the Big pharma’s investment in the country to €3.5bn.

Schizophrenia deal

tics globally, while Pharmathen will retain commercialisation rights for North America and countries not covered by Neuraxpharm.

Pharmathen’s LATT program uses proprietary technologies to replace traditionally available short acting dosage forms, such as tablets or injectables, into longer acting injectable therapies to address unmet needs of prescribers and patients.

CNS specialists Newron Pharmaceuticals SpA has licenced its voltage-gated sodium channel blocker evenamide to Myung In Pharm Co. Ltd, which will commercialise the second-line schizophrenia drug in South Korea. According to the deal, Myung In Pharm will contribute 10% of the total patient population to be enrolled into Newron’s upcoming pivotal Phase III trial. In addition, the company will pay upfront and milestone fees to Newron. Further financial details were not disclosed.

■

Faster testing of antibiotics

DIAGNOSTICS Scope Fluidics, a Warshaw-based life sciences company, announced in January that its subsidiary BACTEROMIC has successfully completed the Early Access Programm (EAP) of its same-shift AST assay, confirming market readiness and competitive advantages. The system enables rapid Antibiotic Susceptibility Testing (AST) within the same shift, meaning it delivers results within 6-8 hours. Comparative testing showed that BACTEROMIC provided accurate Minimum Inhibitory Concentration (MIC) values in 96% of cases, while the leading competitor achieved only 38%. During proof-of-concept testing, over 400 clinical bacterial strains were analysed, achieving at least 90% essential agreement (EA) with reference methods. The system delivered accurate results four main bacterial groups: Acinetobacter, Enterobacterales, Enterococcus, and Staphylococcus Future developments include faster detection of critical bacteria like Pseudomonas and expanding BACTEROMIC to positive blood culture analysis. Following the $130m sale of its Curiosity Diagnostics to BIO-RAD, Scope Fluidics is now driving the commercialisation of BACTEROMIC, while working on two new projects: EDOCERA for stroke risk detection and DSC027 for metabolic syndrome diagnosis.

Hungary’s bio-based potential

REPORT Coinciding with the end of the Hungarian Presidency of the Council, a new report sheads light on the country’s bio-based potential. The “County Report on Hungary”, published by the Bio-based Industries Consortium (BIC) in January, maps out the country’s biobased growth potential, emphasising under-exploited resources. According to the report, Hungary’s utilised agricultural area makes up 55% of its territory, a notable proportion among EU Member States. Hungary’s bioeconomy, valued at €9.6bn in 2020, employs over 374,500 people. Hungary is classified as a “Moderate Innovator” in the European Innovation Scoreboard (EIS), alongside Poland and the Czech Republic. The forestry sector spans two million hectares, main-

ly oak and black locust, with significant wood harvesting for fuel and industry. The country has a growing biotech industry and untapped biorefinery potential, mostly focused on biofuels. Additionally, Hungary has large residual biomass volumes that could be better utilised. A recent BIC and Renewable Carbon Initiative (RCI) report indicates that by 2050, 20% of the global carbon demand in the chemical and basic materials industry could be sustainably sourced from biomass. Currently, industry relies on over 90% of fossil-based carbon, making this a significant opportunity for defossilisation. With substantial biomass resources and a growing bioeconomy, Hungary is well-positioned to support the EU’s green transition goals. ■

Resistance evolves rapidly

RESEARCH A study on the development of antibiotic resistance in Staphylococcus aureus published in January revealed that bacteria can rapidly evolve resistance to many experimental antibiotics (10.1126/scitranslmed.adl2103). The findings underscore the need to predict future resistance at early stages of drug development. Antibiotic resistance poses a challenge similar to that of a pandemic, with some bacteria developing resistance to new antibiotics within just a few years. S. aureus, a major cause of drug-resistant infections, is particularly concerning. To better understand how resistance may emerge, Martins et al. examined how the bacteria interacted with eight antibiotics targeting Gram-positive bacterial pathogens, either currently in development or recently approved. With the exception for one candidate, S. aureus readily evolved resistance to nearly every antibiotic tested. Furthermore, some approved antibiotics could induce cross-resistance to other drugs as well. Antibiotic resistance in nature may easily evolve from the selection of preexisting genetic variants. For this reason, the authors suggest that future studies should focus on examining multiple bacterial pathogens and consider the impact of environmental factors (see also page 48f ). ■

Oncologists identify Achilles heel of cancer

PHYSIOLOGY 101 years after the discovery of the Warburg effect, there is good news in the otherwise barren field of cancer research. There may indeed be the ‘magic bullet’ described by Paul Ehrlich, which eradicates all types of cancer. This new, untrickable drug target has been discovered by oncologists at the German Cancer Research Centre.

The findings are, as so many before them, still provisional, as they have not been clinically proven, and are currently limited to liver cell cancer. However, what the team led by Almut Schulze from the German Cancer Research Centre in Heidelberg has discovered sounds almost unbelievable. For several years now, it has been considered disproven what Otto Warburg postulated in 1924: that cancer cells arise by switching their energy production from respiration to glycolysis and, as a result, should die if this metabolic pathway is blocked. Tumours, however, are far more flexible in utilising various energy sources needed for their rapid proliferation. When glycolysis is blocked, the malignant tissue survives by generating energy through the respiratory chain, consuming oxygen.

