Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, today announced that it has secured EUR 10M from Bpifrance to support the further clinical development of OVX836, its lead broad-spectrum influenza vaccine candidate. The grant financing is part of the Healthcare Innovation 2030 plan by the French government to promote leadership in medical innovation including enhanced preparation and response to pandemics and infectious diseases such as influenza. Osivax will apply the funds to prepare OVX836 for a Phase 2b field efficacy clinical trial to assess its efficacy against a broad range of circulating strains.
“We are deeply appreciative of the level of trust bestowed upon our approach from the French government and view this additional non-dilutive funding from Bpifrance as a validation to our novel pan-influenza approach. We are now well-positioned to accelerate the development of OVX836 through a large field efficacy trial, a critical milestone toward providing an improved influenza vaccine against currently circulating and emerging strains,” commented Alexandre Le Vert, CEO and Co-Founder of Osivax.
“Supporting Osivax in the development of its innovative broad-spectrum influenza vaccine is a critical part of our efforts to advance French biomedical research and ensure our ability to effectively fight against ongoing and future infectious diseases,” added Jeremy Berthuin, Health Sector Manager for Bpifrance. “We look forward to the progress Osivax will make as it propels OVX836 through the next stages of clinical development.”
Osivax’ OVX836 is a nucleoprotein-targeting influenza vaccine developed using the company’s proprietary oligoDOM® technology. Across four clinical trials including a completed Phase 1 and Phase 2a and two ongoing Phase 2a trials, the vaccine candidate has already shown promising safety and immunogenicity results in 800 subjects. The company recently published clinical data from its Phase 2a dose optimization trial revealing that OVX836 induced a significant increase of Nucleoprotein-specific cellular immune responses, including CD4+ and CD8+ T-cells, and initial efficacy signals. OVX836 is being further evaluated in two ongoing Phase 2a trials, an extended dose optimization study in elderly subjects with initial results expected by the end of 2022 and a combination trial with a conventional flu vaccine, with initial data expected in the first half of 2023.
Osivax’ influenza vaccine, OVX836 targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, NP is much less likely to mutate, providing a broader and more universal immune response. Osivax’ oligoDOM® technology enables the design and production of recombinant version of the NP which self-assembles into a nanoparticle, thus triggering powerful T-and B-cell immune responses. OVX836 has shown promising safety, immunogenicity, and efficacy in preclinical and clinical trials (Phase 1 and Phase 2a) and continues to be evaluated in additional studies.
Osivax is a biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOM®, to transform current and new vaccines by generating superior T-cell responses in addition to strong and sustained B cell responses against highly mutating viruses. The company is establishing proof of concept with its highly validated lead influenza candidate, OVX836, which is currently in Phase 2 testing with over 800 subjects tested. Osivax is also exploring the broader application of its technology in a variety of indications. The company will expand into other infectious disease indications through combinations and collaborations worldwide.
Bpifrance is the French national investment bank. It finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extra financial services (training, consultancy) to help entrepreneurs meet their challenges (innovation, export, etc.). For more information, please visit: www.bpifrance.fr and presse.bpifrance.fr – Follow us on Twitter: @Bpifrance – @BpifrancePresse