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 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 —
Excerpt from the Press Release:
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.
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