RegulatoryOsivax Gets Flu Vaccine License to Go For Combo...

Osivax Gets Flu Vaccine License to Go For Combo Shot Vision

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Osivax has obtained a license from GC Biopharma for its influenza vaccine, giving the French biotech an opportunity to build on early clinical evidence suggesting that its midstage candidate could enhance the protection provided by conventional flu vaccines.

Terms of the Agreement

Under the agreement, Osivax will develop a combination vaccine that brings together its OVX836 with GC Biopharma’s newly licensed GC FLU. OVX836 is an investigational influenza A vaccine designed to target nucleoprotein (NP), a very conserved internal antigen. GC FLU, meanwhile, is a non-activated seasonal influenza vaccine that stimulates antibodies against hemagglutinin proteins found on influenza A and B viruses.

Osivax has obtained non-exclusive rights to GC FLU everywhere except Japan and Korea. The French company will oversee development and marketing of the combined vaccine outside Korea, where GC Biopharma is headquartered. GC Biopharma will provide the vaccine component and receive royalties from the resulting product.

Partnership Key Components

The partnership is based on evidence that combining OVX836 with a conventional flu vaccine could provide greater protection against influenza A. Traditional vaccines such as GC FLU generate antibodies against viral surface proteins, but those proteins evolve over time. As a result, vaccine makers must reformulate seasonal shots regularly, and even updated vaccines may provide only partial protection against circulating strains.

OVX836 instead targets NP, which remains relatively conserved among influenza A strains. By prompting T cells to recognize this internal protein, OVX836 could complement the antibody response generated by conventional vaccines and potentially make the combined approach more effective than either vaccine administered alone.

Osivax found early clinical support for this strategy in a Phase 2a trial involving 60 healthy volunteers who received OVX836 alongside GSK’s Fluarix Tetra. Based on the findings, the company concluded that complementary immune responses and broader protection across strains could give the combination an advantage over existing single-component flu vaccines. This was a major victory for the company, as it provided a major leap over what others and the firm itself has on offer. Osivax subsequently evaluated the approach in a larger Phase 2 trial.

In those clinical trials, participants received OVX836 and Fluarix Tetra as separate injections. Osivax identified the need for a single-shot formulation partly because requiring two injections could discourage vaccination, particularly among people who are uncomfortable with needles. The agreement with GC Biopharma gives the company access to the components needed to develop a single injection combining OVX836 with an inactivated influenza vaccine.

The CEO’s Words

Osivax CEO and Co-Founder Alexandre Le Vert said that, in spite of decades of advances in influenza vaccination, substantial unmet need remains for vaccines capable of delivering broader and longer-lasting protection as influenza strains continue to evolve. He described the agreement as an important step toward creating an improved seasonal flu vaccine by combining Osivax’s T-cell-focused technology with GC Biopharma’s established GC FLU vaccine and manufacturing expertise. 

He added that the collaboration is a central part of Osivax’s strategy to develop a next-generation seasonal influenza vaccine while maintaining the company’s independence.

Osivax has secured a non-exclusive global license from GC Biopharma to use its marketed GC FLU vaccine alongside Osivax’s experimental OVX836 in a planned single-injection influenza vaccine. The agreement gives Osivax an opportunity to develop a combination shot designed to provide broader and potentially more durable protection against influenza.

Osivax Targets a Single-Shot Flu Vaccine

The Osivax combination will pair OVX836, an influenza A vaccine candidate targeting the highly conserved nucleoprotein (NP), with GC FLU, an inactivated seasonal influenza vaccine that targets hemagglutinin (HA). The companies believe the two approaches could complement each other by generating different types of immune responses.The licensing agreement gives Osivax the components needed to pursue its single-shot vision. Previously, combination studies involved separate injections of OVX836 and conventional flu vaccines. A single injection could potentially simplify vaccination and reduce the burden associated with receiving multiple shots.

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