- Vaxcyte Inc (NASDAQ: PCVX) announced positive topline results from the Phase 1/2 proof-of-concept study evaluating VAX-24, the company's investigational 24-valent pneumococcal conjugate vaccine (PCV), in healthy adults aged 18-64.
- VAX-24 met the primary safety and tolerability objectives, demonstrating a safety profile similar to Pfizer Inc's (NYSE: NYSE:PFE) Prevnar 20 (PCV20) for all doses studied.
- In the study, VAX-24 met or exceeded the established regulatory immunogenicity standards for all 24 serotypes at the conventional 2.2mcg dose, which the company intends to move forward into a Phase 3 program.
- At this dose, VAX-24 met the standard opsonophagocytic activity (OPA) response non-inferiority criteria for all 20 serotypes common with PCV20, of which 16 achieved higher immune responses.
- Additionally, at all three doses, VAX-24 met the standard superiority criteria for all four serotypes unique to VAX-24. These four incremental serotypes cover 10-15 percent of strains causing invasive pneumococcal disease (IPD) over the current standard of care in adults.
- VAX-24 demonstrated a safety and tolerability profile similar to PCV20 at all doses studied.
- The full six-month safety follow-up is ongoing for the Phase 2 portion of the study. Final results are anticipated in 1H of 2023.
- Price Action: PCVX shares are up 71% at $35.18 on the last check Monday.
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