Vaxcyte announces FDA clearance of IND for VAX-24

Vaxcyte announced that the U.S. Food and Drug Administration, FDA, has cleared the Company’s infant Investigational New Drug, IND, application for VAX-24, its lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease, IPD. Vaxcyte plans to initiate the infant Phase 2 study in the second quarter of 2023, with topline safety, tolerability and immunogenicity data following the primary three-dose immunization series expected by 2025. The study design will include a primary immunization series consisting of three doses followed by a subsequent booster dose. "The clearance of the VAX-24 infant IND application marks an important step in expanding the development of our lead, broad-spectrum PCV candidate in this important and vulnerable population," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. "Based on the positive data from our Phase 1/2 proof-of-concept study in adults, we believe VAX-24 has the potential to deliver a best-in-class profile with broader coverage and better immune responses relative to the standard-of-care for both the adult and pediatric populations."