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Vaxcyte Doses First Participants in Phase 2 Portion of Ongoing VAX-24 Phase 1/2 Clinical Proof-of-Concept Study in Adults
-- Following Prespecified Review of Phase 1 Safety and Tolerability Data, Independent Data Monitoring Committee Recommends Study Proceed as Planned -- --
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Following Prespecified Review of Phase 1 Safety and Tolerability Data, Independent Data Monitoring Committee Recommends Study Proceed as Planned -- -- Company Expects to Announce Topline Results from Both the Phase 1 and Phase 2 Portions of the Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease and Pneumonia by the End of 2022 -- -- VAX-24 is a 24-Valent Pneumococcal Conjugate Vaccine (PCV) Designed to Deliver Broad-Spectrum Protection -- SAN CARLOS, Calif., April 04, 2022 (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, announced today that the first participants were dosed in the Phase 2 portion of its ongoing Phase 1/2 clinical study evaluating VAX-24 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults. The initiation of the Phase 2 portion of the study in healthy adults 50 to 64 years of age occurred after the independent Data Monitoring Committee completed a prespecified review of Phase 1 safety and tolerability data and recommended that the study progress as planned. The Company expects to announce topline safety, tolerability and immunogenicity results from both the Phase 1 and Phase 2 portions of the VAX-24 study by the end of 2022. “Moving forward with the larger Phase 2 portion of the VAX-24 Phase 1/2 study is an exciting step toward delivering potential clinical proof-of-concept data for our lead, 24-valent PCV candidate,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We developed VAX-24 with the intent of improving upon the standard-of-care pneumococcal vaccines by delivering the broadest spectrum PCV and we look forward to announcing the topline safety, tolerability and immunogenicity results from both the Phase 1 and Phase 2 portions of this study by the end of this year.” The VAX-24 Phase 1/2 clinical proof-of-concept study is a randomized, observer-blind, dose-finding, controlled study designed to evaluate the safety, tolerability and immunogenicity of VAX-24 in healthy adults (NCT05266456). The Phase 1 portion of the study is evaluating the safety and tolerability of a single injection of VAX-24 at three dose levels and compared to Prevnar 20™ in 64 healthy adults 18 to 49 years of ag...