ISSN 2364-2351 | A 60711 |
Life Sciences and Industry Magazine Winter Edition 2023 | Volume 22 | 20 €
Interview Marco Rupp, Biobased Industries Consortium, on how to make the circular bio-based economy a success.
Cellular Agriculture
Boom or exodus? Targeted Therapies
Manufacturing
BioFairs Compass
Progress with antibody-drug conjugates against solid tumours
Billion-euro expansion of new obesity blockbusters in Europe
Attractive Life Sciences Events in the first half of next year
Giving your work a new shine The New LCMS-9050 Q-TOF mass spectrometer integrates the world’s fastest and most sensitive quadrupole technology with TOF architecture. Facilate your work and improve your results thanks to trusted mass accuracy stability, ultra-stable polarity switching, highest speed for MS/MS and a great versatility with flexible extensions. Discover all the advantages of the new LCMS-9050 – also available as an upgrade for your LCMS-9030.
www.shimadzu.eu/new-shine
Reduced ambiguity in compound identification and structural elucidation.w Less effort for instrument management, more time for the real data. Increased availability and throughput on the system.
Learn more about LCMS-9050 Q-TOF!
European Biotechnology | Winter Edition | Vol. 22 | 2023
Plant breeding innovation reloaded? The European Court of Justice ruling from 2018 which put the latest breeding methods under the EU GMO legislation was a huge pushback for plant breeding innovation in the EU. With the proposal for a new regulation for certain new genomic techniques (NGTs) published on 5 July 2023, some faith in a rebirth of plant breeding innovation may just start to return. The European plant breeding and seed sector welcomes that the Commission proposal finally recognises the need for a differentiated regulatory approach to certain NGTs from the burdensome GMO legislation. The proposal establishes a verification process to confirm if a NGT plant is meeting the equivalence criteria to be categorised as conventional-like (Category 1). Consequently, those Category 1 plants should also be subject to the same regulatory requirements PETRA JORASCH, holds a PhD in as conventional breeding products. It is therefore inconsistent plant molecular biology from the that Category 1 NGT plants are considered GMOs for organic University of Hamburg. She is an farming. This does not allow organic farming to benefit from internationally recognised industry any of the NGT-derived product innovations in plant breedadvocacy expert with more than 20 ing – specifically those that enhance environmental sustainayears of experience in plant science bility of crop production- that we expect in the years to come. and breeding as well as relevant Euroseeds welcomes that national competent authorities are intellectual property protection the responsible bodies for conducting the verification procesystems and a deep knowledge dure. This increases accessibility for SMEs. We nevertheless reof the relevant policy frameworks. gret that the Commission took a very conservative approach Petra joined Euroseeds in February in view of the limited numbers of genetic changes for an NGT2017 as the spokesperson of the EU plant to be covered by the equivalence criteria for Category 1. plant breeding sector on modern This does not allow polyploid crops which include multiple plant breeding methods and copies of the same gene to benefit in the same way from the innovative technologies. application of NGTs if each copy is counted separately. Breeding companies invest up to 20% of their turnover in research & development and rely on legal certainty for their investments. The verification process should therefore be effective and predictable based on clear criteria and the scientific expertise of member states’ competent authorities.
Picture: © Euroseeds
Euroseeds reiterates that any GMO-approach (Category 2) -even if it includes a lighter risk assessment- is unworkable, specifically for SMEs. We expect import approval applications for Category 2 plant products to be the same as for classical GMOs but we do not consider the GMO system suitable for cultivation approvals. This will again lead to a situation which allows for import of innovation but restricts the cultivation of such innovations for EU agriculture. We remain committed to contribute and to advocate for a system of intellectual property rights that takes the needs of all stakeholders involved in the development of innovative technologies and products into account. Such system needs to successfully balance effective protection and fair, broad access, to the benefit of Europe’s agri-food L sector and society.
INTRO
3
CONTENTS
European Biotechnology | Winter Edition | Vol. 22 | 2023
COVER STORY
INSIGHT EUROPE
REGIONAL NEWS
6 Italy becomes first country worldwide to ban cell-based meat
60 Northern Europe: Sweden, Denmark, Norway and Finland
8 New EMA fees; Glyphosate market approval confirmed until 2033 10 Novel Food: First pre-registration at EFSA for a hybrid cell-based food 12 One STEP beyond
ECONOMY
62 Western Europe: France, Belgium, The Netherlands and the UK 64 Central Europe: Germany, Switzerland and Austria 66 Southern Europe: Italy, Spain, Croatia, Cyprus, Greece and Portugal
20 Analyst commentary 21 European Biotech Stocks 24 Update on clinical trials
42
A looming EU foodtech exodus? Will Europe once again grow dependent on the US and Asia – this time in the potential billion-dollar market for cultivated meat, fish and dairy products? Over 90% of EU biotechs with a corresponding product range decide to have their products approved in Singapore or the US because of slow responses from an unmotivated EU food authority and hesitant investment in industrial production facilities. Dubai is also trying to attract EU innovators with big equity investments.
26 IP comment; VectorY Tx BV closes one of this year’s largest Series A financing rounds in Europe 27 AMR: Consortium evaluating new preclinical efficacy model
68 Eastern Europe: Poland and the Czech Republic
SCIENCE & TECHNOLOGY 69 Mining the somatic genome 70 BIC’s 10 th jubilee celebration 71 Improving CAR-T cell therapies 72 Green feed for fish
28 Interview: Marco Rupp, Bio-based Industries Consortium, Brussels
73 Roots of memory T cells found 74 Evotec at dewpoint
30 In Focus: Techparks and Manufacturing sites 32 Manufacturing Sites: Novo Nordisk and Eli Lilly expand obesity drug manufacturing in Europe with billion-dollar investments 50 Spanish EU Council Presidency set to speed up draft regulations
PICK & MIX 74 New products 75 News from Biotech Associations 79 Biopeople 80 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, Margarita Milidakis, Maren Kühr; Advertising: Oliver Schnell, +49-30-264921-45, Christian Böhm, +49-30-264921-49, Wolfgang Gutowski, +49-30-264921-35; 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 Interrelations GmbH. 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 Interrelations GmbH 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: Alexey - stock.adobe.com; ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.
Picture: © Alexey - stock.adobe.com
4
CONTENTS
European Biotechnology | Winter Edition | Vol. 22 | 2023
ADC
EU POLICY
EDITORIAL
Move or not?
Take your best shot It has taken two decades, but the field of antibody-drug conjugates is finally hotting up – underlined by Pfizer’s megatakeover of Seagen for over US$40bn, as well as other deals that are making headlines. Clinical data in the area show better-than-ever results, while interesting moves in the field and new payloads are drawing lots of attention.
12
Pictures: © Rochak Shukla - Freepik.com (left); Andre Suter-blubber.li - stock.adobe.com (left above); Wikipedia, org - diliff (middle); BIOCOM Interrelations GmbH (right) ;
EU STEPs back
14
In response to biotechnology being prioritised in the US under the Inflation Reduction Act, EU Commission President Ursula von der Leyen wanted to hit back with the €360bn STEP initiative – but Member States were only willing to provide €10bn. MEPs are now lobbying for €13bn.
SPECIAL Biofairs Compass
Italy’s right-wing government under Giorgia Meloni has made a decision about foodtech. In mid-November, it became the first country in the world to ban the industrial production of food based only on cells rather than vertebrates (see p. 6). Instead, the government is standing behind farmers, who fear biotechnological food production could replace traditional agricultural methods. Specialists for cellular agriculture say the area has a huge number of advantages: less water, pesticide, land and fertilizer consumption, and over 90% reduction in CO2 emissions (see p. 42). Italy’s decision also reveals a flaw in EU policy. In an era when Asia, China and the US are increasingly relying on biotech, the EU promise of jobs AND growth no longer works, because job-making agriculture will remain low-tech as long as Member States block new genomic techniques (NGT, see p. 50) or food biotech. The bureaucracy involved highlights the problem. EU food authority EFSA can check the safety of novel foods for up to three years, and in the end a political vote by Member States can extend waits to 4-6 years. In innovation-hungry nations, the whole process can take as little as nine months. The situation could end with an exodus of European innovators. Instead of complaining about backlogs, EU decisionmakers should curtail the endless discussions and streamline authorisation. The potential is there.
54 Pharmapack 2024, Porte de Versailles, Paris, France 56 BIO-Europe Spring 2024, Barcelona, Spain 58 Swiss Biotech Day 2024, Basel, Switzerland
Thomas Gabrielczyk Editor-in-Chief
5
INSIGHT EUROPE
European Biotechnology | Winter Edition | Vol. 22 | 2023
Blow for cellular-ag In mid-November, the Italian Parliament has adopted a law that bans the production and sale of cell-cultured meat and fish on the domestic market. A similar marketing ban is also being discussed in Romania. Biotechnologists organised in Cellular Agriculture Europe stressed the (draft) law unlawful and not in line with EU regulations.
FOOD-TECH
The animal welfare organisation OIPA Italia accused Italy’s government led by Prime Minister Giorgia Meloni of only following the interests of farmers. Synthetic cultivated meat could be the solution for “animal-friendly production, ecological sustainability and food safety”, the activists stressed. In addition, the meat alternatives grown from muscle satellite cells could be of interest to consumers who do not want to follow a vegetarian or vegan diet. According to the Italian consultancy Nomisma, €1.3bn had already been invested in the development of in-vitro meat by the spring of this year. The Italian parliament backed the bill by 159 votes to 53. “Italy is the world’s first country safe from the social and economic risks of synthetic food,” stated Agriculture Minister Francesco Lollobrigida. Italy’s Health Minister Orazio Schillaci invoked the precautionary principle to justify the ban. There was “no scientific proof” that the consumption of lab-
grown meat has no harmful effects”, he said. Severe penalties are threatened in the event of violations of Italy’s new law, such as fines of €10,000 to €60,000 or up to 10% of the annual turnover of the companies concerned. Subsidies or tax concessions are to be cancelled.
the European Commission and member states as a novel food and that requires a safety assessment by EFSA, authorisation by member states and the European Commission.” After market authorisation, however, Italy’s new law could be challenged by the European Commission.
No approved product in EU yet
Protest from industry
For now, the law will have little effect, as cultivated meat has so far only been approved for human consumption in Singapore and the US (see European Bio technology, Autumn edition). Up to now, only the German sausage manufacturer The Cultivated B in mid-September preregistered a hybrid product made from plant protein and pork from cell culture developed by the Plantly Butchers (see p. 10). Earlier before, Wolfgang Gelb mann from European food watchdog, the EFSA, said: “In Europe, we do not have such products yet on the market [...] because they are considered by regulators,
Cellular Agriculture Europe, a coalition of cultivated meat producers, protested against Italy’s move, stressing it goes against Italian consumers’ free choice. “Contrary to what was said in the discussions surrounding this legislative proposal, the European Union does have an appropriate regulatory system in place for the safety assessment and approval of cell-cultured products with the Novel Foods Regulation,” the association said. There is no legal reason for Italy to preempt [the EFSA’s] risk assessment and risk management process, Cellular Agriculture Europe added. “As the European association of cultivated meat or seafood producers, we call on the Commission to take action to ensure that the EU law is enforced in all member states. European regulations also provide that technical regulations must be notified to the European Commission before their actual adoption, allowing other member states and stakeholders to provide comments on potential barriers to the EU internal market. The Italian authorities’ withdrawal of their notification and today’s vote blatantly contravene the EU law”, stated the interest group. Italy in 2022 was home to a 0.4bn market for plant-based protein alternatives. Francesca Gallelli, Public Affairs Consultant at the food-tech think tank, Good
Model calculations of the most important greenhouse gases (GhG) emitted by conventional compared to cultivated meat production.
Picture: © Good FoodInstitute Europe
6
Order now and discover our fast delivery service
Simplify Process Scale-Up We assist you to scale up your bioprocess − Eppendorf Bioprocess Solutions for Cell & Gene Therapy Development - Flexible, Scalable, Industrial The BioFlo® 320 offers flexibility, better control, and maximum functionality while occupying a fraction of the valuable lab space of similar systems. This means greater efficiency and productivity at a lower operating cost for your lab. BioBLU® Single-Use Bioreactors were developed as true replacements for existing reusable vessels.
> Sterility Assurance Level (SAL): 10 -6 > Simplified handling reduces crosscontamination > Reliable scalability from 250 mL - 40 L through industrial design > Proven for animal and human cell lines > Increased productivity with reduced turnaround time between runs
www.eppendorf.com/BioBLUc Eppendorf ®, the Eppendorf Brand Design, and BioBLU® are registered trademarks of Eppendorf SE, Germany. BioFlo ® is a registered trademark of Eppendorf, Inc., USA. All rights reserved, including graphics and images. Copyright ©2023 by Eppendorf SE.
INSIGHT EUROPE
Food Institute Europe, said: “This bill not only deprives consumers of choice but also isolates Italy from the investment and job creation offered by this burgeoning industry. The debate surrounding cultivated meat in Italy has been fuelled by misinformation, as hearings in the Senate intentionally excluded cultivated meat companies and supporters while allowing false claims from opponents of this sustainable food. We welcome the intention of the government to submit the law to the EU scrutiny, and we hope member states can voice their concerns regarding its potential violation of the single market,” said Gallelli. Local industry stakeholders also criticised the decision of Italy’s Chamber of
Francesco Lollobrigida has been Minister of Agriculture since October 2022.
Deputies. The Italian Alliance for Complementary Proteins, which brings together industry companies, researchers and non-profit associations stated: “This bill tells Italians what they can and cannot eat, stifles innovation, and likely violates EU law. It is truly disheartening that Italy will be excluded from a new jobcreating industry and barred from selling more climate-friendly foods. Once famous for pioneering world-changing innovations – Italian politicians are now choosing to go backwards while the rest L of the world moves forward.” t.gabrielczyk@biocom.eu
European Biotechnology | Winter Edition | Vol. 22 | 2023
Pesticide oligarchy GLYPHOSATE The European Commis-
sion will single-handedly authorise the herbicide active ingredient glyphosate in the EU for a further ten years. The authorisation until the end of 2033 was announced after the 27 EU member states failed to approve or reject this proposal by a qualified majority on the second attempt. According to legal experts, the German government now faces the problem that the ban on glyphosate-containing sprays in Germany, which comes into force on 1 January 2024, conflicts with the authorisation of the active ingredient under European law. A majority of EU member states voted in favour of the Commission’s authorisation proposal at the meeting of the Appeal Committee in mid-November. However, the 17 countries did not represent a qualified majority of 55% of the Mem-
ber States and 65% of the EU population. Italy, who originally voted for the Commission proposal, Germany, France, the Netherlands, Bulgaria, Belgium and Malta abstained. Austria, Luxembourg and Croatia rejected a renewed authorisation of the weedkiller that is potentially carcinogenic. According to the Commission, safety assessments carried out by the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) were ordered to develop guidelines in order to be able to assess possible indirect effects of glyphosate on biodiversity. The EFSA admitted during the authorisation process that there are data gaps in this area. It was also unable to conclusively clarify nutritional risks for consumers. In Germany, spraying of Bayer AG‘s glyphosate L is prohibited from 1 January 2024.
New EMA fees
Poor grades
EU FINANCE The European Council will
EU PHARMA LEGISLATION A study of
decide over a provisional new fee system for the European Medicines Agency in December. The switch from a flat-rateto a cost-based fee system has already been adopted by the EU Parliament’s ENVI committee, in mid-October. The new regulation foresees to establish a single legal instrument for pharmacovigilance and marketing authorisations. In addition to the annual inflation rate adjustments of fees, the EMA will be enabled to take fees for scientific advice and third party evaluations. Cost is expected to fall for market authorisations of veterinary medicines, while it is expected to become higher for medicines for human use. The new fee regulation is going to be set in force on January 1, 2025. For the market authorisation of a new biological, fees are going to amount to €732,400 plus remuneration costs of €296,200 for the rapporteur, €190,000 for the co-rapporteur and €24 300 for the PRAC-rapporteur.
consultancy firm Dolon commissioned by the EU Big Pharma interest group EFPIA estimates that the Commission’s reform of the pharmaceutical legislation will reduce the incentive for companies to invest in new medicines in Europe by 55% over the next 15 years. R&D investment would fall by a further third by 2040 due to worsened last-to-expire protection. According to the study, Germany (minus €626m/y), Belgium (–€381m) and France (–€326m) are among the countries most affected. The key driver of this negative impact is the shortened duration of regulatory data protection that may result in the loss of 45 new treatments for rare diseases per year. The Dolon modelling also suggests that heightened environmental requirements could halve the number of RDP-reliant medicines due to higher manufacturing costs. Additionally, the pharma companies say, the new stricter definition of the term “unmet medical need” would also impact competitive edge
Picture: © Ministero delle Politiche Agricole
8
La Your st Savi ng aim l !! C
al c i g e! ed! l o l a Bio Big Sually discuss o Sin End ill be individ r order w a e ulk Y B
ium ines Prems Cytok Clas
IL-6 IL-18
TNF-a
IL-21
Premium Class Cytokines – Save 20% Elevate Your Research With SEC-HPLC High Purity Cytokines Now – 31 December
RSV Products – Save 20% Antibody
Antigen
Applications in Therapeutic Antibody, Vaccine, and Immunodiagnostic Assay Development
Gene
Lysate
Now – 31 December
for all catalog products!
Academia Special Offer – 15% off Secure Your Research Funding for the Future Pre-Order & Credit Note Available! Now – 15 December
Sino Biological Europe GmbH
Düsseldorfer Str. 40, 65760 Eschborn, Germany
Tel: +49(0)6196 9678656 Email: order_eu@sinobiologicaleu.com
www.sinobiological.com
INSIGHT EUROPE
European Biotechnology | Winter Edition | Vol. 22 | 2023
EU following the US German Cultivated B is the first company in the world who applied for EU-Novel-Food authorisation at the European Food Safety Authority of a hotdog made from plant protein and cultivated pork muscle cells. C ELLULAR AGRICULTURE
German Cultivated B (Heidelberg) is the first company in the world that pre-registered a partially cell-based meat product with the European Food Safety Authority (EFSA) for approval as a novel food. In midSeptember The Cultivated B, a manufacturer of plant protein, pre-registered its hybrid product from plant protein and pork from cell culture, which was developed by The Plantly Butchers GmbH. Both companies are subsidiaries of the sausage manufacturer InFamily Foods, which since 2022 is responding to falling demand for meat and sausage products produced by its subsidiary The Family Butchers by adding culture-based protein products to its portfolio. The Finnish Solar Foods Oy was the first company that registered a single cell protein product at the EFSA. In October 2021 it submitted a dossier for application of the dried protein powder Solein® produced by an auxotrophic Campylobacter strain.
hybrid hot dog as “remarkable milestones for the entire European novel food sector. “This can serve as a model for other countries such as Germany so that it doesn’t run the risk of falling behind,” said Bogumil.
Slow Food
proval time is “well under 12 months,” according to Bogumil, which is why most alternative protein manufacturers are aiming for initial approval there. In order to give European producers of cell culture and microbial protein products an incentive to set up shop, the government of the Netherlands passed a regulation in this summer that allows tastings of fermenter-produced meat and seafood before EFSA approval (see European Biotechnology 3/2023). It only takes two weeks until approval for the tasting, which is important for manufacturers as pre-market test. One reason for the liberal regulation in The Netherlands is certainly that the development of cell-cultured meat began there. The cell-based burger developed by MosaMeat NV founder Mark Post at University Maastricht was offered for tasting in London back in 2013 – in a very small group and under restrictive conditions. Bogumil describes both the Dutch tasting regulation and the EFSA registration of the
Since the Solein safety assessment is expected to be published in April 2024, industry experts expect approval of the hybrid hot dog produced by The Cultivated B in specially developed bioreactors in 18 months at the earliest. Previous approval times for novel food products in the EU “are between 18 and, at worst, 48 months,” says industry expert Tanja Bogumil, CEO at Berlin-based Lovely Day Foods GmbH that produces vegan egg protein by precision fermentation. According to industry think tank Good Food Institute (GFI) Europe, EFSA’s testing of novel foods provides a thorough, evidence-based assessment of food safety and nutritional value. In Singapore and the US, where two cell cultured chicken meat products were recently approved, the ap-
The Cultivated B will produce the ingredients for its hybrid hot dog in Canada in scalable AUXO V™ bioreactors that can be operated by non-experts.
Not vegan at all Neither Mark Post’s cell-cultured burger nor The Cultivated B’s hot dog are vegan products – fetal bovine serum is often used in production but producers are working to replace FBS by defined synthetic growth media. The production of products decoupled from agriculture, however, is expected to save more than 70% CO2 and 65% water as well as a lot of agricultural land after having been scaled-up. According to Bogumil, as meat production reaches planetary limits, “a complete decoupling of meat production from agriculture” is L necessary. t.gabrielczyk@biocom.eu
Picture: © Shutterbug75 - pixabay.com
10
INSIGHT EUROPE
European Biotechnology | Winter Edition | Vol. 22 | 2023
A STEP beyond In light of the US$330bn US Inflation Reduction Act, Commission President Ursula von der Leyen in June promised to put €360bn in key strategic technologies including biotech. However, the planned STEP regulation was downsized to €10bn due to a lack of support by EU member states. A committee of the European Parliament has now proposed to increase the budget. INDUSTRY
At the beginning of October, the EU parliament’s committees on Industry, Research and Energy as well as the Committee on Budgets adopted the proposal to establish a “Strategic Technologies for Europe Platform (STEP)” to promote critical strategic technologies through various means such as financial support, the “Sovereignty Label” and the “Sovereignty Portal”
Give me all your money Additionally, they called for increase of the budget to €13bn from existing budgets on which the EU Council is set to decide until the end of the year: €1.5bn from the EU defence fund, €0.5bn from Horizon Europe that EVP member Christian Ehlers want to boost by €80bn, €3bn from the EU Invest programme and €5bn from the Innovation Fund. Co-rapporteur Ehlers said that €10bn is too poor to effectively support the active decarbonisation of the EU economy as established in new EU legislations, including the Critical Raw Materials Act (CRMA) and the Net-Zero Industry Act (NZIA). According to the European Parliament, biotechnology and bioprocess engineering are essential to keep Europe’s bio pharmaceutical development, agriculture and bioeconomy internationally competitive. If the benefits of biotechnology were fully utilised, the EU economy could grow in terms of priorities such as sustainable development, public health and environmental protection. The STEP platform would therefore “accelerate and improve access to finance for EU companies wishing to invest in biotechnologies”. Concrete funding initiatives are to focus on biomanufacturing, for example,
and thus stand up to the US initiatives of the IRA programme.
Biologisation of the EU industry According to the EU biotech association EuropaBio, biotechnology plays a key role in translating the fossil-based economy into a circular bioeconomy. They want to see the ‘EU Biotech and Biomanufacturing Initiative’ which EU Commission President Ursula von der Leyen’s mentioned in her State of the European Union address of 13 September come true. In its new “Rotterdam Statement”, EuropaBIO stressed that the EU must start with a bioproduction scale-up coupled with regulatory improvements such as an extension or the planned deregulation of new genomic techniques (NGTs) to microorganisms by Q4/2024. According to the paper “enabling regulation must be underpinned by coherent over-arching
European Parliament in Strasbourg
policy frameworks across industrial applications.” This requires re-positioning and connectedness across EU institutions. Additionally, a clear investment pathway from R&D to market access is required to scale up food-tech and industrial biotechnology in Europe, the Rotterdam Statement says, which was presented to more than 200 industrial biotech experts at this year’s EFIB in Delft. EuropaBio sees enzymes, microorganisms and living cells as an a key enabler of the EU’s transition from a fossil-based economy to a green and competitive bioeconomy in multiple sectors, including chemicals, pharmaceuticals, food, feed, fragrances, detergents, paper/pulp, textiles and bioenergy. The call on to create a climate which support European biotech companies in winning the global technology race in the industrial biotechnology sector in order to strengthen the EU’s straL tegic autonomy and food security. t.gabrielczyk@biocom.eu
Picture: © Diliff - wikipedia.org
12
Experience subcellular in situ from the single cell leader
10xgen.com/insitu
RUBRIK
European Biotechnology | Winter Edition | Vol. 22 | 2023
The death cap mushroom (Amanita phalloides) produces cell toxins that are now being tested in the clinic as ADCs. Results are expected soon.
Pictures: xxx
14
CANCER
European Biotechnology | Winter Edition | Vol. 22 | 2023
Cancer: Hit it with your best shot After decades of development, antibody-drug conjugates (ADCs) are increasingly making headlines, although the earliest authorisations were somewhat less successful than theory predicted. Researchers now finally appear to be mastering the interplay between antibody, linker and toxin. The next wave of ADCs is just around the corner T HERAPEUTICS
Picture: © Andre Suter-blubber.li - stock.adobe.com
W
hen the first antibodydrug conjugated cotherapy was approved, e u ph o ric o b s e r ve r s viewed it as a breakthrough. Modified ADCs loaded with a cytotoxic payload have long been a goal in the field. The initial hopes proved to be misplaced, however, and practical experience has since revealed that the fragile complex of a protein-chain antibody – usually coupled to a cytotoxin via a linker – interacts with the body’s physiology in ways that are still far from being sufficiently understood. If toxins detach from their antibody transport system too early and unspecifically, it can affect healthy cells and tissue close to the targeted tumour. This ‘collateral damage’ could mean high toxicity, and was a fundamental reason the first wave of approvals disappeared from treatment schedules. The first ADC to be approved back in 2000 was Mylotarg, which was pulled from the market in 2010 because death rates actually increased under medication. It was relaunched in 2017, but meaningful traction really only set in when the technology for each component improved and second-generation ADCs were introduced, among them Takeda’s Adcetris in Hodgkin lymphoma (2011) and Genentech/Roche’s toxin coupled variant of trastuzumab, Kadcyla (2013). Since then, clinical and com-
mercial wins have continued to rack up, including for programmes combining ADCs with checkpoint inhibitors (i.e. Padcev/Keytruda). The field of developers has subsequently split even more into those specialised in coupling the toxin to the anti body and those who test and optimise a range of cytotoxins from nature – or known chemotherapy cytostatics – in tissue-specific delivery to the tumour. A smaller fraction of companies and development projects in Big Pharma companies is focused on antibody variants, along with smaller fragments and their various modifications, to see whether they could be made even better at specifically delivering toxins to a desired target site, generally due to better penetration of tumour tissue.
Good ideas can take time But smaller antibody derivatives have not yet proven to be more successful than their larger cousins. Faster degradation rates and other pharmacokinetic dynamic factors could be reduced with a number of space-taking attachments, but this also appeared to reduce penetration into tumour tissue – a hoped-for advantage of smaller fragments. Experienced developers on the ADC front have now told European Biotech nology that the years of research have
helped to clarify many outstanding issues. Specialisation in linker technology and cytotoxins has brought a lot of progress, while many licensing deals and acquisitions can now be seen in the area. Some were the subject of discussion at major partnering events like BIO-Europe 2023, which took place this time around in Munich.
Deals that are making headlines The ADC space has heated up in a big way in the last few years. Over US$125bn in partnerships and M&A have been reported since 2019, including this year’s Pfizer US$43bn mega- acquisition of Seattle Genetics (Seagen) and a record US$5.5bn upfront deal between Merck (MSD) and Daiichi Sankyo. There are hundreds of assets across thousands of trials in the field in various indications. Eight approvals in the last five years (raising the number to 13 in total) have done more than crack open the door. Looking at pipelines and assets in later clinical phases, it seems more like a dam has broken. If you include the radiopharma space in the ADC landscape as well, as a closely related technology for delivering killing substances spatially in cancer, an overview of what is going on where becomes even more entangled. Active players in the ADC arena are depicted in the table on the next page.
15
CANCER
European Biotechnology | Winter Edition | Vol. 22 | 2023
But what is actually happening can only be explored here in part. That said, let’s look at some notable deals and individual companies that, although small, are trying to approach the area in sustainable ways. That’s a tough thing to do in an era when small companies are often swallowed up by Big Pharma before they even really get up and rolling. Eli Lilly,
for instance, seems to be buying everything that’s not nailed down at the moment. Its acquisition of Emergence Therapeutics has already caused a stir in the ADC space. No figures were given for the deal, but it can only be assumed that the sums involved are in the high tripledigit million range. The acquired FrancoGerman firm had a spectacularly short
independent life, with headline-grabbing start-up financing. Founded in 2019, Emergence Therapeutics really started to appear on industry radars at the end of 2021 with an impressive Series A financing round of US$94m (around €87m at the time). Initially founded in Marseille (France) and located in Duisburg (Germany), the company was able to bring
An incomplete (due to dynamics) list of European biotechnology and pharma companies active in the ADC space
Company
Country
Company
Country
› Valanx Biotech GmbH
Austria
› Philogen S.p.A.
Italy
› Precirix N.V.
Belgium
› Byondis B.V.
Netherlands
› UCB S.A.
Belgium
› Tagworks Pharmaceuticals B.V.
Netherlands
› Sotio a.s.
Czech Republic
› Nordic Nanovector ASA
Norway
› Adcendo ApS
Denmark
› Ryvu Therapeutics S.A.
Poland
› Genmab A/S
Denmark
› Genagon Therapeutics AB
Sweden
› Mablink Bioscience S.A.S. /Eli Lilly
France
› Immedica Group AB
Sweden
› OSE Immunotherapeutics S.A.
France
› Oncopeptides AB
Sweden
› Pierre Fabre Group
France
› Swedish Orphan Biovitrum AB
Sweden
› Sanofi
France
› ADC Therapeutics S.A.
Switzerland
› Seekyo Therapeutics Inc.
France
› Araris Biotech AG
Switzerland
› Servier
France
› Debiopharm Group
Switzerland
› Bayer AG
Germany
› GlycoEra AG
Switzerland
› BioNTech SE
Germany
› Lonza AG
Switzerland
› Boehringer Ingelheim GmbH
Germany
› Novartis AG
Switzerland
› Emergence Therapeutics AG/Eli Lilly
Germany
› Roche
Switzerland
› Glycotope GmbH
Germany
› Abzena Ltd.
United Kingdom
› Heidelberg Pharma AG
Germany
› Almac Group Ltd.
United Kingdom
› ITM Isotope Technologies Munich SE
Germany
› AstraZeneca plc
United Kingdom
› medac GmbH
Germany
› Avacta Group plc
United Kingdom
› Merck KGaA
Germany
› BiVictriX Therapeutics plc
United Kingdom
› Tubulis GmbH
Germany
› Cancer Research UK
United Kingdom
› Veraxa Biotech GmbH
Germany
› Elasmogen Ltd.
