Osivax, a clinical-stage biopharmaceutical company, has secured $19.5 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to advance its universal influenza vaccine candidate OVX836. The multi-year agreement, announced on August 26, 2025, represents a significant milestone in the development of next-generation pandemic preparedness tools.
Novel Approach Targets Conserved Viral Component
OVX836 represents a first-in-class approach to influenza vaccination by targeting the nucleoprotein (NP), a highly conserved internal antigen of the influenza virus. Unlike traditional vaccines that target surface antigens prone to mutation, this strategy potentially offers broader protection against both circulating and emerging influenza A strains.
"Osivax is excited to explore our universal flu vaccine approach and the potential of OVX836 to transform global influenza preparedness," said Alexandre Le Vert, CEO and Co-Founder of Osivax. "With BARDA's support, we are accelerating our path toward late-stage development and preparing for future large-scale efficacy trials."
The vaccine utilizes Osivax's proprietary oligoDOM™ technology, which enables the design and production of a recombinant version of the nucleoprotein that self-assembles into nanoparticles. This platform is designed to trigger powerful T-cell and B-cell immune responses, potentially providing superior and sustained protection compared to conventional approaches.
Comprehensive Clinical Development Program
OVX836 has demonstrated encouraging clinical progress, having been tested in 7 clinical trials involving over 1,400 participants. The studies have shown promising safety, immunogenicity, and efficacy outcomes, supporting the vaccine's advancement toward late-stage development.
The company is currently conducting Phase 2 clinical trials, with the BARDA funding positioned to accelerate progression toward larger efficacy studies. The agreement includes provisions for potential additional funding that could support a Phase 2b trial and chemistry, manufacturing, and controls (CMC) scale-up activities.
Strategic Funding Allocation
The $19.5 million award will be distributed across critical development activities. Of the initial funding, $11.5 million will support continued development of the OVX836 candidate, while $8 million is allocated for preparation of a large field efficacy study. The agreement also includes options for additional funding to support advanced clinical trials and manufacturing scale-up.
The funding will enable ongoing clinical development, large-scale trial preparation, and process development necessary for manufacturing scale-up. This comprehensive approach addresses both the scientific and operational challenges of bringing a universal influenza vaccine to market.
Addressing Critical Public Health Need
The development of broadly protective influenza vaccines represents a growing priority for pandemic preparedness and seasonal outbreak response. Current influenza vaccines require annual reformulation due to viral mutation, limiting their effectiveness against emerging strains and pandemic threats.
Osivax's approach of targeting the nucleoprotein, which is much less likely to mutate compared to surface antigens, could potentially address these limitations. The company's broader ambition extends to developing a pan-respiratory virus vaccine capable of preventing all strains of influenza, with plans to expand into other infectious disease indications through combinations and collaborations.
The BARDA funding reflects the strategic importance of developing next-generation influenza vaccines that can be rapidly deployed during both seasonal outbreaks and pandemic emergencies. This investment supports the broader goal of enhancing global preparedness for respiratory virus threats through innovative vaccine technologies.
