Vaxcyte Announces Positive Phase 1/2 Results for VAX-31, Advances to Phase 3

VAX-31 Phase 1/2 Study Results:
Vaxcyte reported positive topline data from the Phase 1/2 study of VAX-31, its 31-valent pneumococcal conjugate vaccine candidate, in adults aged 50 and older. The vaccine demonstrated robust immune responses for all 31 serotypes and was well-tolerated.

Advancement to Phase 3:
Based on the positive results, VAX-31 will advance to a Phase 3 program. Vaxcyte plans to initiate a Phase 3 pivotal, non-inferiority study by mid-2025 and announce topline safety, tolerability, and immunogenicity data in 2026.

Vaccine Development:
Vaxcyte is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Its lead candidate, VAX-24, is a 24-valent pneumococcal conjugate vaccine.

Funding and Market Performance:
Vaxcyte has raised a total of $863M in funding over 11 rounds. The company's stock soared 46.7% in premarket trading after announcing positive data for its pneumococcal vaccine candidate.

Competitive Landscape:
Vaxcyte aims to compete with Pfizer’s Prevnar 20 in the pneumococcal market. The company's vaccine has shown non-inferiority against 90% of the serotypes covered by Prevnar 20 among adults 65 and older.