Even more surprising are the results from Schulze and her colleagues: they discovered in mouse models of liver cancer, specifically hepatocellular carcinoma, and similarly in human cancer cell cultures, an enzyme of glycolysis. After blocking this enzyme, glycolysis switched from an energy-producing to an energy-consuming process (10.1038/ s42255-024-01201-w). The tumour cannot avoid the massive energy deficit by switching to other metabolic pathways. The tumour grows slower and eventually freezes its proliferation. When Schulze and her colleagues blocked enzymes that were upstream or downstream of this new cancer target,

Glycolysis consists of two distinct phases: the energy investment phase and the energy harvesting phase in the first phase, glucose is (in an irreversible last reaction step) broken down into 2 molecules of fructose 1,6-bisphosphate (FBP) at the cost of 2 ATP molecules. The second step, which starts with the Aldolase A-catalysed reversible conversion of FBP into glyceraldehydes-3-phosphate and dihydroxyacetone phosphate, gives rise to 1 pyruvate molecule, 2 ATP molecules, and 1 NADH molecule per molecule of fructose 1,6-bisphosphate.

the effect was not observed. “The glycolytic enzyme Aldolase A is essential for liver cancer cells, even though the glycolytic pathway itself appears to be dispensable,” concludes Schulze.

Surprisingly simple

The effect of Aldolase A blockade is surprisingly simple: first, the cell must invest

energy to produce the high-energy intermediate fructose bisphosphate. When Aldolase A1 is switched off, fructose bisphosphate accumulates in the cell, with the energy it contains remaining unused, as if trapped. The cell cannot benefit from the energy that would normally be gained in the subsequent steps. Glycolysis has shifted from an energy-producing to an energy-consuming process. Moreo -

Dreaming of a magic bullet 2.0

ver, the energy deficit drives the production of more fructose bisphosphate, creating a vicious cycle.

“By switching off aldolase A, we can overcome the metabolic adaptability of cancer cells. We not only block energy production through glycolysis, but also prevent the cell from switching to other metabolic pathways, as the energy is trapped in fructose bisphosphate. Targeted blockade of aldolase A could therefore be a promising strategy for combating cancer cells,” says first author Marteinn Snaebjornssonere. He and his colleagues are currently investigating whether the preclinical aldolase A inhibitor aldometanib (LXY-05-029), which was filed for patent by Chinese Xiamen Vivohealths Technology Co. Ltd to treat diabetes, obesity and Alzheimers’, can be developed as cancer medicine.

“We don’t yet know anything about the licence status in terms of cancer, but we do know that aldometanib probably shows few side effects preclinically. We are now starting tests in animal models,” revealed study leader Schulze to EuropE an BiotEchnology.

Basis reseach

Commercialisation of the promising research results is apparently not being considered. But perhaps it should be. Because according to SNS Insider, the global Liver Cancer Therapeutics Market size was valued at US$3.12bn in 2023 and is projected to reach US$15.69bn by 2032, at a CAGR of 19.21% during the forecast period 2024-2032. And if successful it might be of some use to patients. ■

t.gabrielczyk@biocom.eu

Waste as a resource

CRITICAL RAW MATERIALS Bioleaching specialist BRAIN Biotech AG and Swiss PX Group are scaling their partnership in gold recovery from e-waste with BRAIN’s proprietary Pseudomonas metallosolvens platform. In February, the partners, that previously tested two mobile bioleaching plants (BioXtractor) in pilot scale will now test process performance at cubic metre scale to provide gold nuggets from urban waste (see photo). “Our goal is to integrate the biological extraction process as a key component alongside other technologies to enable the recycling of all materials in e-waste, including copper, plastics, and other metals,” said Dr. Alexandra Levesque, Head of Chemical R&D at PX Group. ■

GM threats

GMO The global market of genetically (GM) modified crops is growing, with 32 countries globally expected to reach revenues of US$35.56bn in 2033 from US$24.80bn in 2024. However, despite an annual growth rate of 5.3% identified by Coherent Market Insights, the almost fully saturated GM crop market in the US and a rapidly expanding Asian market, restraints such as environmental concerns surrounding the technology may outweigh drivers such as the high demand of food driven by a growing population in the light of new data from ten US states in the US corn belt. Ye and colleagues reported in February that while pest pressure decreased through rootworm-resistant Bt maize, its overuse – due to low rootworm pressure and lack of planting appropriate levels (20%) of non-Bt maize hybrids – particularly in the eastern corn belt, resulted in an US$1.6bn lifetime loss of growers in this region due to resistant genotypes (s ci EncE 387, eadn9388). The researchers suggest to implement regulations that balance short-term incentives by farmers with long-term agricultural and environmental sustainability to ensure that Bt crops remain viable tools for pest management. ■

EBV program

MS Finnish immunologist Joona Sarkkinen and colleagues have deciphered how the Epstein-Barr virus (EBV) reprogrammes B cells so that they turn against the myelin sheaths of the patient’s own nerve cells triggering multiple sclerosis (MS). When comparing deep cervical lymph nodes, which swell in MS patients, and three controls, they found an explanation for the autoimmune reaction: B cells with an EBV infection-typical transcription profile as well as immune-depleted follicular T helper cells led to EBV reactivation, which could be seen from increased EBV DNA concentrations (10.1126/sciimmunol.adl3604). ■