United Kingdom
› Mundipharma International Ltd.
Ireland
› GSK plc
United Kingdom
› Biond Biologics Ltd.
Israel
› Hikma Pharmaceuticals plc
United Kingdom
› Nectin Therapeutics Ltd.
Israel
› Iksuda Therapeutics Ltd.
United Kingdom
› Teva Pharmaceutical Industries Ltd.
Israel
› NanoMab Technology Ltd.
United Kingdom
› MediaPharma S.r.l
Italy
› Oxford BioTherapeutics Ltd.
United Kingdom
› Menarini Group
Italy
› Pheon Therapeutics Ltd.
United Kingdom
Source: ©Biocentury´s BCIQ
16
European Biotechnology | Winter Edition | Vol. 22 | 2023
The better way to DNA!
numerous French investors on board, but also attracted Rhineland-based investors like NRW.BANK, High-Tech Gründerfonds and Gründerfonds Ruhr in addition to French investors such as Kurma Partners and Bpifrance. Its single asset and target-specific approach led investors to throw money at Emergence, and encouraged Eli Lilly to buy it. The startup’s most mature candidate (ETx-22) targets Nectin-4, a membrane surface protein commonly found on malignant cells but rarely expressed by healthy cells. This antigen has recently been clinically validated by the approval of Astellas and Seagen’s Padcev (enfortumab vedotin), another ADC that targets Nectin-4 for urothelial cancer. In October 2021, Emergence obtained the rights to develop the novel compound using Mablink Bioscience’s proprietary PSARlink druglinker technology. Using the proprietary linker and payload technology, Emergence was developing ETx-22 to be a next-generation, Nectin-4-targeting ADC that can deconjugate from tumour cells and thus reduce side effects such as skin toxicities, which is particularly dose-limiting for Padcev. According to the company, the technology allows for higher doses of ETx-22, thereby increasing its efficacy without triggering more safety concerns. Eli Lilly’s next acquisition in the space seemed like a no-brainer: the US pharma
High Quality Grade Plasmid & Minicircle DNA
bought French firm Mablink Biosciences, which can obviously add value to asset companies by providing a specific linker technology. Once again, numbers in the acquisition have been kept secret until final approval by different state legislatures – expected in a few weeks – is given. But guesses are that the purchase will surpass the Emergence deal, as Mablink’s PSARlink™ is a multipurpose innovative hydrophilic linker using a polysarcosine arm, and could potentially broaden the therapeutic index of many ADCs to come, unleashing their full therap eutic impact.
Customized High Quality Grade DNA for GMP production of viral vectors, RNA and CAR-T cells QC including CGE service pDG/pDP plasmids for AAV production 2 plasmid system Serotypes including AAV8 & AAV9 GFP transfer plasmids
More in the linker space Other linker companies are also very much in the spotlight. German-based Tubulis for example, with founders from Berlin and Munich based at the Martinsried IZB start-up centre, was able to enjoy spectacularly high financing rounds (especially for Germany) with €60m from VCs like Andera Partners, Seventure Partners, BioMedPartners, Occident and others, but also preclinical drug developer Evotec SE from Hamburg in 2022. This may be due to the small company’s goal: maximising the overall performance of ADCs. Company CEO Dominik Schumacher characterises their vision as a “mission to address the main bottlenecks in the field and innovate the ADC from
ITRRESCUETM In Stock service
Ask for
GMP grafeting gmbh | stock.adobe.com
Picture: ©Tubulis GmbH
Different linkage technologies promise different results
PlasmidFactory.com PlasmidFactory GmbH Meisenstraße 96 | 33607 Bielefeld Germany | +49 521 2997 350
European Biotechnology | Winter Edition | Vol. 22 | 2023
A fine pen with 5 km writing performance. The body is made from biotechnologically produced biopolymers – fully compostable in the garden. Made in Europe Available for 3 EUR exclusively at the
biospheria.shop/en
BIOMATEC®
all sides, not only the linker. The linker is a core element of the ADC and the efficient binding between chemical agent and antibody is an important step in creating improved ADCs,” he adds. “But focusing on the linker alone is not sufficient to realize the full potential of ADCs. This is the reason we also focused on improving the payload and the antibody early in the evolution of Tubulis.” The firm’s technology platform, with expertise and know-how extending to both ends of the linker – payload and antibody carrier – has not only sparked interest among venture capitalists, but is also the foundation stone for a huge collaboration deal closed earlier this year with Bristol Myers Squibb. In addition to the deal’s upfront payment of US$22.75m, future instalments totalling up to US$1bn could come if different milestones are reached. The partnership gives BMS exclusive access to Tubulis’ proprietary P5 conjugation platform and tubutecan payloads for the development of a selected number of versatile and customisable antibody drug conjugates for cancer therapy. The platform enables the generation of ultra-stable ADCs that have the potential to actively reduce unwanted off-target toxicities and are optimised for the targeted delivery of potent topoisomerase-1 inhibitors – sought-after candidates after the billion-dollar Merck/ Daiichi Sankyo deal. The Japanese company brought this class of toxins via ADC to approval, and have several more in late-stage clinical testing. Others are now looking for assets and technology to grab at least a slice of the pie in the topoisomerase-1-inhibition race. Tubulis’ new partner Bristol Myers Squibb (BMS) will assume sole responsibility for the development, manufacturing and commercialisation of any resulting ADC candidates. “This strategic agreement with BMS is an important validation of the potential of our approach in developing next-generation ADCbased therapeutics and our cutting-edge ADC conjugation technologies that accommodate advanced ADC design to tackle tumours with high unmet medical need,” said Schumacher, adding that
“collaborations and partnerships are part of our business model and we will continue to explore opportunities that fit into our strategic development plan. We have built a broad suite of proprietary technologies that allow us to combine different antigen-binding molecules, linkers and payloads with unprecedented stability. This enables us to open completely new avenues to apply ADCs, and provides us with a significant level of flexibility.”
CDMOs in the house A lot depends on the parameters of a specific linker technology, and being a technology company makes it easier for a larger corporate to pick up and integrate a firm into its own portfolio. A rather remarkable deal in this area was made by CDMO Lonza in the ADC space. The Swiss company recently bought Synaffix, a company with expertise in linker technology, in order to explicitly extend its well-known production expertise as a CDMO to the ADC area. It even wants to become a kind of one-stop shop for developers of antibody drugs who are considering achieving an even greater tissue-specific effect with an additionally coupled cytotoxin and/or at the same time looking to convince investors with a product variant. Lonza could thus step out of the production partner segment, placing one foot in a new area as a development partner and acquiring its own (purchased) expertise in drug conjugation. In the words of Lonza, the new addition of the Dutch firm to the portfolio – different award-winning platforms in linkerconjunction with sugar – will combine Lonza’s development and manufacturing capabilities with the Synaffix ADC technology platform and “will provide customers and licensees with a comprehensive service to rapidly discover, develop, scale-up and commercialise novel and differentiated ADCs.” These enhanced capabilities are meant to streamline the path to clinic and commercialisation. Whether Lonza will add further ADC building blocks to its portfolio is still up in the air – as is the strategy of shifting a contract manufacturing business’ focus to an early
European Biotechnology | Winter Edition | Vol. 22 | 2023
stage in drug design, offering added value. Will it find resonance in the community and with customers and manufacturers? Only time will tell.
What you link is what you get Like the ‘linkers’, the field of ‘cyto toxers’ has also broadened considerably. Approved drugs are spread out over a range, but four out of 13 of them carry monomethyl auristatin E or F (MMAE or MMAF). Those are toxins that inhibit cell division by binding to tubulin dimers and disrupting the microtubule network. Two approved ADCs that use inhibitors of topoisomerase-1 have opened a new path for payload attractiveness, and topoisomerase-2 is also in the crosshairs. What comes next? Will it turn out to be nothing more than playing with Legos? Clicking together the ADC components of choice, then hitting the clinic? Another German company that has been active in this field for long time, Heidelberg Pharma AG, has pointed out that despite the seemingly modular nature of ADC components – antibody, toxin, linker – what’s decisive is the resulting molecule as a whole. Its physicochemical and pharmacological properties are not just the sum of the individual pieces. They can’t be reliably predicted beforehand, and can only be fully understood through testing and analysis. That is the
most time-consuming aspect of drug development in any area, as laboratory and in vivo models provide only an approximation of the disease and drug effects in patients, and the physiology of humans can only be understood in humans. Andreas Pahl, CSO at Heidelberg Pharma (HDP), explained his company’s strategy as aiming not only to be expert with individual ADC components like linkers, antibodies or cytotoxic payloads, but as positioning itself as a drug development company with substantial ADC expertise. The ADC field is becoming increasingly competitive as Big Pharma acquires many technologies or entire companies in the area. By adding this know-how to their pipelines and combining it with their clinical and disease expertise as well as extensive resources, they are usually able to bring drug candidates to approval more frequently and faster than a single-asset company.
Clinical proof is within sight Although the area sees busy Big Pharma entering at various stages, Pahl sees advantages for smaller companies like Heid elb e r g Phar ma wit h a growing pipeline: if they can deliver the research and development expertise built up over years and decades to the ADC space at just the right time. And he sees the time as ripe for yet another payload
CANCER
that has been in development for a long time and is ready to top up the toolbox once the run for topoisomerase inhibitors has cooled down: RNA-polymerase II inhibitors, like alpha-amanitin, derived from the death cap mushroom (Amanita phalloides). “If it takes that long, everyone thinks you have problems. But even Daiichi took 15 years before the breakthrough came. At HDP, we are now right on the cusp of being able to deliver this clinical data for our lead programme in the next half year,” he told European Biotechnology. Pahl added: “We are entering the right time window for our ADCs and we have built up very good patent protection for Amanitin and the respective biomarkers for many years to come. Yes, we are a ‘single player’ with this payload, which is always a risk. But our first-in-human trial, which is currently in the dose-finding phase, has been going well and we are already receiving expressions of interest from pharma. So it’s really very exciting at the moment.” Everything depends on data from the clinic. Dominik Schumacher, with a preclinical pipeline at Tubulis, is aware of this: “Our main focus,” he emphasised, “is currently to further advance our pipeline of ADC candidates towards clinical evaluation.” Even with help from others: Oncoteq AG (Switzerland) just entered a global partnership on a CD30-ADC from Tubulis. L g.kaeaeb@biocom.eu
19
FINANCIAL MARKETS
European Biotechnology | Winter Edition | Vol. 22 | 2023
Encouraging signs in a tough year for European biotech Continuing geopolitical uncertainty has perpetuated volatility in global markets, exacerbated by higher inflation and interest rates. The impact has left the biotech market in a limbo as investors eschew riskier investments, but there are signs of a potential recovery ahead.
CHRIS MAGGOS, MANAGING DIRECTOR OF COHESION BUREAU
Following t he COVID -19 boom, general uncertainty has had a lasting deleterious impact on biotech assets. The Nasdaq Biotechnology index is down 9% as of late November, underperforming the wider market, and compared to a loss of 10% in 2022. The IPO window for European biotech remains mostly closed, but with exceptions. Yet there are encouraging signs for the industry and, accordingly, for investors. Big Pharma’s pockets are well filled thanks to recent blockbuster earnings from treatments for diseases like COVID-19, metabolic disorders, cancer, and others. But their pipelines don’t look quite as exciting as they might – so there is both financial scope and motivation for acquisitions and licensing of biotech assets.
Some more of those positive indications: the UK biotech sector raised £563 million in venture capital and public financings in Q3 2023, according to data from Biotech Finance. That’s an increase of 48% from the previous quarter and is the strongest period since the historical highs of 2021. In November, VectorY Therapeutics completed one of the largest private biotech rounds in Europe this year, with a €129m Series A financing. In the European pharmaceutical industry, there were 83 M&A deals announced in Q3 2023, worth a total of $10.7bn, which is 102% higher than Q3 2022, according to GlobalData. The $5.7bn acquisition of Abcam by Danaher was the largest disclosed deal.
At recent industry conferences, notably the recent BIO-Europe partnering event, discussions indicated that large pharmaceutical companies now believe that rights to most late-stage assets have been acquired or are over-priced. As a result, we can expect these companies to start using their large cash reserves on buying in earlier stages, i.e. before clinical proof of concept, to address areas of increasing medical need. Case in point, Boehringer Ingelheim has announced this November the acquisition of privately-held Swiss biotech T3 Pharmaceutical for CHF 450m. This evidence of Big Pharma shopping for assets has historically encouraged investors, in turn, to speculate on which small biotech companies might be most attractive to acquirers, thus driving increased investment and potentially a new wave of financings in biotech. L
News from the floor Abivax SA Abivax SA’s debut on the US market received a somewhat mixed reception at the end of October, as the firm priced on the low end of its proposed range and ended the first day of trading in the red. But the company managed to pull in about $235.8m in gross proceeds, the majority of which will support late-stage efforts for obefazimod, an oral candidate with a novel mechanism of action it hopes to advance in the lucrative inflammato-
ry bowel disease space. In 2015, Abivax launched what was then Europe’s largest biotech initial public offering (IPO) when it raised €57.7m by offering its first openly traded shares on the Euronext Paris exchange. BioNTech SE The German vaccine maker is turning back to cancer and forwards to the ADC-space (see also pages 14f) in closing several deals with partners in China. BioNTech is paying MediLink
Therapeutics US$70m upfront for rights to an ADC that targets human HER3 and is rivaling frontrunner Daiichi Sankyo. Just a few months before, the company from Mainz signed a global strategic partnership with DualityBio from Shanghai for two investigational ADCs directed against general cancer targets. Here the upfront payment totalled US$170m, but could end in the commercial setting with over US$1.5bn. L
Picture: © Cohesion Bureau
20
FINANCIAL MARKETS
European Biotechnology | Winter Edition | Vol. 22 | 2023
COMPANY
QUOTE
M-CAP
52 WEEKS INDICATOR low high
COMPANY
QUOTE
M-CAP
2cureX AB
206.0
3,600k
Biosergen AB
1.22
49,200k
4SC AG
7.35
74,800k
Biotage Sweden AB
11.11
896,900k
AB Science SA
2.82
141,500k
Bioventix plc
43.60
224,500k
Abcam plc
20.79
4,355,100k
Biovica International AB
0.25
10,100k
Abionyx Pharma SA
1.24
42,000k
Bioxxmed AG
0.57
2,800k
Abivax SA
9.50
608,900k
Bivictrix Therapeutics plc
0.10
8,500k
Ablivia AB
0.03
23,000k
Brain AG
3.50
77,600k
AC Immune SA
2.74
232,900k
C4X Discovery Holdings plc
14.42
37,900k
Acticor Biotech SA
3.76
46,000k
Calliditas Therapeutics AB
8.15
477,300k
Active Biotech AB
0.03
8,400k
Camurus AB
39.14
2,190,000k
Adaptimmune Therapeutics plc
0.43
105,600k
Cantargia AB
0.30
50,100k
ADC Therapeutics SA
0.64
61,300k
Carbios SAS
20.70
355,300k
Addex Therapeutics Ltd
0.05
3,800k
ADL Bionatur Solutions SA
0.41
24,200k
Adocia SAS
8.30
113,000k
Advicenne SA
1.87
22,100k
Aelis Farma SAS
13.20
165,000k
Affimed NV
0.46
64,900k
Akari Therapeutics plc
2.82
16,300k
ALK-Abelló A/S
12.42
2,520,000k
Alkermes plc
22.40
3,740,000k
Allarity Therapeutics A/S
0.48
2,200k
Alligator Bioscience AB
0.03
20,700k
Altamira Therapeutics Ltd
0.14
1,300k
Alvotech SAS
8.64
2,310,000k
Alzinova AB
0.23
10,600k
Amniotics AB
0.0
500k
Annexin Pharmaceuticals AB
0.06
6,000k
52 WEEKS INDICATOR low high
European Biotech Stocks The unique and most complete list of share price developments of biotech companies listed in Europe – exclusively in European Biotechnology Magazine. COMPANY
QUOTE
M-CAP
Aprea Therapeutics AB
3.41
13,600k
Cellectis SA
2.60
186,100k
Aqua Bio Technology ASA
0.23
10,900k
Cellink AB
4.42
322,500k 163,600k
Arctic Zymes Technologies ASA
3.44
174,700k
Celon Pharma SA
3.21
Arecor Therapeutics plc
2.08
61,000k
Celyad Oncology SA
0.34
13,100k
Argenx BV
452.10
26,600k,000
Centessa Pharmaceuticals plc
6.10
659,000k
Arix Bioscience plc
1.27
164,300k
Centogene NV
1.07
30,700k
Arocell AB
0.04
8,900k
Cline Scientific AB
0.02
800k
Arterra Bioscience SpA
1.58
10,600k
Co.don AG
0.03
500k
Asarina Pharma AB
0.07
1,500k
Coegin Pharma AB
0.02
200k
Ascelia Pharma AB
0.25
8,300k
CombiGene AB
0.22
4,400k
Ascendis Pharma A/S
84.25
4,690,000k
Cosmo Pharmaceuticals NV
42.50
693,300k
Autolus Therapeutics plc
4.38
754,600k
CRISPR Therapeutics AG
62.50
5,040,000k
Avacta Group plc
162.21
461,700k
CSL Ltd
153.70
75,410,000k
Avadel Pharmaceuticals plc
10.50
801,300k
Curevac NV
5.09
1,110,000k
Axichem AB
0.59
12,600k
Cyxone AB
0.0
800k
Basilea Pharmaceutica AG
36.88
439,300k
DBV Technologies SA
1.56
150,600k
Bavarian Nordic A/S
21.46
1,672,900k
Destiny Pharma plc
0.82
78,100k
Bergenbio ASA
0.01
35,400k
Diagonal Bio AB
0.03
1,500k
Bicycle Therapeutics plc
12.70
381,300k
Diamyd Medical AB
0.65
53,400k
Bioarctic AB
20.42
1,500k,000
Diasorin SpA
88.32
4,710,000k
Biocartis NV
0.29
27,200k
DMS Imaging
0.02
25,300k
Bioextrax AB
0.27
7,200k
e-Therapeutics plc
0.11
64,200k
Biofrontera AG
0.48
30,700k
Elicera Therapeutics AB
0.41
8,400k
Biogaia AB
9.32
902,800k
Ellen AB
0.09
400k
Bioinvent International AB
1.32
87,700k
Enzymatica AB
0.34
56,200k
Biomed-Lublin SA
1.03
72,600k
Epigenomics AG
0.48
400k
Biomérieux SA
98.74
11,700k,000
Erytech Pharma SA
4.22
25,700k
BioNTech SE
90.60
21,610,000k
Eurobio Scientific SA
16.88
179,300k
Biophytis SA
0.01
5,600k
Eurocine Vaccines AB
0.01
200k
Bioporto Diagnostics A/S
0.33
125,900k
Eurofins Scientific SE
53.64
10,200k,000
BioSenic SA
0.04
6,400k
Evaxion Biotech A/S
0.79
22,400k
52 WEEKS INDICATOR low high
21
22
FINANCIAL MARKETS
COMPANY
QUOTE
European Biotechnology | Winter Edition | Vol. 22 | 2023
M-CAP
Evgen Pharma plc
0.0
1,000k
Evolva SA
0.86
3,900k
Evotec SE
18.61
52 WEEKS INDICATOR low high
COMPANY
QUOTE
M-CAP 84,300k
MDxHealth SA
3.09
Medesis Pharma SA
0.87
3,900k
3,220,000k
Medigene AG
1.58
37,100k 177,800k
Expres2ion Biotech Holding AB
0.09
4,700k
Medincell SA
6.09
Faron Pharmaceuticals Oy
3.05
210,800k
Medivir AB
0.02
1,500k
Fermentalg SA
0.27
11,100k
Mendus AB (Immunicum AB)
0.05
33,700k
Merus BV
21.80
1,210,000k
Metabolic Explorer SA
0.48
23,300k
1.19
80,900k
Fluicell AB
0.07
2,000k
Formycon AG
61.60
988,000k
Fusion Antibodies plc
3.72
2,400k
Mithra Pharmaceuticals SA Modus Therapeutics Holding AB
0.15
2,500k
Molecular Partners AG
4.10
133,600k 598,000k
Gabather AB
0.21
1,900k
Galapagos NV
34.06
1,240,000k
Genedrive plc
0.08
8,300k
Morphosys AG
17.0
Geneuro SA
0.93
24,500k
Nabriva Therapeutics plc
1.25
4,000k
Genfit SA
3.01
149,800k
Nanobiotix SA
5.27
243,500k
Genflow Biosciences plc
0.02
5,400k
Newron Pharmaceuticals SpA
4.98
89,000k
GENinCode plc
0.07
6,300k
Nextcell Pharma AB
0.23
7,800k
Genmab A/S
288.80
18,390,000k
NFL Biosciences SA
1.60
12,500k
Genomic Vision SA
0.0
600k
Nicox SA
0.40
19,300k
Genovis AB
4.04
264,500k
Niox Group
0.70
294,500k
Genoway SA
4.08
37,100k
NLS Pharmaceutics AG
0.41
12,100k
Gensight Biologics SA
0.52
33,500k
Nordic Nanovector ASA
0.11
25,900k
Novacyt SA
0.61
52,100k
Novozymes Biopharma DK A/S
48.72
10,821,700k
Gentian Diagnostics AS
3.26
49,000k
Genus plc
23.42
1,520,000k
Global Bioenergies SA
1.91
35,400k
Nucana plc
0.38
23,900k
Glycorex Transplantation AB
0.23
5,900k
Nykode Therapeutics ASA
1.67
521,400k
Guard Therapeutics International AB
0.0
2,000k
ObsEva SA
0.04
3,700k
Hansa Biopharma AB
0.19
9,900k
Okyo Pharma Ltd
1.38
41,500k 14,800k
HBM Healthcare Investments AG
180.60
1,260,000k
Oncimmune Holdings plc
0.20
Heidelberg Pharma AG
2.79
126,300k
Oncoarendi Therapeutics SA
0.85
14,300k
Hemogenyx Pharmaceuticals plc
0.03
42,700k
Oncopeptides AB
0.72
65,200k
Herantis Pharma Oyj
1.50
15,800k
OncoZenge AB
0.29
3,400k
Hofseth Biocare ASA
2.70
93,200k
Open Orphan plc
0.21
138,800k 27,400k
Hookipa Biotech AG
0.47
40,400k
Optibiotix Health plc
0.30
Hybrigenics SA
0.01
3,200k
Orphazyme A/S
0.10
3,600k
Idorsia Ltd
1.76
331,800k
Oryzon Genomics SA
2.01
117,800k 89,100k
Immatics NV
7.79
607,000k
OSE Immuno SA
4.30
Immunic AG
0.92
44,200k
Ovoca Bio plc
0.0
300k
Immunovia AB
0.22
9,200k
Oxford Biodynamics plc
0.34
67,200k
Immupharma plc
0.02
416,400k
Oxford Biomedica plc
2.24
216,800k
Index Pharm. Holding AB
0.0
1,100k
Oxurion NV
0.0
3,100k
Infant Bacterial Therapeutics AB
0.66
8,500k
Paion AG
0.32
2,600k 56,700k
InflaRx NV
1.35
76,600k
Pangaea Oncology SA
1.86
Innate Pharma SA
2.28
184,600k
PCI Biotech Holding ASA
0.23
8,100k
Integragen SA
1.03
6,900k
Pharma Mar SA
38.50
703,400k
Intervacc AB
0.53
41,800k
Pharming Group NV
1.07
709,600k
Inventiva SA
3.71
198,500k
Pharnext SA
0.0
3,909
IO Biotech Inc.
0.99
72,000k
Photocure ASA
4.30
116,500k
IRLAB Therapeutics AB
0.59
31,200k
Physiomics plc
0.02
2,300k
Isofol Medical AB
0.05
8,900k
Pieris Pharmaceuticals Inc.
0.20
19,600k
ISR Holding AB
0.22
13,400k
Plant Advanced Technologies SA
7.45
8,100k
Kancera AB
0.30
25,600k
PolyPeptide Laboratories (Sweden) AB
19.55
645,700k
Kuros Biosciences AG
3.93
147,700k
Polyphor AG
0.05
2,900k
Lipigon Pharmaceuticals AB
0.02
2,100k
Poolbeg Pharma plc
0.10
51,000k
Lipum AB
0.71
6,600k
Poxel SA
0.37
12,700k
Lytix Biopharma AS
0.51
20,800k
Predilife SA
5.85
21,400k 212,500k
MaaT Pharma SA
6.24
72,300k
Probi AB
18.50
Mabion Ltd
4.26
74,500k
Promore Pharma AB
0.0
300k
Mainz Biomed BV
1.03
18,000k
ProQR Therapeutics BV
1.33
110,000k
Marinomed Biotech AG
34.40
51,200k
Prostatype Genomics AB
0.01
800k
52 WEEKS INDICATOR low high
FINANCIAL MARKETS
European Biotechnology | Winter Edition | Vol. 22 | 2023
COMPANY
QUOTE
M-CAP
52 WEEKS INDICATOR low high
COMPANY
QUOTE
M-CAP
Theradiag SA
1.40
18,300k
Theranexus SA
1.18
9,300k
65.12
46,000k 48,500k
Proteome Sciences plc
0.05
14,200k
Prothena Corporation plc
30.40
1,630,000k
Pure Biologics SA
2.19
7,000k
Tissue Regenix Group plc Tiziana Life Sciences plc
0.47
TME Pharma NV
0.34
1,900k
Transgene SA
1.45
144,800k
Q-Linea AB
0.27
33,500k
Qiagen NV
37.36
8,570,000k
Quantum Genomics SAS
0.08
3,600k
Redx Pharma plc
0.28
108,900k
Trinity Biotech plc
0.34
13,500k
Relief Therapeutics Holding AG
1.97
21,800k
Ultimovacs ASA
10.31
347,600k
Reneuron Group plc
0.04
2,300k
uniQure NV
6.25
295,000k
Ryvu Therapeutics SA
13.08
302,400k
Vaccibody AS
1.61
531,500k
Saniona AB
0.60
36,500k
Valbiotis SAS
5.78
10,200k
Santhera Pharmaceuticals AG
9.34
98,700k
Valerio Therapeutics
0.17
27,000k
Sareum Holdings plc
0.69
49,200k
Valirx plc
12.65
843,600k
Scancell Holdings plc
0.11
103,900k
Valneva SE
5.40
725,500k
Scandion Oncology A/S
0.15
5,900k
VectivBio AG
15.74
972,000k
Selvita SA
13.26
243,400k
Verici Dx plc
0.12
20,400k
Sensorion SA
0.44
88,700k
Verona Pharma plc
12.15
938,400k
SenzaGen AB
0.64
15,600k
Vicore Pharma Holding AB
1.32
147,300k
Shield Therapeutics plc
5.90
46,100k
Virax Biolabs Group Ltd
0.23
3,300k
Silence Therapeutics plc
10.60
370,000k
Virogates A/S
1.01
3,700k
Simris Alg AB
0.0
4,100k
Vita 34 AG
4.0
67,300k
Skinbiotherapeutics plc
22.38
42,600k
Vivoryon Therapeutics AG
4.0
185,400k
Softox Solutions AS
0.30
3,100k
WntResearch AB
0.01
3,500k
Sophia Genetics SA
3.47
237,000k
X4 Pharmaceuticals Inc.
0.72
123,000k
Sprint Bioscience AB
0.18
12,100k
Xbrane Biopharma AB
1.37
37,300k
Stayble Therapeutics AB
0.02
700k
Xintela AB
0.02
6,400k
Summit Therapeutics plc
1.87
1,310,000k
Xlife Sciences AG
39.90
212,800k 113,300k
Swedish Orphan Biovitrum AB
21.98
7,500k
Xspray Pharma AB
4.99
SynAct Pharma AB
0.57
20,100k
Yourgene Health plc
0.03
no data
Synairgen Research Ltd
0.08
15,200k
Zealand Pharmaceuticals A/S
24.38
1,260,000k
Targovax ASA
0.61
4,400k
52 WEEKS INDICATOR low high
All quotes are listed in Euro. All data is provided without guarantee. The effective date is 27th November 2023. These Europe-based biotech companies are traded on European stock markets.
How do I find a new job or a new employee? Now, there is an easy solution: eurobiotechjobs.net, the Europe-wide job market for biotechnology and the life sciences. Presented by the European Biotechnology Network.
23
24
REGULATORY AFFAIRS
NEWS Dual attack on cancer Immune-oncology drug developer Cytovation ASA has reported positive initial data from Part 2 of its Phase I/IIa CICILIA basket trial with all study endpoints met. In heavily pretreated patients with advanced and metastatic solid tumours CyPep-1 showed no dose-limiting toxicities and early signs of efficacy. CyPep-1 combines inhibition of the Wnt/beta-catenin pathway with tumour-specific cell destruction and immune activation through neoantigen release and in situ vaccination.
Fighting AMR In October, phage-based antibiotics specialist Phaxiam Therapeutics SA hat got the green light by the French regulatory authority ANSM to conduct a Phase I safety study with PP1493 and PP1815 in endocarditis infections caused by S. aureus.
Better bladder Munich-based CatalYm GmbH has dosed the first patient in a Phase II trial of its anti-GDF-15 antibody visugromab in patients with muscle-invasive bladder cancer. The observational study builds on the ongoing GDFather-2 study (NCT04725474) in metastatic bladder cancer.
Good response rate Cantargia AB’s IL1RAP-binding antibody nadunolimab achieved a an overall response rate of 50% in 12 patients with triple-negative breast cancer. Preliminary results of an ongoing Phase Ib trial were presented at the ESMO 2023 in Madrid.
