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Vaxcyte Announced Topline Results From Phase 1/2 Study Of VAX-31, The Company's 31-valent Pneumococcal Conjugate Vaccine Candidate; At All Doses, VAX-31 Demonstrated Robust Opsonophagocytic Activity Immune Responses For All 31 Serotypes

Benzinga ·  Sep 3 07:12
  • At Middle and High Doses, VAX-31 Met or Exceeded Regulatory Immunogenicity Criteria for All 31 Serotypes
  • At All Doses Studied, VAX-31 Was Observed to be Well Tolerated and Demonstrated a Safety Profile Similar to Prevnar 20.
  • Topline Results Further Validate Potential of Vaxcyte's Carrier-Sparing Platform to Deliver Broadest-Spectrum Pneumococcal Conjugate Vaccine Candidates that Provide Protection Against Both Currently Circulating and Historically Prevalent Serotypes.
  • For Adult Indication, VAX-31 Selected to Advance to Phase 3 Program; Vaxcyte Plans to Initiate Phase 3 Pivotal, Non-Inferiority Study by Mid-2025 and Announce Topline Safety, Tolerability and Immunogenicity Data in 2026.
  • For Pediatric Indication, in Parallel with Ongoing VAX-24 Study, Company Plans to Initiate VAX-31 Infant Phase 2 Study in First Quarter of 2025 Following IND Application Submission and Clearance.
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