Groundbreaking protein study

BIOBANK The UK Biobank announced in January the launch of world’s most comprehensive study of circulating proteins, aiming to measure up to 5,400 proteins in 600,000 samples. This unprecedented study will analyse blood samples from half a million participants and 100,000 second samples taken up to 15 years later. Researchers will explore how changes in protein levels over mid-to-late life influence disease development. The study will begin with 300,000 samples, including data from 250,000 volunteers and 50,000 follow-up samples. A pilot study in 2023, published in Nature (doi: 10.1038/s41586-023-06592-6), analysed nearly 3,000 proteins in 54,000 participants, identifying over 14,000 links between genetic variants and protein lev-

Aspirin fights cancer metastasis

CANCER A study published in Nature in March suggests that aspirin may enhance the immune response against cancer metastasis in mice (doi: 10.1038/ s41586-025-08626-7). Cancer cells often find ways to evade immune surveillance. One example is the production of thromboxane through platelets, which can suppress T cell activity at metastatic sites. Aspirin has already been associated with reduced metastasis, but the mechanism remains unclear. Researchers from the University of Cambridge have now identified a novel immunosuppressive pathway targeted by aspirin to improve

els. Findings from this research have advanced predictions for diseases like breast cancer, cardiovascular issues, and Parkinson’s disease. The full study, funded by 14 biopharmaceutical companies, will expand this dataset ten-fold. This effort promises to revolutionise our understanding of disease mechanisms and treatment options. “For the first time at this scale, researchers will be able to detect the exact causes of diseases by comparing how protein levels change over mid-to-late life in a large group of people”, said Sir Rory Collins, Chief Executive of UK Biobank. “This truly exciting study of proteins will significantly speed up drug discovery, leading to major improvements in public health and care everywhere."

BIOCOM CARD

Europe Individual

› European Biotechnology Magazine Subscription

› European Biotechnology Guide 2025

› Guide to German Biotech Companies 2025

› conveniently accessible ePapers

› Discount for BIOCOM events for 1 person

› additional partner offers

Price: 80 Euro p.a. (incl. VAT)

Students 50% discount (subject to proof of enrolment)

BIOCOM CARD

■

Europe Corporate

› European Biotechnology Magazine Subscription

› European Biotechnology Guide 2025

› Guide to German Biotech Companies 2025

› conveniently accessible ePapers

anti-metastatic immunity in mice. Multiple mouse cancer models treated with aspirin exhibited a lower rate of metastasis to other organs. By inhibiting cyclooxygenase and reducing thromboxane production, aspirin reduced T cell suppression, thereby restoring their antimetastatic function. These findings suggest that, in mice, aspirin could serve as a potential adjunct therapy for preventing cancer metastasis by amplifying the natural immune response. The authors suggest exploring a combination of aspirin with other immunotherapies to further enhance its anti-metastatic effects. ■

› Discount for BIOCOM events for 2 persons

› additional partner offers

Price: 120 Euro p.a. (plus VAT)

european-biotechnology.com/card

Destination for process technology

POWTECH TECHNOPHARM 2025 From 23 to 25 September 2025, Nuremberg will again become the hub where everything revolves around technologies for processing powders, solids and liquids. The part Ec congress will once again be held alongside it in 2025.

powt E ch tE chnopharm looks set to be a successful event, with around 600 exhibitors expected in Nuremberg in September. Around 80 percent of the exhibition space has already been booked. “The feedback we are getting from all parties is that the entire processing community is already looking forward to the exhibition once again. People have gradually got their heads around the new cycle – two consecutive years of powt Ech tEchnopharm every September, followed by a break in the third year – which makes it easier for people to plan,” says Marianny Eisenhofer, Director powt E ch tEchnopharm, of the status quo around six months ahead of the event. “In terms of international presence, we are also already making good progress and are looking forward to the expertise and innovative solutions of our exhibitors.”

Spotlight on pharma

Extending the brand to powtEch tEchnopharm puts the spotlight on the pharmaceutical and life sciences industry, especially

GxP-compliant manufacturing of liquid, semi-solid and solid pharmaceuticals. The supporting organisation, the International Association for Pharmaceutical Technology (APV), is an honorary sponsor. The tEchnopharm Forum has been set up specifically to showcase the various segments of the pharma industry. At the new “Pharma-in-Focus” pavilion, companies will present specific products and solutions to the high-calibre professional audience with relatively little effort but significant impact.

part Ec congress

The partEc Scientific Congress on the latest particle research takes place concurrently with powt E ch tE chnopharm . The new Chair, Professor Lutz Mädler from the Leibniz Institute for Materials Engineering in Bremen, is working with the VDI Association of Process and Chemical Engineering to plan yet another high-calibre programme featuring keynotes, lectures, poster sessions and awards ceremonies at the highest international standard. ■

POWTECH TECHNOPHARM

SAVE THE DATE: From 23 to 25 September 2025, Nuremberg will once again be the destination for the entire processing technology world in Europe. Around 600 exhibitors will present their innovative technologies for processing powders, solids and liquids, with hands-on exhibits and experts offering in-depth experience and the latest expertise. Coupled with a top-class supporting programme, this is the perfect basis for developing practical, detailed solutions together with you and for you as a visitor. We look forward to welcoming you!

