Vaxcyte reports positive Phase 1/2 data for VAX-31; all serotypes meet immunogenicity criteria

Vaxcyte, Inc.

VAX-31 showed robust OPA responses for all 31 serotypes at all doses; safety profile similar to Prevnar20.
At high and middle doses, VAX-31 met or exceeded non-inferiority criteria for all 20 serotypes common with PCV20.
For 11 unique serotypes, all three doses met superiority criteria.
Company selects VAX-31 for adult Phase 3; plans to initiate pivotal study by mid-2025 with topline data in 2026.
Also plans VAX-31 infant Phase 2 study in Q1 2025.

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