Osivax 公布 OVX836 流感疫苗 Phase 2b 数据

Results support combination strategy for influenza vaccines

Osivax has reported phase 2b results for OVX836 and outlined the next stage of development for its next-generation seasonal influenza vaccine strategy.

The study evaluated OVX836 in 2,850 healthy adults in Europe and delivered what the company describes as the first consistent efficacy signal for a monovalent nucleoprotein-based influenza vaccine across both major influenza A subtypes.

The trial did not meet its pre-specified primary endpoint of 50% vaccine efficacy, with a point estimate of 24% that was not statistically significant.

Secondary endpoints showed emerging efficacy signals, including 28% for CDC-defined influenza-like illness, 27% for A/H3 and 25% for A/H1N1pdm09. OVX836 also demonstrated a favourable safety profile and induced robust NP-specific antibody and T-cell responses. Osivax said these findings support advancing OVX836 in combination with traditional seasonal influenza vaccines to provide a complementary layer of protection.

Dr Nicola Groth said: “Large efficacy studies are designed not only to evaluate clinical benefit, but also to deepen our understanding of novel immune mechanisms under real-world conditions.”

She added: “While the study did not meet its primary endpoint, the consistency of the efficacy signal across influenza A subtypes, together with the observed immunogenicity and favourable safety profile, reinforces our confidence that nucleoprotein-targeted immunity can provide a complementary mechanism of protection alongside conventional seasonal influenza vaccines.”

Alexandre Le Vert said: “These results provide a clear direction for the future development of OVX836. Rather than replacing existing seasonal influenza vaccines, we believe the greatest opportunity lies in complementing them.”

He added: “By combining strain-specific antibody protection with the broad cellular immunity induced by OVX836, we aim to develop next-generation influenza vaccines capable of delivering broader and more durable protection against seasonal influenza.”

Osivax has secured collaborations with GC Biopharma and a second undisclosed pharmaceutical partner to support development of single-injection combination candidates. The first phase 1/2 combination study is expected in Q4 2027.