Yours

Marianny Eisenhofer Director POWTECH TECHNOPHARM

› QUICK FACTS

When?

Tuesday, 23. Sep 2025: 09:00 - 18:00

Wednesday, 24. Sep 2025: 09:00 - 18:00

Thursday, 25. Sep 2025: 09:00 - 17:00

Programme Highlights

› POWTECH Forum – STAGE TALKS

› TECHNOPHARM Forum – STAGE TALKS

› VDMA Special Show

› Pavilion “Pharma-in-Focus”

› Networking-Pavilion for Newcomer and established companies

› “Young Innovators”

› Network “Women4Processing”

› Campus Pavilion

› Students’ Day

› VDI Contests chemPLANT and ChemCar

› Live Explosions

Exhibition Centre Nuremberg, Halls 9 - 12

www.powtech-technopharm.com/en

Sector review

BIOENERGY Trade association Bioenergy Europe has published it’s 2024 Landscape Report. It highlights bioenergy as a critical component of Europe’s transition to a net-zero economy, revealing that bioenergy accounted for 54% of Europe’s renewable energy mix in 2022 and avoided 300 million tonnes of CO2 emissions annually. The report, led by Secretary General Jean-Marc Jossart, emphasises bioenergy’s potential to create 1.5 million jobs, boost EU GDP by €70bn by 2050, and strengthen energy security. Key recommendations include promoting bio-based carbon removal technologies, modernising heating systems, ensuring sustainable biomass supply, and maintaining regulatory stability to drive the EU’s decarbonisation efforts.

■

Patent analysis

European Biotechnology

ALTERNATIVE PROTEIN The first analysis of its kind has revealed a remarkable 960% increase in patent publications by European alternative protein innovators over the past decade. This finding comes from a report by the Good Food Institute (GFI) Europe, a nonprofit dedicated to fostering a sustainable, secure, and equitable food system by diversifying protein production. According to the report, European companies and public research organisations published 1,191 patents related to plant-based foods, cultivated meat, and fermentation technologies in 2024 alone. The cumulative total of alternative protein patents published by European entities now exceeds 5,000, with an average annual growth rate of 32%. While plantbased innovations dominate the landscape, the report highlights gaps in foundational research for cultivated meat and precision fermentation. These areas require greater attention to advance technologies such as cell culture media and microbial strains, which are critical for scaling production and achieving cost parity with animal-based products.

■

Ireland: ibec.ie/ibia Denmark: danskbiotek.dk The Netherlands: hollandbio.nl

Life Sciences Meets Lab Automation

SLAS EUROPE 2025 SLAS is pleased to bring together the laboratory automation and life sciences research communities at the SLAS Europe 2025 Conference & Exhibition at the Congress Center Hamburg, 20-22 May.

Hamburg’s world-class academic institutions will be well-represented with Jan Baumbach, Ph.D., Director of the Institute for Computational Systems Biology delivering the opening keynote address on 21 May. See the science where it happens on 20 May as three local companies – AcCELLerate, Fraunhofer ITMP/Revvity, and Evotec –open their doors for half-day scientific discovery sessions. (Additional ticket required; transportation provided by SLAS.)

Interconnecting Lab Automation

The Society for Laboratory Automation and Screening’s 2025 Europe Conference & Exhibition delivers valuable access to applications of lab automation and innovation to life sciences research and drug discovery through scientific sessions, exhibitor tutorials, Solutions Spotlight presentations, and insightful keynote addresses.

This year’s conference includes three scientific tracks:

› Advances in Lab Automation : Delegates can learn about AI/ML and High-throughput Experimentation for Chemistry Expansion, Sample Management, Scaling Complex in vitro Cell Models (special ELRIG session), and AI-Driven Advances in Structural Biology and Imaging.

› Advances in Drug Discovery : This track includes sessions on Data-driven Drug Discovery, Image-driven Development for Medical Applications, Multi-omics in Drug Discovery, and Drug Repurposing and Systems Pharmacology.

› Screening Applications & Diagnostics: Delegates can benefit from sessions on Functional Genomics in Drug Discovery and Precision Medicine, Innovating Minimally Invasive Diagnostics from Biomarkers to Digital Health, Phenotypical Screening in the Digital Era,

UPCOMING EVENTS

› May 20-22, 2025, Hamburg SLAS Europe 2025 Conference & Exhibition

and Label-free Technologies to Enable Screening in More Native Contexts.

Poster presentations are still being accepted until 28 April. Students and early-career professionals as well as industry-centered researchers are invited to submit an abstract for presentation, which offers a highly interactive platform to showcase one’s work, engage in detailed discussions with other attendees, and effectively network with a diverse field.

Four of SLAS’s 18 topical interest groups (TIGs) will host in-person discussions -- Automated Chemistry, Proximity Assays, Sample Management, and Automation and Screening in Agri-Tech.

A highlight of every SLAS conference is its dynamic exhibition. More than 110 exhibitors will be displaying their technologies, services and products. Delegates will have plenty of time to peruse their applications, new product demos and tutorials, and visit with the start-up and emerging companies in the Innovation AveNEW hub!

