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Highlights

Genopole and Croda Pharma ally for the Biopharma Innovation Summit


Genopole partnered with Croda Pharma to organize the Biopharma Innovation Summit, a day-long scientific event dedicated to biopharmaceutical innovation held Thursday 14 November at the heart of the biocluster.
Journée Croda - table ronde intitulée « Essais cliniques phases 1 et 2 : comment surmonter les obstacles réglementaires et financiers ? » Nov. 2024 Journée Croda - table ronde intitulée « Essais cliniques phases 1 et 2 : comment surmonter les obstacles réglementaires et financiers ? » Nov. 2024

Close to 100 participants were present for the Biopharma Innovation Summit, an event organized by Genopole and Croda Pharma and focused on new technologies energizing biotherapy development (formulations, delivery systems and adjuvants).

To present this first edition of the Biopharma Innovation Summit, Genopole united its expertise with that of Croda Pharma, a leader in the fields of pharmaceutical excipients, vaccine adjuvants and lipid-based drug delivery systems.

Genopole Chief Executive Gilles Trystram and Croda Pharma President Guillaume Douillet where there to welcome the event’s participants, close to 100 in all, who learned about current research and technologies aimed at accelerating the development of biomanufacturing and increasing its yields while also guaranteeing optimal quality.

CitationGilles Trystram emphasized Genopole’s mission and the event’s strategic interest: “Genopole ensures continuity in biotech innovation. We support 17 laboratories, under the supervision of renowned French research institutions, carrying out basic to industrial-scale research most notably in health and biotherapies but also in diagnostics, patient accompaniment and much more. And we accompany the growth of 66 businesses, half of which are active in the field of health. The Biopharma Innovation Summit forwards those aspects, giving these entities an opportunity to grow networks, increase visibility and lay paths for partnerships and financing“.

Through the Biopharma Innovation Summit, current and alumni start-ups accompanied by Genopole were able to present their innovations to an audience of pharmaceutical companies, investors, other biotechs, academic researchers, and representatives from institutional partners like SATT Paris-Saclay and France Biolead.
Four companies, directly tied to the day’s specific topics, were given a spotlight:

  • AGS Therapeutics (located at Genopole): Manuel Vega, the president and founder of AGS, presented the company’s innovative microalgae extracellular vesicles (MEVs) for use as a delivery system for bioactive molecules, vaccines and gene therapies. These MEVs are produced by Chlorella single-cell microalgae. They can be easily manufactured in large quantities with only water, light and minerals. MEVs can carry a large range of biological molecules: mRNA, siRNA, oligonucleotides, plasmids, proteins and more. Also, they are administered noninvasively (oral, nasal, topical (ocular) routes) and able to target difficult-to-reach tissues (intestinal epithelium, spleen, retina, choroid, neurons, etc.).
  • SE Therapeutics (Gene.iO, Shaker alumni, currently at the Genopole incubator): Daniel Hamaoui, the president and founder of SE Therapeutics, is developing novel intracellular biologics delivery methods for deployment in cell and gene therapies. Instead of viral vectors, SE Therapeutics is developing patented protein vectors, which may enable significantly lower manufacturing costs and thus forward the industrialization of biotherapies.
  • bYoRNA (Gene.iO alumni): Presented by Thierry Ziegler, the company’s cofounder and technical & operational director, bYoRNA is focused on the development and biomanufacturing of therapeutic messenger RNA (mRNA) via yeast fermentation. The company’s technology allows for the production of humanized mRNA in a unique cell culture. It will be able to furnish high-quality mRNA at lower costs, as compared to current enzyme-based methods.
  • Abolis located at Genopole): During a roundtable talk, Gwenaël Servant, Abolis’s vice-president for business & strategy, presented the company’s solution to move the manufacturing of compounds of interest (raw materials, intermediates, active ingredients) away from conventional petrochemical processes and toward biological production. Having recently raised €35 million from industrials and investors looking for innovations in sustainability, Abolis is targeting several markets, such as health, cosmetics, nutrition and chemistry, among others.

