Business
Vaxcyte Announces FDA Clearance of Investigational New Drug Application for VAX-24 for the Prevention of Invasive Pneumococcal Disease
-- Company Expects to Deliver Topline Immunogenicity Results from the Phase 1/2 Clinical Study by End of 2022 -- -- VAX-24 is a 24-Valent Pneumococcal
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Company Expects to Deliver Topline Immunogenicity Results from the Phase 1/2 Clinical Study by End of 2022 -- -- VAX-24 is a 24-Valent Pneumococcal Conjugate Vaccine Candidate Designed to Provide Broad-Spectrum Protection -- SAN CARLOS, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for VAX-24, its lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease. Vaxcyte expects to initiate the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022 and announce topline immunogenicity results by the end of the year. “Clearance of our first IND is an important milestone as we transition to being a clinical-stage company with VAX-24, our lead, broad-spectrum PCV candidate, as it advances into the clinic to generate proof-of-concept data in adults,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We currently expect to deliver topline results from our VAX-24 Phase 1/2 clinical study by the end of 2022, while also continuing to advance the rest of our pipeline including VAX-XP, our PCV candidate with an expanded breadth of coverage of greater than 30 strains.” “The global impact of pneumococcal disease in children and adults remains significant, and the public health community continues to advocate for vaccines that can offer broader protection to prevent pneumococcal disease,” added Jim Wassil, Chief Operating Officer and Head of Clinical Development at Vaxcyte. “Our PCV franchise, consisting of VAX-24 and VAX-XP, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease.” 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. The Phase 1 portion of the study will evaluate the safety and tolerability of a single injection of VAX-24 at three dose levels administered to approximately 64 healthy adults 18 to 49 years of age. Th...