VAX-31 Optimized Dose, with Majority of Serotypes Dosed at 4.4mcg and Balance at 3.3mcg, is Designed to Elicit Even Stronger Immune Responses in Infant Population to Protect Against Invasive Pneumococcal Disease (IPD) Company Intends to Release Topline Data from Primary Immunization Series and Booster Dose Either Sequentially or Together by End of First Half of 2027 VAX-31 is Designed to Provide Greater Coverage Against Both Currently Circulating and Historically Prevalent Strains Relative to Standard-Of-Ca ...

VAX-31 Phase 1/2 Study Results Overview - VAX-31 demonstrated a safety profile similar to Prevnar 20® (PCV20) at all doses studied[14] - VAX-31 induced robust OPA immune responses for all 31 serotypes (STs) at all doses studied, with all three doses advanceable to Phase 3[14] - The VAX-31 data validate the potential of Vaxcyte's carrier-sparing platform to deliver the broadest-spectrum PCVs[15] Immunogenicity Data - High and Middle doses of VAX-31 met or exceeded OPA regulatory immunogenicity criteria for all 31 STs, while the Low dose met the criteria for 29 of 31 STs[17] - For the 20 STs common with PCV20, the High dose had 18 with GMR greater than 10, the Middle dose had 13 with GMR greater than 10, and the Low dose had 8 with GMR greater than 10[17] - For the 11 additional STs unique to VAX-31, all 11 met the superiority criteria at all doses[17] Clinical Development Plan - Vaxcyte plans to initiate a Phase 3 pivotal, non-inferiority study for VAX-31 in adults by mid-2025, with topline results expected in 2026[18] - Vaxcyte plans to initiate a VAX-31 infant Phase 2 study in 1Q:2025 following IND submission and clearance[18] Market Opportunity - The pneumococcal vaccine market is expected to reach approximately $13 billion by 2027[105] - VAX-31 is designed to increase coverage to more than 95% of IPD circulating in U S adults[104]