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Consortium including ElsaLys Biotech and Novadiscovery awarded €3.35 million by Bpifrance to advance inolimomab in graft-versus-host disease

  • NOVA awarded €2.4 million to leverage Jinkō®, its best-in-class clinical trial simulation platform, to conduct in silico studies for graft-versus-host disease

  • Research academic teams of the consortium - Institut de Recherche Saint Louis [1] & Institut Mondor de Recherche Biomédicale [2] to receive €0.95 million for their collaborative work with ElsaLys on in vitro and in vivo mechanisms of action of inolimomab

  • ElsaLys Biotech utilising in silico studies to accelerate the European approval of inolimomab in both adult and paediatric populations with this rare and life-threatening disease

Lyon, France – 19 January 2021: The Silikotac Program consortium, consisting of ElsaLys Biotech, Novadiscovery (“NOVA”) and two expert academic teams from Hôpital St Louis (Paris) and Hôpital Henri Mondor (Paris), has been awarded €3.35 million in non-dilutive funding by Bpifrance to support development of inolimomab in graft-versus-host disease (GvHD), the main complication that may occur after an allogeneic hematopoietic stem cell transplantation. The ambition of the Silikotac Program is to create the first French industrial and scientific immunotherapy chain group focused on GvHD.

This financing is part of the PSPC (Projet de recherche et développement Structurant pour la Compétitivité) program fund from Bpifrance, a financing initiative from the French government to support new and emerging industries within France.

ElsaLys Biotech is a clinical stage company developing inolimomab, an immunotherapy product, for steroid-refractory acute graft-versus-host disease in adult and paediatric populations.

NOVA is a leading health tech company using in silico proprietary technology to optimize clinical trial development and predict drug efficacy. NOVA, which has been awarded €2.4 million, will conduct in silico clinical trials utilising its innovative Jinkō® platform. The results will be used to support future regulatory approval applications by ElsaLys for inolimomab in Europe. Jinkō® is NOVA’s best-in-class clinical trial simulation and disease modelling platform. Its workflows are designed to closely resemble those of real-life clinical studies.

The two academic teams in the Silikotac consortium, from Institut de Recherche Saint Louis & Institut Mondor de Recherche Biomédicale, have been awarded €0.95 million to:

  • Further deepen the in vitro mechanism of action of inolimomab at molecular and cellular level
  • Evaluate new protocols for broadening and optimizing inolimomab use in the GvHD algorithm treatment using several in vivo preclinical models

ElsaLys announced in July 2020 the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for inolimomab for the treatment of Steroid-Refractory acute graft-versus-host disease (aGvHD) in grade II-IV adult patients. In Europe, the French National Agency for the Medicines and Health Products Safety (ANSM) granted a Temporary Authorisation for Use (ATU) for inolimomab renewed at the end of 2020. Inolimomab is therefore available in France to adults and paediatric patients over 28 days of age for the treatment of acute steroid-refractory or steroid-dependent graft-versus-host disease. Further early access applications will be submitted in other European countries while ElsaLys continues to work on the filing of marketing approval in Europe and the US.

Dr. Christine Guillen, CEO and Co-founder, ElsaLys Biotech, said: “Patient numbers for rare diseases are limited and simulating clinical trials in a virtual population can help strengthen data packages submitted for regulatory approval. We are engaged, like regulatory agencies are, in using in silico trials for ethical concern and we think this approach can be key to accelerate the development of innovative drugs, notably in paediatric population.”

François-Henri Boissel, CEO, NOVA, said: “We are excited to be leveraging Jinkō®, our unique simulation platform, to support ElsaLys in bringing an important treatment to patients. NOVA’s mission is to help companies enhance their R&D activities and optimize outcomes for patients. The use of in silico trials is relatively new, but regulatory authorities are working towards providing a framework for expanded use as a third pillar of the R&D drug paradigm in addition to in vitro and in vivo approaches.”

[1] Institut de Recherche Saint Louis, Pr Vassili Soumelis, Unité 976, Inserm and Université de Paris

[2] Institut Mondor de Recherche Biomédicale, Pr José Cohen, Unité 955, Inserm and Université de Paris Est Créteil


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