FDA clears investigational NDA for VAX-31 to prevent invasive pneumococcal disease

FDA clears investigational NDA for VAX-31 to prevent invasive pneumococcal disease | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

VAX-31 (Vaxcyte), an infant and adult investigational 31-valent pneumococcal conjugate vaccine (PCV) candidate to prevent invasive pneumococcal disease (IPD), has received infant Investigational New Drug (IND) application clearance from the FDA according to an announcement from Vaxcyte.¹

The potential broad-spectrum PCV candidate is being studied to prevent IPD in both the pediatric and adult populations, and is designed to cover approximately 94% of IPD in US children under 5 years of age. With this acceptance, Vaxcyte plans to initiate a phase 2 VAX-31 infant study—a randomized, double-blind, active-controlled, dose-finding trial—by the end of January 2025.¹

The study, according to Vaxcyte, will include a primary immunization series made up of 3 doses at 2, 4, and 6 months of age, respectively, followed by a subsequent booster at 12 to 15 months of age. The vaccine company expects topline safety, tolerability, and immunogenicity data from the study to be available in mid-2026, with topline data from the booster dose to follow approximately 9 months later.¹

Clearance of the IND for the pediatric population was supported by safety, tolerability, and immunogenicity data from the VAX-31 phase 1/2 study in adults. VAX-31 has potential to provide protection against currently circulating and historically prevalent serotypes. VAX-31 was designed to cover approximately 86% of acute otitis media in children under the age of 5 years in the United States.¹

Results from the phase 1/2 adult study was announced on September 3, 2024, in which data from 1015 healthy adults aged 50 years and older were included. The vaccine candidate was well tolerated and demonstrated a safety profile at all doses studied through the 6-month evaluation period. "At the middle and high doses, VAX-31 met or exceeded the OPA response non-inferiority criteria(1) for all 20 serotypes common with PCV20," stated Vaxcyte in a September announcement of the phase 1/2 adult data.²

Approximately 300,000 children younger than 5 years of age die each year across the globe because of Streptococcus pneumoniae, the leading cause of vaccine-preventable fatalities in this age group, per Vaxcyte.¹

According to the Centers for Disease Control and Prevention, vaccination is recommended for all children younger than 5 years of age, and those aged 5 to 18 years with risk conditions.³

"We are incredibly proud of the significant progress we continue to make with VAX-31, underscored by the clearance of the infant IND application and receipt of the Breakthrough Therapy designation for adults,” Jim Wassil, executive vice president, CEO, Vaxcyte, said in a statement. "The body of positive evidence generated by the VAX-31 and VAX-24 adult studies validates the potential of our site-specific, carrier-sparing platform to deliver best-in-class, broad-spectrum PCVs designed to provide protection against both currently circulating and historically prevalent serotypes while raising the bar for immunogenicity."¹

References:

1. Vaxcyte provides positive regulatory updates on VAX-31 pediatric and adult programs. Vaxcyte Inc. Press release. November 12, 2024. Accessed November 12, 2024. https://investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-provides-positive-regulatory-updates-vax-31-pediatric

2. Vaxcyte Reports Positive Topline Data from Phase 1/2 Study of VAX-31, its 31-Valent Pneumococcal Conjugate Vaccine Candidate, in Adults Aged 50 and Older. Press release. September 3, 2024. Accessed November 12, 2024. https://investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-reports-positive-topline-data-phase-12-study-vax-31-its

3. Pneumococcal vaccination. CDC. Updated October 26, 2024. https://www.cdc.gov/pneumococcal/vaccines/index.html