European Biotechnology | Winter Edition | Vol. 22 | 2023
Update of ongoing clinical trials MYELODYSPLASTIC SYNDROME
Faron Pharmaceuticals Ltd (Turku, Finland), has announced to start Phase II testing of its anti-Clever-1 antibody bexmarilimab plus standard of care in hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndromes (MDS). The company will enrol up to 32 patients in Finland and the US to assess the safety and efficacy of bexmarilimab in patients with aggressive myeloid leukaemias. Patients will be randomised 1:1 between the selected recommended doses for expansion (RDE) of 3 mg/ kg or 6 mg/kg bexmarilimab before moving into a Phase II/III extension of the study. Data from the first 20 patients (10 per group) will be reviewed for exposure benefit for the two selected dose levels. Following the selection of a final dosing, Faron intends to discuss a potential registrational study plan with the FDA. In previous studies, bexmarilimab produced a 50% remission rate in doublet dose cohorts. Eight out of 11 patients achieved complete remission in the bone marrow. The highest overall response rate (ORR) of 80% was observed among the previously failed HMA MDS group (4 out of 5 patients). SOLID TUMOURS
Testing different dose levels of its adoptive cell therapy BNT 221-01, a combination of Claudin 6 (CLDN6)-targeted Car-T cells (derived from NEO-PTC-01, initially developed by BioNTech SE’s subsidiary Neon Therapeutics) and the mRNAbased Car-T booster CarVac (CAR-T cell amplifying RNA vaccine), BioNtech reported acceptable safety and tolerability data and first hints to efficacy in solid tumours at the ESMO conference at in Madrid at the end of October. 38 patients, most of which with ovarian cancer (14) and with germ cell tumours (11) were treated. Treatment emergent adverse events (TEAEs) above grade 3 were observed in 23 patients (61%), including 20 (53%) with TEAEs related to CART cells. From 21 patients treated with
the combination, nine (43%) had TEAEs above grade three related to both drugs, and two (10%) to CARVac. Related TESAEs were observed in eight patients (21%). Dose limiting toxicities (DLTs) occurred in two patients from different cohorts, grade 4 cytokine release syndrome (CRS) at 5×108 CAR-T cells and grade 4 pancytopenia at 1×10 8, hence a maximum tolerated dose (MTD) could not be determined. One death was assessed as treatment-related after the data cut-off. However, cytokine-release syndrome, which generally occurs in patients treated with Car-T cell therapy, was predominantly (95%) grade 1 or 2 and observed in 18 (47%) patients. It is still too early to assess the efficacy. However, 28 efficacy-evaluable patients, 9 patients (32%) showed a partial response and a further nine had stable disease ([SD], so theoretically the unconfirmed overall response rate [ORR] would be 32%, the disease control rate [DCR]: 64%. Of 19 patients treated with a higher dose of Car-T cells, eight showed partial response and further eight stable disease resulting in an unconfirmed ORR of 42% and a disease control rate of 84%. CAR-T expansion was dose-dependent, with improved persistence by addition of CARVac. MULTIPLE MYELOMA
Barcelona-based IDP Pharma SA has kicked off a not blinded Phase I/II study with its myc-targeted compound IDP121-001 in patients with the cMyc-driven haematological malignancy multiple myeloma. The cMyc oncogene is activated in 70% of all tumours. IDP-121 is designed to impair cMyc protein function and selectively degrade the target. The selective peptidomimetic acts by simultaneously obstructing the formation of the cMyc/Max complex while augmenting cMyc degradation through the intrinsic cellular machinery. According to the Catalan drug developer, future trials will include solid tumours in combination with standard of care therapies.
European Biotechnology | Winter Edition | Vol. 22 | 2023
DUCHENNE DYSTROPHY
Swiss Pharma giant Roche AG‘s shares fell by 5% after the company missed reaching the primary endpoint of improvement in functional motor abilities in a post-approval confirmatory Phase III trial with its Duchenne muscular dystrophy (DMD) gene therapy delandistrogene moxeparvovec in boys who can walk aged 4-7 years. In the study, the gene therapy licenced from Sarepta Therapeutics Inc improved 2.6 points on their NSAA total score 52 weeks after treatment, compared to 1.9 points in placebo-treated patients (n=125). Peak sales of the gene therapy were predicted by Global Data analysts to reach US$5.9bn. In all pre-specified, timed functional key secondary endpoints, time to rise from floor and 10 metre walk test, clinically meaningful and statistically significant improvements were observed. Both endpoints are prognostic factors for disease progression and loss of ability to walk. Additionally, a clinically meaningful and statistically significant improvement was also observed for the pre-specified secondary endpoint stride velocity 95th centile that measures speed of walking via a wearable device. The companies said that all data will be further analysed and will be discussed with health authorities to determine the path forward. KIDNEY DAMAGE
showed zero staining intensity, indicating that C3 deposits were cleared. Excessive deposition of C3 breakdown products in the kidney lead to inflammation and damage of the kidney, often causing kidney failure. PROGRESSIVE MS
In mid-October, Immunic AG in Martinsried reported interim results from its ongoing Phase II CALLIPER study of the Nurr1 activator vidofludimus calcium in patients with progressive multiple sclerosis. The data from half of the 203 patients recruited after 24 weeks – particularly with regard to the biomarkers of the serum neurofilament light chain (NfL) and the acidic gliaprotein (GFAP) – give hope that the effect of vidofludimus calcium surpasses that of ocrelizumab (Roche AG). The Roche antibody is the only drug authorised to date in this indication. While this reduced Nfl by just 12.4% in patients with primary progressive MS (PPMS), treatment with vidofludimus calcium reduced Nfl by 18.8% – in all patients with PMS, Nfl levels were reduced by an average of 6.75% after 24 weeks. The interim analysis of the second biomarker GFAP was also encouraging: after two weeks of treatment with vidofludimus calcium, the GFAP level increased less (3.7%) than with placebo (4.4%). After 48 weeks, the effect was even more pronounced.
BRIDGING THE GAP FROM TARGET TO LEAD
Swedish Sobi AB and Apellis Pharmaceuticals Inc have announced positive results from their Phase II NOBLE study investigating pegcetacoplan for the treatment of post-transplant recurrence of primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G). At week 12, out of the ten patients (IC-MPGN: n=2; C3G: n=8) treated with pegcetacoplan, eight (80%) showed a reduction in C3c staining reflecting damage-causing deposits by one or more orders of magnitude of intensity from baseline. Furthermore, five (50%) patients showed a reduction in C3c staining by two or more orders of magnitude of intensity from baseline. Finally, four (40%) patients
LUNG CANCER
Scorpion Therapeutics Inc and Parisbased Pierre Fabre Laboratories have started toxicity testing within a Phase I/II dose escalation and expansion trial evaluating STX-721, Scorpion’s multitarget tyrosine kinase inhibitor monotherapy in patients with locally advanced or metastatic NSCLC harbouring EGFR ex20ins mutations. STX-721 is mutantselective and thus expected to provide a better tolerability/efficacy profile in comparison to currently available treatments that most often lead to dose reductions or interruptions. In the study, the partners will determine the maximum tolerated and a lower optimal-bioL logically active dose.
MEET US! Biofit December 12 – 13, Marseille
Antibody Engineering & Therapeutics (AET) December 13 – 16, San Diego
+49 531 481170–0 info@yumab.com www.yumab.com
ECONOMY
IP FLASH
By Ute Kilger, Partner, Boehmert & Boehmert, Munich, Germany EPO The Enlarged Board of Appeal disregard said product or at least its spe(EBoA) of the European Patent Office cific composition as state of the art. The will decide upon a question of high rel- product or its composition could be reevance for patents in the field biotech- garded as “hidden information” and nology. The question to be decided con- was, thus, not publicly available. This cerns the interpretation of what has been view seems to be in line with an old de“made available to the public”. The spe- cision of the EBoA G2/88: “the question cific patent claims a material suitable as to be decided is what has been “made an encapsulating mateavailable” to the public: rial for solar cell having a the question is not what Is “the hidden” certain composition. The might have been “inherquestion now is whether ent” in what was made publicly available? a product put on the maravailable” to the pubket before the date of fillic.” And:„a line must be ing of a European patent application is to drawn between what is in fact made be excluded from the state of the art for available, and what remains hidden or the sole reason that its composition or otherwise has not been made available“. internal structure could not be analysed Another important question in this regard and reproduced without undue burden arises in the field of biotech inventions: if by the skilled person before that date. any “hidden information” was regarded At a first glance one could think – if the as novelty destroying for later patent approduct was there and if it falls under the plications what would this mean for natclaim of the later patent application – the urally occurring substances? Would this product should be novelty destroying or mean that these are not patentable ancould be a starting point for the consid- ymore? This conclusion would be quite eration of inventive step for the later filed detrimental for industry. In this context patent application. On the other hand, a we should keep in mind that a patent patent is obtained only for an enabling should incentivise investments into indisclosure of the invention. The same re- novations. Without patents such investquirement of enablement should apply ments could not be secured. Who would to a product that may be state of the art invest into the development of natural for the later application. If the compo- occurring compounds as medicaments if sition or internal structure of a product such compounds could not be patented cannot be analysed and reproduced, anymore? Therefore, a line must be carethe enabling disclosure is not derivable fully drawn between what is in fact made from the mere existence of the product. available and what “remained hidden” L As a consequence, it may be correct to on a case by case basis.
European Biotechnology | Winter Edition | Vol. 22 | 2023
Money boost EUROPE Dutch VectorY Tx BV has closed one of this years’ largest Series A financing rounds in Europe at €129m to push its vectorised antibody pipeline in CNS proteinopathies. EQT Life Sciences and Forbion co-led the €129m Series A financing that will support clinical development of VectorY Therapeutics BVs lead programme VTx-002 in Amyotrophic Lateral Sclerosis (ALS), and preclinical development of VTx-003 in Huntington disease as well as further programmes in early development stage. Both programmes are based on VectorY’s vectorised antibody platform in proteinopathies that consists of a structurally engineered AAV5 vector with modified capsid and the transgene that carries the instructions for a cell to make the therapeutic antibody. New and existing investors also participated in the financing, including MRL Ventures Fund, Insight Partners, the ALS Investment Fund, Forbion Ventures, BioGeneration Ventures (BGV) and an unnamed business angel. VTx-002 is the company’s vectorised antibody programme delivered to the brain using a one-time modified AAV vector with high CNS tropism that can cross the blood-brain barrier. Upon brain expression, the antibody targets TDP-43 for the treatment of ALS. In most people with ALS the TDP-43 protein is misfolded and forms aggregates in the cytoplasm of motor neuron cells. This is problematic for two reasons. Firstly, it leaves too little functional TDP-43 in the nucleus. Secondly, the build-up in the cytoplasm is toxic. The combination of too little nuclear TDP-43 (loss of function) and toxic cytoplasmic aggregation (gain of toxicity) is thought to contribute to loss of motor neuron cells in ALS. According to the company, VTx-002 selectively clears misfolded and aggregated TDP-43 from the cytoplasm of neurons thereby restoring the function of TDP-43 in the nucleus leading to preservation of neuronal cell funcL tion and health.
Pictures: Boehmert & Boehmert
26
European Biotechnology | Winter Edition | Vol. 22 | 2023
INSIGHT EUROPE
AMR alliance testing efficacy The Innovative Medicine Initiative 2 Joint Undertaking (IMI2 JU)-funded €25m project COMBINE is joining forces with CARB-X & CAIRD, iiCON and Pharmacology Discovery Services to improve in vivo antibiotics testing. Together, the partners are set to evaluate a pneumonia animal model that helps predicting efficacy of new antibiotics that fight Gram-negative bugs.
ANTIBIOTIC TESTING
The development of novel antibiotics is crucial in the fight against antimicrobial resistance (AMR) but has been neglected for decades due to a lack of development incentives. Another difficulty is the assessment of the efficacy of novel antibiotics targeting multidrug-resistant Gram-negative pathogens using infection models. Usually, preclinical in vivo PK/PD models play a crucial role in antimicrobial efficacy investigations and provide the basis for the selection of dosing regimens in clinical applications. However, there are a lot of models in use that do not allow comparison of results. The IMI2-JU’s COMBINE consortium will now start validation of a mouse pneumonia model that could serve as a globally harmonised standard pre-clinical model for the AMR community. Using a small panel of reference and clinical Pseudomonas aeruginosa and Klebsiella pneumoniae isolates, the consortium has so far identified a set of strains with suitable virulence that met the endpoint criteria set up.
Picture: © David Naylor, Uppsala University
Powerful partnership Five partners have now joined forces to evaluate this pneumonia model: The Innovative Medicines Initiative project COMBINE that developed the pneumonia model for tests of small-molecule antibiotics that fight Gram-negative bugs from the CDC and WHO priority pathogen list, will collaborate with CARB-X, CAIRD, iiCON and the Eurofins division Pharmacology Discovery Services. Data from the model will support the establishment of a reference strain bank of clinically relevant, well-characterised Gram-negative strains. COMBINE is
approved antibiotics used in clinical settings, with CAIRD leading the work to provide a benchmark for new experimental antibiotics through back-translation of clinical data from human plasma and lungs. Another strategic partner, iiCON, is working with the Antimicrobial Pharmacodynamics and Therapeutics (APT) group at the University of Liverpool and Infex Therapeutics to support the development of experimental models of invasive bacterial and fungal diseases and mathematical modelling to ensure optimal dose selection. Another important part of the work will be facilitated by Eurofins’ Pharmacology Discovery Services, supplying data on the efficacy of standard antibiotics in mouse lung infection models. Anders Karlén, Professor of ComputerAided Drug Design, Uppsala University and project coordinator, COMBINE.
also providing a framework to bridge the gap between preclinical data and clinical outcomes using mathematical modelling approaches. According to the partnership agreement, the alliance will share data and expertise, and exchange ideas on study design for validation and benchmarking studies. The work on the pneumonia model is led by a team at Statens Serum Institute in Denmark, with COMBINE in vivo experiments will be performed at three different project partner sites: the Statens Serum Institute, the Paul-EhrlichInstitute and at GlaxoSmithKline (GSK) in order to test inter-laboratory reproducibility. Boston-headquartered organisation CARB-X will play an important role in this work by supporting the validation of the pneumonia model with
Open for new partners COMBINE has a coordinating role in the AMR Accelerator, a cluster of public-private partnership projects funded by the IMI2-JU. The initiative brings together academia, pharma industry, patient organisations, non-profit organisations, and SMEs to develop a robust pipeline of antibiotics. “We are excited to bring standardised tools to those working to fill the pipeline with new antibiotics, and proud to be part of a community of stakeholders working together to combat antimicrobial resistance”, said Anders Karlén, Professor of Computer-Aided Drug Design at University Uppsala and academic project coordinator of COMBINE. Scientists interested in joining the COMBINE efforts are welcome to contact the coordinator at IMI-COMBINE@ L pei.de t.gabrielczyk@biocom.eu
27
INTERVIEW
European Biotechnology | Winter Edition | Vol. 22 | 2023
Action plan needed In 2012, the European Commission pioneered the bio-based Economy. Since then, many players have adopted plans to create a circular bioeconomy including the US, China, India and many others. European Biotechnology spoke with Marco Rupp from the Bio-based Industries Consortium on where the EU stands and can go. CIRCULAR BIO-ECONOMY
in an inclusive way. Thus, we invited members of the European Commission, of the European Parliament, the EU Council, from institutions, NGOs, and think tanks to discuss certain topics with us in workshops about global competition, consumer aspects, etc. The Trend Report was an outcome of those discussions.
EuroBiotech_What can the bio-based economy contribute to the green transition, what role do you see for synbio and biotech approaches with algae, microorganisms, cells and cell-free systems? Rupp_If you talk about the green transi-
tion, bio-based must be part of the solution. Biotech is a means to an end in the sense that you want to manufacture certain bio-based products. If you want to make an impact on the consumer side, you need these technologies but the impact is realised once a bio-based product is on the market. So, in that sense biotech is always a tool. Whether microorganisms or cell-free systems. Our members must decide on the method to be used. EuroBiotech_In your opinion, what are the main obstacles in the EU and elsewhere to the transition from a linear, fossil-based economy to a sustainable circular economy? Rupp_ I think we currently have a locked-
in situation because fossil resources are cheap and readily available. In addition, the use of fossil resources has been optimised over decades in certain sectors such as the chemical industry or the materials sector, where bio-based solutions compete with them. I think we have made good progress in recent years, but what we really need to see is a better market uptake and incentivisation of such market uptake. So we need clear targets for our sector to bring bio-based products to the market. This could be done via a kind of Renewable Materials Directive, similar to renewable energy incentives in the energy sector. We also need better acknowledgement of renewable carbon, the carbon that is captured from the air by plants and biomass and
MARCO RUPP manages public affairs and sustainability activities at BIC. He graduated as economist. Marco has over 20 years of private and public sector expertise in various management functions.
then converted into a product. Renewable carbon must replace fossil carbon in products. EuroBiotech_Indeed, we already see a big interest from chemical industry to decarbonise its processes. Most recently, he Bio-based Industry Consortium (BIC) published its first Trend Report. What was your motivation? Rupp_We felt that it was time to docu-
ment what progress we have made on the technological and financial side last year. We also felt that there are some gaps on the regulatory side and of course, we as BIC have certain ideas how to bridge those gaps but we wanted to discuss them
EuroBiotech_A decade ago, the EU was a pioneer in bioeconomy, launching the very first bioeconomy strategy worldwide in 2012. Since then, many countries have adopted similar strategies. Where does Europe stand today, and what would the BIC like to see added to the original strategy, and where should Europe focus its efforts? Rupp_Yes, if you look toward the US,
China, but also India, Singapore or the G20, there is increased attention and planning for the bioeconomy. I think the motivations are different. Due to geopolitical crises we have a stronger need for strategic autonomy; that might have driven the US efforts (to invest billions of dollars in biotechnology and biomanufacturing as a new priority technology and thus in the bioeconomy and set up the Inflation Reduction Act). More autonomy from fossil imports but also more reliance on bio-based materials is one motivation. In China there is a big focus on the bioplastics side. If you look at India, they come from the bioenergy corner, but companies also look beyond that to the materials and chemical sectors. Singapore, (due to its dependency on food imports) is very strong on novel food. So, the motivations are very different. Europe was leading in most of those aspects. If you look back to 2012, all other countries admired Europe. I think we
Picture: © BIC
28
European Biotechnology | Winter Edition | Vol. 22 | 2023
have done a lot on the strategy side but not on the action side. And that’s where we need to get to now. EuroBiotech_So what has to be done to bring European companies back to the top? Rupp_We see three lines of action. One
definitely concerns market uptake, i.e. we need to make it much clearer where Europe’s strengths lie in the area of biobased products. As we can’t do everything, we need to be much clearer about which markets we want to promote, for example through the Renewable Materials Directive. Secondly, we need to scale up production. Do we have enough sustainably-sourced biomass at an acceptable price? Is our biotech production infra st ruc ture suf f icient – for rapid technology transfer and commercialisation? And money will also play a role. If you look at how funding is incentivised in the US, I think we can be a bit bolder there. We need to look at government funding for projects of common European interest. We need to find synergies between EU, national, public and private funding. And the last point concerns innovation. I think we need to get better (i.e. faster) at scaling up and authorising first-of-its kind innovations, and we also need new forms of experimentation, like regulatory sandboxes and living labs.
Pictures: © Solar Foods
EuroBiotech_ Of course, what falls under the term bioeconomy is not exactly clear and is often cross-sectoral. In the case of an update of the EU bioeconomy strategy, would it not be more helpful from the BIC’s point of view to look at the specific needs of the individual sectors. i.e. cellular agriculture? Rupp_We welcome the mandate from the
EU Member States and the Commission to make an update. But I think it needs to be complemented by an action plan. In the action plan we should look at which sectors we can take action in. Personally, I see huge potential in the materials sector, which per definition cannot be decarbonised because you always need carbon in the chemicals and materials sector, it can only defossilized. For that carbon you
have three choices: it can come from recycling fossil products and materials, from biomass or it comes from CO2. I think we have to take the bio route more strongly. EuroBiotech_What exactly can processes that utilise renewable resources, synbiotechnology or biotechnology contribute to social, ecological and economic sustainability in the materials, construction, chemicals, energy, transport or food and animal feed sectors? Do you have any figures on its potential? Rupp_The EU bioeconmy sector is already
huge in Europe. We are talking about 18 million people employed across the sectors involved, €2.4tr revenues annually, of which one third comes from the biobased industries. Estimates of the WBCSD assume that the circular bioeconomy represents a US$7.7tr business opportunity until 2030. About 20% of of the carbon demand for the chemical and materials sectores is expected to be bio-based will come from the chemical and materials sectors. EuroBiotech_ Why is the recycling of fossil carbon not enough to avert the climate catastrophe? Rupp_The overall goal is to leave virgin
fossil in the ground. Carbon recycling is not enough because you have losses during the recycling. That is why carbon from CO2 from the air can be converted by gas fermentation, or you use carbon from biomass. EuroBiotech_Which policy measures in other regions of the world are exemplary for Europe? Rupp_There is no one-fits-it-all solution.
On the materials side, I am thinking of China and its focus on bioplastics. I have mentioned Singapore’s or the USA’s foodtech focus and fast-track-approval of novel food. Though there are microbial alternatives to pesticides and fertilizers, it takes too long in Europe to bring them to the market. EuroBiotech_You also mentioned scaling production as an important means to bring the bioeconomy forward. What
INTERVIEW
kind of support European companies would need? Rupp_Capital is key after we have man-
aged to improve market acceptance. We need more money for demonstrationscale projects and access to capital if we want to grow the bio-based industries from niche to norm. EuroBiotech_Is bio-based enough to create strategic autonomy (problem of resource limitation), or do we need to build on additional technologies or auxotrophic processes? Rupp_You are probably right in saying
that we might not have enough biomass to fully replace fossil resources. We need more clarity about what amount of biomass is potentially available for biobased solutions in the long-term. We curr e n t l y s e e s o m e t r e n d s t h a t m ay significantly affect the availability of biomass including the trend towards plantbased diets or to reduce food intake. The producers of staple foods can already feel the impact of the latter trend. If you look at biorefineries, they were always about food and feed, fuels and non-food or industrial applications. Ideally, it should be a win-win situation. However, complementary technologies such as microbial carbon sequestration, i.e. in the alternative protein production sector, will play an important role. EuroBiotech_What are the main conclusions and recommendations from the BIC Trend Report 2023 to policy makers? Rupp_We need more regulatory certainty
and more targeted policies to bring the bioeconomy forward. Secondly, we need a European “Bio”-coordinator in the newly elected Commission. EuroBiotech_What are other key messages from the Trend Report? Rupp_We need not to be too pessimis-
tic. Europe is well-known for its strong focus on sustainability. We still have a good starting point for the bioeconomy in Europe. But we have to put the biobased economy higher on the political L agenda. t.gabrielczyk@biocom.eu
29
BIOPARKS & MANUFACTURING
European Biotechnology | Winter Edition | Vol. 22 | 2023
Square metres: the new gold The European real estate market has seen a peak-to-trough fall in values of roughly 20%, also due to interest rates, which are now broadly expected to peak at the end of 2023. With tech-parks and production facilities, the demand for newly constructed buildings is unrestrained and dynamic.
FACILITIES
The production of biopharmaceuticals, as well as microbial or cell-based industrial production has found a new bottleneck: space for R&D, scale-up and production. While the pandemic has mainly triggered the expansion of R&D centres and production sites for pharmaceuticals, vaccines and diagnostics, other sectors such as chemicals, food or energy are now pushing in the wake of the defossilisation of industrial production. The call from Europe's life science community for more incubators, demonstration and production space is becoming increasingly audible. The industry is gearing up for expansion, and property developers, contractors and regulators have their work cut out. Whether it is biopharmaceuticals, biobased plastics or novel foods from CO2, insects, cells or precision or single cell fermentation, to, scale up and produce these biotech products, facilities are needed. Techparks and incubators have to evolve
in providing production plants nearby and find themselves locked in a scientific campus area where expansion often is not easy. The demand for new therapeutic formats such as mRNAs, cell & gene therapies, molecular machines or conjugates, vegan proteins or enzymatically produced defossilised chemical products and energy is ever increasing.
Expansion is everywhere Europe has not yet set up a major support programme for organic production like the USA, and there is no initiative like the “BioMade” initiative there, which positively promotes and propagates biotech production on its own doorstep. However, the sheer pressure to place large production capacities on the European market in order to be local and avoid expensive or insecure logistics chains, which can become shaky in times of cri-
Single Cell Protein specialist MicroHarvest launched a facility in Lisbon in November.
sis, is currently leading to a wave of expansion onto the famous “greenfield sites”. For example, the diabetes and obesity specialists Eli Lilly and Novo Nordisk are investing billions of euros globally, i.e. in an expansion in Germany, in the middle of an industrial park with no other life science speciality (Eli Lilly, Alzey near Mainz, see p. 32) or are expanding the site by building over the large car park areas with new production capacity (Novo Nordisk in Kalundborg and Chartres, France, see p. 32). Those who can offer space for expansion, who can offer good transport connections, who can offer proximity to qualified labour are now lucky. The managers of the Central European biotech scene, with the start-up centres close to the universities and university hospitals where these start-ups were founded, have long ignored the expansion area, as the SME was usually bought up faster than it could grow. And when growth was required, the startup preferred to look for a new building close to the incubator’s old location, as proximity to science was still important there. The demand for space for production sites is now coming from several sides: global players who want to access the skilled labour of the innovation hubs, the new food generation with food from the laboratory, the bio-based production of materials, animal feed, energy and also health products from the fermenter through to a new wave of biopharmaceutical production in Europe, such as bioL similars. g.kaeaeb@biocom.eu
Picture: © MicroHarvest GmbH
30
END-TO-END BIOLOGICS CDMO SERVICES From Process Development to Aseptic Fill & Finish
Mammalian & Microbial Services: Cell Line Development · Process Development (USP & DSP) Analytical Methods Development & Qualification · Formulation Development cGMP Manufacturing: Cell Banking (MCB, WCB) · Drug Substance & Drug Product Manufacturing Release & Stability Testing · Regulatory & CMC Support Northway Biotech US 828 Winter St. Waltham MA 02451
Northway Biotech EU Mokslininku St. 4 Vilnius 08412 Lithuania
To learn more contact us: www.northwaybiotech.com ｜ email: BD@northwaybiotech.com
BIOPARKS & MANUFACTURING
European Biotechnology | Winter Edition | Vol. 22 | 2023
Production in Europe When Big Pharma expands production capacities, there is often a lot of money involved. The latest investments by the market leaders in the obesity/diabetes market should also be seen in this light. Officially, multipurpose plants are being built. In reality, however, it is all about the €90bn market for first to third generation obesity drugs outlined by Pfizer CEO Albert Bourla. ELI LILLY/NOVO NORDISK
In the race for market share for the incretin semaglutide and tirzepatide, the aim is to expand production capacities as quickly as possible in Europe and the USA, where Novo Nordisk is unable to meet demand two years after tirzepatide was approved. For this reason, the plant in France is now being expanded by 2028 at the latest, while the Kalundborg facilities (see photo) will be ready by 2025.
While Novo Nordisk’s main competitor Eli Lilly in the emerging market of effective drugs that fight obesity announced an investment of €11bn to scale production of its dual GLP1/GIP agonist tirzepatide at five new production sites globally, the Danish company now made public that it is investing €6bn to expand its production site in Kalundborg, Denmark, and additionally €2.1bn for the expansion its existing production facility for injectables in Chartres, France.
Building capacity The investment in Kalundborg features a new 170,000-square-meter API facility that will be able to make multiple products including an oral form of semaglutide Novo is developing. Work on the expan-
sion will begin this year, and construction will be completed in stages from the end of 2025 to 2029. Novo Nordisk A/S’ investment in Chartres will significantly increase the capacity of the production site by expanding aseptic production and finished product processes as well as the current quality control laboratory. The investment will enable the diabetes/obesity specialist to meet future demand for its GLP-1 agonist semaglutide that has already been marketed as a diabetes drug but two years ago got additional FDA approval to fight obesity in obese patients with BMI >30 and those with severe comorbidities with BMI >27. As Novo CEO Lars Fruergaard Jørgensen mentioned, the investment won’t be the end of Novo’s manufacturing expansion. Whilst there are over two million people with obe-
sitas world-wide, according to Jørgensen, ”we are far from getting to a billion people.” In the US, with 70% share in the global obesity drug market, estimated by GlobalData to reach US$37.06bn in 2031, Novo was lately not able to satisfy demand for its GLP1 agonist semaglutide, who has been FDA-approved there in 2021. According to GlobalData, GLP1receptor agonists will dominate the market by 2031 with a 70.9% market share. The facilities of Novo Nordisk, which already had a strong footprint in the European market, will more than double the size of the site in Chartres. The plant will be designed as a multi-product facility to accommodate current and future processes and provide state-of-the-art technologies and working environments. The construction projects have already been initiated and will be completed in stages between 2026 and 2028, while Eli Lilly’s German plant in Alzey, near Mainz will be ready in 2027. Novo’s investment is expected to create more than 500 new jobs to maintain 24/7 production when construction is complete and the facilities are finalised. Up to 2,000 external employees will be employed during the construction phase.
Eli Lilly’s offensive in Europe Despite its later start into the US market with trizepatid as an obesity treatment, analysts such as Costanza Alciati, from GlobalData see advantages for Eli Lilly: “Novo Nordisk’s GLP-1 agonist Wegovy (semaglutide) has – until now – monopolised the obesity market.” However, in type 2 diabetes clinical trials, tirzepatide has proven its superior efficacy to sema-
Picture: © Novo Nordisk A/S
32
HYBRICK BERLIN
Lettable area Approx. 22,000 sqm
Main uses Lab, office, production
BUILT FOR THE FUTURE OF LIFE SCIENCES
Available from Winter 2025
Im Marienpark 42 – 48 12107 Berlin
Hybrid spaces for research, development and production. Hybrick Berlin and Hybrick X are two developments within the innovation campus Marienpark in the south of Berlin, set amidst spacious green areas and surrounded by impressive industrial landmarks as well as historic buildings. Hybrick Berlin and Hybrick X meet the highest standards in sustainability and ESG.
Get in touch. contact-hybrick@investa.de +49 30 856 215 781 hybrick.com
HYBRICK X
Lettable area Approx. 11,000 sqm
Main uses Clinical and commercial manufacturing
Available from Spring 2026
Scan to explore our rental areas
Altes Gaswerk 41 - 44 12107 Berlin
BIOPARKS & MANUFACTURING
glutide due to its dual agonist properties, and thus the Danish company could lose its market share to its competitor. Consequently, Eli Lilly announced the expansion of its production in Europe. In Germany, an expected major market, Eli Lilly wants to invest US$2.3bn to build a new production plant in Alzey-Ost, Rhineland-Palatinate, near its German headquarters in Bad Homburg. The company made the announcement in Berlin in the presence of the Federal Minister for Economic Affairs, Robert Habeck (Alliance 90/The Greens), and the Federal Minister for Health, Karl Lauterbach (SPD). ”In addition to the US$2.3bn we are investing in the construction of a new injectables manufacturing facility, we will invest US$100m in partnerships, incubators, venture capital and laboratory space with the EU biotech ecosystem,” said Ilya Yuffa, Vice Executive President Eli Lilly & Company (Indianapolis). Initially, tirzepatide will be manufactured for the European market in Alzey and additional sites in France and Italy, added Edgardo Hernandez, President Manufacturing. He referred to Eli Lilly’s 25 market launches in the past few years and investments of US$11bn worldwide for the expansion of production and pointed out that several products are to be manufactured in the new plant in the
European Biotechnology | Winter Edition | Vol. 22 | 2023
long term. In addition to the 1,000 jobs that will be created in Alzey, 1,900 temporary workers will be involved in the construction. In the US market, Novo Nordisk currently has a clear lead over Lilly with semaglutide. Lilly’s rival product was only approved by the FDA in November and has also been recently authorised in Europe.
