Business
Vaxcyte Announces FDA Clearance of Investigational New Drug Application for VAX-31 for the Prevention of Invasive Pneumococcal Disease in Adults
-- Company Expects to Initiate VAX-31 Phase 1/2 Study in Healthy Adults This Quarter-- -- Topline Safety, Tolerability and Immunogenicity Results from VAX-31
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Company Expects to Initiate VAX-31 Phase 1/2 Study in Healthy Adults This Quarter-- -- Topline Safety, Tolerability and Immunogenicity Results from VAX-31 Phase 1/2 Study Expected in the Second Half of 2024 -- -- VAX-31 is a 31-Valent Pneumococcal Conjugate Vaccine Designed to Provide Coverage for Approximately 95% of Disease Currently Circulating in the U.S. Adult Population -- SAN CARLOS, Calif., Oct. 19, 2023 (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 Company’s adult Investigational New Drug (IND) application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). Vaxcyte expects to initiate the VAX-31 Phase 1/2 clinical study in adults in the fourth quarter of this year and announce topline safety, tolerability and immunogenicity results in the second half of 2024. “The FDA clearance of the VAX-31 IND application represents an important step toward our goal of building a best-in-class PCV franchise, including VAX-31 and VAX-24, the 24-valent PCV for which we achieved positive results in two adult Phase 2 clinical studies,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “Given VAX-31, which will be the broadest-spectrum PCV to enter the clinic, leverages the foundation already established with VAX-24, we are very excited about the promise of this vaccine candidate. We expect to advance VAX-31 into the clinic this quarter and announce topline safety, tolerability and immunogenicity results in the second half of 2024.” “The VAX-31 Phase 1/2 study, which will enroll approximately 1,000 adults aged 50 and older, is designed to enable us to understand the clinical potential of VAX-31 to improve upon the standard-of-care for adults by providing a broader-spectrum of protection,” said Jim Wassil, Executive Vice President and Chief Operating Officer at Vaxcyte. “With VAX-31, we are leveraging our cell-free platform to develop a PCV candidate with expanded coverage against approximately 95 percent of the serotypes that currently cause IPD in the U.S. adult population. This is important given IPD contributes to high-case f...