The Rooftop Garden Party, daily coffee breaks and lunches will also provide delegates with diverse networking and collaboration opportunities in a relaxed atmosphere! Several registration options and rates are available including fullconference, exhibition only, student rate and more. ■

FIND OUT MORE! slas.org/europe2025

Early Bird Discounts: Until 31 March

Revolutionising Oral Drug Delivery

AUSTRIAN START-UP NovoArc GmbH, an Austrian biotech startup and BIOTECH AUSTRIA member, develops lipid-based formulations to enable the oral delivery of drugs that currently require injection. Its innovative approach paves the way for more convenient and effective treatments.

The challenge of oral drug delivery is ensuring that therapeutics survive the harsh GI conditions while achieving efficient intestinal uptake. NovoArc’s platform addresses this by engineering protective lipid-based carriers that stabilize APIs and enhance absorption. This technology enables oral delivery for medications like antibiotics, insulin, and mRNA vaccines.

Nature-Inspired Technology

NovoArc takes inspiration from nature. Microorganisms in hot sulfur springs endure extreme temperatures and acidity due to specialized lipids in their cell membranes. NovoArc uses these lipids to protect APIs in the GI tract and during storage. This strategy enhances drug stability, enabling oral administration and improving patient compliance.

NovoArc has the expertise and IP to chemically modify lipids based on customer needs. By adjusting lipid properties, the company enhances drug encapsulation or functionalises lipids with ligands for targeted drug delivery.

UPCOMING EVENTS

› April 1, 2025, Vienna Preclinical Workshop

› April 10, 2025, Vienna 4th BIOTECH CIRCLE AUSTRIA

NovoArc collaborates with pharma partners to accelerate drug development. The company supports partners from formulation to market-ready products, providing specialty lipids to drive innovation and bring new therapies to patients.

Positioned for Success

Founded by David Wurm, Julian Quehenberger, and Oliver Spadiut, and support-

ed by an expert advisory board, NovoArc is a leader in oral drug delivery. With recent funding from AWS and FFG, NovoArc is advancing its technology and expanding its platform. In collaboration with pharmaceutical partners, NovoArc aims to bring its first products to clinical trials, paving the way for a new generation of orally administered pharmaceuticals. NovoArc is also a proud member of BIOTECH AUSTRIA (www.biotechaustria.org), benefiting from its strong industry network, advocacy, and collaboration opportunities within the Austrian and European biotech landscape. BIOTECH AUSTRIA fosters innovation and supports companies like NovoArc in bringing groundbreaking technologies to market.

For more information, visit novoarc.at

■

Annual general meeting

The BIOTECH AUSTRIA hybrid annual meeting took place on 25 February 2025 in Vienna, 2025 being the fifth anniversary. Next to the usual agenda items; the discharge of the board members, the approval of the annual report and presentation by the auditors, President Peter LlewellynDavies, Treasurer Reinhard Kandera and Secre tary Georg Casari presented a review of the past year. Over 20 events took place: workshops, lunches, the traditional Biotech Circle Austria and the an-

nual conference Biotech Summit Austria in Innsbruck. This year’s Biotech Summit will take place in Graz and hopes to be just as successful as the previous events. Two new board members were appointed, Guido Gualdoni and Thomas Moser. Finally, members of the Strategy Working Groups presented the issues being focused on by BIOTECH AUSTRIA in the coming years: Financing and Capital Markets, the EU Biotech Act, Infra structure and Collaboration with Universities.

■

The founding team Julian Quehenberger, David Wurm and Oliver Spadiut

Connecting Europe’s biotech community

SAVE THE DATE Join YEBN’s top biotech event in Budapest! Connect with innovators, learn from professionals, and shape the future of biotech. Don’t miss this opportunity to network and grow, join us now!

As an association that operates primarily online across Europe, we recognize the value of meeting in person and building meaningful connections. That’s why we are committed to hosting our largest annual event in a different European city each year – our Delegate Assembly will take place then. This event offers a unique opportunity to engage with our institutional members in dynamic settings, creating a space of knowledge exchange and opening new windows for collaboration.

In 2025, the Queen of the Danube will welcome us. YEBN, in collaboration with MABE (the Hungarian Biotechnology Students’ Association), is organizing three days of activities in Budapest. If you’d like to join us, save the date: May 1st to 3rd. Stay tuned to our social media for more updates!

What can you expect?

This event aims at connecting biotech students and young professionals from across Europe. The gathering will be a vibrant hub of knowledge exchange, collaboration, and networking, drawing leaders and enthusiasts from the biotech sector. The event kicks off on May 1st with a welcoming dinner, setting the stage for the days ahead. May 2nd is dedicated exclusively to YEBN members and affiliates, including team-building activities in the morning, followed by a workshop, and the General Assembly in the afternoon. The day will finish with a themed dinner, where you can meet with others alike in a relaxed envi-

ronment. On May 3rd, the event opens to a broader audience. The morning session includes keynote speeches, and a workshop focused on the future of biotech. The afternoon, co-organized with EIT Health Innovators (EIT-HIC), offers plenty of opportunities to build your network with a lunch and a career path panel. The day ends in a dinner and after-party, where we will celebrate the connections made and futures plans of cooperation.

Why should you participate?