Innovation race As Lilly’s competing dual GLP-1/GIP agonist tirzepatide is expected to catch up, Novo Nordisk launched a Phase III trial with the aim of proving the superiority of its pipeline combination therapy CagriSema, a combination of semaglutide with the long-acting amyline analogue cagrilintid, as a weight loss drug over its active comparator, tirzepatid (Zepbound). CagriSema is anticipated to compete directly with Zepbound once it reaches the market. For now, Eli Lilly has started an aggressive marketing campaign for tirzepatid of the pond – in the US, for example, with a 30% lower monthly price of just over US$1,000 compared to semaglutide. Since, according to analysts, both companies will not be able to meet the demand for the slimming injections, which won’t be reimbursable in Germany, addi-
Model of Eli Lilliy’s production plant in Alzey, Germany
tional production capacity will have to be built up worldwide. “This is a highly interesting growth area for us, and of course we want to work on satisfying demand worldwide,” said Yuffa. Federal Health Minister Karl Lauterbach said he views Eli Lilly’s decision in favour of the production site as a positive signal for the research location Germany. Yuffa said that Eli Lilly wanted to increasingly invest in the biopharma ecosystem in Europe, but that no projects had yet been finally decided. Although Phase III data on both obesity drugs appear to show that Eli Lilly‘s dual GLP1/GIP agonist tirzepatide led to a slightly greater weight reduction, there is no statistically significant data from a direct comparison of active ingredients. As with all drugs, there are some side effects, for example dose-limiting gastrointestinal disorders. Studies running until 2032 will investigate the increased risk of medullary thyroid and pancreatic cancer observed in animal experiments. At the end of October, the PRAC Committee of the European Medicines Agency (EMA) announced there was no link between the GLP-1 agonists exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and a higher risk to get cancer of the thyroid. A study on the drugs‘ effect on suicidal behaviour is pending. The effects of muscle atrophy and reduced bone density, which have also been observed, are not being investigated further by the companies. Diabetologist Eric Topol criticises the fact that there is no exit strategy for the highly effective obesity drugs, meaning that weight gain can be expected again after discontinuation. There are currently ten companies that clinically develop inkretins for weight reduction with Novo Nordisk and Eli Lilly are expected both having a market share of 45%. While Novo’s semaglutide originally is a diabetes drug, Eli Lilly’s tirzepatid is a second generation product also used in diabetes. Other competitors such as Pfizer, Sanofi or AstraZeneca are developing triple inkretins that block appetite and have been shown to reduce weight up to 20 kg within 40 weeks in people with a BMI over 30. t.gabrielczyk@biocom.eu
Pictures: © Lilly Deutschland GmbH
34
ADVERTORIAL
European Biotechnology | Winter Edition | Vol. 22 | 2023
The future finds a new home: HAVEL LABS With HAVEL LABS, a unique campus is being developed in Berlin-Spandau. Spanning over 20,000 m2, this space is designed for forward-thinking work environments. Modern industrial workplaces and logistics concepts, aligned with GMP (Good Manufacturing Practice) guidelines, can be e ffortlessly realised on the premises, as can laboratories ranging from safety level S1 to S3 in a ccordance with German Genetic Engineering Safety Regulations. MODERN FACILITIES
Picture: © bloomimages
In Berlin-Spandau on the site of the historical Prussian rifle factory from the 19 th century, HAVEL LABS is emerging as a Work-Life-Place of the future, precisely tailored to the requirements of companies in the Life Science sector.
Companies in the Life Science sector face a multitude of challenges arising from the complexity and dynamically evolving nature of this industry. When choosing a business location, criteria such as modularity and flexibility are given high priority. HAVEL LABS precisely embody these requirements while at the same time exuding historical charm. The project development includes two iconic new buildings constructed in ecological hybrid-timber construction, as well as five listed buildings that will be revitalised to current standards and provided with contemporary new building extensions. The spectrum of design possibilities ranges from high-quality, flexibly designed laboratory spaces to administration and training rooms, to modern workplaces in the industrial produc-
tion sector, as well as storage and logistics. The campus also sets the stage for the future in terms of environmental and climate protection: the use of ecological building materials is an essential part of the area's consistent ecological overall concept, which includes not only the careful use of resources but also climate-friendly energy supply. Facade and roof greening will additionally have a positive impact on the local microclimate.
Where the future meets the city The location of the campus is outstanding: situated directly on the banks of the Havel River, HAVEL LABS offer a unique, unobstructed view of the water. Natural outdoor spaces invite relaxation during breaks and after work.
Accessibility is also optimal: the nearby subway station Zitadelle allows for convenient direct connections to the Berlin City centre, the high speed train station Spandau, and a total of five Berlin districts. HAVEL LABS do not only offer modern high-end workplaces but also the exceptional opportunity of commercial living space. This benefits employees as well as guests and customers, elevating HAVEL LABS to a unique work-life place with a high quality of stay within Berlin. A location that takes companies from the future industries of biotech, medical technology, and pharmaceuticals to a new level in recruiting specialised personnel. Developer: ARE Austrian Real Estate, Vienna and Central City, Berlin Architecture: Gewers Pudewill, Berlin Scheduled Construction Start: Q1/2024 Planned Overall Completion: Q4/2026 Address: Zitadellenweg 20 E-G, 13599 Berlin Contact us: Alexander Kollo Phone: +49 173 5782540 E-Mail: kollo@centralcity.de
www.havellabs.de
35
All for one, one for all! BIOCOM CARD Europe Individual
BIOCOM CARD Europe Corporate
› European Biotechnology Magazine Subscription
› European Biotechnology Magazine Subscription
› European Biotechnology Guide 2024
› European Biotechnology Guide 2024
› Guide to German Biotech Companies 2024
› Guide to German Biotech Companies 2024
› conveniently accessible ePapers
› conveniently accessible ePapers
› Discount for BIOCOM events for 1 person
› Discount for BIOCOM events for 2 persons
› additional partner offers
› additional partner offers
Price:
80 Euro p.a. (incl. VAT)
Price:
120 Euro p.a. (plus VAT)
Ccflower - Freepik.com
Students 50% discount (subject to proof of enrolment)
european-biotechnology.com/card
European Biotechnology | Winter Edition | Vol. 22 | 2023
SigmaPlot® 15
ADVERTORIAL
37
Regression Designed Specifically to Meet the Needs of Scientists, Professional Researchers and Engineers
Principal Component Analysis
Global Curve Fit
Technology Park Heidelberg x hip The Heidelberg Technology Park is adding a new building, LAB22, to its by now six locations all over the city of Heidelberg. INNOVATION
The Heidelberg Innovation Park (hip) has rapidly developed into a thriving hotspot for entrepreneurs, pulsating with potential for the digital and biotech sectors. Lord Mayor of Heidelberg Eckart Würzner stated 'The Heidelberg Innovation Park is a pioneer in modern economic area and LAB22 is our latest addition to the Business Development Center and our impressive Bio Production Park. Start-ups and young companies in IT, AI, BioTech, and Life Sciences receive high-quality spaces crucial for their further development. They benefit from the high density of universities and scientific institutions in Heidelberg, as well as from the acceleration programs of our Technology Park team.’
SigmaPlot is an easy-to-use scientific graphing & statisticalANCOVA data analysis software package for researchers, scientists and engineers who need to create precise, publication-quality graphs that best communicates their research results for presentations, technical publications, and the web. Along with advanced curve fitting, a vector-based programming language, macro capability and over 50 frequently used statistical tests, SigmaPlot also provides more than 100 different 2D & 3D graph types from which one can choose a full range of graphing options such as technical axis scales, multiple axes, multiple intersecting 3-D graphs and much more. SigmaPlot now has SigmaStat included with it which is a perfect tool to visualize and understand basic and advanced statistics. ®
SigmaPlot offers: • • • • • •
Latest updates: • •
•
International network
•
LAB22 stands not only as a building but also as a symbol of Heidelberg Technology Park’s commitment to innovative, dynamic, and sustainable economic development. Its integration within the strong BioTech cluster BioRN, and international cooperations via the International Association of Science Parks and Areas of Innovation as well as the presence of entities like BioLabs Heidelberg, further enriches its offering. BioLabs Heidelberg, known for its fully-equipped laboratories and mentorship for start-ups, chose LAB22 for its German location, thereby enhancing the park's international appeal.
•
40 years of experience and innovation As Heidelberg Technology Park approaches its 40th anniversary in 2024, it reflects on its journey of supporting approximately 500 companies in health, diagnostics, therapy, and advanced technological fields. LAB22 is not just a new building; it is the next chapter in a story of enduring commitment to innovation, collaboration, and growth.
Complete Advisory Statistical Analysis Award-Winning Technical Graphing Capability Powerful and Easy-to-use Data Analysis Ability to Customize every Element of Graph Precise Publication-Quality Graphs Ability to Publish your Work Anywhere
Includes a New Heat Map Macro Removes all dependencies on old redistributable by removing Lead Tools and uses Windows Graphics Device Interface + (GDI+) for graph export Uses the latest Sentinel License Manager which is compatible with the latest Microsoft Server 2022 Uses a hosted licensing service for smooth license activation and validation Has a new and refreshed ribbon manager that enhances the already commendable user experience in SigmaPlot
North America & South America Inpixon USA 2479 E. Bayshore Rd, Suite 195. Palo Alto, CA 94303, United States saves.sales@inpixon.com Germany, Austria, & Eastern Europe Inpixon GmBH Königsallee 92a, 40212 Düsseldorf, Germany saveskontakt@inpixon.com UK & Western Europe Inpixon UK Ltd
Contact us: Technologiepark Heidelberg GmbH Im Neuenheimer Feld 582 69120 Heidelberg E-Mail: technologiepark@heidelberg.de
268 Bath Road, Slough, SLI 4DX, UK saves.sales@inpixon.com
©2022 by SYSTAT Software, Inc. SYSTAT, SigmaPlot, SigmaStat, TableCurve2D, TableCurve3D and PeakFit are trademakes of SYSTAT Software, Inc. All other product or brand names are trademarks or registered trademarks of their respective holders.
ADVERTORIAL
European Biotechnology | Winter Edition | Vol. 22 | 2023
Leipzig: fast-growing life science ecosystem This scrappy young city in the heart of Europe is rapidly becoming a magnet for successful start-ups and companies looking for plenty of room to grow, as well as a culture of cooperation and trust.
LIFE SCIENCES HUB
Leipzig has long been a leader when it comes to innovation: 110 years ago, Hall 12 at the Leipzig Fair hosted the world’s largest International Building Exhibition. Now it is one of the city’s sites for the industries of the future: the life sciences information and communications technology in healthcare. It all began more than 20 years ago when the Free State of Saxony made a commitment to advancing innovative industries in the region. Spurred by an initial investment of ~€200 m, the hub in Leipzig soon became a success story. It is now known particularly for its expertise in the fields of cell, immune and gene therapies, robotics, digital health, diagnostics and knowledgeintensive services. As the host of BIOEurope 2022, the city has now made the leap into the Champions League of life science locations in Europe.
Giving companies room to grow One of the things that sets the city apart from other locations is its room for growth. At the BioCity Campus, 100,000 m2 of space is available exclusively for the life science and tech sector. At its core is the 20,000 m2 biotech and business incubator BIO CITY LEIPZIG, complemented by the 6,400 m² BioCube, both of which offer modern lab, office, manufacturing and storage spaces. Even more space for growing companies is being created going forward: Starting in 2025, CLL CityLab Leipzig will offer 8,600 m² of customisa-
to open in 2027. In addition, most of this prime real estate is located near the city centre, with a bustling scene of restaurants, hotels and cultural attractions.
Offering a thriving ecosystem of partners
Prof. Dr. Dr. Ulrike Köhl Director of the Fraunhofer IZI “Medicine and research have played a key role in Leipzig for a very long time. The Fraunhofer IZI complements the existing portfolio within this scientific hub, especially in the field of applied biomedical research.”
ble lab and office space on five floors, and the new two building ensemble BioSquare will have a gross floor space of 26,000 m2 for hybrid lab/office solutions. Leipzig’s centrally located Innovation Centre is slated to open in 2026 and will provide more than 10,000 m2 of S2-labs, office areas, conference rooms and maker spaces for prototyping. And last but not least, 10,000 m² of space is dedicated to life science startups and companies in Hall 12 on the city’s historic fairground, which plans
Leipzig has developed a thriving ecosystem of hospitals, research institutes and renowned companies located in close proximity to one another. They not only form a stimulating R&D environment, but are accelerating the growth and success of the region’s life science industry. It includes three Max Planck Institutes, two Fraunhofer Institutes, two Helmholtz Centres, five Leibniz Institutes, three ZUSE Institutes, the BBZ Centre for Biotechnology and Biomedicine and HTWK Leipzig University of Applied Sciences Leipzig University itself is a research powerhouse: The medical faculty’s Innovation Centre for Computer-Assisted Surgery (ICCAS) is a pioneer in robot-navigated surgery which is combining medicine and IT in exciting ways. The university is establishing a digital vaccine library to help prevent future pandemics and a brand new research and transfer hub to accelerate drug development. In addition, the university is a source of highly qualified graduates eager to join the local workforce. Thanks to this interconnected life science ecosystem, Leipzig has become a leading hub for regulatory preclinical work, process devel-
Picture: © Fraunhofer IZI
38
ADVERTORIAL
European Biotechnology | Winter Edition | Vol. 22 | 2023
CLL CityLab Leipzig: five floors for innovation
BioSquare: flexible room for growth
Hall 12 at the Old Trade Fair: new vistas
opment, and cell and gene technology (CGT) manufacturing.
macrophages. With more than 17 years of experience, the Fraunhofer IZI was involved in the production of the clinical investigational medicinal products for the EU’s registration trial of the world’s first CAR-T cell therapy. More than 3,500 cell therapy test samples for clinical trials have been manufactured at the Fraunhofer IZI since its inception.
Pharma. This groundbreaking 3 month program qualifies people from outside the life science industry for laboratory work so they can quickly fill local demand for specialised staff. In addition, biosaxony fosters collaborations and partnerships to speed up innovations for the life sciences and the global healthtech market. Start-ups and young companies from around the world also receive support through the specialised business accelerators SpinLab (for e-Health/m-Health) and MEDICAL FORGE (for Smart Medical Devices).
Enabling companies to help patients faster
Pictures: © de+ Architekten, Berlin mit Bacher Landschaftsarchitekten, Berlin
The Fraunhofer Institute for Cell Biology and Immunology (IZI) is an expert in CGT and has a worldwide reputation for the quick transfer of scientific results into patient care. Through Good Laboratory Practice (GLP) testing, process development and the manufacture of clinical trial samples, it ensures that experimental drugs quickly find their way into clinical application. The Institute operates clean room facilities as well as quality control laboratories and has extensive experience with regulatory procedures and obtaining manufacturing approvals. Together with clinical and corporate partners, it researches and tests new technologies for modifying immune cells (viral/ non viral), as well as alternative effector cells such as natural killer cells and
Moving the industry forward in strong networks The Fraunhofer IZI is a key member of Leipzig’s life science ecosystem and a leading partner of the SaxoCell innovation cluster. Among other things, this consortium of research institutes, hospitals and industrial partners in the Free State of Saxony is working on merging CGT with automation technologies, digitalisation and artificial intelligence. The Institute has also teamed up with the industry association ‘biosaxony’ and other partners to launch the qualification initiative QualiBio-
Curious about what else Leipzig has to offer? Find out more by going to Contact us: Deutscher Platz 5c 04103 Leipzig Tel: +49 351 7965-500 Leipzig-for-lifechangers.com
Success in numbers 50 ha of development space 50 companies and institutes on the BioCity Campus 4.500 highly skilled jobs 40.000 students enrolled at university and colleges 500 m² co-working lab for start-ups 60.000 m² newly created lab and office spaces €160 m of investment into new lab spaces
Future expansion of the BioCity Campus Leipzig by a further 36 ha on the site of the Old Trade Fair.
39
ADVERTORIAL
European Biotechnology | Winter Edition | Vol. 22 | 2023
The Mainz Life Science Hub in Germany The city is investing in the future by establishing a modern campus and strengthening Mainz as a hub for life sciences. Space with convenient transport connections close to the city centre is available to found or relocate start-ups, companies and research facilities. L IFE SCIENCE CAMPUS
able link between ecological sustainability and urban development.
An efficient ecosystem
The site of the future modern life science campus within easy reach of the city.
Thanks to the resounding success of the biotech sector in fields such as oncology, ageing research, and mRNA, Mainz has been catapulted into the global spotlight. The City of Mainz wants to leverage this positive momentum and has set itself an ambitious vision: to significantly expand the life science and biotech industry over the next few years and develop into a thriving location with international appeal. This vision entails investing in the construction of modern buildings, laboratory and office space with a focus on biotechnology on the 12 ha Life Science Campus near the University and University Medical Center. This boasts excellent transport links and there are plans to build several residential neighbourhoods nearby. Additionally, as soon as sites that are still used by the military (“An der Goldgrube”, the GFZ barracks planning area) have been handed over,
additional space will become available in the immediate vicinity of BioNTech’s head office. In the medium term, there are plans for a mixed-use district combining research, offices, housing as well as community and public facilities in one location.
Prospects for development Under the auspices of the city's planning department, the City of Mainz is conducting an international urban and open space planning competition for an area of 50 ha. This area lies directly adjacent to the current university expansion site and the Life Science Campus that is under development. It is being held to explore the potential to attract additional life science and biotech companies to the region, with the aim of developing the campus with the highest possible standards, creating a sustain-
Mainz as a location for life sciences and biotechnology offers an efficient ecosystem with significant players. The city and its environs are extremely well positioned thanks to the presence of major companies such as BioNTech, Boehringer Ingelheim, Merck, Sanofi and Schott. The wider region is also home to other companies in the life science and biotechnology sector as well as suppliers. Academic and research institutions provide a rich pool of knowledge and make a vital contribution to the region's economic success. Nine collaborative research institutes, six hospitals as well as a university (Johannes Gutenberg Universität Mainz) and a university of applied sciences with top-notch reputations are the driving force behind interdisciplinary research in the field of life sciences and related fields of (specialised) research. In this way, the Mainz Life Science Hub is an ideal location to successfully conduct research, found new companies and grow sustainably. Contact us: Felix Wälder, Managing Director, biomindz GmbH, Schillerplatz 18, 55116 Mainz, Germany felix.waelder@biomindz.com, www.biomindz.com
Picture: © Lukas Görlach
40
Let Your Ideas Grow Lab and Office Spaces for Start-ups and SMEs Opening
© Gustav Zech Stiftung Management GmbH
Q1 2024
Welcome to LAB22, the new building of the Heidelberg Technology Park! You are looking for independent lab and office spaces starting from 160 sqm in a central and innovative environment with access to a great infrastructure? You are a mediumsized company in the fields of Life Science, BioTech, MedTech, IT, or AI? Then LAB22 is the perfect place for you.
The building offers independent rental units, flexible in size, including private restrooms and kitchen areas. All utility lines are already laid in the ceiling, allowing a quick customization of your spaces according to your needs. As a tenant at LAB22, you will not only join an engaged community, but also benefit from the international network of researchers and companies as well as the consulting services at the Heidelberg Technology Park. Being located at the site of Heidelberg Innovation Park (hip), LAB22 also makes you part of a center for innovation.
Contact: Moritz Schindler | Phone: +49 6221 50257-22 | moritz.schindler@heidelberg.de
www.lab22-heidelberg.de
RUBRIK
Cultivated protein is a huge market promise though technical and regulatory hurdles still make it a niche market.
European Biotechnology | Winter Edition | Vol. 22 | 2023
Pictures: xxx
42
CELLULAR AGRICULTURE
European Biotechnology | Winter Edition | Vol. 22 | 2023
Boom or exodus? Europe is the cradle of the cell-based meat sector. However, companies that have developed microbial, fungal and cell-based alternatives to conventional meat, fish or dairy products – or to plant-based protein alternatives, which are often expensive and not very tasty – face major hurdles when it comes to authorisation and production on the continent. Will companies soon begin leaving Europe for greener pastures?
FOOD BIOTECH
Pictures: © Mary_Ukraine - stock.adobe.com (left); Corden BioChem GmbH (right)
R
arely have entrepreneurs and politicians around the world been so unanimous in their assessment of the emerging market for cell-based and microbially produced meat, fish and dairy product alternatives. On the occasion of the US market launch of its cell-based chicken product in June 2023, founder and CEO of manufacturer Upside Foods Uma Valeti called it “a dream come true” and said the market approval “marks a new era”. Good Meat Inc, a company that was given FDA/USDA marketing permission the same day, had already received the world’s first ever authorisation for a cell-based meat product in Singapore three years earlier. In addition to the 20 companies worldwide that cultivate meat and fish alternatives from muscle stem cells, 136 biotech companies are churning out completely animal-free alternatives produced in fermenters instead of through livestock farming. At the end of September, German Research Minister Bettina Stark-Watzinger confirmed Valeti’s enthusiasm for this new way of producing food: “I am certain that these products will revolutionise our diet. Bio technology is the key to this – whether in the production of animal-free beef or pea protein. There is a market worth billions waiting to be tapped.” So what’s behind the enthusiasm, which has also gripped stock market analysts? According to the Food and Agriculture Organization of the United Nations (FAO), meat, fish and dairy products from factory farming are responsible for
at least 15% of global CO2 emissions and 40% of all global deforestation. And that isn’t even counting the consequences that animal feed production has on soils and biodiversity. In contrast, the cultivation of protein or fat alternatives, which are often produced from waste sidestreams or directly from CO2, promises carbon savings of 99% compared to conventional livestock farming. It demands neither agricultural land nor artificial fer-
tilisers, antibiotics or pesticides, and requires much less water. In 2022, researchers from the Potsdam Institute for Climate Impact Research analysed the environmental land use impacts that substituting fermentation derived microbial protein for ruminant meat would have. Replacing just 20% of per-capita beef consumption with microbial protein from sugar-fed fermentation by 2050 would reduce deforestation and related land-use change emissions by 50%. A group of researchers in Finland found that microbial protein obtained from hydrogen-oxidising bacteria results in environmental impacts 53%100% lower than conventional meat.
Tailwinds for producers
DR KLAUS PELLENGAHR Managing Director, Corden Biochem GmbH, Frankfurt/Main
?
What role do the comparatively high energy prices in Europe play for foodtech producers and CDMOs?
!
In Europe, especially in Germany, energy costs are far too high by global standards. We are seeing in biotechnology what we are already seeing in the chemical industry: there is a risk of a major exodus from Europe.
That’s reason enough for many governments to support the development financially. A month after Stark-Watzinger made her comments, the budget committee of the German Parliament earmarked €38m from its 2024 draft budget for the new biotechnological production methods and to set up a coordinating centre of excellence. “A great signal,” stressed Tanja Bogumil, the Managing Director of Berlin-based Lovely Day Foods, which has developed Perfeggt, a bio-identical protein substitute produced by precision fermentation, “even if the sum is of course small if you want to set up an industrial production plant.” That would cost a threedigit million sum. The companies, which are in global competition, are dependent
43
CELLULAR AGRICULTURE
European Biotechnology | Winter Edition | Vol. 22 | 2023
Total alternative protein industry forecast by year released
on an inflow of funds and smooth support in the race towards regulatory approval and market adoption. Numerous governments elsewhere in Europe have also recognised the potential of new production methods that might appear technical at first glance, but are sustainable at the second. In the Netherlands, which pioneered the development of cell-based meat, the government has earmarked €60m for cellular agriculture over the next few years, while the UK and France in 2022 invested £20m and €56m respectively in R&D and the decoupling of protein production from factory farming. The Finnish government also contributed to the €46m raised by Solar Food Oy, which produces singlecell protein by biomass fermentation directly from CO 2 and electrolysed water.
Institute (GFI), which supports the sector’s development, US$6.1bn of that came from alternative meat and seafood (up 8% from 2021) and US$21.6bn from sales of plant-based milk, cheese, and yoghurt (up 7%). However, because sales growth in plant-based products has been dropping, biotech developers of second- and third-generation products hope they can soon offer more attractive, tasty options.
The global race to the top
Hot on the tail of plant-based burgers, milk, cheese, fish and egg substitutes – which have so far left a lot to be desired in terms of flavour and price – the next waves of innovation are already rolling in. They involve protein and fat alternatives produced from organic waste side-streams by biomass and precision fermentation or cell culture. With the addition of species-specific secreted hemes pioneered by companies like Impossible Foods or Motif FoodWorks,
But biotech and foodtech companies are poised to spark a revolution in the food industry not only in Europe, where Maastricht-based Mosa Meat NV in 2013 presented the world’s very first beef burger from cell culture. In fact, it’s already begun, with plant-based alternatives to meat, fish and dairy products hitting global sales of US$27.7bn last year. According to the Good Food
“Brands need to tailor their messaging and marketing to clearly connect existing products to consumers’ emotional and functional needs.” Neeru Ravi, Principal, Boston Consulting Group
or the myoglobins attained by Belgium’s Palaeo NV through precision fermentation, alternative meat now tastes meatier. Alongside price, that’s still the most important purchasing criterion, even for environmentally conscious consumers. A new report released by FoodLabs in partnership with Dealroom, a global data provider, reveals that European food and agtech startups raised US$1.9bn in VC funding in 2022. It was the most active year ever, with a 20% increase over 2021. While plant-based meat alternatives have proliferated in recent years, industry experts say most would still not pass a blind taste test – particularly when it comes to replicating the texture of certain meat cuts, such as steak. However, fermented mycoprotein players believe fungi will be able to rise to the challenge. “We work with mycelium because it’s got structural and nutritional benefits. We can create a much more realistic muscle structure, and mycelium has huge nutritional benefits,” said Nick Wood, COO of UK-based startup Adamo Foods. Natalia Drost, Strategic Projects Lead at Hamburg-based Mushlabs GmbH (now Infinite Roots), which is culturing edible mushroom mycelium by fermentation of brewer’s pomace in cooperation with Bitburger brewery, claims that
Picture: © GFI from different sources
44
European Biotechnology | Winter Edition | Vol. 22 | 2023
common meat alternatives don’t work because they lack cysteine and threonine. The company competes with Quorn, whose fungus strain does not fall under the EU Novel Food Regulation. Mushlabs is planning to first launch mycelium-based meatballs, but also has fish and dairy products in its portfolio.
Singlecell producers like MicroHarvest, which kicked of a 25kg/day pilot plant in Portugal in November, believe its protein products can reach price parity with conventional ones. Market launch for pet food proteins is expected by 2025. Market watchers predict that once they achieve price and flavour parity
CELLULAR AGRICULTURE
with conventionally produced foods, sales of meat and dairy substitutes will end their current niche existence. Analyst firm Jefferies sees such novel foods generating annual sales of US$90bn in 2040, while consultants at Kearney estimate the market potential to be 100 times higher. Even though Deloitte re-
Biomanufacturing (finally) hits the policy headlines Europ ean biomanufacturing had a promising 2023. Not because we’ve seen a significant upscale, but because the issue finally made policy headlines in Europe in a meaningful way – hopefully one increasing momentum into the mandate of the European Commission following elections in 2024. And let’s face it, this is key to Europe’s competitiveness across major strategic points. When I last wrote here, EuropaBio was launching a Biomanufacturing Platform (see European Biotechnology Spring 2023), with the mission to represent biomanufacturing at the highest policy levels. It was launched just after the US Executive Order ‘Advancing Biotechnology and Biomanufacturing Innovation for a Safe, Sustainable and Secure American Bioeconomy’, the first in a flurry of US initiatives supported by the hefty financial clout of the Inflation Reduction Act. And the US is not alone. China, India and most recently the UK also have ambitious biomanufacturing programmes. All different but all with the same goal: to be a competitive leader for biomanufacturing.
Picture: © EuropaBio
STRATEGIC AUTONOMY
So has European biomanufacturing made the policy grade this year, in the face of accelerating global maneuvering for future economic and trade dominance? Despite a lukewarm start with the Net Zero Industry Act (NZIA), Europe picked up the biotech pace in June with the STEP regulation (Strategic Technologies for Europe Platform,
Claire Skentelbery, Director General, EuropaBio, Brussels.
see p. 13), where biotech is prioritised alongside deep and digital technologies, as well as cleantech. Whilst it unlocks no new money, it fences in and focuses funding towards the technologies deemed critical for Europe’s industry across sectors. Biomanufacturing found a voice in the September State of the Union address from Commission President Ursula von der Leyen, with a promised Biotechnology and Biomanufacturing Initiative to be published in Q1/2024. It holds the potential to address some of the key elements that lie within Europe’s power to unlock the biomanufacturing investment and scale required in this race. Will we see bold moves to create a framework and playing field for biomanufacturing? Finally, October completed the calendar, when biotechnologies were identified as a critical technology area for the EU’s economic security. It was included because of its transformative nature, and
ability for radical change and Member States will produce risk assessments by the end of 2023. These actions will fall under the shadow of the forthcoming Mario Draghi report, expected to focus strongly on Europe’s competitiveness. Whilst individually they may lack the crisp punch of a single federal initiative, they are recognition by the EU that it needs an economic Commission that makes the EU market work as a whole, rather than as 27 “bridged” markets with differing local conditions. Will it be enough? We’ll find out by monitoring industrial investments in Europe, with depth of investment into long term capacity that give Europe skin in the game of global supply chains and make it a player rather than a payer. Ask me again next year. Claire Skentelbery, Director General EuropaBio holds a PhD in biochemistry and has led industrial scientific networks and associations for almost 20 years, starting in the Cambridge UK biotechnology cluster. She was part of the founding team behind the Council of European BioRegions and the European Biotechnology Network and led the cross-sectoral Nanotechnology Industries Association before joining EuropaBio in 2020. In addition to her current role as Director General at EuropaBio, she is also the Vice Chair of the International Council of Biotechnology Associations (ICBA) and Governing Board Member for the Innovative Health Initiative (IHI).
