Vaxcyte Provides Positive Regulatory Updates for VAX-24 Adult and Pediatric Programs
-- Company Receives FDA Fast Track Designation for VAX-24 in Adults --
-- Vaxcyte Completes Successful Pre-IND Meeting with FDA Regarding VAX-24 Pediatric Program, Supporting Path to Proceed Directly into Infants --
-- VAX-24 is 24-Valent Pneumococcal Conjugate Vaccine Designed to Deliver Broad-Spectrum Protection to Prevent Invasive Pneumococcal Disease --
SAN CARLOS, Calif., Aug. 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, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VAX-24, the Company’s 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in adults ages 18 and older. The Fast Track designation is an FDA process that has been designed to facilitate the development and expedite the review of drugs, including vaccines, that treat or prevent serious conditions and fill an unmet medical need.
The Company also completed a successful pre-Investigational New Drug (IND) meeting with the FDA regarding the VAX-24 pediatric program. Vaxcyte received positive written feedback from the FDA supporting the initiation of a pediatric study that proceeds directly into infants, contingent on satisfactory topline safety, tolerability and immunogenicity results from the ongoing VAX-24 Phase 1/2 clinical proof-of-concept study in adults 18 to 64 years of age. This approach provides the Company with an accelerated clinical path to deliver a potentially best-in-class PCV, VAX-24, to the pediatric population, which represents the largest portion of the pneumococcal vaccine market in the United States.
“We are very pleased with the FDA’s feedback, which we believe provides an expedited path to deliver VAX-24 to adults and children, while also underscoring the need for a PCV that provides broader protection to prevent this serious disease,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. “By leveraging our site-specific technology, the XpressCF™ cell-free protein synthesis platform, VAX-24 is designed to improve upon the standard-of-care PCVs and surpass the coverage of those currently available without compromising overall immune response.”
“Despite high vaccination rates, a broader spectrum PCV remains an important public health need, especially in vulnerable populations such as infants and older adults, due to substantial disease driven by emerging serotypes not covered by currently available vaccines,” said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte. “With multiple milestones anticipated over the next 12 months for VAX-24, we expect strong, continued momentum.”
About VAX-24 and the Ongoing Adult Clinical Program
VAX-24 is intended to improve upon the standard-of-care PCVs for both children and adults by covering the serotypes that are responsible for most of the pneumococcal disease currently in circulation. Vaxcyte aims to efficiently create and deliver high-fidelity, broad-spectrum vaccines, such as VAX-24, by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform. Vaxcyte is deploying this approach with VAX-24 in order to add more pneumococcal strains without compromising the overall immune response.
VAX-24 is currently being evaluated in two clinical studies in adults:
About the FDA’s Fast Track Program
About Pneumococcal Disease
Janet Graesser, Vice President, Corporate Communications and Investor Relations