Pitches and roundtables for the Biopharma Innovation Summit agenda

Genopole thanks Paul-Henri Derrien, director of industrial development at France Biolead, who, with Rebecca Wood, sustainability manager at Croda Pharma, led a roundtable entitled “Sustainability and bioprocesses: are they compatible?“. Also participating in that discussion were Gwenaël Servant from Abolis, Alexandre Fontayne, biologics CSO at Unither Pharmaceuticals, James Humphrey, R&T Specialist and Dennis Christensen, head of Global R&D for adjuvant systems at Croda Pharma.
The roundtable was focused on the integration of sustainability in biomanufacturing and the steps already taken thereto. The participants discussed the effects of regulations on CDMOs and the benefits of sustainable practices as concerns not only business economics but also a company’s corporate image.

A second roundtable was held under the banner, “Phase 1 and 2 clinical trials: overcoming regulatory and financial obstacles“. Led by Biotech Consultant Laurent Pépin, this second discussion involved Joël Crouzet, a biotech entrepreneur, Sam Collaudin, a biotech strategy expert, and Adrien Clavairoly a principal associate at the life sciences investments company AdBio Partners.
Finding financing in early clinical trial phases is difficult in Europe. Investors hesitate to put money into phase 1 or 2 trials because of the high risks and low yields associated with them. However, when they are convinced to do so, the amount of financial support given today is greater than it was in the past. Thus, the participants advised researchers to let their ambition run and to seek out strong financing as soon as their innovations benefit from patent protection, a clear view going forward, a complete development plan and KOL validation. Calling upon CROs with up-to-date knowledge on current regulations for early clinical trials was advised, as was not showing a lack of commitment to the project and not engaging with certain countries like China for manufacturing, so as to not close doors to the American market. The structuration of such a development plan is crucial for reassuring investors. Obtaining public financing, notably from Bpifrance or Europe (EIC) was also identified as a major advantage for leveraging venture capital.

Genethon and Yposkesi welcome visitors

A day of visits to several Genopole labs was held on 13 November, the day before the summit, to illustrate the biocluster’s research dimension. Several labs within Genethon (AFM-Telethon), opened their doors to welcome visitors, who then went on to visit Yposkesi an SK pharmteco company located at Genopole.

Technological Development Director Patrick Santambien, presented Genethon’s, research orientations for rare diseases to the visitors.
For example, patented work done by Genethon led to the first authorized gene therapy for SMN1-associated spinal muscular atrophy (SMA). That therapy is currently commercialized by Novartis under the brand name Zolgensma.
Another disease that Genethon is working on is Duchenne muscular dystrophy, characterized by a defect in the DMD gene, which codes for dystrophin, a protein vital to muscle function. In 2020, the lab received ANSM approval for a clinical trial to test a gene therapy delivering a shortened but functional version of DMD via an AAV vector. The currently available results show good tolerability, significant expression of the therapy’s “microdystrophin” protein, and notable functional improvements in patients.
The visitors then went on to discover the work being done by the Neuromuscular Diseases and Gene Therapy laboratory headed by Inserm Research Director Ana Buj-Bello. Her team partnered with American colleagues at the University of Washington and Harvard Medical School to develop a gene therapy for myotubular myopathy, a disease causing potentially severe muscle weakness almost exclusively in boys.
Genethon is also active in rare hereditary disorders affecting the liver. Guiseppe Ronzitti, who heads the Immunology and Liver Diseases team, spoke to the visitors about the development of gene therapy vectors in the settings of Crigler-Najjar syndrome and glycogen storage diseases (GSDs) such as Pompe disease (GSD type II) and Cori’s disease (GSD type III). Thereafter, Patrick Santambien spoke more largely on the optimization of production processes for gene therapy viral vectors, a focus of the Bioproduction Technologies Laboratory. This latter works in partnership with such entities as Thales, for the integration of AI solutions, or Samabriva for the development of AAV vector production processes involving plant-based expression systems.

Because research ideally leads to production, the next logical step for the visit was to discover Yposkesi, a CDMO developing and industrializing processes for the production of therapeutic vectors in the setting of genetic diseases. The visitors discovered the entire process: development, upscaling, and vector purification & production, all carried out in strict conformity to current good manufacturing practices.

This day of visits and encounters provided the biocluster’s accompanied businesses with information and contacts useful for their growth.

Genopole thanks Medicen and MabDesign for their support in communicating the event to the biotech community and thus in ensuring its success.

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With the support from
Région île de France