45
CELLULAR AGRICULTURE
European Biotechnology | Winter Edition | Vol. 22 | 2023
Production process for the manufacture of plant-based protein alternatives (top) and those produced by precision fermentation (bottom)
search from 2022 predicted that plantbased protein alternatives would reach price parity with conventional products this year, and products produced by fermentation or cell culture would follow by 2025 and 2032, experts are sceptical. Experts from Brain Biotech AG, which is scaling up production with cheesebrewer Formo Bio, say that “prices between €30–€50/kg are a very ambitious estimate.”
Political support still missing Despite a potentially huge EU sales market, however, most developers – including those from Europe – are currently almost without exception looking to Asia, the US or the Middle East for approvals and production. That’s because it remains easier to raise money there for scaling up, while rapid market access is more likely than in the EU. “In both Singapore and the US, developers of cultured meat, fish and dairy products receive market authorisation in well under 12 months,” explains Ivo
Rzegotta, Public Affairs Manager at the Good Food Institute Europe. In the EU, on the other hand, authorisation under the Novel Food Regulation “only takes 18 months on paper, but significantly longer in practice,” he says. That’s one reason why many companies first seek authorisation where the process is faster and, above all, more reliable. The current negative record for EU food watchdog EFSA is 48 months for the approval of chia seeds under the Novel Food Regulation. And unlike in Singapore, developers don’t receive any specific guidance on which documents they need to submit for the safety assessment. Another special feature is that representatives from EU member states, the EU Commission and other stakeholders decide on EU market authorisation in the so-called PAFF Committee after the scientific safety assessment has been completed by EFSA. “A qualified majority is required for market authorisation, i.e. 55% of the votes of the Member States representing 65% of the population,” explains Rzegotta. Since this procedure
– for which there are no time limits – also makes market authorisation subject to political preferences, many financially weak EU-based SMEs prefer the more secure authorisation in Singapore or the US, but also in Switzerland or the UK. There the safety assessment is similar, but quicker due to the willingness of the competent authorities to engage in dialogue, and the subsequent authorisation decision is made on the basis of scientific facts. The example of Italy shows how susceptible the decision-making process is in the EU to political interests. At the beginning of November, the right-wing government under Giorgia Meloni made Italy the first country in the world to ban and penalise the marketing of cell-based products (see p. 10) in order to protect the interests of its farmers. Similar endeavours are underway in Romania. Together, the two countries represent around half the number of inhabitants that would be required for a blocking minority on the PAFF Committee. That example illustrates why the Good Food Institute is calling for more transparency in PAFF Committee decisions. However, according to Rzegotta, the think-tank doesn’t recommend changing the Novel Food Regulation, a battle that could take a decade. Instead, it supports national actions like that in the Netherlands, which eased pre- market tastings this year to allow Dutch companies to carry out fast-track approved pre-market tests in non-public environments (see European Biotechnology 03/2023). The UK and Switzerland are preparing similar national regulations to allow market adoption of product developers before EU market authorisation. Following Good Meat and Upsite Food’s US market launch, just one company (Germany’s InFamily Foods manufacturing subsidiary) has filed market authorisation at the EFSA: for a hybrid plant- and pork-cell based hot-dog. Protein producer The Cultivated B. are in presubmission phase of their dossier this September, and are now waiting for first feedback, which EFSA says will come due by April 2024. Solar Foods
Picture: © GFI Europe
46
European Biotechnology | Winter Edition | Vol. 22 | 2023
Oy will get feedback from the authority on its xanthobacter-based protein powder Solein in April 2024, two-and-a-half years after submitting its dossier. According to Rzegotta, three precision fermentation companies have also submitted a dossier to the EFSA: Perfect Day, Impossible Foods, and Remilk from Israel.
Fear of the great exodus
Picture: © PROJECT EADEN GmbH
The EU Commission, which is striving for greater strategic autonomy from food imports, is seriously concerned about increasing ‘authorisation tourism’ among European developers – not to mention the billions that could be lost if European companies move to places that provide more support. “Our biggest concern is that companies will leave,” stressed Adrian Leip (Head of Sector, Bioeconomy, DG Research & Innovation at the European Commission), at a stakeholder
meeting held at the headquarters of precision fermentation specialist Formo Bio in October. Like most EU companies, Formo is shooting for market authorisation of its first cheese product in Singapore next year. “We are thinking about how we can speed up the authorisation process,” Leip said. According to him, strong opposition against decoupling meat, milk and fish production by precision fermentation or cellular agriculture from traditional agriculture is coming from EU farmers’ organisations. Formo Bio CEO and co-founder Raffael Wohlgensinger says it can take three years to obtain market authorisation from the EU’s food watchdog EFSA. That explains the company’s conundrum: “In view of the next round of financing needed for scaling up production, the question is: do we stay here or go where it’s easier?” In milk-hungry Dubai, for example, the young Swiss CEO was offered €100m in
CELLULAR AGRICULTURE
aid to set up a production facility and €100m in equity capital. Funding for companies in the US on average is six times greater than in Europe. However, according to Rzegotta “th e times where all investments went to the US are over.” Solar Foods Oy tells a similar story. The Finnish company, which produces its protein powder Solein from atmospheric CO2 and electrolysing water, is currently building a commercial-scale plant for its single- cell protein. While Singapore granted marketing authorisation in 2022, less than a year after the application was submitted, the EU authority EFSA wrote that it would not decide on the safety assessment of an application submitted in October 2021 before April 2024. It’s impossible to tell why the EFSA needs so much time for the safety assessment. Some industry stakeholders say it’s because there’s no incentive for the food safety authority to do it faster.
The Berlin start-up Project Eaden uses 3D printing to link plant-based meat fibres with fat threads in order to copy the texture of meat.
47
CELLULAR AGRICULTURE
In response to a question posed by European Biotechnology, Leip had no answer as to why practices in Singapore are not simply copied. The city-state, which is poor in agricultural land and 90% dependent on food imports, has declared 30% import autonomy a priority. It’s exerting pressure in a completely different way than Europe – just like China or the US do. There biotechnology has been a high priority technology since 2022.
Asia on the offensive The Asian-Pacific cellular agriculture food association APAC and GFI APC will further advance the regulatory approval of cultured meat in the region. Launching at the Singapore International Agri-Food Week, a group of eleven stakeholders from nine countries signed a memorandum of understanding to establish a forum to help develop nations’ regulatory frameworks via increased data and knowledge-sharing between countries, streamline review processes for companies hoping to enter multiple markets at once, and reduce trade barriers. These include GFI India and Isra-
European Biotechnology | Winter Edition | Vol. 22 | 2023
el, Cellular Agriculture Australia, Japan Association for Cellular Agriculture, Cell AgriTech (Malaysia), University of Brawijaya (Indonesia), Future Ready Food Safety Hub (Singapore), Society for Food Sustainatech (South Korea), and law firm Dentons’ China branch. Of the 156 core companies worldwide known to be working with cultivated meat and seafood, 37 are active in Asia, whilst 42 are US-headquartered firms. From the 136 companies, that were producing meat, fat, fish or dairy products, 63 did so via precision fermentation, 70 via biomass fermentation. In 2022, 55 of the firms were located in Europe, 42 in the US, 21 in Asia and 11 in Israel. More than 100 additional companies have joined the industry through partnerships or business-to-business (B2B) product or service offerings.
Europe as a potential market In 2022, Germany was by far the largest market in Europe for protein foods produced without animals. Sales of €1.9bn there topped the UK (€1.1bn), which ranked second in European turnover. Germany actually ranked twice – it also
came in as the country with the most sceptical consumers when it comes to food innovations or genetically-engineered ingredients. More surprising perhaps is that German consumers are open to dairy products, fish and cheese produced using optimised microorganisms and cell-based processes. According to recent surveys, 57% of over-25s and 82% of under-25s would at least like to try them. That’s 30% more than in the US, surveys reveal. Greater animal welfare plays a role in that, but also CO2 savings, a lower footprint for agricultural land, fertiliser, pesticides, animal feed and 65% less water. All that makes precision fermentation and cell-based alternatives attractive to many consumers in an era of climate crisis. “Acceptance is not the problem,” emphasises Rzegotta. “Europe is catching up, but Germany is only attracting 1.6% of investments despite its strong market position (...) The next five to six years will be decisive for market success of EU companies,” he believes. Time to act for national governments – to cushion the fear-based EU authorisation and investL ment climate. t.gabrielczyk@biocom.eu
Alternative protein consumption will grow in three waves, according to the study “Food for Thought: The Protein Transformation” released by Boston Consulting Group (BCG) and Blue Horizon. Analysts believe that alternative proteins must reach parity with animal proteins in three key areas: aste, texture and price. In 2020, 574 million metric tons of animal-based meat were consumed.
Picture: © BCG
48
European Biotechnology | Winter Edition | Vol. 22 | 2023
ADVERTORIAL
Scaling precision fermentation To address the demands of a growing population and enhance food and nutrition security, a transition from traditional chemical-derived production is essential. Biomanufacturing, known for its efficient use of natural resources, offers an ideal solution. Acies Bio recently added fermentation capacity and more versatile equipment for downstream processing and formulation.
BRINGING FERMENTATION TO MARKET
The global demand for new fermentation technologies is rapidly growing, yet the capacity to meet this demand lags behind. Acies Bio, a leading European microbial biotechnology company, is addressing this issue with a pilot facility boasting a fermentation volume exceeding 35 m3. Equipped to handle a broad range of fermentation volumes, from 1L to 10,000L, Acies Bio is wellprepared. The team of skilled scientists and bioprocess engineers possesses extensive expertise with diverse microbial species, including bacteria, yeast, filamentous fungi, and more exotic microbes.
Picture: © aciesbio
Scaling biomanufacturing Fast scale-up of fermentation and isolation processes is crucial for introducing new products to the market. Acies Bio combines state-of-the-art fermentation capabilities with a diverse range of downstream processing (DSP) equipment, enabling the seamless execution of even the most complex operations in one location. This integrated approach not only saves time but also optimises resources. In many cases, downstream processing plays a pivotal role in ensuring the effective performance of new technologies. Acies Bio's expertise extends to biomass separation techniques such as centrifugation and filtration, cell disruption, solvent extraction, precipitation, and various
Acies Bio offers efficient development and scailing of microbial technologies.
chromatographic steps for final purification. Additionally, the company specialises in diverse drying approaches for live microorganisms, including vacuum drying, spray drying, fluid-bed drying, freeze drying, and encapsulation. This extensive knowledge, coupled with cutting-edge technology and strong in-house analytical support, positions Acies Bio as an ideal research and development (R&D) and smallscale Contract Manufacturing Organisation (CMO) partner, ensuring high productivity for various microbial prod-
ucts and maintaining favourable goods costs (COGS) throughout their lifecycle. Acies Bio recently formed a strategic partnership, enhancing its CMO capabilities with an additional fermentation capacity of up to 200 m3 (4 x 50 m3) within the EU-based One-Stop-Shop offering. This expansion facilitates a streamlined development process for microbial technologies, from concept design to biomanufacturing, effectively addressing scalability challenges in a time- and cost-efficient manner. The R&D team, fortified by this strategic partnership, focuses on developing a robust strain, bioprocess, and downstream scheme, ensuring efficiency and reliability. This approach allows a seamles scale-up to meet demand without protracted technology transfer steps or unexpected legal obstacles. With the combined R&D and production expertise, Acies Bio is dedicated to supporting partners in enhancing sustainability and expanding their innovative microbial-based portfolio. Choose Acies Bio for a reliable and efficient path to innovation in sustainable microbial-based products. Contact us: ACIES BIO D.O.O. TEHNOLOŠKI PARK 21 1000 LJUBLJANA SLOVENIJA +386 59 075 995 E-Mail: info@aciesbio.com
49
INSIGHT EUROPE
European Biotechnology | Winter Edition | Vol. 22 | 2023
Spanish EU presidency bets on biotech solutions The Spanish EU Council Presidency wants to leverage the potential of the biologisation of medicine and food production. In order to ensure the internationally competitive use of biotech in drug development, breeding and food production, the Spanish presidency aims to pass laws this year to ensure the strategic autonomy of the EU in the agricultural and food industry through the use of new genomic techniques and in the biopharma, chemical and traffic sectors.
BIOSPAIN
At BioSpain 2023 in the catalan capital Barcelona, several panels discussed the Spanish EU Presidency’s goal of setting the course for the internationally competitive use of biotechnology in drug development, plant breeding and food production through a new non-bureaucratic legal framework. Thirty pre-selected start-ups demonstrated new approaches to make drug development more effective and to decarbonise food and industrial production. Experts agreed that the reform of EU pharmaceutical legislation and deregulation of new genomic techniques in plant breeding are crucial for EU biotech companies to catch up with leading biotech nations such as the US and China.
the key points of the expected Council position before it makes its own decision in January. The aim is for the Council, Parliament and Commission to reach an agreement more quickly in the subsequent trialogue. The Slovak Republic, Hungary, Poland, Croatia and Cyprus argued in favour of the EU states being able to continue to decide for themselves whether or not NGT plants may be cultivated on their territory. France and Lithuania demand this for so-called NGT2 plants, which must be safety-checked and labelled, but which the Commission can order to be cultivated if there is positive experience with cultivation from other countries. A total of eleven EU member states, which
want to ban NGT plants in organic farming before the (Germany) or in the Agriculture Committee.
BioSpain opens gates Two months earlier, at the openings of the record-breaking BioSpain, Ion Arocena, CEO of the meetings’ co-organiser AseBio had stressed: “It’s time to place biotechnology at the core of a new, more sustainable European growth model. Europe needs to boost investment in R&D and enabling infrastructure, generate and grow innovative [biopharmaceutical] companies, and increase biomanufacturing capacity”, particularly in the emerging markets for precision med-
Another Inflation Reduction Act? At the end of November, it became clear that Spain is serious about orienting the EU industry towards biotechnological solutions rapidly. Though at first reading, EU agriculture ministers were split about a Council-adapted version of the EU Commission’s deregulation proposal on the use of new genetic techniques (NGT) in plant breeding, which is supported by trade, Spain wants to speed up the decision about the draft. The Council Presidency first wants to adopt a socalled "general approach" in the Agriculture Council on 12 December, before Belgium takes over the Council Presidency in January. Such a general approach serves to speed up the legislative process by informing the European Parliament of
Ana Polanco Alvarez, President of AeBio at the opening of BioSpain 2023
Picture: © AseBio
50
European Biotechnology | Winter Edition | Vol. 22 | 2023
Picture: © Alexandros Michailidis, © UE
icine, mRNA, and & gene therapies. Until December, the Spanish EU Presidency will push to allow the deregulated application of New Genomic Technologies to bred climate-resilient crops, explained Arocena, and to design microbes that produce food, chemicals and energy carriers such as biomethane and other bio(tech)fuels more sustainably. A planned reduction in EU bureaucracy is intended to significantly cut approval times for novel foods, such as climate and animal-friendly cultured meat, fish and dairy products, which are at least twice as long in Europe as in the US and in Singapore, and to keep the beckoning billions of euros in sales for the globally emerging industry in the block. At BioSpain 2023 in Barcelona, more than 80 institutional investors gave a clear signal that they see European biotechnology as an important investment target, evidenced by start-up pitches in the segments drug discovery & delivery, diagnostics, agri-biotech as well as food & nutrition, with more than 30 pre-selected start-ups presenting. With 2,100 visitors, 1,000 companies, 220 exhibitors and 5,000 partnering meetings, BIOSpain 2023 was, according to Arocena, “about 30% up compared to all figures of BioSpain 2018, the last in presenceevent before the pandemic – breaking all previous records. It was a true showcase of European innovators in pharma, agriand industrial biotech.” By the time of the next BioSpain in two years, he said, Europe must manage to have an appropriate regulatory framework in place for biotechnology. “It is time to act now,” Arocena stressed. Reciting study results commissioned by the European Pharma Federation EFPIA, Raquel Tapia, General Manager of Sanofi Spain, called for targeted investments into European biomedicine clusters instead of green field funding.
Cutting red tape ”To expand clusters in Europe and enhance the global competitiveness of the biotechnology sector, there must be a strong commitment to it, both from the
INSIGHT EUROPE
"The supply of safe, nutritious food of sufficient quality and quantity is a global challenge for the whole planet," said Luis Planas Spain’s Minister for Agriculture and Fisheries at an informal agri-council meeting in September.
public and private sectors. It needs to be done urgently because Europe needs to regain its competitiveness in R&D compared to other regions of the world.” Clusters play a key role as a link between those who have the capacity to finance projects and those with the capacity to develop innovations. ”We must learn from what is happening in other regions like the United States, where their biotechnology cluster combines leading academic institutions, scientists, and industry, including robust technology transfer mechanisms that allow the rapid translation from academic laboratories to research and, subsequently, large-scale development with investment and resources,” she concluded. Additionally, Europe and the UK must speed up the approval and conduction of clinical trials for biologics, cell and gene therapies and modernise the application of its regulatory framework. CRO specialists told European Biotechnology at BioSpain that Spain has outperformed the UK in terms of speed and quality in recent years due to model contract clauses that speed up agreements of study sponsors and hospitals and by cutting red tape. Making industrial and food production
more sustainable by biotech processes was another major focus at BioSpain. ”The bioeconomy is undergoing rapid transformation thanks to revolutionary advances in biotech,” said Víctor Guallar, CSO, and co-Founder of Barcelona-based AI-based drug discovery, enzyme engineering and nucleic acids design specialist Nostrum Biodiscovery Srl. The same could happen in precision fermentation and cellular agriculture in Europe. In mid-September, German InFamily Foods filed the first application for pre-market approval in the EU for a product from cellular agriculture, which provides significant savings in area, water, pesticide and fertiliser consumption along with a better CO2 footprint. However, approval times for cultivated meat, fish and dairy products made by precision fermentation are much shorter (less than 12 months) in Singapore and the US compared to the EU, where the EFSA bureaucracy needs 18 to 48 months for market approval. EU Foodtech SMEs thus are calling to cut the red tape at the EFSA and for the abolition of the Member States’ vote on the safety of their novel foods in the final step before market authorisation, because the safe-
51
INSIGHT EUROPE
European Biotechnology | Winter Edition | Vol. 22 | 2023
AseBio Director General Ion Arocena, General Director of Biocat, Robert Fabregat.
ty of the products have already been extensively reviewed before this step.
Path towards biologisation Genome editing and synthetic biology drive the development of new biological products and processes and circularisation saving huge amounts of waste produced by the currently dominant linear fossil-based consumption and waste concept. According to Nostrum-CEO Guallar, finally, AI and supercomputing techniques will accelerate progress, harnessing the benefits of new biotechnologies.” However, the emerging suppliers of novel foods need a lot of support and communication campaigns to convince consumers that their products are no more synthetic than conventional foods, which are perceived as natural due to decades of advertising campaigns. In contrast, novel foods excreted by bioengineered microorganisms and grown in huge fermenters, which are perceived as non-natural, are much more sustainable, animal-friendly and healthier than the "unnatural" images in our minds would have us believe. Targeted breeding through New Genomic Techniques (NGT) could also contribute to more sustainability of agriculture. Biotech offers the hope to speed up targeted trait
generation. An often cited example is crops produced by NGT that are more resilient to abiotic and biotic stress thus better adapted to the consequences of climate change mainly produced by the G20 states which are responsible for estimated 80% of global CO2 emissions. ”Climate change is exerting significant pressure on the food production system, so ensuring food security and mitigating its effects will not be possible without innovation in agriculture, which includes the use of new techniques like genetic editing,” stressed Richard Borreani, the Public Affairs and Sustainability Manager of Bayer Crop Science at BioSpain. At the food session of BioSpain, Maria Sada, Head of EIT Food Education Programs for UAM-IMDEA Food in Madrid, said that plastics and chemicals have made many problems in the past. “Now we have sustainable solutions that are perceived as dangerous because we use genetically engineered bacteria that secrete proteins, fats etc. Maybe it would be a good idea to give more information to the public so they can see that is a one-sided view. At the green start-up pitch, sponsored by Bayer Crop Science, selected biotechs presented futuristic approaches how biotech can contribute to better medicines and more sus-
tainability. In line with the drafted EU plastic packaging regulation, PHA specialist Biodriven Technologies said that bacterial bioplastics could significantly reduce the eight million tons of not degradable plastics entering the oceans annually. The company’s CBO Alvaro Caselanos Caro reported that PHA production could be circularised and that the polymer degrades completely. The company will start mass production in 2027 latest. A ready-to-use concept to reduce the 31% food waste by monitoring the shelf-life of pharmaceutical and other perishable products was presented by Luia Chimeno, CEO of the startup Oscillium in Barcelona. The smart labels show the shelf life of the products like a traffic light and lead to a 30% cost reduction and 20% higher profitability by saving waste. A futuristic approach to using broccoli waste was presented by Miguel Marquez, CEO of Ingredalia SL. The start-up has been producing freeze-dried vitamin-rich pills from the extracted recyclables since 2021.
Focus on biopharma start-ups Whether the ten start-ups selected by Ysios Capital from hundreds of applications for the drug discovery/delivery pitch will soon become portfolio companies of the 80 institutional investors at BioSpain remains to be seen. But the first-in-class approaches of spin outs such as Palo Biofarma (asthma), Bold Therapeutics (gastrointestinal diseases), Gyala Therapeutics (AML), Remab (AMR), ZeCardio (cardiomyocyte regeneration), Neurofix Pharma (neuropathic pain), Neurofix Pharma (Friedreich’s ataxia), D-Sight (diabetic retinopathy), Incliva (repurposed, reformulated and cheap SMA drug) and Laminar Pharmaceuticals (glioma), are now enjoying high visibility. Arocena told European Biotechnology he hopes to see all ambitous regulatory attempts to create a clustered, debureaucratised and more competitive sector become reality until next BioSpain L in 2025. t.gabrielczyk@biocom.eu
Picture: © AseBio
52
Euro BioFairs Compass 1st half-year 2024
© Rochak Shukla - Freepik.com
II Guide to Life Sciences Events
SPECIAL
54
EURO BIOFAIRS COMPASS
European Biotechnology | Winter Edition | Vol. 22 | 2023
24th and 25th January Porte de Versailles, Paris France
Pharmapack 2024 P HARMAPACK Pharmapack is Europe’s largest event dedicated to the pharmaceutical packaging and drug delivery industries. With an extensive c onference agenda, it provides invaluable opportunities for networking and showcasing innovations.
Pharmapack 2024 is taking place on 24th25th January 2024 at Paris Expo, Porte de Versailles, Paris, France. It will bring together nearly 5500 pharma executives from more than 75 different countries and more than 350 exhibitors at the heart of the pharma packaging and drug delivery industry. Beyond the exhibition floor, there will be several sessions delivered by industry experts that will take place over the
2-day event to discuss the very latest market trends in the drug delivery space. Running alongside will be workshops and the returning ‘innovation gallery’ which will showcase exhibitor innovations providing a window on the latest trends and cutting-edge developments. The ‘learning labs’ will provide an opportunity to hear from different exhibitors on their research and products.The show floor will also feature Start-up hub, a platform
Heart of pharma
industry is seeking new partnerships and displaying greater openness in its criteria for consideration. Companies of all sizes are aiming to expand their networks and secure their supply chains. Pharmapack 2024 will bring together industry thought leaders, experts, and exhibitors to share knowledge, insights, and cutting-edge research. Our carefully curated events aim to facilitate networking and inspire attendees to innovate and contribute to the advancement of the industry.
GREETING Pharmapack 2023 concluded with the drug delivery and packaging community anticipating significant growth through 2023, driven by sustainability initiatives and innovations. One major trend this year is the marriage of connected devices with sustainability goals, with even smaller companies embracing this approach. The
Laura Murina Brand Manager, Pharmapack
for young start-up companies to exhibit their innovations, providing for valuable brand visibility. All these sessions will be streamed for online audiences. Inperson attendees can also participate in guided expert led walk-throughs on the ‘innovation tours’. The much-awaited Pharmapack Awards will return this year celebrating the best products and innovations from the pharma packaging world in two categories of ‘exhibitor innovation’ and ‘health products’- with an awards ceremony on 24th January. “The great thing about Pharmapack is that it remains the absolute heart of the drug packaging and delivery industry. The 2024 edition will feature three new zones including a French Pavilion– bringing partnering opportunities for French innovators and manufacturers” added, Laura Murina, Brand Manager, Pharmapack. L
› QUICK FACTS In 2023 some 5,000 attendees from over 250 companies and 78 countries descended on the Paris Expo for what was one of the most convivial exhibitions in memory. Contact https://www.pharmapackeurope. com/en/content-programme/callfor-speakers-2024.html Registration www.pharmapackeurope.com
24-25 January 2024 Paris, France
Pharmapack by CPHI 2024 is unveiling three new zones We are introducing three new zones next year: biopackaging, packaging services, and the French pavillion. Scan the Code to Learn More About Pharmapack’s Three New Zones
At the heart of Pharma
EURO BIOFAIRS COMPASS
European Biotechnology | Winter Edition | Vol. 22 | 2023
18–20 March 2024 Barcelona Spain
BIO-Europe 2024 ®
BIO-EUROPE SPRING Join the BIO-Europe Spring, the premier springtime life science partnering conference, taking place in the vibrant city of Barcelona, Spain, from March 18-20, 2024.
The eighteenth annual BIO-Europe Spring®, the premier springtime partnering conference, will be taking place March 18-20, 2024, in Barcelona, Spain. Expanding on the success of EBD Group’s flagship conference, BIOEurope®, BIO-Europe Spring will bring together over 3,700 leading executives from around the world. Specifically, more than 20,000 partnering meetings will be hosted to connect leaders from academia, start-ups, and young biotech companies with forward-thinking investors and pharma companies. Explore world-class workshops, thought-provoking panels, and innovative company presentations, while delving into an active exhibition showcasing cutting-edge technologies and services. The variety of networking opportu-
› QUICK FACTS Registration www.bioeuropespring.com Save €700 when you register before January 31, 2024
nities make this event an unrivalled forum for companies across the biotech value chain to connect, collaborate, and drive innovation. The partnering platform, partnering ONE®, continues to be the gold standard of connection. Scheduled meetings will take place face-to-face during the conference days as well as digitally during the digital partnering days, March 26–27, 2024. Additionally, on demand content will be made available leading up to the event as well as during the digital days. Using a single login, delegates can experience the digital portion of the event from anywhere, including one-to-one meetings L and conference activities.
Come to Barcelona GREETING For this year’s event, we are pleased to be hosted by Biocat. Barcelona serves as an ideal setting for BIO-Europe Spring due to its unique combination of vibrant culture, cutting-edge research, and a thriving life sciences community. This cosmopolitan city offers a dynamic environment that enhances collaboration and innovation in the biotechnology and healthcare sectors. We look forward to welcoming you to Barcelona for Europe’s “must-attend” springtime partnering conference this March! Claire Macht EBD Group
Pictures: EBD Group
56
March 18–20, 2024 | Barcelona, Spain
Connecting the global biopharma community to elevate life science partnerships The 18th annual BIO-Europe Spring will take place March 18–20, 2024 in Barcelona, Spain, and it will convene over 3,700 life science professionals representing more than 2,000 companies from over 60 countries. Attendees will take part in 20,000+ one-to-one meetings over the course of the event.
Produced by:
In collaboration with:
Register before January 31, 2024 and save up to €700! bioeuropespring.com
EURO BIOFAIRS COMPASS
European Biotechnology | Winter Edition | Vol. 22 | 2023
April 22-23, 2024 Congress Center Basel, Switzerland
Swiss Biotech Day One of Europe’s premier biotechnology conference in Basel will attract about 2,000 professionals from the global life sciences community.
SWISS BIOTECH DAY 2024
› QUICK FACTS This year, the Swiss Biotech Day set a new benchmark with close to 1,800 participants from 44 nations. In 2024, it will once again provide a platform for networking, engaging discussions, and the exploration of advancements in R&D, manufacturing, data management, artificial intelligence, and innovative financing. Equally attractive for biotech companies, their suppliers, investors and pharma partners, the biotech conference will again stage high-level experts from the life science industry and offer space for networking during one and a half day. Partnering allows to take advantage of opportunities and synergies arising from the close collaboration between biotech and phar-
REGISTRATION swissbiotechday.ch Phone: +41 52 569 82 27 register@swissbiotechday.ch HIGHLIGHTS
› Meet about 2,000 senior experts from the life science industry
› Thematically focused panel disma, or to find interesting partners for future projects and jointly drive the development of innovative products and platform technologies. International biotech delegations use the „Global Village” to strengthen their ties with Switzerland as a biotech hub and promote cross-border investments, public-private partnerships, research and development collaborations and exchange of talent. The program will be presented in English with thematically focused panel discussions. Exhibitors, the celebration of the Swiss Biotech Success Stories award winners, and company presentations, as well as an excellent catering complement the cornerstones of L the event.
cussions and company pitching sessions › Pre-scheduled one-to-one partnering meetings › Innovative biotech start-ups and medium-sized biotech companies › More than 100 exhibitors and Global Village with international delegations from all over the world › Swiss Biotech Success Stories Awards › Swiss Biotech Report 2024 with the most important facts, trends, innovation factors and sources of innovation in the Swiss biotech industry › General Assembly of the Swiss Biotech Association
Pictures: © Swiss Biotech Association
58
© Swiss Biotech Association
Save the date
!
SWISS BIOTECH DAY
22
April 22-23, 2024
... ONE BIOTECH CLUSTER Congress Center Basel
As one of the leading biotechnology conferences, the Swiss Biotech Day has developed into a truly global networking day, attracting many international delegations.
