The Food and Drug Administration (FDA) has granted Fast Track designation to VAX-24 for the prevention of invasive pneumococcal disease in adults 18 years of age and older.
VAX-24 is an investigational 24-valent pneumococcal conjugate vaccine (PCV). The immunogenicity, safety, and tolerability of VAX-24 is being compared to Prevnar 20 in an ongoing phase 1/2 clinical proof-of-concept study (ClinicalTrials.gov Identifier: NCT05266456) in adults 18 to 49 years of age (phase 1) and in adults 50 to 64 years of age (phase 2). Topline safety results are anticipated later this year.
The Company expects to initiate a pediatric study contingent upon satisfactory results from the proof-of-concept study. A separate phase 2 study (ClinicalTrials.gov Identifier: NCT05297578) is also evaluating VAX-24 vs Prevnar 20 in adults 65 years of age and older.
“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, CEO 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.”
Vaxcyte provides positive regulatory updates for VAX-24 adult and pediatric programs. News release. Vaxcyte, Inc. Accessed August 4, 2022. https://investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-provides-positive-regulatory-updates-vax-24-adult-and