This event features the importance of collaboration in building a robust and interconnected biotech ecosystem. Participants will have the opportunity to learn from industry and academia professionals, share best practices, and expand their professional network. As for the previous years, we hope the atmos -

UPCOMING EVENTS

› May 1-4, 2025, Budapest YEBN Annual Event

phere will be one of excitement and optimism, as students and young professionals alike come together to share ideas and points of views on the biotech sector in Europe. As our field continues to flourish, events like these serve as necessary platforms for pioneering discoveries and fostering collaborations that will significantly reshape the future of healthcare and technology. By participating in such gatherings, young professionals not only gain invaluable insights but also become part of a dynamic network that is shaping tomorrow’s innovations. Join us to be at the forefront of biotech advancements and contribute to a brighter, healthier world.

If you have any questions regarding this event, or you want to be involved in what we do, please contact us at contact@yebn. eu. We are always ready and excited to further connect Europe. Let’s shape the future of biotech, together. ■

Chemspec Europe 2025

NETWORKING The world's leading exhibition for Fine and Specialty Chemicals returns to Cologne for its 38th edition, offering opportunities for fostering valuable business connections, cutting-edge innovations, industry insights and tailored manufacturing solutions.

› Christiane Beck, Event Director for Chemspec Europe, RX

The event introduces exciting developments, expanded exhibition space, and enhanced digital tools designed to foster new business connections. Set to take place at Koelnmesse, Cologne, this year's event will span across two halls, offering over 8,000 sqm of exhibition space to accommodate growing demand from exhibitors and attendees worldwide.

Chemspec Europe is the go-to event for industry specialists seeking to source custom product solutions and new partnerships. This dynamic event connects manufacturers, suppliers, distributors, and service providers from key sectors such as: Pharmaceuticals, Agriculture, Paints & Coatings, Personal Care & Cosmetics, Construction, Food & Feed, Water Treatment, Electronics & Batteries and many more.

Chemspec Europe 2025 will host over 300 leading international companies from Germany, Switzerland, France, the Netherlands, UK and global markets including the USA, India, and China. Some of the industry biggest names such as Albemarle Corporation, Arxada AG, CABB AG, Curia, ESIM Chemicals, Evonik, Johnson Matthey, Lanxess, Midas Pharma, Miltitz Aromatics, PI Industries, SEQENS, SRF, and WeylChem will showcase their latest innovations and cutting-edge expertise.

The Chemspec Europe 2025 conference programme remains a major highlight, delivering expert-led discussions on critical industry trends, regulatory challenges, and sustainability. Topics will include:

› Global Market Drivers & Regional Trends

› Decarbonisation & Green Chemistry

› Supply Chain Resilience

› Innovation Forum (Day 1 Afternoon): Bridging the gap between established industry leaders and visionary startups, this session will explore groundbreaking developments and future-focused solutions.

Specialised lecture theatres will delve deeper into industry-specific insights, with a range of case studies and regulatory discussions:

› The Agrochemical Stage: Covering biopesticides, bio-stimulants, agricultural policy, and the evolving landscape of sustainable agrochemicals.

› The Pharmaceutical Stage: Exploring the latest in personalised medicine, drug formulation, and pharmaceutical innovations.

› The Regulation Stage: Addressing REACH and REACH-like regulations, global chemicals management, and best practices for product stewardship.

› This year’s Insight’s stage, a new addition to the show, will address the key challenges facing the industry and provide practical guidance on overcoming obstacles.

The show features a tailored Matchmaking Programme, connecting visitors with

exhibitors that share similar business interests. Upgraded Visitor Plus tickets grant access to the Matchmaking Lounge for prearranged meetings with key industry contacts including both visitors and exhibitors.

Venue information

Chemspec Europe 2025 | Hall 4.2 & 5.2, Koelnmesse, Cologne, Germany

4th June 2025 | 09:00 - 17:00 5th June 2025 | 09:00 - 17:00

Ticket Prices:

› Advance Ticket (Before 20 May 2025): €55

› Standard Ticket (After 21st May 2025): €90

› On-Site Purchase: €105

› Visitor PLUS Ticket (Enhanced Matchmaking Programme & Lounge Access): €2000

Secure your ticket now at: www.chemspeceurope.com

Don’t miss the opportunity to connect, collaborate, and discover the future of the industry in Cologne this June at Chemspec Europe 2025! 