What you can expect: › Meet 1,800+ senior experts from the life science industry › 70+ exhibitors and Global Village with international delegations from all over the world › Swiss Biotech Success Stories Awards sector is internationally visible. The project-specific “WHITE BIOTECHNOLOGY” GROUPand medium-sized biotech participating companies (most of them young and inSWISS BIOTECH... › InnovativeWORKING biotech start-ups companies ternationally less savvy) find a comprehensive partner › Thematically focused panel discussions which is helping to put them in the public window. Leading chemical companies are exploring the op...is an alliance of four leading Biotech reg Regions are important portunities that have been opened up by modern bio- The participating Life Science › Swiss Biotech Report 2024 Sign in on our website at Switzerland (Bio Alps, BioPolo Ticino, Bas carriers of the dynamics in the Biotech sectechnology, especially in the field of “white” or indusGreater Zurich Area). They have comb › Pre-scheduled one-to-one partnering meetings internal www.swissbiotechday.chand tor, thus enhancing the common understanding of the trial biotechnology. And they are also applying these forts to streamline interests of the national › General Assembly the Swiss stay isupdated about any news. knowledge brought into technologies,of wherever it makesBiotech sense. TheAssociation SBA takes industry. This and moreand sector. The SWX Swiss Exchange holds a
Europa Bio, the European Biotech Association, where such initiatives seriously and has formed a working the SBA is an active member. group specifically dedicated to white biotechnology. The Swiss Industrial Biocatalysis Consortium is an important partner in this effort. The group includes leading multinational companies that support white biotechnology as a pillar of economic growth. The Media partners: planned activities are in agreement with OECD strategies. In partnership with the Swiss Biotechnet (see pages 14/15) the SBA develops training programmes and useful support tools for the industry. It is of importance that the industry specifies its training needs so that the academic side can create tailor-made education. Host: Swiss Biotech Association | Marketing: BIOCOM Interrelations GmbH | Event Organization: bamconn GmbH This strategy ensures that the industry gets the right Domenico Alexakis workforce with the right education. The SBA profits is Executive Director from the marketing alliance “Swiss Biotech” (see box) of the Swiss Biotech in a multiplied form. Thanks to Swiss Biotech, the Association.
position in terms of lifescience listings and companies from that industry – be they loc Switzerland or abroad – access to an inter ly recognised financial marketplace. The in was co-founded by the SBA which also ma the executive office of Swiss Biotech. Host:
For further information p www.swissbiotechasso www.swissb
60
NORTHERN EUROPE
European Biotechnology | Winter Edition | Vol. 22 | 2023
Full coffers for Nordic biotechs
AI exchange ARTIFICIAL INTELLIGENCE Researchers at Karolinska Institutet and governmentfunded research organisation SciLifeLab are using artificial intelligence (AI) techniques from satellite imaging to analyse extensive data from tumour tissue. The approach addresses the challenge of interpreting the vast amount of data generated by recent advances in tumour imaging. Traditional AI methods often operate as “black boxes,” lacking clear explanations. Thus, the research team turned to well-established analysis techniques from satellite imaging and ecology. “We realised that the interpretation of tumour images is similar to the interpretation of satellite images and that the relationships between cells in a tissue are similar to the relationships between species in ecology,” explains Jean Hausser, senior researcher at the Department of Cell and Molecular Biology, Karolinska Institutet, who led the research. “By combining techniques used in satellite imaging and ecology and adapting them for the analysis of tumour tissue, we have now been able to turn complex data into new insights into how cancer works.” The scientists published their findings in Nature Communications (DOI: 10.1038/s41467023-42878-z). They now plan on applying their method in clinical trials. The researchers are collaborating with a major cancer hospital in Lyon, France, and the Mayo Clinic to analyse patient responses to cancer treatment. “The long-term goal is to be able to tailor cancer treatments to individual needs and avoid unnecessary side effects,” says Hausser.
FINANCINGS Funds were flowing for many Northern companies this fall. MinervaX ApS, a privately held Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), completed a €54m upsized financing. The financing includes investment from new investors EQT Life Sciences and OrbiMed, with participation from existing investors Novo Holdings, Pureos Ventures, Sanofi Ventures, Trill Impact Ventures, Adjuvant Capital, Wellington Partners, Industrifonden, Sunstone LifeScience Ventures, and LF Invest. This financing will enable MinervaX to progress its novel GBS vaccine towards Phase III clinical trials. Medivir, a Swedish pharma company focusing on the development of innovative treatments for cancer in areas of high unmet medical need, resolved to carry out a new issue of shares of approximately SEK148m (around €13m). The funds will finance the continued follow-up in the phase Ib/II study of Medivir’s lead asset, fostroxacitabine bralpamide (fostrox), as well as the acceleration of preparations for the pivotal Lenvima + fostrox study. Oslo-based Nykode Therapeutics ASA raised NOK505m (around €43m) in a Private Placement through the allocation of 29,549,400 new shares. Nykode intends to use the proceeds to advance clinical studies of its lead compound VB10.16, an immunotherapy targeting malignancies caused by the cancer inducing Human Papillomavirus 16, continue the expansion of its pipeline, and accelerate research activities. Finnish protein maker Solar Foods closed an oversubscribed €8M Series B financing, led by Finland’s Springvest Oy. The company will expand Solein protein production and support the construction of a commercial production plant. Lauxera Capital Partners invested €17 million in Swedish biotech BioLamina AB, which specialises in recombinant proteins supporting the maintenance, expansion, and differentiation of stem cells and pri-
mary cells for both research and therapeutic purposes. Abera Bioscience, a Swedish novel vaccine platform company, received a £1.8m (around €2.1m) funding award from the UK Vaccine Network programme. This non-dilutive funding is awarded to Abera’s project, titled “Novel OMV vaccine platform for quick response to Disease X”, aimed at enhancing pandemic preparedness. Modus Therapeutics Holding AB raised SEK60.6m (€5.3m), through a Rights Issue of SEK40.3m and an Offset Issue of SEK20.3m. The money will finance a clinical phase IIa study in anaemia of chronic kidney disease and other other clinical activities. Stockholm-based Sigrid Therapeutics secured US$4m (€3.65m) in an oversubscribed funding round. The funds will be used in accelerating the commercialisation of the company’s flagship product SiPore, an orally-administered medical device for the safe reduction of blood sugar levels in people at risk of developing diabetes, prediabetics, and newly diagnosed type 2 diabetics, across diverse markets
Vaccine launch MPOX Bavarian Nordic A /S announced that the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has voted to recommend routine use of JYNNEOS, the company’s FDA-approved mpox vaccine, in adults at risk of mpox infection. With an estimated 2 million eligible individuals in the US, Bavarian Nordic aims for a commercial launch of JYNNEOS in the first half of 2024. “The broadened ACIP recommendation recognises the significance of maintaining a high awareness of the disease among risk groups and the importance of ensuring broader access to the vaccine beyond an outbreak situation,” said Paul Chaplin, President and CEO of Bavarian Nordic.
European Biotechnology | Winter Edition | Vol. 22 | 2023
Rich pickings for Novo Nordisk SEMAGLUTIDE Novo Nordisk A/S’ anti-obesity drug Wegovy (semaglutide) has been making headlines across the world since it was approved for the treatment for chronic weight management. It comes as no surprise that Novo Nordisk’s sales increased by a third to DKK166.4bn in the first nine months of 2023. Now, all signs point to another label expansion for the drug: The company’s FLOW trial, investigating the effectiveness of semaglutide in diabetic patients with chronic kidney disease, has been halted ahead of schedule due to interim results indicating effectiveness. While Novo Nordisk will remain blinded to the data until the trial’s completion, the promising findings are expected to boost sales of its subcutaneous glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the type 2 diabetes and obesity markets. According to analysts at G lobalDa ta, there are significant sales in store for the compound, which is marketed as Ozempic in Type 2 diabetes and Wegovy in obesity. Global Data forecasts sales reaching US$2.1bn and US$8.1bn
by 2031, respectively, in the US market. Positive trial results in the FLOW trial suggest the drug may also be used to treat patients with chronic kidney disease. In addition, Novo Nordisk has already announced that a label expansion is underway in the US to include the use of semaglutide for cardiovascular risk reduction. The FDA granted priority review for the company’s application in this indication. In November, a study published in the New England J ournal of M edicine, funded by Novo Nordisk, further underlined semaglutide’s effectiveness against heart attacks and strokes in patients that were overweight, obese or had preexisting cardiovascular disease but without diabetes (doi: 10.1056/ NEJMoa2307563). However, the distribution of the drug may still present challenges due to ongoing supply shortages of semaglutide. To counter these hurdles and increase Novo Nordisk’s ability to meet future market demands, the company announced a planned investment of DKK42bn in its Kalundborg facilities, etc. (see p. 32)
NORTHERN EUROPE
NEWS Microbiome service Microbiome bioinformatics company Clinical Microbiomics A/S has merged with CosmosID Inc, a USbased CLIA-certified microbiome CRO. This merger creates the world’s first microbiome service company with the aim to assist scientists globally in understanding the microbiome’s impact on health. Clinical Microbiomics is continuing on its trajectory of rapid expansion. Just a year ago, the company merged with metabolomics company MS-Omics.
Genome understanding The Finnish Genomics Initiative FinnGen has successfully collected and generated genomic data from 500,000 individuals. Now, the project enters its next phase with €52m of new funding. In this phase, the data collected will be analysed to understand disease mechanisms and disease progression. In addition to public funding, the project is supported by 13 biopharmaceutical companies.
Picture: wildpixel - istockphoto.com
Overcoming resistance Scandion Oncology A/S has revealed positive results from part 2 of its CORIST phase IIa trial, demonstrating prolonged survival for patients with metastatic colorectal cancer treated with SCO-101, Scandion’s lead compound that inhibit the drug efflux pump and cancer stem-cell marker ABCG2. The patients, who were lacking other active treatment options, showed a median overall survival of 10.4 months, a substantial improvement compared to historical data. Biocoal created from seaweed
61
62
WESTERN EUROPE
European Biotechnology | Winter Edition | Vol. 22 | 2023
TALENs for gene therapy
Globalisation LICENSING Paris-based Pierre Fabre Laboratories SA has extended its global partnership with US-based Atara Biotherapeutics Inc., licencing tabelecleucel commercialisation rights for Northern America. The French drug maker already licensed the commercialisation rights for the EU-approved allogeneic T cell based second-line treatment of adult and paediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a rare, acute, and potentially deadly haematological malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression. The orphan disease has a median survival of 0.7 months. Under the new extended licence agreement for the US and Canada, where the BLA for tabelecleucel is expected in Q2/2024, Atara will receive up to US$640m and double-digit tiered royalties on net sales from Pierre Fabre Laboratories. In addition, Pierre Fabre has agreed to pay all expected global development costs. Near-term payments to Atara including US$30m in cash upfront and initial inventory purchase at closing as well as US$100m in potential regulatory milestones through BLA approval. The geographical expansion of the licensing rights encompasses the USA, Canada and all remaining territories. Pierre Fabre Laboratories acquired the rights for Europe in October 2021.
DRUG DEVELOPMENT AstraZeneca plc has paid French cancer cell therapy developer Cellectis SA US$25m upfront and US$220m in equity in an US$2.2bn R&D deal for up to ten cell and gene therapies. Under the co-development agreement, that includes a US$80m equity investment and an option for a further equity investment of US$140m by AstraZeneca plc into Cellectis SA, the French TALEN specialist initially is set to receive up to US$245m in cash with the potential for additional milestones and tiered royalties for providing 25 genetic targets and its gene editing platform and allogenic CART cell manufacturing platform to develop drug programmes in indications such as oncology, immunology, and rare diseases. AstraZeneca will have the option to select and license ten of the targets and resulting candidate products before IND filing. Additionally, the Swedish-British pharma giant will fund Cellectis’ research costs and pay US$25m upfront. Cellectis is eligible to receive an inves-
tigational new drug (IND) option fee and milestone payments ranging from US$70m–US$220m for each of the ten candidate products plus tiered royalties. AstraZeneca committed to initially subscribe 16 million of Cellectis ordinary shares (at $5 per share) by 6 November for a total of US$80m resulting in 21% of voting rights, 22% of share capital, and the right to nominate a non-voting observer on Cellectis’ Board of Directors. Furthermore, AstraZeneca will have the right to participate pro rata in future share offerings of the French company. A non-binding memorandum of understanding includes the option for AstraZeneca to acquire 10 million convertible preferred shares with single voting right and 18 million convertible preferred shares without voting rights at US$5 per share, which would result in an ownership of 44% of Cellectis share capital and 30% of voting rights. Cellectis’ programmes UCART22, UCART123, and UCART20x22 will not be affected by the agreement with Astra Zeneca.
Bet on TLA1 blockers Roche AG announced to take over Telavant Holdings for the €7.25bn and acquire commercialisation rights for its autoimmunity repressing drug RVT-3101 in the US and Japan. The Basel-based pharma giant cites the excellent Phase IIb data of the anti-TLA1 antibody RVT-3101 in 245 patients with ulcerative colitis, 36% of whom showed clinical remission, as the reason for the investment. A Phase II study in Crohn’s disease is ongoing. Roche sees expansion opportunities in other autoimmune indications in addition to the billion-dollar potential in Crohn’s disease and ulcerative colitis. RVT-3101 is a potential first-in-class agent that targets both inflammatory and fibrotic pathways by inhibiting tumour necrosis factor-like cytokine 1A (TL1A). It has been shown to modulate the severity of inflam-
mation and fibrosis by stimulating the TH1 and TH17 pathways, in addition to activating fibroblasts. Roche will also obtain an option to enter into a global collaboration with Pfizer, which held 25% of the jointventure with Roivant Sciences (75%), on a next-generation p40/TL1A directed bispecific antibody, currently in Phase 1. Roche will start a Phase III trial for RVT-3101 as soon as possible. Merck Sharp & Dome in June acquired Prometheus Biosciences for US-$10.8bn, to kick-off a Phase III trial of its anti-TLA1 antibody PRA-023 (now MK7240) in 1,020 patients with ulcerative colitis. At the beginning of October, French Sanofi SA entered an US-$1.5bn partnership with Teva to bring its anti-TLA1 programme TEV’574 to Phase III testing and market approval.
European Biotechnology | Winter Edition | Vol. 22 | 2023
Melting amyloid aggregates CELL THERAPY In mid-November, Amyl Therapeutics SA has secured a €5m extension to its €18.3m Series A financing from existing investors Merieux Equity Partners (Lyon), Noshaq (Liege), and the new investor Evren Ucok (Istanbul). In addition, the Liege-based company cashed in €6.1m a non-dilutive financing from the Walloon region. Amyl Therapeutics said it will use the financing to accelerate the development of its preclinical FC fusion lead targeting a common motif in different amyloid fibril types to treat neurodegenerative diseases and AL amyloidosis, The ultimativ goal is to demonstrate preclinical proofof-concept for Amyl’s lead therapeutic candidates by mid-2024, and to start clinical development in AL amyloidosis. The lead candidate drug conformationally target the cross-beta amyloid fold,
disrupting the interactions between peptides essential for the formation of fibrils of toxic protein aggregates of various types (amyloid-beta (Abeta), Tau and alpha-synuclein) which accumulate in the brain, causing Alzheimer’s disease, Parkinson’s disease and other neurodegenerative disorders. It is also active on light chains (AL) of transthyretin (TTR) amyloid fibrils, which accumulate in peripheral organs, causing systemic amyloidosis. As Amyl’s candidate is a polypeptide fusion molecule that comprises the Fc portion of an antibody and a binding site that attaches to the cross-beta amyloid fold found in all amyloid aggregates, it offers a major advantage over classical monoclonal antibodies that do not target a combination of different amyloid fibrils observed in most neurological diseases caused by amyloid aggregates.
WESTERN EUROPE
NEWS Bionic nanoparticles In mid-November, Cambridge-based ViaNautis Bio Ltd closed a US$25m Series A financing co-led by 4BIO Capital, BGF, and UCB Ventures with participation of seed investors Eli Lilly and Company, Origin Capital, Meltwind and O2H. Starting with its cystic fibrosis candidate VNS002, the company will use the proceeds to build a proprietary pipeline in lung and neurological conditions based on it polyNaut platform. Polynaut applies nanoparticle-like polymer materials, which can cross biological membranes and the blood-brain barrier to precisely guide encapsulated small molecules, pDNA, mRNA, siRNA and antisense oligonucleotides to targets in the cytoplasma. Vianautis Bio (founded in 2018 as SomaServe) seeks to build partnerships with biopharma companies.
EIB for animal welfare
Diseases caused by deposits of amyloid fibrils are often characterised by the buildup of multiple types of pathologic protein aggregates.
Money for bio-based CDMOs Pictures:Amyl Therapeutics SA
DRUG DEVELOPMENT Good news
for bio-based CDMOs: In November, Scottish Enterprise and Innovate UK announced a new bio-based manufacturing Launchpad designed to fund Scotch SMEs and their manufacturing partners with up to £2m. Successful applicants for the £75m programme will receive up
to £100,000 for single SME-led projects under the Minimal Financial Assistance competition strand and up to £2m (2570% funded) for Collaborative R&D projects led by a UK business of any size that grow activities in the bio-based manufacturing innovation cluster in Scotland. Deadline is 13 December 2023.
In Ovo NV has bagged a €40m loan from the European Investment Bank to expand the company’s Ella ® technology, designed to eliminate the need for culling of 6.5 billion male chicken per year in the poultry industry by biochemical analysis of the allantoic fluid.
Breathe French Sanofi SA’s second Phase III trial of duplimab demonstrated a 34% reduction in exacerbations and significant lung function improvements. The Paris-based pharma major see the results as an affirmation of the drug’s potential to become the first approved biologic for COPD.
63
CENTR AL EUROPE
European Biotechnology | Winter Edition | Vol. 22 | 2023
Morphosys’ data leaving space for interpretation
Bio-Battery ENERGY The Austrian technol-
ogy and construction group STRABAG is investing €100m in the development and production of safe, sustainable and affordable energy storage solutions. Through the connection with the storage manufacturer CMBlu Energy (Germany), STRABAG plans to realise the development of specific large-scale storage projects more quickly and easily through construction and infrastructure support. CMBlu Energy AG, based in Alzenau in the north-westernmost part of Bavaria, has quietly developed into the leading battery company at present, with a storage system based on organic materials. Inspired by the citric acid cycle of natural energy storage in living organisms, electrons are circulated in large tanks between a redox-flow and solid-state battery in aromatic rings of the organic solid-flow battery storage system. STRABAG AG and CMBlu Energy have therefore set themselves the goal of significantly boosting the energy transition through their complementary connection. The background to this is the strategic decision to combine the best storage technology with the best construction and infrastructure expertise. This opens up a tangible opportunity for industrial companies, municipal energy suppliers and grid operators to build large “warehouses for electricity” with organic SolidFlow batteries in the coming years and thus utilise renewable energies even more flexibly. The system is already running in Arizo na (USA), Germany and in Austria.
CANCER The former antibody platform developer in Planegg, close to Munich, had the interest of the community on its side in the middle of November. MorphoSys published topline data of its clinical phase 3 for Pelabresib. The drug was incorporated in a transformative move of Morphosys by buying US company Constellations Pharma in 2021 for about US$1.7bn and putting their own antibody pipeline aside. 430 patients took part in the study, in which the drug candidate for the treatment of myelofibrosis was tested. Based on the data, the biotech company intends to apply for marketing authorisation in the USA and Europe next year. The reception of the news was quite mixed. The reason lies in the study results: While MorphoSys is celebrating the data on the important primary endpoint, among others, as a success, Pelabresib in combination with Ruxolitinib does not
provide good data in an important secondary endpoint (TSS50) compared to placebo plus Ruxolitinib. The key passage in the biotech company’s announcement: “TSS50, another key secondary endpoint, was achieved at week 24 in 52% of patients in the Pelabresib plus Ruxolitinib-treated group compared to 46% in the Placebo plus Ruxolitinib-treated group (95% CI [-3.5; 15.5], p = 0.216). In intermediate-risk patients, TSS50 at week 24 was achieved by 55% of patients in the Pelabresib plus Ruxolitinib-treated group compared with 45% in the Placebo plus Ruxolitinib-treated group (95% CI [0.35; 19.76], p < 0.05).” With this data however, there is a real risk that the FDA and EMA will not grant approval as authorities attach great importance to TSS50 as a secondary endpoint. The data as presented does not make approval any more certain.
Sandoz’ Ribbon cuts BIOSIMILAR The newly independent Swiss company Sandoz AG has inaugurated new infrastructure succesively: a bioanalytical competence centre for biosimilars south of Munich in Holzkirchen (photo: Sandoz CEO Richard Saynor, r.) and an expansion of antibiotics production in Kundl/Kufstein (Austria). Central Europe is to remain the focus of the generics and biosimilars company. L
Picture: © Sandoz AG
64
European Biotechnology | Winter Edition | Vol. 22 | 2023
Boehringer goes all in early ACQUISITION With the whopping valuation of CHF450m (about €461m) German privately held pharma company Boehringer Ingelheim acquired preclinical stage company T3 Pharma from Basel, Switzerland. The core technology of the company, published already in 2015 in Journal of Cell Biology, is the key to this huge price tag, as the spin-out of Basel University is using live bacteria as their vector to deliver drugs to solid tumours and entering the often ‘cold’ tumourmicroenvironment (TME) with the help of the bacterial movement capacities.
To do this, the company utilises the bacterial type-III secretion system (T3) to secrete bioactive proteins. This secretion system is part of the natural machinery of several (pathogenic) bacteria and functions like a nano syringe that injects specific effector proteins into human target cells. “This brings us one step closer to our vision of bringing about a paradigm shift in cancer treatment,” commented Michel Pairet, member of the Boehringer Ingelheim Board of Managing Directors and responsible for innovation. The T3 Pharma team around CEO Simon Ittig will continue development in Basel.
CENTR AL EUROPE
NEWS Approval I The Austrian-French company Valneva SE has received the world’s first approval from the US FDA for a vaccine against the Chikungunya virus: for the live vaccine IXCHIQ ® in people aged 18 and over. The FDA decided in the accelerated approval procedure (FDA “accelerated approval”).
Approval II Swiss Santhera Pharmaceuticals (SIX: SANN) announced that the US Food and Drug Administration (FDA) has approved AGAMREE® (previously known as vamorolone) as an oral suspension at a concentration of 40 mg/ml for the treatment of Duchenne muscular dystrophy (DMD) in patients two years of age and older. The cortisone derivative was codeveloped with ReveraGen BioPharma Inc.
Yersinia enterocolitica are among bacteria using a type-III secretion system that T3 Pharma has genetically modified to use it in site specific manner in solid tumours.
Picture: © CDC, USA.gov
Swiss Neoantigens attract VCs FINANCING French VC firm Andera Partners was leading an oversubscribed €67.5m Series C financing for cancer immunotherapy company Nouscom AG, based in Basel, Switzerland. This financing will enable Nouscom to complete the Phase II clinical trial of its cancer vaccine NOUS-209. In addition to Andera, Bpifrance and M Ventures are lead investors in this financing round, with other new and existing investors such as EQT Life Sciences and Versant Ventures also participating. The ongoing randomised Phase II clinical trial is testing the combination of
NOUS-209, a universal vaccine targeting 209 common neoantigens, in combination with pembrolizumab for the treatment of metastatic colorectal cancer (mCRC) with mismatch repair/microsatellite instability (dMMR/MSI). At the same time, the company is awaiting the results of the ongoing Phase Ib trial with NOUS-209 in Lynch syndrome (LS) carriers. LS carriers have an increased risk of developing certain types of cancer due to a genetic predisposition. The cancer vaccination is intended to prevent the development of cancer at an early stage.
All goes well in Allgaeu Vetter Pharma-Fertigung GmbH & Co. KG has completed the shell of a new production building at its Ravensburg site, which will house several commercial filling lines. This marks an important milestone on the way to final completion of the building, comprising a total investment of €230m, following the start of construction in early November 2021. The CDMO, which emerged from a Ravensburg pharmacy plans to open the first cleanrooms at the end of 2024. Other investments include the expansion of the laboratory space for analytical services and the expansion of filling capacities nearby.
65
SOUTHERN EUROPE
Prostate cancer DETECTION Mid November Curium Pharma Ltd. announced the initial administration of piflufolastat (18F), a novel 18 F-PSMA PET tracer intended for detecting prostate-specific membrane antigen (PSMA) positive lesions in prostate cancer patients. The injections took place in Greece through Curium’s exclusive distributor, SYN Innovation Laboratories AE. This tracer aids in primary staging of high-risk prostate cancer patients before curative therapy and in locating cancer recurrence based on rising PSA levels post-primary treatment. The European Commission granted marketing authorisation for the piflufolastat in July 2023, and SYN Innovation Laboratories holds exclusive manufacturing and distribution rights for Curium’s PET products in Greece, producing at their Athens facilities.
Pilot plant SCALING SUSTAINABILITY MicroHarvest’s Lisbon launch of a pilot plant in November marks a vital step in commercialising their single-cell protein ingredients. This plant showcases scalability, achieving 25kg of daily production within 200m2. Partnering with a manufacturer, they aim for a 1-ton/day capacity and anticipate releasing their first product in three months. MicroHarvest’s technology promises sustainable protein production, garnering attention for its potential to minimise resource consumption in various sectors.
European Biotechnology | Winter Edition | Vol. 22 | 2023
Home test
Jyseleca-deal
BREASTCANCER Cyprus-based Davion Healthcare Plc has granted a Global Manufacturing and Distribution Licence of its breast check home test for Breast Anomalies to NeuRX Health Inc for US$120m, alongside ongoing royalty payments. The agreement, pending completion in January 2024, involves NeuRX paying Davion the stipulated sum for the licence and ongoing royalties based on global sales of the product. The breast check, is expected to be available internationally by the end of the first quarter of 2024 through various retail outlets and online platforms. This move follows Davion’s recent USD$30m IPO fundraising round and NASDAQ listing preparations. NeuRX foresees high demand for the product.
ACQUISITION The Italian pharmaceutical company Alfasigma S.p.A. signed a letter of intent to acquire their filgotinib from Belgian Galapagos NV for €50m upfront, with potential milestone payments of €120m and royalties on European sales. Filgotinib is an oral oncedaily medication, currently approved for two indications: rheumatoid arthritis and ulcerative colitis. This acquisition includes European and UK Marketing Authorisations, development activities, and about 400 positions in 14 European countries. filgotinib saw €54m in net sales in Europe in the first half of 2023. The completion of the transaction depends on regulatory approvals and further negotiations between the companies.
Plant for bioprocess innovation BIOPHARMA Bioingenium is investing €1.5m in a new Barcelona-based plant to boost bioprocess development and therapeutic protein manufacturing for the biopharmaceutical industry. Expected to be operational by mid-2024, this 1,200m2 facility will also expand production for active cosmetic ingredients with an additional investment of €750,000. With a turnover of €1m and a 40% workforce increase in 2022, they aim to diversify into cosmetics and food tech markets.
Primarily catering to the biopharmaceutical sector, Bioingenium offers custom bioprocess development and therapeutic protein production, including enzymes used in mRNA vaccine production. They’ve also ventured into cosmetics since 2017, investing in developing active cosmetic ingredients. Looking forward, they plan to further invest in this and explore sectors like food technology, leveraging their expertise in precision fermentation and aiming to provide enzymes and alternative proteins.
Picture: © Bioingenium
66
European Biotechnology | Winter Edition | Vol. 22 | 2023
Solar-powered bioplastics CIRCULAR ECONOMY Ecocortec d.o.o., a Croatian manufacturer of anticorrosion films and bioplastics and a subsidiary of Ecocortec Corporation, recently transitioned to solar power, becoming Europe’s first solar-powered bioplastics plant. The solar panels installed at the facility generate electricity from solar energy, significantly cutting energy consumption and reducing greenhouse gas emissions. To further promote a circular economy, Ecocortec reprocesses plastic waste from various sources, including in-house production scrap, incoming shipments, and materials
from customers and distributors. They use a regranulation machine to recycle plastic waste into new materials, aiming to extend the lifespan of their products. Additionally, they incorporate recycled content into their films and bags, leveraging patented technology to inhibit corrosion in metal parts. Their aim is to increase the recycled content in plastic packaging, aligning with European goals for 2030. This commitment to sustainability extends across the corporation’s global operations, with ten locations worldwide serving Europe, Asia, and the USA.
SOUTHERN EUROPE
NEWS Circular plastics In October Versalis S.p.A. began construction of a Mantua plant for its technology, set to chemically recycle mixed plastic waste into new polymer materials. Collaborating with Italian engineering company S.R.S. and the National Consortium for the Collection, Recycling and Recovery of Plastic Packaging, it aims to enhance post-consumer plastic recycling. The demo plant, integrating Technip Energies’ purification, plans to handle 6,000 tonnes by 2024.
Upcoming EU-project
The solar panels installed on plant’s roof are generating electricity. This energy is used to power EcoCortec’s facilities.
Picture: © EcoCortec
Dementia action blueprint ALZHEIMER’S INITIATIVE The Greek government has introduced a comprehensive action plan aimed at addressing dementia and Alzheimer’s disease, viewed as a critical challenge for Greece’s ageing population, as it affects 10% of people over 65 years of age and 35% of people over 80 years of age, affecting the social security system, as well as the national economy. Analysts anticipate dementia to become a significant burden on the country’s health system in the future. The plan, part of broader mental health reforms, focuses on ethical treatment and protection of patients’ rights. Dr. Paraskevi Sakka, a leading figure in Alzheimer’s associations, hailed the initiative as a crucial legislative
advancement, emphasising its potential to alleviate the strain on patients and their families. The proposed legislation includes measures to establish legal representatives for patients in early stages of dementia, safeguarding their rights when cognitive functions decline. The plan represents an updated and comprehensive effort building upon prior initiatives, aiming for implementation to alleviate the burdens faced by dementia patients and their caregivers. This isn’t the first national plan for dementia. The one drawn back in 2016 wasn’t implemented to any meaningful extent except by putting some services and structures in place.
Starting in the new year, a new EU project aims to accelerate the EU agri-food industry’s shift to sustainability through energy audits, digital solutions, and addressing global threats until the end of 2026. Agri-food Efficiency with New Energy Audit Measures (AENEAM) will offer tailored programmes, mentoring, and funding access, aiming to build internal expertise for effective change. It will involve operational services for individual companies and collaborations among four countries.
Ardian boosts Dedalus Private investment firm Ardian now owns 92% of Italian Dedalus S.p.A. after buying another 19%. Founder Giorgio Moretti keeps 6% and a board seat. The goal: expand Dedalus, innovate healthcare software, serve more than 500m patients globally. Ardian’s backing since 2016 boosted Dedalus in European healthcare software via strategic mergers.
