Tuesday, February 21, 2023
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 immunisation series expected by 2025.
The clearance of the VAX-24 infant IND application marks an important step in expanding the development of lead, broad-spectrum PCV candidate in the important and vulnerable population. Based on the positive data from Phase 1/2 proof-of-concept study in adults, VAX-24 consists of 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 paediatric populations.
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 paediatric study in healthy infants. Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteraemia, 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 paediatric population underscores the need for a broader-spectrum vaccine.