3D Systems Inc (US) 56

4SC AG (DE) ....................... 20

A

Abliva AB (SE) 63

ABN AMRO Bank N.V. (NL) 64

Alentis Therapeutics AG (CH) 67

Andera Partners (FR) 65

Arctic Therapeutics (ISL) .............. 62

Ascneuron SA (CH) 67

Asklepios BioPharmaceuticals Inc. 32, 34

Aurae Impact (FR) 64

Automata Technologies (GB) 59

B

Bavarian Nordic A/S (DK) 63

Bayer AG (DE) 32, 34

Bell Food Group AG (CH) 64

Berlin Partner GmbH (DE) 29

BIO Deutschland e.V. (DE) ............ 58

BIOCOM AG (DE) 59

Biomed X GmbH (DE) 12

BioVersys AG (CH) 24, 52

Blue Whale Material LLC (US) 19

BlueRock Therapeutics LP (US) 32

Boehmert & Boehmert (DE) 9

Boston Consulting Group (US) 19

Bota Bioscience Inc. (US) 65

Bpifrance SA (FR) 65

Brain Biotech AG (DE) 3, 19, 72

Bright Peak Therapeutics (CH).......... 67

C

Cardior Pharmaceuticals GmbH (DE) 40

Collaborative Drug Discovery (US) 38, 44

Cormorant (DK) .................... 63

CytoTronics Inc (US) 59

Cytovation ASA (NO) 62

CZ Vaccines (Zendal Group) (ES) CP4

D

Daiichi Sankyo (JP) 66

DASGIP an Eppendorf Company (DE) 13

DECHEMA e.V. |

5th Biotech Conference (DE) 17

Dyno Therapeutics (US) 40

E

EG 427 SA (FR) 40

Eikon Therapeutics (US) 20

Eleva GmbH (DE) 30

Eli Lilly (US) ....................... 63

enGenes Biotech (AT) 67

Enifer Biotech (FI) 19

Enilive srl (IT) 69

European Biotechnology Network (BE) CP3

F

FGK Clinical Research GmbH (DE) 41

Firmin srl (IT) 69

Fördergesellschaft IZB (DE) 33

Forbion Capital Partners (NL) 63, 64

Fuse Vectors A/S (DK) ............. 40, 46

G

Gilead Ltd. (US) 63

GlaxoSmithKline (GB) 24

Glycotope GmbH (DE) 66

Gradle Ltd. (NL/CH) 54

Grafiti GmbH (DE) 11

H

Hamilton Company (US) 59

Hangzhou Sciwind Biosciences (CN) 64

Hookipa Biotech AG (AT) 66

I

IA Ventures (US) 57

IBA Lifesciences GmbH (DE) 55

Immedica Pharma AB (SE) 62

Inbrain Neuroelectronics (ES) 68

InFamily Foods Holding GmbH (DE). . . . . 18

Insimili srl (IT) 56, 60

Interius BioTherapeutics Inc (US) 34

Ipsen S.A. (FR) 34

Janssen-Cilag International NV (BE) 32

K

KfW Capital (DE) 64

L Leaps by Bayer (DE) 19

LEO Pharma A/S (DK) 63

Logos Capital (US) 64

LYFE Capital (US) ................... 64

M

Medivir AB (SE) 34

Melio Bioscience (GB) 65

Microsynth AG (CH) .............. 45, 47

MoonLake Immunotherapeutics AG (CH) 32

Mosa Meat NV (NL) 64

Myung In Pharm Co. LTd. (KR) 69

MyxoTech GmbH (DE) 39

n!Biomachines Inc (CA) 18

n6Tec (US) 56

NanoTemper Technologies GmbH (DE)

Neste Oy (FI)

Neuraxpharm GmbH (DE)

New England Biolabs GmbH (DE)

Newron Pharmaceuticals SpA (IT)

nova-Institut GmbH | CCU + RMC Congresses 2025 (DE) 19

Novadip Biosciences SA (BE) 34

Novartis AG (CH) 69

Novo Nordisk A/S (DK) 34, 62, 63, 65

NürnbergMesse GmbH | POWTECH 2025 (DE)

German Biotech Days

09.–10.04.2025 HEIDELBERG This event is the national forum for the German and international biotechnology industry. The German Biotech Days bring together entrepreneurs with scientists and partners from politics, investors, funding institutions and administration, this year, in the life science hub Heidelberg. www.german-biotech.day/

2.-3.4.25

CEBioForum 2025, Warsaw (PL)

Info: Association of Biotechnological Companies BioForum https://cebioforum.com

14.-15.4.25

Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) 2025, Berlin (DE) Info: BGS Group https://pharmap-congress.com

28.-29.4.25

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

29.-30.4.25

LSX World Congress, London (UK) Info: Informa https://informaconnect.com/lsx-world-congress

5.-6.5.25

Swiss Biotech Day 2025, Basel (CH) Info: Swiss Biotech Association https://swissbiotechday.ch

12.-14.5.25

BioEquity Europe 2025, Bruges (B) Info: EBD Group/Biocentury https://conferences.biocentury.com

14.-15.5.25

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

Info: Deutsche Gesellschaft für Materialkunde e.V. DGM https://dgm.de/biomat

15.-16.5.25

ICPO Forum for Theranostics in Precision Oncology, Munich (DE)

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

15.5.25

The Future of Swedish & Danish Life Science, Lund (SE)

Info: Maria Eriksson, Life Science Sweden www.swedishdanishlifescience.se

20.-22.5.25

SLAS Europe 2025, Hamburg (DE)

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

30.5.-3.6.25

ASCO Annual Meeting, Chicago (USA)

Info: ASCO – American Society of Clinical Oncology https://conferences.asco.org

4.-5.6.25

Chemspec Europe 2025, Cologne (DE)

Info: Reed Exhibition www.chemspeceurope.com

16.-20.6.25

EuPA 2025, Saint-Malo (F)

Info: European Proteomics Association https://eupa2025-stmalo.fr/en

16.-19.6.25

BIO International Convention, Boston (USA)

Info: BIO – Biotechnology Innovation Organization www.bio.org/events/bio-international-convention

