Vaxcyte, Inc. 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.
Based on the positive topline results from the VAX-24 Phase 1/2 proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18-64 years of age, the FDA supported the initiation of a pediatric study in healthy infants. Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteremia, remains persistent in the first years of life and is a leading cause of invasive disease in children two years of age and under. The burden of disease in the pediatric population underscores the need for a broader-spectrum vaccine.
“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. We remain focused on advancing our VAX-24 clinical programs and look forward to the anticipated initiation of the infant study and announcement of the topline results from our Phase 2 study in adults aged 65 and older in the second quarter of this year.”
Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte, added, “The 24 serotypes included in VAX-24 cover a significant portion of the IPD currently in circulation that are associated with high case-fatality rates, antibiotic resistance and meningitis. Importantly, the nine incremental serotypes in VAX-24 cover an additional 20-25 percent of strains causing IPD over the current 15-valent standard-of-care PCV in infants. Given the significant burden of disease in young children, there remains a need for broader-spectrum vaccines like VAX-24 and VAX-31, our 31-valent PCV candidate, that are designed to provide greater protection.”