67
EASTERN EUROPE
European Biotechnology | Winter Edition | Vol. 22 | 2023
Lentivirus vector production site
Antibody hunt R&D Estonian biotechnology
CAR-T The Medical University of Warsaw (WUM) has inaugurated a new lentivirus vector production facility at the Świętokrzyskie Oncology Center in Kielce in October. This facility will operate in conjunction with the “Polish Chimeric Antigen Receptor T-cell Network” (CAR-NET), led by WUM. The primary goal of the project is to advance a Polish CAR-T therapy, presenting a promising avenue for the effective treatment of acute lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL)
patients. Over the two-year duration of the project, the focus is on finalising the CAR-T therapy, including the in-country manufacture of CAR-T products. The initiative aims to enhance the accessibility of these treatments, reduce associated costs, and establish a network of proficient treatment centres. All measures are financially supported by the Medical Research Agency, the state agency responsible for development of scientific research in the field of medical and health sciences.
firm Icosagen has entered into a multitarget antibody research agreement with Swedish Salipro Biotech AB. This collaboration is geared towards advancing drug discovery programmes that specifically target challenging membrane proteins, including G protein-coupled receptors and solute carrier transporters. Icosagen brings its expertise in protein production and analytics to complement Salipro’s track record in drug discovery acceleration.
Axon repair GENE THER APY Scientists at the Institute of Experimental Medicine of the Czech Academy of Sciences have achieved a breakthrough in gene therapy that could potentially restore damaged nerve fibres in the spinal cord. In their experiments, treated rats regained sensitivity in their hind limbs to nearly pre-injury levels. The gene therapy involves the insertion of genes into injured neurons, enabling communication with intercellular material, thus promoting axon repair and growth. This achievement is the result of the NEURORECON project at the Centre of Reconstructive Neuroscience, led by neuroscientists from the University of Cambridge. The researchers now hope the results will lead to an advance in the treatment of spinal cord injuries caused by various factors like injuries, tumours, degenerative, or vascular diseases.
Cluster hits the ground running CLUSTER Prague is poised to emerge as a biotechnology leader in Europe with the founding of Prague.bio by the Czech Academy of Sciences and Prague’s University of Chemistry and Technology. This new trade association aims to bridge the gap between research and business, facilitating the development of innovative drugs, diagnostics, and projects to diversify Czech R&D funding. The Prague.bio biotechnology cluster integrates R&D&I activities in medicine and life sciences, bringing together key players from research, the commercial sector, potential investors, and the government. Financing for the cluster will be sourced from members, public funds, sponsors and other partners.
Czech Minister for Science and Research, Helena Langšádlová, underscores the promise of biotechnology in the Czech Republic, citing excellent research and existing commercial success. “Biotechnology [...] is a strategic pillar in the economic development in the Czech Republic, one of the main areas of innovation where we should focus,” Langšádlová said. The association aims to accelerate the sector’s role as a strategic pillar for economic development by facilitating the translation of research results into innovative medicines. The Prague.bio cluster recently hosted its inaugural event, the Prague.bio Conference, drawing 150 academics, investors, and industry representatives.
Picture: © prague.bio
68
European Biotechnology | Winter Edition | Vol. 22 | 2023
SCIENCE & TECHNOLOGY
Mining the somatic genome Flagship Pioneering has committed US$50m to launch Quotient Therapeutics Ltd that links single cell genetic variation with disease phenotypes by its Nanoseq platform, an ultrasensitive sequencing method licenced from the Wellcome Sanger Institute in Cambridge, UK.
SOMATIC GENOMCS
The investment came after two years of work in Flagship’s labs that linked deep phenotyping with a sequencing technology invented at the British Sanger Institute. In mid-November, Flagship Pioneering confirmed to invest $50m in Quotient Therapeutics to advance development of the licenced Nanoseq platform and pursue a pipeline of medicines across a wide range of therapeutic areas and modalities. With the help of laser microdissection and Nanoseq, Dr Iñigo Martincorena, academic founder and advisor of Quotient Therapeutics at the Wellcome Sanger Institute in Cambridge, UK, was able to identify cells or little group of cells in biopsies from ageing people that accumulated cancer-driver mutations. According to Geoffrey von Maltzahn, Co-Founder and Chief Executive Officer of Quotient Therapeutics and General Partner, Flagship Pioneering, “some genetic changes make a cell resistant or vulnerable to disease, while others can cause disease. We started Quotient to study the natural genetics library inside every tissue, discover gene variants that are beneficial, neutral, or disease-causing, and to harness that knowledge to develop medicines of tomorrow.”
tissue samples, isolation, single cell genotyping, and computation:
› Using clinical samples, diseased tissue is deeply phenotyped to identify cells that are showing disease pathology and those that appear healthy. › Then, cells are isolated for sequencing, enriching for the right cell types and for phenotypes of interest. › Single-molecule genotyping identifies somatic mutations that drive a phenotype with high confidence, demonstrating a 10 million-fold better error rate than standard approaches. › Finally, with the first comprehensive somatic genomics dataset, naturally selected genes, proteins and pathways are identified through proprietary computation pipelines for the development of transformative therapies to cure, prevent or reverse disease. As a result, naturally selected genes, proteins, and pathways are identified as prospective targets for the development of
novel therapies intended to cure, prevent, or reverse disease. Quotient claims its approach has the potential to discover firstin-class meds including immune disease, cardiometabolic disease, infectious disease, oncology, neurodegenerative disease, rare disease, and ageing.
Towards single-cell genomics Academic co-founders of Quotient include Professor Sir Mike Stratton, MD, PhD, Inigo Martincorena, PhD, and Peter Campbell, PhD, from the Wellcome Sanger Institute, and Hao Zhu, MD, from University of Texas Southwestern. In addition to von Maltzahn and Rubens, Quotient is led by Scott Hayton, Ph.D., as Acting Chief Operating Officer, Caroline Fox, M.D., MPH, as Senior Vice President, Head of Genetics and Target Discovery, and Simon Brunner, Ph.D., as Co-Founder and Head of Platform. Quotient is co- located in Cambridge, MA and UK with reL search facilities in both cities. t.gabrielczyk@biocom.eu
Picture: © Onur Pinar, Wellcome Sanger Institute, Cambridge, UK
First-in-class meds Quotient’s Somatic Genomics platform utilises single molecule DNA sequencing technology to reveal the extensive variation encoded in the somatic genome at highest resolution. Created by Flagship scientists in partnership with leading geneticists at the Wellcome Sanger Institute and the University of Texas Southwestern, this platform is able to study natural selection at the cellular level through four steps: phenotyping of cells from clinical
Dr Iñigo Martincorena, cofounder of Quotient Therapeutics Ltd
69
SCIENCE & TECHNOLOGY
European Biotechnology | Winter Edition | Vol. 22 | 2023
BIC: Ten year jubilee At the celebration of the 10th anniversary of the Bio-based Industry Consortium (BIC), the student team BioAroma was presented with the BISC-E 2023 award, which is endowed with €5000 in prize money. BIO-BASED INDUSTRIES CONSORTIUM
Around 200 invited guests joined the celebration. The French team BioAroma received the cash prize for first place in the BISC-E 2023 competition and a one-year free BIC membership. The annual competition is part of BIC’s efforts to promote entrepreneurship in education by challenging students to propose breakthrough biobased innovations to solve environmental, societal or economic problems. Nurdana Orynbek, Anastasyia Valak hanovitch and Aiganym Abduraimova from AgroParisTech presented an innovative fermentation process using a nonGMO yeast strain to produce 2-phenylethanol (2-PE) from apple pomade and whey. The aromatic substances with a rose-like scent are increasingly used in the cosmetics and food industries. The biotechnological process has the potential to replace the currently applied toxic chemical synthesis of 2-PE or the costly, labour-intensive and seasonal extraction from flowers. BioAroma has demonstrated the economic feasibility of its process compared to that of 2-PE extracted from flowers. The team’s solution addresses the current environmental issues of the flower extraction method, with 1,000 times lower impacts on land use and GHG emissions. Belgian team Vsycle took second place with an approach to save fruit from frost damage via novel antifreeze proteins (AFPs) to sprayed on fruit blossoms of apples, pears, berries and grapes. Their AFP product is non-toxic, biodegradable, and remains active even at low concentrations. Third place went to Team O-LIVE from Italy for the production of resources for the cosmetic industry from waste cooking oils. They obtain oleic acid from the waste cooking oils using an enzymatic reaction catalysed by lipase. This oleic acid is then used to make oleyl alcohol, a biocompati-
Team BioAroma from Paris AgroTech took the first prize in Brussels.
ble resource used as an emollient, solvent, viscosity control and perfuming agent replacing the chemical synthesis.
Rethinking what happened In addition to much praise for the cooperation between the Bio-based Industry Consortium and the European Commission, plenary speakers also voiced criticism. Although the bio-economy was conceived in Europe and first pursued as a political concept, said its spiritual father Dr. Christian Patermann, more and more Asian countries and also the USA are leaving Europe behind in its implementation. The reasons include bureaucratic obstacles for SMEs, a lack of willingness to invest and determination to implement. In contrast, one year after the US goernment declared the biologisation of food and drug development a national priority, however, funds and concrete implementation concepts are available, explained Mary Maxon, Executive Director of the US think tank Schmidt BioFutures. According to Jim Philp, Science and Technology Policy Analyst at OECD, 90% of the investments for the circular bioec-
onomy have been made in the UK and the US so far. He cited the British biohubs Synbicyte and the London Biofoundry as innovative financing and incubator models. The potential of the bio-based bioeconomy to sustainably address global challenges such as climate change must be complemented by current developments in synthetic biology and data analysis, he said, and political incentives must be provided. The first BIC Chair Marc Wubbolts, CEO of the joint venture between DSM and Fonterra, said the picture has changed in 10 years of BIC. If you started with 30 large companies, today 80% of the innovators are SMEs. BIC Chair Rob Beekers emphasised to European Biotechnology that there is too much regulatory burden in the EU compared to the US, that the opportunities of synthetic biology in production need to be used more and that Europe can compete with the US in terms of coproduct development. Patermann stressed that Europe urgently needs an update of its bioeconomy strategy, also in view of the exploding market for novel foods and protein alternatives, and that new financL ing channels must be found. t.gabrielczyk@biocom.eu
Picture: © BIC
70
European Biotechnology | Winter Edition | Vol. 22 | 2023
SCIENCE & TECHNOLOGY
Improving CAR-T therapies US Food and Drug Administration (FDA)-approved CARs contain a costimulatory molecule (4-1BB or CD28) and the TCR zeta chain as the intracellular signaling domain. A systematic analysis demonstrate that CARs containing CD3delta, CD3epsilon or CD3gamma cytoplasmic tails outperformed the conventional CAR T cells in vivo. IMMUNOLOGY
Chimeric antigen receptor (CAR)-T cell therapy is the last hope for many patients with blood, bone marrow or lymph gland cancer when other treatments such as chemotherapy fail. A limiting factor of the very effective therapy is that the cells used in the process quickly reach a state of exhaustion. Researchers at the University of Freiburg have now been able to prevent this exhaustion and thus significantly enhance the effect of the therapy in a preclinical animal model. Results have been reported in Nature Immunology (10.1038/s41590-023-01658-z). The research team headed by Susana Minguet has significantly improved the anti-tumour efficacy of CAR-T cellsby changing the CD3-carrying T cell receptor (TCR) within the chimeric antigen receptor (CAR). Doing so, the German researchers ensured a balance in the activation of immune cells and thus prevented the exhaustion of the immune response.
of the T-cell receptor – gamma, delta and epsilon – can also be used for CARs has not yet been investigated,” said Minguet, who co-led the study with Prof. Dr Wolfgang Schamel. “We found that CARs containing CD3d, CD3e and CD3g cytoplasmic tails outperformed the conventional z CAR T cells in vivo,” added Minguet. According to Schamel,“it was a surprise that the zeta chain showed a lower anti-tumour effect than the other three domains. These eliminated the cancer cells in a leukaemia model significantly better.” The best performance was shown by the delta chain, which gives an inhibitory signal in parallel to the activation of the T cell. “This allows the immune cell to run at ideal speed,” says Minguet. “Our results show that CARs that use one of the other signalling domains instead of the zeta chain could mitigate or prevent the disadvantages of existing therapies
with CAR T cells,” concluded Schamel. When developing new CAR therapies, strategies should therefore be considered to achieve a more balanced immune response. Transcriptomic and proteomic analysis revealed differences in activation potential, metabolism and stimulation-induced T cell dysfunctionality that mechanistically explained the improved antitumour performance. Furthermore, dimerisation of the CARs improved their overall functionality. Using these CARs as minimalistic and synthetic surrogate TCRs, the researchers identified the phosphatase SHP-1 as a new interaction partner of CD3d that binds the CD3d–ITAM on phosphorylation of its Cterminal tyrosine. SHP-1 attenuates and restrains activation signals, and might thus L prevent exhaustion and dysfunction. t.gabrielczyk@biocom.eu
Pictures: Prased S. Adusumuli, FACS/Memorial Sloan Kettering Cancer Center
Surprising result The CAR functions like a sensor by which T cell recognise characteristic surface neoantigens of cancer cells. The synthetic CAR consists in part of elements of the natural T cell receptor, but its structure is greatly simplified in comparison. The CAR has only one of the four different subunits that transmit the signals that trigger the activation of the immune response in unmodified T cells. “The CARs approved by the drug authorities all use the so-called zeta chain, which triggers a particularly strong activation of the T cell as soon as the CAR binds to the surface of a cancer cell. Whether the other three signalling chains
CAR-T attacking cancer cell. TCR overactivation may cause cytokine release syndrome
71
SCIENCE & TECHNOLOGY
European Biotechnology | Winter Edition | Vol. 22 | 2023
Green feed for fish In view of 90% overfished stocks and growing microplastic pollution in rivers and oceans, there is a great need for sustainable fish production methods. In light of the still high cost of cell-based fish manufacture, a Finnish company presented a sustainably produced fish feed in November. Farmed fish grow better and healthier with fungi produced from Nordic forestry by-products, reported EniferBio Oy. CULTURED FISH
As the global demand for fish consumption continues to surge, fish farmers are constantly looking for ways to improve their cultivation techniques. A new study conducted by researchers at the Norwegian University of Life Sciences (NMBU) shows that using a mycoprotein manufactured by Finnish star t-up company EniferBio Oy (Espoo) had a positive impact on salmon’s natural immune system and growth.
Aquaculture production requires huge amounts of new protein feeds. Improving the farmed fish’s immune system is vital for fish farmers, who struggle with a variety of infectious agents that can cause different levels of deformations or even death in large quantities. Enifer’s mycoprotein consists of about 65% protein, 15% beta-glucan, 10% fats and minerals, and has a high concentration of vitamin B. With costs of €3 per kilogram, soybeans are currently the most affordable and commonly used protein source in aquafeed, but at a high price for the environment.
Public-private partnership The study of Enifer, which raised €11m in April, was conducted by a group of researchers led by Professor Margareth Øverland. It demonstrates that juvenile salmon fed with fermented and subsequently dried mycoprotein powder grew better. “The studies show that our mycoprotein not only provides fish with protein, but actually brings clear added benefits to fish health and growth compared to conventional proteins like soya,” said Joosu Kuivanen, COO at Enifer. These benefits arise from the unique composition of our fungal protein. The fact that the product can be produced sustainably from side-products of the pulp and paper industry makes it particularly attractive to the Norwegian salmon industry, he suggests. Replacement of up to 20% of the crude protein content of the feed with Enifer’s fungal protein powder branded Pekilo ®Aqua improved the feed conversion ratio and nutrient utilisation efficiency of Atlantic salmon juveniles reared in freshwater. Already low (5%) concentrations led to a strong T-cell response, innate immunity responses, and enhanced
Alternative to soybean feed
EniferBio’s mycoprotein
antimicrobial activity suggesting the product might allow reduction of antibiotics in aquaculture. Higher (10-20%) inclusion levels additionally showed T1H cell activation and specific responses to beta-glucan, which is abundant in the fermented protein. Furthermore, the research group measured higher levels of specific antibodies against the bacterial salmon pathogen, Vibrio anguillarum. EniferBio now plans to conduct studies that show the protective effects of the sustainable fish feed against fish pathogens even more directly. In 2021, humans consumed 160 million metric tons of farmed and wild fish.
Soybean cultivation is said to increase deforestation, and shipping makes it less sustainable. However, global soybean production is steadily growing, with estimates by the US Department of Agriculture that this running season will produce 403 million tonnes of soybean. Enifer’s mycoprotein provides a lower carbon footprint than imported soybean, as it is produced without using new agricultural land and very little water, offering a sustainable and self-sufficient alternative for the European market. “We have a product that turns today’s waste into a high-value ingredient. We can provide the world’s most competitive protein production process and a product that has been tested on an industrial scale for over 15 years. We are now ready for the next phase of scaling our production and product use cases,” said Simo Ellilä, CEO and cofounder of L the VTT spin-out. t.gabrielczyk@biocom.eu
Pictures: © Enifer Bio
72
European Biotechnology | Winter Edition | Vol. 22 | 2023
SCIENCE & TECHNOLOGY
Killing plaques HEART FAILURE Researchers led by Wolfgang Enard from LMU Munich have identified a microRNA-based mechanism that drives atherosclerosis by weakening the integrity of blood vessel walls. In November, the researchers reported that targeting of miR-206-3p with an experimental compound safely reversed the onset of atherosclerosis in a mouse model. As atherosclerosis is a major risk factor for the development of heart attacks and stroke, companies have attempted to treat atherosclerosis by supporting the action of the chemokine receptor CXCR4, which promotes re-endothelialisation. However, CXCR4 is difficult to target because it’s also expressed in other types of cells, which leads to off-target effects and treatment toxicity. The team from LMU Munich and
NEWS the University of Maastricht tackled this safety roadblock by targeting a pathway that represses CXCR4 specifically in blood vessels. They examined human and mouse endothelial cells and vascular smooth muscle cells, finding that miR-206-3p repressed receptor activity in the cells. When treating mice with a compound code-named CXCR4-TSB that prevents miR-206-3p from interacting with CXCR4 specific to blood vessels, expression of the cxcr4 gene was boosted, reducing the permeability of blood vessels, and prevented diet-induced atherosclerosis in the animals. Weber et al. also observed that plaque specimens from patients with atherosclerosis harboured less CXCR4 and more miR-206-3p as the disease progressed, suggesting miR-206-3p L could also offer a target in humans.
Roots of memory T cells IMMUNOLOGY Swiss researchers have
laid the foundation to produce longer lasting vaccines tracking down the origin of memory T cells. Using mice as a model for the human immune system, the team from the Universities of Basel and Lausanne found that CD8+ T cells with stem-like properties,that expressed the Tcg7 gene product TCF1 (TCM receptor cells) occurred across the primary response to infection. However, this small TCF1-positive cell population expanded relatively independently of systemic inflammation, antigen dose, or affinity, to quantitatively yield TCF1-positive stem cell-like central memory cells after pathogen clearance. Inflammatory signals that led to TCF1 down-regulation lost its selfrenewal capacity and silenced stem cell/ memory genes. As TCF1 expression was demonstrated to restrain cell cycling, it partly explained the limited expansion of TCF1-positive versus TCF1-negative cells during the primary response. This data is consistent with terminal differentiation of T effector cells whose development is initiated by inflammation
in primed stem-like cells, which would otherwise become central memory cells by default. The ability to create enduring memory CD8+ T cells that recognise pathogens upon re-exposure and rapidly mobilise host defences. In contrast to previous assumptions that stem cell-like central memory T cells (TCMs) originate from killer CD8+ T cells that acquire the properties of memory T cells, the new data suggest that TCMs originate directly from stem-like precursor cells. Following TpCM cells during an initial lymphocytic choriomeningitis virus (LCMV) infection, the team headed by Werner Held found that early during the immune response, these cells were predisposed to become TCM, with killer T cells branching off in response to inflammatory cues. The authors confirmed TpCM cell populations expanded following a generalised dendritic cell vaccination, demonstrating the precursors’ potential to be manipulated. Further research has to confirm the results in huL mans.
Fighting AMR In an effort to address the global health threat of antimicrobial resistance (AMR), Innovate UK, LifeArc, and Medicines Discovery Catapult have launched the PACE initiative. With £30m (around €34,5m) in funding, PACE aims to support early-stage innovations aimed at countering AMR. Another initiative formed to improve to evaluate efficacy of new preclinically tested novel antibiotics in an animal model was recently kicked off (see. p. 13)
Targets in TCM A team around Chinese researcher Xiao Gan and Albert-László Barabási from Central European University at Budapest have reported for the first time globally how a variety of herbs commonly used in traditional Chinese medicine (TCM) interact with human proteins. The researchers used symptom-gene association data containing 11,362 diseases, 13,271 genes, and 110,407 associations to derive relationships between proteins targeted by TCM herbs and proteins associated with symptoms. They mapped these symptom-associated genes onto almost all human proteins, and 327,924 protein-protein interactions and found that symptoms that frequently coincide neighboured each other in the human protein interaction network. Moreover, TCM herbs that target proteins in these protein neighborhoods could treat those general symptoms. They validated the findings using clinical records of 1,936 in-patients who were prescribed herbal remedies in a TCM hospital (doi: 10.1126/sciadv. adh0215).
73
NEWS/PRODUCTS
Evotec at dewpoint DRUG DISCOVERY German Evotec SE and Boston-based Dewpoint Therapeutics Inc have entered into a strategic partnership in oncology. With this partnership, the Hamburg-based screening specialists have landed a really big deal: Dewpint Therapeutics, the just four-year-old spin-off from Tony Hyman (MPI for Molecular Cell Biology and Genetics (Dresden) and Richard Young from Whitehead Institute (Boston), has already raised US$137m with a completely new drug concept: it is looking for modulators of so-called molecular condensates. More specifically, this involves transcription activator domains that control the expression of hundreds of genes at phase boundaries by binding to transcription regulators. With its modulators, Dewpoint aims to influence the condensates so that they no longer show a disease-inducing transcription profile but a healthy pattern.
Preclinical focus As part of the partnership, Evotec will use its INDIGO platform to optimise cancer candidates in Dewpoint’s oncology pipeline of condensate modifying therapeutics (c-mods) preclinically up to IND stage. The partnership allows Dewpoint to mitigate the development risk of firstin-class candidates for clinical trials and secures undisclosed milestone payments and royalties for Evotec. Biomolecular condensates are membraneless organelles that form dynamically in the cell by phase separation and lead to localised concentration of molecules that control biological processes. Dysregulation of biomolecular condensates is observed in many diseases, including cancer, diabetes and neurological diseases. Condensate-modifying drugs (“c-mods”) such as Dewpoint’s pipeline promise to be able to treat previously untargetable diseases.
European Biotechnology | Winter Edition | Vol. 22 | 2023
Protein-free surface blocker
Cell-Free Platform
XXX Cell-free protein synthesis (CFPS)
SURFACE BLOCKING PlateBlock™ is an animal-free and protein-free blocker for plastic surfaces (e.g. microtiter plates). It does not contain any protein components and is produced without any raw materials of animal origin. This blocker is optimised for serological assays (antigendown-assays). For this assay format it is essential that the blocking does not cover the epitope of the capture antigen and that the detector antibody does not cross react with the blocking surface. PlateBlock™ is optimised to effectively prevent substitution and background effects like high background levels if the specimen is not highly diluted, as well as cross-link between blocking and detector antibodies. PlateBlock™ is ready-to use and available in bottle sizes of 125 ml and L 500 ml.
systems allow rapid protein production in vitro without the need for living cells, offering distinct advantages. Typical protein synthesis in CFPS systems takes only hours rather than days to weeks required for cell-based production. Moreover, CFPS systems enable the production of difficult proteins and their open nature provides easy manipulation of reaction conditions and high-throughput potential. The CFPS platform developed by Sino Biological has proven itself with the successful production of proteins and antibodies that are difficult to express in other systems. Sino Biological will be able to provide you with high-quality proteins and antibodies with shorter lead times, accelerating your research and development process.
Discover More Now!
CONTACT CONTACT
CANDOR Bioscience GmbH +49 7522 795270 +49 7522 7952729 info@candor-bioscience.de www.candor-bioscience.com
Sino Biological Europe GmbH Düsseldorfer Str. 40, 65760 Eschborn, Germany +49(0)6196 9678656 cro-service@sinobiological.com www.sinobiological.com
Pictures: © CANDOR Bioscience GmbH; Sino Biological
74
ASSOCIATIONS
European Biotechnology | Winter Edition | Vol. 22 | 2023
European Biotechnology is published in co-operation with the following organisations: European Biotechnology Net work
Young European Biotech Network
Europe: european-biotechnology.net
Europe: yebn.eu
Austria: lifescienceaustria.at
Austria: biotechaustria.org
Germany: gasb.de
Switzerland: swissbiotech.org
Keeping up BELGIAN BIOTECH bio.be/essenscia, the Belgian sector federation for biotech and life sciences, unveiled its policy proposals titled ‘Belgian Biotech for a Better World.’ Emphasising the potential to maintain Belgium’s biotech and bio pharma leadership globally, the memorandum outlines three key success factors: fostering innovation, attracting and developing talent, and reinforcing the nation’s unique position as a logistics hub. The booming biotech sector has seen a significant rise in jobs, exports, and research investment over the past decade. To capitalise on this growth, the election memorandum underscores the importance of prioritising innovation, talent development, and logistics infrastructure. It advocates for the continuation of the R&D Biopharma Platform, launched under Prime Minister De Croo, to sustain Belgium’s competitive edge in the global biotech arena.
Falling behind Europe: medicinesforeurope.com
Ireland: ibec.ie/ibia
Denmark: danskbiotek.dk
The Netherlands: hollandbio.nl
Germany: biodeutschland.org
Portugal: www.p-bio.org
UK: biopartner.co.uk
France: france-biotech.org
Council of European BioRegions
Italy: assobiotec.it
Sweden: swedenbio.com
Hungary: hungarianbiotech.org
Europe: cebr.net
Spain: asebio.com
Norway: biotekforum.no
Finland: finbio.net
Belgium: bio.be
European Biotechnology covers the biotechnology sector of the current 27 EU member states, Norway, Switzerland, and UK. If you would like to subscribe, please refer to european-biotechnology.com.
LEGISLATION EFPIA has released research on the European Commission’s draft Pharmaceutical Legislation, highlighting potential adverse effects on Europe’s competitiveness, its innovative life-science sector, and patient care. According to the competitiveness check carried out, the proposals could accelerate Europe’s decline in global innovation compared to the USA, China, and Japan. A 55% reduction in regulatory data protection incentives may lead to a substantial decrease in investments for breakthrough medicines over the next 15 years, resulting in an estimated 16 million years of life lost across the EU. The biotech sector, particularly SMEs, faces heightened risk, with nine out of ten research projects for data protection-dependent medicines potentially becoming economically unviable, exacerbating the trend of the biotech base relocating to the US and China
75
ASSOCIATIONS
European Biotechnology | Winter Edition | Vol. 22 | 2023
Cheers to Austrian Biotech UPCOMING EVENTS The 1. BIOTECH SUMMIT AUSTRIA – a milestone event for the Austrian and international biotechnology community – took place in Graz in the middle of October. Two days of insightful discussions and networking were on offer. EVENT REVIEW
The overbooked event, co-hosted by BIOTECH AUSTRIA, the pioneering association for biotechnology in Austria, and the dynamic styrian cluster organization Human.technology Styria, left a lasting impression on the industry. The decision to hold the summit in Graz was based on the remarkable expertise and prominent figures in the research and business landscape in Styria, which hosts a dynamic biotech community. And the organisers’ call was heard. The summit exceeded expectations with more than 200 participants from ten countries, an array of enriching activities, including career sessions, startup pitches and extensive networking opportunities. The program covered the biotech vision of Big Pharma, funding and financing opportunities for startups and established companies, and a comprehensive discussion of the regulatory landscape for clinical trials as well as the impact of AI. Participants included international venture capitalists like Wellington Partners,
Hadean Ventures and Gateway Ventures and pharmaceutical companies such as Novartis, Lundbeck, Abbvie and MSD. The conference concluded on a high note with a gala dinner and celebration at a stunning event location embedded in a mountain situated below the castle in the heart of Graz. Peter Llewellyn-Davies, President of B IOTECH AUSTRIA, reflected on the
Lejla Pock (CEO Human.technology Styria), Kuntal Baveja (Country President Novartis Austria) and Peter LlewellynDavies (President BIOTECH AUSTRIA)
› December 20, 2023, Vienna Punsch-Netzworking › January 24, 2024, Vienna 13. CEO Lunch › April 24, 2024, Vienna 3. BIOTECH CIRCLE AUSTRIA
significance of this first summit, stating, “The BIOTECH SUMMIT AUSTRIA is an exceptional platform where major players from the industry come together to delve into the latest innovative trends and developments in biotechnology and associated technologies. Austria’s stateof-the-art biotech sector is indeed thriving, and this event was perfect to unite, educate, and fuel the growth of our industry.” Lejla Pock, CEO at Human.technology Styria, expressed agreement with the event’s positive outcome, adding, “We are pleased that, together with BIOTECH AUSTRIA, we have succeeded in organizing this groundbreaking event and bringing Styrian biotechnology into the spotlight. This summit embodied our shared commitment to driving innovation and collaboration within the biotech industry. The program was rich with keynotes, panels, workshops, and a remarkable lineup of speakers. We are thrilled by the connections made, the insights gained, and the positive impact this event will have on the future of biotechnology in our country.” Austria’s strongly expanding biotech industry is at an exciting juncture, and the summit was well-timed to address the sector’s burgeoning needs. It has set the stage for future editions. The next edition of the summit will take place in Innsbruck from 10 to 11 October 2024. www.biotech-summit-austria.com
Pictures: © BIOTECH AUSTRIA
76
European Biotechnology | Winter Edition | Vol. 22 | 2023
Meet at the Swiss B iotech Day
The program will be presented in English with thematically focused panel discussions. Exhibitors, the celebration of the Swiss Biotech Success Stories award winners, and company presentations, as well as an excellent catering complement the cornerstones of the event.
EVENT PREVIEW On April 22 and 23, 2024, Switzerland’s premier biotechnology conference will once again attract about 2,000 professionals from the global life sciences community and provide a platform for networking and international collaboration.
