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Vaxcyte Advances to Second Stage of Ongoing Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease in Infants
-- Initiation of Stage 2 Approved by Independent Data Safety Monitoring Board Following Review of Stage 1 Safety and Tolerability Data -- -- The Stage 2
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Initiation of Stage 2 Approved by Independent Data Safety Monitoring Board Following Review of Stage 1 Safety and Tolerability Data -- -- The Stage 2 Portion of VAX-24 Infant Study Will Include Prevnar 20® (PCV20) as Study Comparator -- -- Company Expects to Announce Topline Data from Primary Immunization Series by 2025, Followed by Topline Data from Booster Dose Approximately Nine Months Later -- SAN CARLOS, Calif., July 11, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced that the ongoing Phase 2 study of VAX-24 in healthy infants is advancing to the second and final stage of the study. The independent Data Safety Monitoring Board approved advancing to the second stage of the study following the review of the safety and tolerability results from the first stage. The Phase 2 study is evaluating the safety, tolerability and immunogenicity of VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). Vaxcyte expects to share topline data from the primary three-dose immunization series of the study by 2025, followed by topline data from the booster dose approximately nine months later. “Today’s news illustrates the steady momentum of our VAX-24 infant clinical program and underscores our commitment to progressing the evaluation of VAX-24 relative to the broadest-spectrum standard-of-care PCV available for this vulnerable population,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. “We designed VAX-24 to deliver broader coverage and improved immune responses and we look forward to sharing topline data from the primary three-dose immunization series by 2025.” Vaxcyte’s Phase 2 infant study is being conducted in two stages and compares VAX-24 to the broadest-spectrum standard-of-care PCVs currently available. Stage 1 of the study evaluated the safety and tolerability of a single injection of VAX-24 at three dose levels in a dose-escalation approach compared to VAXNEUVANCE™ (PCV15) in 48 infants. The Stage 2 portion is evaluating the safety, tolerability and immunogenicity of VAX-24 at the same three dose levels compared to PCV20 in approximately ...