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Vaxcyte Doses First Participants in Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease in Infants
-- Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series by 2025 -- -- The Nine Incremental
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series by 2025 -- -- The Nine Incremental Serotypes in VAX-24 Cover an Additional 20-25 Percent of Strains Causing Invasive Pneumococcal Disease Over the Current Standard-of-Care PCV in Infants -- SAN CARLOS, Calif., March 30, 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 first participants were dosed in the Phase 2 study of VAX-24 in healthy infants. This study will evaluate 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). The Company expects to share topline data from the primary three-dose immunization series of the Phase 2 study by 2025. Vaxcyte’s Phase 2 infant study is being conducted in two stages and compares VAX-24 to the broadest standard-of-care PCV, which is currently PCV15. Stage 1 of the study, which is now currently underway, is evaluating the safety and tolerability of a single injection of VAX-24 at three dose levels and compared to PCV15 in approximately 48 infants in a dose-escalation approach. The Stage 2 portion will evaluate the safety, tolerability and immunogenicity of VAX-24 at the same three dose levels and compared to PCV15 in approximately 750 infants. The study design includes a primary immunization series consisting of three doses followed by a subsequent booster dose. “The initiation of our Phase 2 clinical study in infants is a significant advancement for VAX-24, which we believe has the potential to deliver a best-in-class profile with broader coverage and better immune responses relative to the standard-of-care today,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We look forward to sharing the topline safety, tolerability and immunogenicity results from the primary immunization series by 2025, as well as the opportunity to gain additional insights from the full data set into the clinical potential of VAX-24, including the optimal design and powering of a Phase 3 program, in this population.” “Despite the effectiveness of current va...