CO2-based Chemistry

29.–30.04.2025 COLOGNE The 13th international CO2-based Fuels & Chemistry Conference focusses on biogenic CO2 sources, CO2 capture, green hydrogen production, CO2based fuels, Carbon Capture and Utilisation (CCU) and Power-to-X technologies for a sustainable chemical industry. More than 250 leading international experts are expected to attend. https://co2-chemistry.eu

19.-20.6.25

World Bio Markets – Driving the commercialisation of the bioeconomy, Le Hague (NL) Info: Paul McDonald, TNP Media Ltd. www.worldbiomarkets.com

16.-18.9.25

ILMAC 2025, Basel (CH) Info: MCH Group https://www.ilmac.ch/de

5th Biotech Conference

16.–18.06.2025 FREIBURG The 5th Biotech Conference on single-use technologies for bio-based applications presents new trends and new areas of application for these technologies. A practice-oriented exhibition of European companies will complete the event. www.dechema.de/en/Biotech/2025

5th BIOTECH Conference 2025

Single-Use Technologies for Biobased Applications 16 – 18 June 2025 Konzerthaus Freiburg/D

17.-18.9.25

Life Sciences Baltics, Vilnius (LT) Info: Life Science Baltics https://lifesciencesbaltics.com

30.9.-2.10.25

Festival of Biologics 2025, Basel (CH) Info: Terrapinn https://www.terrapinn.com

7.-9.10.25

BIOSPAIN 2025, Barcelona (ES) Info: ASEBIO https://asebio.com

12.-14.10.25

World Health Summit 2025, Berlin (DE) Info: WHS Foundation GmbH www.worldhealthsummit.org

13.-14.10.25

Nordic Life Science Days 2025, Gothenburg (SE) Info: Olivier Duchamp, SwedenBio www.nlsdays.com

28.-30.10.25

CPHI Europe 2025, Frankfurt am Main (DE) Info: Informa www.cphi.com

Winners & losers

EUROPE According to the Commission president Ursula von der Leyen, the aim of the new Clean Industrial Deal is to make the EU the global market leader in the circular economy by 2030. Clean tech is the new buzz word.

BIOTECHNOLOGY , or more specifically, AI-supported biotechnology, was at the centre of the previous Green Deal plan, but has now been replaced by the new term ‘cleantech’. Within the EU Commission’s 24page communication, the term biotechnology is completely lacking, although the Draghi report clearly stated that half of the innovative cleantech companies supported by the EIB are biotech start-ups. ■

I’m in biotechnology because

ULRICH KINZEL, Partner Investment Banking, Bryan Garnier

“... it is a global community of enthusiasts united by the goal to tackle the vast areas of unmet medical need with cutting-edge science. That´s why I am in too.”

Obesity adding weight

The number of patients living with obesity keeps growing, and following the recent advances in the therapeutic space, more patients are being prescribed pharmacotherapy on top of the usual diet and exercise lifestyle changes. With physicians and patients awareness expected to increase, sales of obesity medications are forecast to reach US$173.5bn in the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan) by 2031, projects GlobalData plc.

The really very last word

What will be written in the history books about Mr Putin and Mr Trump in the future? I would wager the following: ‘In the first half of the 21th century, these two elderly individuals were responsible for the catastrophic failure of the world’s leaders to focus on imminent climate change. Their backward-looking and self-serving policies were the cause of terrible damage to the biosphere. Countless ecosystems

have been irreversibly destroyed and many millions of people have died as a result.’ Today, it is completely open what will be written about Europe in this context. Either nothing at all, or: ‘Due to considerable pressure, the European states finally decided to go further. With the realisation of the Green Deal,

the United States of Europe became a shining example of responsible policy for a liveable future on this planet.’ ■ B ernado Glavo

Yes and no

SCANDINAVIA The Scandinavian countries presented themselves in excellent shape in the life sciences sector, not least at the recent BIO-Europe in Stockholm. This is due to their strong scientific foundation, robust companies, and regional as well as thematic clusters that continuously drive innovation efforts forward. Denmark and Sweden are in the process of approving multi-billion-pound strategic programmes to further expand the sector. But the governments still need to give their approval. However, in Norway, the co-governing Labour Party has now said “no”. The Norwegian Arbeiderpartiet rejected a proposal that Norway should develop its own life science strategy. Billions are already being invested in Oslo, and that, they argue, should be sufficient. Indeed the government invests € 6bn in life science infrastructure and a new university hospital in Oslo. ■

Next issue 2025

SUMMER EDITION Our next issue will focus on tech parks + biomanufacturing hubs, bioengineering, and automated discovery of new modalities. Companies are invited to present their activities in the EuropE an BiotEchnology m agazinE. Want to participate? Just contact Oliver Schnell (-45), Andreas Macht (-54), Christian Böhm (+49-30-264921-49) or please mail: marketing@biocom.de. Publication date is 26 June 2025; deadline for ads is 13 June 2025.

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save the planet!

Biodiversity loss, climate apocalypse, billions of people in turmoil. New strategies are desperately needed. Biotechnology creates confidence and solutions. The European Biotechnology Network is a non-profit organisation that aims to facilitate cooperation between all professionals in biotechnology and life sciences on the European continent. Find out about (free) membership on our website www.european-biotechnology.net

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