Highlights of the Swiss Biotech Day › About 2,000 senior experts from the life science industry
› Thematically focused panel discus-
Equally attractive for biotech companies, their suppliers, investors and pharma partners, the Swiss Biotech Day will again stage high-level experts from the
life science industry and offer space for networking, during one and a half days. Partnering allows to take advantage of opportunities and synergies arising from the close collaboration between biotech and pharma, or to find interesting partners for future projects and jointly drive the development of innovative products and platform technologies. International biotech delegations use the „Global Village” to strengthen their ties with Switzerland as a biotech hub and promote cross-border investments, public-private partnerships, research and development collaborations and exchange of talent.
sions and company pitching sessions › Pre-scheduled one-to-one partnering meetings › Innovative biotech start-ups and medium-sized biotech companies › More than 100 exhibitors and Global Village with international delegations from all over the world › Swiss Biotech Success Stories Awards › Swiss Biotech Report 2024 with the most important facts, trends, innovation factors and sources of innovation in the Swiss biotech industry › General Assembly of the Swiss Biotech Association Find more info and register at swissbiotechday.ch.
About 2,000 participants from more than 40 nations are expected at the Swiss Biotech Day 2024.
The Global Village offers international biotech delegations a versatile and effective platform.
Parallel sessions feature numerous thematically focused panel discussions addressing key trends in the industry.
As one of the leading biotechnology conferences in Europe, the Swiss Biotech Day set a new benchmark this year with close to 1,800 participants from 44 nations. In 2024, it will once again provide a platform for networking, engaging discussions, and the exploration of advancements in R&D, manufacturing, data management, artificial intelligence, and innovative financing.
Opportunities and synergies
Pictures: © Swiss Biotech Association
ASSOCIATIONS
77
ASSOCIATIONS
European Biotechnology | Winter Edition | Vol. 22 | 2023
Young European Biotech Network The YEBN is a non-profit organization born 21 years ago with the objective of guiding life science students and young professionals through their careers, building bridges between academia and industry, and fostering European collaborations to create a positive impact on our society.
INTRODUCTION
Some members of the YEBN and its affiliates at the last Delegate Assembly in Strasbourg, France. If you want to be part of our team, expand your network, and have new and exciting experiences, take action and contact us!
YEBN strives to create tools that support the growth of young professionals and recent graduates, fostering both their professional and personal development. Our aim is to empower and give voice to emerging bioleaders dedicated to making a positive impact on society. We always seek new members to join our association and Executive Board. If you want to be part of an international association fostering collaboration and synergies and have the opportunity to expand your experiences and network, read on! YEBN’s DNA lies in our core principles – our four bases that define our actions are:
› Young: YEBN is powered by a dynamic community of emerging bioleaders, encompassing students and young professionals engaged in academia and industry alike. › European: our focus is on the European sphere, collaborating closely with regional and national associations. Our goal is to contribute to the greater good of society and make a meaningful impact on an international scale. › Biotech: we focus on Biotechnology and the Life Sciences sector. › Network: a network brimming with inspiration, information, connections,
the exchange of knowledge, training, and innovation. The nucleus of the association is formed by life science students, young researchers, and professionals working together to keep meeting our values. In parallel, students and young researchers have an opportunity to develop themselves on a professional and personal level. The collaboration with associations and the implication of people is what makes us move forward. The YEBN is formed by Institutional Members, which are local organizations that share our goals. Our current Institutional Members are: › NGB - New Generation of Biotechnologists (France) › AYB - Association of Young Biotechnologists (Poland) › Biotecnologi Italiani - National Association of Italian Biotechnologists (Italy) › NBV - The Dutch Biotechnology Association (Netherlands) We are currently expanding our reach and we are working on adding more associations to our network, like MaBE in Hungary. We are also building partnerships with synergic organizations that can bring value to our members, like the collaboration with the Society for Laboratory Automation and Screening (SLAS) to connect with their network of more than 21,000 global community members.
Get inspired, get involved! If you are an individual, an association, or a company aligned with our goals and want to contribute to our community, please contact us. We will be thrilled to discuss any possible collaboration and shared endeavor. Write to us at contact@yebn.eu. Get inspired, get involved.
Picture: © YEBN
78
European Biotechnology | Winter Edition | Vol. 22 | 2023
Chief Business Development INGENZA LTD. Masha Kononov has
joined Ingenza Ltd. as the new Director of Business Development at the end of Oc tober. The UK-based company develops biological systems for the manufacture of therapeutics, enzymes and consumer products for hu- Masha Kononov man health and the global environment. Kononov has been involved in business development and R&D in the biotechnology and pharmaceutical sectors for more than 25 years. She has worked in various companies around the world. Most recently, she worked in business development at Leukocare AG, Arcinova/Quotient Sciences L and Catalent Pharma Solutions
New CEO took over
ly CEO of Paion AG, Managing Director of Imevax GmbH and CEO of Midatech Pharma for five years. Philipps was CEO and founder of Talisker Pharma (founded in 2004 and later acquired by EUSA Pharma in 2006). He was also Chairman of Prosonix from 2007 to 2012. His career has also included senior positions at Johnson & Johnson and Novartis. In 2022, he founded the Sofiia Okunevska Foundation, which provides medical aid and relief supplies to Ukraine. Etienne Sokal will assume the role of Chairman of the Scientific and Medical Advisory Board and Vice Chairman of the Board L of Directors.
Non Executive Director NANOSYRINX The new non-executive director of NanoSyrinx, Anthony Johnson M.D., comes from Goldfinch Bio where he served as CEO. He is also Chairman of the Board of Directors of Outrun Therapeutics. As a qualified medical doctor with over 20 years of experience in various senior positions at biotech and pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb and GlaxoSmithKline, he brings extensive and broad L expertise to the young company.
Pictures: © Ingenza/Cellaion/Closed Loop MedicineEnhance3D Genomics
CELLAÏON The biotech company Cel-
laïon, based in the Walloon biotechnology valley in Mont-St-Guibert, Belgium, has appointed a new CEO: Dr James Neil Phillips has taken on the role, succeeding Cellaïon’s founder Etienne Sokal. Phillips is a registered medical doc tor and holds an MBA from Bayes Business School in London. With over 25 years’ experience James Neill Phillips in the pharmaceutical industry, he brings expertise in product development and commercialisation. He was previous-
Technology Leader CLOSED LOOP MEDICINE Londonbased Closed Loop Medicine Ltd has announced the appointment of Konstantinos Vlassis as Chief Technology Officer (CTO). He is a seasoned technology leader with more than 20 years’ experience in building high performing agile teams. Vlassis has also become a member of the Executive Leadership Team. Prior to joining Closed Loop Medicine, Konstantinos
BIOPEOPLE
was also CTO at Medis Medical Imaging, where he introduced a fully agile continuous integration and delivery process while initiating a comprehensive digital transformation of the company’s products incorporating AI/ML tools. Before that, he was interim CTO at Winnow Konstantinos Systems Ltd, where Vlassis he led the development and successful release of the awardwinning AI product Winnow Vision, used in the hospitality industry to reduce food waste. Vlassis holds an MBA from Cass Business School and an MSc Information Systems from Brunel University. Closed Loop Medicine developing a combination of prescription medicines and software products with patient-centred digital experiences to redefine precision medicine. To achieve this, the company is using its L proprietary technology platform.
New COO welcomed ENHANCE3D GENOMICS The new COO of UK-based Enhance3D Genomics, Hazel Jones, has over 10 years of senior leadership experience in oncology research. Prior to joining Enhanc3D Genomics, Jones held various roles within AstraZeneca, including Executive Product Director of Clinical Data, and Head of Hazel Jones Business Planning and Operations in Oncology R&D. She was also previously Head of Combination Therapies at Cancer Research UK. Jones holds a BSc in Pharmacology and completed her PhD in Biochemistry at the University of Leeds. L
79
80
COMPANY INDEX
10x Genomics B.V. (NL). . . . . . . . . . . . . . 13 Abcam plc (UK). . . . . . . . . . . . . . . . . . . . 20 Abera Bioscience (SE). . . . . . . . . . . . . . . . 60 Abivax SA (F). . . . . . . . . . . . . . . . . . . . . . 20 Acies Bio d.o.o. (SI) . . . . . . . . . . . . . . . . . 49 Adamo Foods (UK). . . . . . . . . . . . . . . . . . 44 ADC Therapeutics S.A. (CH). . . . . . . . . . . 16 Adcendo ApS (DK). . . . . . . . . . . . . . . . . . 16 Adjuvant Capital (USA). . . . . . . . . . . . . . . 60 Alfasigma S.p.A. (IT). . . . . . . . . . . . . . . . . 66 Alnylam Pharmaceuticals Inc. (USA) . . . . 82 ALS Investment Fund . . . . . . . . . . . . . . . . 26 Amyl Therapeutcs SA (BE). . . . . . . . . . . . . 63 Andera Partners (F). . . . . . . . . . . . . . . 17, 65 Apellis Pharmaceuticals Inc. (USA). . . . . . 25 Araris Biotech AG (CH). . . . . . . . . . . . . . . 16 Ardian (IT) . . . . . . . . . . . . . . . . . . . . . . . . 67 ARE Austrian Real Estate GmbH (AT) . . . . 35 AstraZeneca AB (SE/UK). . . . . . . . . . . . . . 16 Atara Biotherapeutics Inc. (USA). . . . . . . . 62 Avacta Group (UK). . . . . . . . . . . . . . . . . . 16 Bavarian Nordic A/S (DK). . . . . . . . . . . . . 60 Bayer AG (DE) . . . . . . . . . . . . . . . . 8, 16, 82 Bayer CropScience GmbH (DE) . . . . . . . . 52 BIOCOM (DE) . . . . . . . . . . . . . . . . . . . . . 36 BioGeneration Ventures (NL) . . . . . . . . . . 26 Bioingenium SL (ES). . . . . . . . . . . . . . . . . 66 BioLamina AB (SE). . . . . . . . . . . . . . . . . . 60 Biomatec (DE) . . . . . . . . . . . . . . . . . . . . . 18 BioMedPartners AG (CH) . . . . . . . . . . . . . 17 biomindz Life Science Hub Mainz (DE) . . 40 BioNTech SE (DE). . . . . . . . . . . . . 16, 20, 24 BiVictriX Therapeutics plc (UK). . . . . . . . . 16 Boehringer Ingelheim (DE). . . . . . 16, 20, 65 Bold Therapeutics (CA). . . . . . . . . . . . . . . 52 Bpifrance. . . . . . . . . . . . . . . . . . . . . . . . . 17 Brain Biotech AG (DE) . . . . . . . . . . . . . . . 46 Bristol Myers Squibb (USA). . . . . . . . . . . . 18 Byondis BV (NL). . . . . . . . . . . . . . . . . . . . 16 Cancer Research UK. . . . . . . . . . . . . . . . . 16 CANDOR Bioscience GmbH (DE) . . . . . . 74 Cantargia AB (SE). . . . . . . . . . . . . . . . . . . 24 Catalym GmbH (DE). . . . . . . . . . . . . . . . . 24 Cellaion (BE). . . . . . . . . . . . . . . . . . . . . . . 79 Clinical Microbiomics A/S (DK) . . . . . . . . 61 Closed Loop Medicine (UK). . . . . . . . . . . 79 CMBlu Energy (DE). . . . . . . . . . . . . . . . . . 64 Corden Biochem GmbH (DE). . . . . . . . . . 43 CosmosID Inc. (USA). . . . . . . . . . . . . . . . 61 Curium Pharma Ltd.. . . . . . . . . . . . . . . . . 66 Cytovation AS (SE) . . . . . . . . . . . . . . . . . . 24 D-Sight (BE) . . . . . . . . . . . . . . . . . . . . . . . 52 Daiichi Sankyo (JP). . . . . . . . . . . . . . . 15, 18 Danaher Group (USA) . . . . . . . . . . . . . . . 20 DASGIP GmbH Eppendorf Company (DE) . 7 Davion Healthcare Plc (Cyprus). . . . . . . . 66 Debiopharm S.A. (CH). . . . . . . . . . . . . . . 16 Dedalus S.p.A. (IT). . . . . . . . . . . . . . . . . . 67 EBD Group BIO-Europe Spring (DE). . 56, 57 Ecocortec d.o.o. (HR). . . . . . . . . . . . . . . . 67 Elasmogen Ltd. (UK). . . . . . . . . . . . . . . . . 16 Eli Lilly (USA). . . . . . . . . . 16, 32, 34, 63, 82 Emergence Therapeutics (F/DE). . . . . . . . . 16 Enhance3D Genomics (UK)79. . . . . . . . . 79
European Biotechnology | Winter Edition | Vol. 22 | 2023
EQT Partners AB (SE). . . . . . . . . . . . . . 26, 60 European Biotechnology Network (BE). . CP3 Evotec SE (DE) . . . . . . . . . . . . . . . . . . 17, 74 Evren Ucok (TR). . . . . . . . . . . . . . . . . . . . 63 F. Hoffman La Roche AG (CH) . . . 16, 25, 62 Faron Pharmaceuticals Ltd. (FI). . . . . . . . . 24 FGK Clinical Research GmbH (DE). . . . . . 19 FoodLabs (DE) . . . . . . . . . . . . . . . . . . . . . 44 Forbion Capital Partners (NL) . . . . . . . . . . 26 Formo Bio GmbH (DE). . . . . . . . . . . . . . . 47 Galapagos NV (BE). . . . . . . . . . . . . . . . . . 66 Genagon Therapeutics AB (SE) . . . . . . . . . 16 Genmab A/S (DK). . . . . . . . . . . . . . . . . . . 16 GlycoEra AG (CH) . . . . . . . . . . . . . . . . . . 16 Glycotope GmbH (DE). . . . . . . . . . . . . . . 16 Good Meat Inc. (USA) . . . . . . . . . . . . . . . 43 Gründerfonds Ruhr (DE). . . . . . . . . . . . . . 17 Gyala Therapeutics (ES). . . . . . . . . . . . . . . 52 Heidelberg Pharma AG (DE). . . . . . . . 16, 18 High-Tech Gründerfonds (DE). . . . . . . . . . 17 Hikma Pharmaceuticals plc (UK) . . . . . . . 16 Hybrick Berlin | Investa Holding (DE). . . . 33 Icosagen A/S (EST) . . . . . . . . . . . . . . . . . . 68 IDP Pharma SA (ES) . . . . . . . . . . . . . . . . . 24 Iksuda Therapeutics Ltd. (UK). . . . . . . . . . 16 Immedica Group AB (SE) . . . . . . . . . . . . . 16 Immunic AG (DE). . . . . . . . . . . . . . . . . . . 25 Impossible Foods Inc. (USA). . . . . . . . . . . 47 Industrifonden (SE). . . . . . . . . . . . . . . . . . 60 Infinite Roots (DE). . . . . . . . . . . . . . . . . . . 44 Informa Markets Pharmapack (USA). . . 54,55 Ingenza Ltd. (UK). . . . . . . . . . . . . . . . . . . 79 Ingredalia S.L. (ES) . . . . . . . . . . . . . . . . . . 52 Inpixon GmbH (DE). . . . . . . . . . . . . . . . . 37 Insight Partners (USA). . . . . . . . . . . . . . . . 26 ITM Isotopen Technologie SE (DE) . . . . . . 16 Kurma Partners (F). . . . . . . . . . . . . . . . . . . 17 Lauxera Capital Partners (UK). . . . . . . . . . 60 Lonza AG (CH). . . . . . . . . . . . . . . . . . 16, 18 Lovely Day Foods (DE). . . . . . . . . . . . . . . 43 Lovely Day Foods GmbH (DE) . . . . . . . . . 10 Mablink Bioscience SA (FR). . . . . . . . 16, 17 medac GmbH (DE). . . . . . . . . . . . . . . . . . 16 MediaPharma S.r.l (IT) . . . . . . . . . . . . . . . 16 Medivir AB (SE). . . . . . . . . . . . . . . . . . . . . 60 Meltwind Advisory LLP (UK). . . . . . . . . . . 63 Menarini Biotech S.r.l. (IT) . . . . . . . . . . . . 16 Merck & Co (USA). . . . . . . . . . . . . . . 15, 18 Merck KGaA (DE). . . . . . . . . . . . . . . . . . . 16 Merck Sharp & Dohme (DE). . . . . . . . . . . 62 Merieux Developpement SAS (F) . . . . . . . 63 MicroHarcest (PT). . . . . . . . . . . . . . . . 45, 66 MinervaX ApS (DK). . . . . . . . . . . . . . . . . . 60 Moderna Inc. (USA). . . . . . . . . . . . . . . . . 82 Modus Therapeutics Holding (SE). . . . . . . 60 MorphoSys AG (DE). . . . . . . . . . . . . . . . . 64 Mosa Meat NV (NL). . . . . . . . . . . . . . 10, 44 MRL Ventures Fund (USA) . . . . . . . . . . . . 26 NanoSyrinx Ltd. (UK). . . . . . . . . . . . . . . . 79 Nectin Therapeutics (IL) . . . . . . . . . . . . . . 16 Neon Therapeutics (USA). . . . . . . . . . . . . 24 Neurofix Pharma (ES). . . . . . . . . . . . . . . . 52 NeuRX Health Inc. (USA). . . . . . . . . . . . . 66 Noshaq (BE). . . . . . . . . . . . . . . . . . . . . . . 63
Nostrum BioDiscovery (ES). . . . . . . . . . . . 51 Nouscom AG (CH). . . . . . . . . . . . . . . . . . 65 Novartis AG (CH). . . . . . . . . . . . . . . . . . . 16 Novo Holdings (DK). . . . . . . . . . . . . . . . . 60 Novo Nordisk A/S (DK). . . . . . . . . 32, 34, 61 NRW.Bank (DE) . . . . . . . . . . . . . . . . . . . . 17 Nykode Therapeutics ASA (NO). . . . . . . . 60 Occident Group AG (CH). . . . . . . . . . . . . 17 Oncoteq AG (CH). . . . . . . . . . . . . . . . . . . 18 OrbiMed Advisors (USA) . . . . . . . . . . . . . 60 Origin Capital (UK). . . . . . . . . . . . . . . . . . 63 Oscillium (ES). . . . . . . . . . . . . . . . . . . . . . 52 Paleo BV (BE). . . . . . . . . . . . . . . . . . . . . . 44 PaloPalobiopharma S.L. (ES). . . . . . . . . . . 52 Pfizer Inc. (USA). . . . . . . . . . . . . . . . . 15, 82 Phaxiam Therapeutics SA (F). . . . . . . . . . . 24 Pierre Fabre (FR). . . . . . . . . . . . . . . . . 25, 62 PlasmidFactory GmbH & Co. KG (DE) . . . 17 Premier Research Group Ltd. (USA). . . . . 11 Prometheus Biosciences (USA). . . . . . . . . 62 Pureos Partners AG (CH). . . . . . . . . . . . . . 60 Quotient Therapeutics Ltd. (USA). . . . . . . 69 RemAb Therapeutics (ES) . . . . . . . . . . . . . 52 Remilk (IL) . . . . . . . . . . . . . . . . . . . . . . . . 47 Ryvu Therapeutics SA (PL) . . . . . . . . . . . . 16 Salipro Biotech AB (SE). . . . . . . . . . . . . . . 68 Sandoz AG (CH). . . . . . . . . . . . . . . . . . . . 64 Sanofi S.A. (F). . . . . . . . . . . . . . . . . . . 60, 63 Santhera Pharmaceuticals (CH). . . . . . . . . 65 Scandion Oncology A/S (DK). . . . . . . . . . 61 Scorpion Therapeutics Inc. (USA). . . . . . . 25 Scottish Enterprise (UK) . . . . . . . . . . . . . . 63 Seattle Genetics (USA). . . . . . . . . . . . . . . 15 Seventure Partners (F). . . . . . . . . . . . . . . . 17 Shimadzu Europa GmbH (DE) . . . . . . . . CP2 Sigrid Therapeutics (SE). . . . . . . . . . . . . . . 60 Sino Biological Europe GmbH (DE) . . . 9, 74 Soar Foods Oy (FI) . . . . . . . . . . . . . . . . . . 47 Sobi AB (SE). . . . . . . . . . . . . . . . . . . . . . . 25 Solar Foods (FI). . . . . . . . . . . . . . . 44, 46, 60 Stadt Leipzig, Der Oberbürgermeister (DE).38, CP4 Strabag (AT) . . . . . . . . . . . . . . . . . . . . . . . 64 Sunstone Life Science Ventures (DK). . . . . 60 Swiss Biotech Association (CH). . . . . . . . . . . 58, 59 SYN Innovation Laboratories AE (GR). . . . 66 Synaffix B.V. (NL). . . . . . . . . . . . . . . . . . . 18 T3 Pharmaceuticals AG (CH) . . . . . . . 20, 65 Takeda Pharmaceuticals (JP). . . . . . . . . . . 15 Technologiepark Heidelberg (DE). . . . 37, 41 Telavant Holdings (USA). . . . . . . . . . . . . . 62 The Cultivated B (DE). . . . . . . . . . . . . . . . 10 The Plantly Butchers GmbH (DE). . . . . . . 10 Trill Impact Ventures (SE) . . . . . . . . . . . . . 60 Tubulis GmbH (DE) . . . . . . . . . . . . . . . . . 17 UAB BiotechPharma (LT) . . . . . . . . . . . . . 31 Upside Food (USA). . . . . . . . . . . . . . . . . . 43 Valneva SE (F/AT). . . . . . . . . . . . . . . . . . . 65 VectorY Tx BV (NL). . . . . . . . . . . . . . . 20, 26 Versalis S.p.A. (IT). . . . . . . . . . . . . . . . . . . 67 Vetter Pharma-Fertigung GmbH (DE) . . . . 65 ViaNautis Bio Ltd. (UK) . . . . . . . . . . . . . . 63 Wellington Partners (DE). . . . . . . . . . . . . . 60 Ysios Capital Partners (ES). . . . . . . . . . . . . 52 YUMAB GmbH (DE). . . . . . . . . . . . . . . . . 25 ZeCardio Therapeutics (ES). . . . . . . . . . . . 52
EVENTS
European Biotechnology | Winter Edition | Vol. 22 | 2023
9.-12.4.24
Pharmapack 2024 24.–25.1.2024 PARIS Pharmapack is
the leading European event for Pharmaceutical Packaging, Drug Delivery, Medical Devices and Machinery. Since 1997, the event has grown from a conference with a small table-top exhibition, to an event hosting 300+ exhibitors and welcoming attendees from 75 different countries. www.pharmapackeurope.com
Analytica 2024, Munich (DE) Info: Messe München GmbH www.analytica.de
10.-11.4.24
BOOM Summit, Basel (CH) Info: DayOne/Kenes Group https://boom-summit.com/
29.-30.4.24
12.-14.5.24
BioEquity Europe 2024, San Sebastian (ES) Info: EBD Group/Biocentury https://conferences.biocentury.com
BIO International Convention, San Diego (USA) Info: BIO – Biotechnology Innovation Organization https://www.bio.org/events
5.-6.6.24
New Horizons in Biologics & Bioprocessing, Stockholm (SE) Info: Maria Eriksson, Life Science Sweden www.bioprocessing.se
6.2.24
8 th ECP, Frankfurt am Main (DE) Info: BCNP Consultants, https://ecp-event.com
12.-15.2.24
Barcelona Health Innovation Week 2024, Barcelona (ES) Info: Biocat https://bcnhealthinnovationweek.biocat.cat/
21.-22.2.24
CLIB International Conference CIC2024, Düsseldorf (DE) Info: Cluster Industrielle Biotechnologie e.V. https://www.clib-cluster.de
6.-7.3.24
8 AMR Conference Novel Antimicrobials and AMR Diagnostics, Basel (CH) Info: Boris Mannhardt, bamconn GmbH www.amr-conference.com th
13.-14.3.24
Pictures: © Informa markets/EBD Group/SBA
Cellulose Fibres Conference 2024, Cologne (DE)/online Info: nova Institut, www.cellulose-fibres.eu
25.-27.3.24
8 Global Congress on Plant Biology and Biotechnology 2023, Singapore/ +++ online +++ Info: Magnus Group, https://plantbiologyconference.com th
27.-28.3.24
ForumLabo Lyon, Lyon (F) Info: CIFL, www.forumlabo.com/lyon
EUBCE 2024 – 31st European Biomass Conference & Exhibition, Marseille (F) Info: ETA Florence Renewable Energies www.eubce.com
26.-27.6.24
World Bio Markets – Driving the commercialisation of the bioeconomy, Le Hague (NL) Info: Paul McDonald, TNP Media Ltd., www.worldbiomarkets.com
BioVaria 2024, Munich (DE) Info: Esther Lange, Ascenion GmbH www.biovaria.org/
3.-6.6.24
14.12.23
24.-27.6.24
Connect in Pharma, Genf (CH) Info: Eleanor Gravette, Easy Fairs https://www.connectinpharma.com/
Swiss Biotech Day 22.–23.4.2024 BASEL Swiss Biotech Day will once again provide a platform for networking, engaging discussions, and the exploration of advancements in R&D, manufacturing, data management, artificial intelligence, and innovative financing. https://swissbiotechday.ch
10.-14.6.24
ACHEMA 2024, Frankfurt am Main (DE) Info: DECHEMA www.achema.de
19.-20.6.24
Chemspec Europe , Düsseldorf (DE) Info: Mac Brooks Exhibitions https://www.chemspeceurope.com
BIO-Europe Spring 18.–20.3.2024 BARCELONA The
spring edition of Europe’s most important partnering congress for the biotechnology and pharmaceutical industries BIO-Europe. Barcelona will host the next edition, at the Barcelona International Convention Centre (CCIB). https://informaconnect.com/ bioeurope-spring
30.6.-3.7.24
European Congress on Biotechnology – Grand Challenges for Biotechnology: Health; Food Security; and Global Warming, Rotterdam (NL) Info: European Federation of Biotechnology, www.ecb2024.com/
8.-10.10.24
CPHI Milan 2024, Milan (IT) Info: CPhI Global Office, www.cphi.com
4.-5.11.24
European Forum for Industrial Biotechnology & the Bioeconomy – EFIB, Marseille (F) Info: EuropaBio https://efibforum.com
11.-14.11.24
esib – European Summit of Industrial Biotechnology, Graz (AT) Info: acib – austrian center of industrial biotechnology, www.esib.at
3.-4.12.24
8 th MedFIT, Lille (F) Info: Eurosante www.medfit-event.com
81
ENCORE
Winners & losers
European Biotechnology | Winter Edition | Vol. 22 | 2023
Market growth
I’m in biotechnology because ...
is investing more than US$11bn globally in production sites for GLP-1/GIP drugs to catch up with rival Novo, which is also spending billions to ramp up production. The winners in any case: the property developers.
RNA The RNA therapeutics market, as per MarketsandMarkets™ Inc’s report, is projected to grow from US$13.7bn in 2023 to US$18.0bn by 2028 at a CAGR of 5.6%. Factors driving this growth include increased collaborations among industry players, expanding RNA therapeutic modalities, and approvals for COVID-19 booster vaccines. Emerging RNA types like saRNAs and circRNAs are broadening therapeutic scopes. Challenges include RNA degradation by RNases, difficulties in RNA delivery to cells, and immunogenicity, necessitating innovative solutions for development and manufacturing. Opportunities lie in advancing RNA aptamer-based therapeutics, offering advantages over traditional drug therapies. The market is dynamic, with key players like Moderna Inc., Pfizer Inc., and Alnylam Inc. driving innovation and competitive developments.
ELI LILLY
BAYER AG has the headlines against it: first a blood-clotting drug flops, losing out to rival Pfizer. Then a US court awarded three Monsanto plaintiffs up to US$1.5bn - but the judgement is not yet final, and Bayer hopes to spare the money. The rumour mill is now churning again, whether the company would be better off separating agritechnology and pharmaceuticals. The share price arrived in depth as in 2006.
DR LIESBETH CEELEN, CEO, BioLizard, Ghent
“... I strongly believe that effective use of data is the foundation for more efficient and sustainable drug and diagnostic development, and creates tangible outcomes.”
COVID-19: digital leap According to a survey by GlobalData plc, the COVID-19 pandemic accelerated digital transformation within organisations, with over 80% of respondents agreeing. Despite the challenges faced, like movement restrictions and disrupted logistics, emerging technologies such as AI, telemedicine, and cloud computing gained prominence. Many see the pandemic not as a hindrance but as a catalyst for innovation, helping businesses stay competitive and resilient.
% What accelerated the digital transformation process? 100
COVID-19 Inflation other Global
80 60 40 20 0
Europa
North Amerika
Asia-Pacific
Global
The really very last word
Next issue 2024
Seriously? You want me to write this, the last word at the end of this messed-up year? Actually, everyone will be glad when it’s over. What the hell, we have to struggle with so much these days. Wars, mass migrations, inflation, crazy autocrats, rising CO2 emissions, stifling bureaucracy, extremists on the rise, and now winter! Or however we will call this dark season in the future. And you’re supposed to
SPRING EDITION BIO-Europe Spring is just
come up with something positive? Well, there might be something: it’s small, supposedly green, but it can grow. It is often found in young people, but not only. It makes you strong, but is not a steroid. You can’t buy it, you can only have it. It is tax-free, which is better not to speak out loud. And not to forget: Biotechnologists especially need it, otherwise they would be in the wrong job. What I mean: hope, of course. Bernado Glavo
around the corner when our next issue will be published. Bioprocessing and Precision Fermentation are topics. Players in these fields are invited to present their offering in our special in European Biotechnology. Want to participate? Just contact Christian Böhm (+49-30-264921-49), Oliver Schnell (-45), Wolfgang Gutowski (-35) or please mail: marketing@biocom.de. Publishing date is 7 March 24; deadline for ads is 23 February 24.
Data source: Data from Global Data Plc.; Picture: © BioLizard NV
82
European Biotechnology Net work
Let’s save the planet!
Join the European Biotechnology Network!
Find out about (free) membership on our website www.european-biotechnology.net ©master24 - stock.adobe.com
C O R P O R AT E M E M B E R S 9 / 2 3
COVID-19, 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.
European Biotechnology Network AISBL Avenue Louise 65, Box 11 | 1050 Brussels Belgium | Tel: +32 (0)2 588 70 71 www.european-biotechnology.net info@european-biotechnology.net
Successful translation – made in Leipzig
Getting cell and gene therapies from bench to market can be challenging. That’s why you need a strong partner at your side. Leipzig’s life science cluster in the heart of Europe offers a unique range of support: State-of-the-art R&D. Efficient transfer services. Swift approval pathways. Extensive networks. A thriving business landscape. Whether you are still a start-up or a mature company set to expand - look to Leipzig and become a LifeChanger with us!
Leipzig-for-lifechangers.com