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Vaxcyte Announces FDA Clearance of Investigational New Drug Application for VAX-24 for the Prevention of Invasive Pneumococcal Disease in Infants
-- Infant Phase 2 Study Initiation Expected in the Second Quarter of 2023, with Initial Topline Safety, Tolerability and Immunogenicity Data by 2025 -- --
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Infant Phase 2 Study Initiation Expected in the Second Quarter of 2023, with Initial Topline Safety, Tolerability and Immunogenicity Data by 2025 -- -- Based on Positive Topline VAX-24 Phase 1/2 Proof-of-Concept Study Results in Adults, FDA Supported Initiation of Pediatric Program in Infants -- SAN CARLOS, Calif., Feb. 21, 2023 (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, announced today 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 anticipat...