Osivax Collaborates with GC Biopharma to Develop OVX836 Combination Vaccine with GC FLU
Single-Shot Next-Generation Influenza Vaccine Alliance
French clinical-stage biotech Osivax has secured a non-exclusive, sub-licensable license to GC Biopharma Corp. (006280)'s marketed seasonal influenza vaccine GC FLU, covering the global market excluding South Korea and Japan. Osivax will lead the development and commercialization of the combination vaccine, while GC Biopharma will handle long-term supply of GC FLU and royalty collection. The key of the deal is not merely securing distribution rights but combining different immune pathways into a single injection to enhance the breadth and duration of protection offered by existing seasonal vaccines.
Targeting Both NP and HA in a Single Design
OVX836 is a recombinant influenza A nucleoprotein (NP) vaccine candidate developed using Osivax's self-assembling nanoparticle platform, oligoDOM. It induces T-cell and B-cell responses through a highly conserved internal antigen. GC FLU is a standard-dose inactivated vaccine targeting hemagglutinin (HA) of influenza A and B, with a trivalent formulation currently listed by WHO. By targeting the frequently mutated HA and relatively conserved NP together, the combination aims to overcome the limitations of existing vaccines, which are dependent on annual strain match. Osivax previously confirmed the tolerability and complementary immune responses of OVX836 combined with GSK's Fluarix Tetra in a Phase 2a trial.
Phase 2b Trial as a Development Milestone
OVX836 was evaluated for efficacy, immunogenicity, and safety in a Phase 2b trial (NCT05569239) involving 18- to 59-year-old healthy individuals, with a single intramuscular dose of 480 micrograms. The trial status is currently Active, not recruiting, following participant recruitment. According to Osivax, OVX836 has been administered to over 4,000 individuals across seven clinical trials, but the GC FLU monovalent combination vaccine is a new candidate requiring separate clinical development and regulatory validation. Therefore, short-term value drivers are subsequent data confirming the formulation stability, HA antibody response retention, NP-specific T-cell response, and actual infection prevention efficacy.
Regulatory Foundation and Competitive Landscape
GC FLU is a marketed product that received WHO prequalification on April 12, 2011, with current trivalent single-dose and multi-dose formulations maintained on the WHO list, providing a foundation for global procurement and production. Competing standard vaccines include GSK's Fluarix, Sanofi's Fluzone and high-dose Fluzone, CSL's adjuvanted Fluad, recombinant Flublok, and Moderna's mRNA vaccine MFLUSIVA. The global influenza vaccine market is projected to grow from $9.04 billion in 2025 to $13.13 billion in 2030, meaning OVX836's combination vaccine must clinically demonstrate broad protection to surpass the procurement and distribution advantages of existing major brands.
This agreement combines the conserved nucleoprotein-targeting immunity of Phase 2b OVX836 with the HA antibody response of WHO-prequalified GC FLU, marking a pivotal event in transitioning Osivax's technology platform into a real-world seasonal vaccine candidate. In the short term, GC Biopharma's manufacturing infrastructure will accelerate Osivax's formulation development, while GC Biopharma gains long-term supply revenue and royalty pathways. Mid-to-long-term value hinges on whether the combination vaccine can demonstrate superior infection prevention efficacy and protection duration compared to leading brands like Fluarix, Fluzone, Fluad, Flublok, and FDA-approved mRNA vaccine MFLUSIVA in the $13.13 billion market expected by 2030. From an R&D perspective, the 480 microgram dose data accumulated in the Phase 2b trial will serve as a benchmark for immune interference, safety, and subsequent late-stage trial design.
Source: FierceBiotech (rss)
https://www.fiercebiotech.com/biotech/osivax-bags-flu-vaccine-rights-pursue-combination-shot-vision