Osivax announced that its Phase 2b trial of flu vaccine OVX836 in 2,850 European adults missed its primary endpoint of 50% efficacy, yielding an unstatistically significant 24% point estimate. However, the trial demonstrated consistent secondary efficacy signals across influenza A subtypes. The biotech is now pivoting to single-injection combination candidates alongside GC Biopharma and an undisclosed partner, with Phase 1/2 trials planned for Q4 2027.
Phase 2b trial design and results
- ▪Osivax's lead flu vaccine candidate OVX836 failed to meet its pre-specified primary endpoint of 50% vaccine efficacy in a Phase 2b trial, generating a non-statistically significant point estimate of 24%.
- ▪Osivax's Phase 2b Asuniva trial evaluated a 480 µg dose of OVX836 against placebo in 2,850 healthy adults aged 18–59 across Belgium, France, Finland, and Germany.
- ▪The Phase 2b trial of OVX836 demonstrated a favorable safety profile while inducing robust nucleoprotein-specific antibody and T-cell immune responses in study participants.
- ▪In secondary endpoints of Osivax's Phase 2b trial, OVX836 demonstrated preliminary vaccine efficacy point estimates of 28% for CDC-defined influenza-like illness, 27% for A/H3, and 25% for A/H1N1pdm09.
Pivot to combination vaccine strategy
- ▪Following the Phase 2b trial results, Osivax pivoted its development strategy toward combining OVX836 with traditional seasonal influenza vaccines.
- ▪Osivax anticipates launching its first Phase 1/2 clinical study for its combination influenza vaccine candidate in the fourth quarter of 2027.
- ▪Osivax entered into a distinct strategic collaboration agreement with an undisclosed global pharmaceutical partner to access established seasonal influenza vaccines for single-injection combination candidate development.
- ▪Osivax established a strategic collaboration with GC Biopharma to access established seasonal influenza vaccines to develop single-injection combination vaccine candidates incorporating OVX836.
- ▪Osivax's combination strategy seeks to combine the broad cellular immunity generated by OVX836 with the strain-specific antibody protection of established seasonal flu vaccines into a single injection.
OVX836 design and platform technology
- ▪Osivax's OVX836 is a first-in-class influenza A vaccine candidate targeting the nucleoprotein, a highly conserved internal antigen less prone to mutation than surface antigens.
- ▪Osivax uses its oligoDOM platform technology to produce a recombinant nucleoprotein that self-assembles into nanoparticles, triggering broad T-cell and B-cell immune responses.
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