US FDA Approves Vaxcyte's IND Application For VAX-31

Vaxcyte, Inc., a vaccine innovation company that develops b>high-fidelity vaccines to protect humans from the consequences of bacterial diseases, announced that the FDA has approved the company's adult Investigational New Drug (IND) application for b>VAX-31 a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).

Vaxcyte anticipates that the VAX-31 phase 1/2 clinical research in adults will begin in the fourth quarter of this year, with topline safety, tolerability, and immunogenicity data expected in the second half of 2024. “The FDA clearance of the VAX-31 IND application represents an important step toward our goal of building a best-in-class PCV franchise, including VAX-31 and VAX-24, the 24-valent PCV for which we achieved positive results in two adult phase 2 clinical studies,” said Grant Pickering, chief executive officer and co-founder of Vaxcyte. “Given VAX-31, which will be the broadest-spectrum PCV to enter the clinic, leverages the foundation already established with VAX-24, we are very excited about the promise of this vaccine candidate.

We expect to advance VAX-31 into the clinic this quarter and announce topline safety, tolerability and immunogenicity results in the second half of 2024.” The VAX-31 phase 1/2 clinical study is a randomized, observer-blind, active-controlled, dose-finding clinical study designed to evaluate the safety, tolerability and immunogenicity of VAX-31 compared to Prevnar 20 (PCV20) in approximately 1,000 healthy adults aged 50 and above. The phase 1 portion of the study will evaluate the safety and tolerability of a single injection of VAX-31 at three dose levels (low, middle and high) administered to approximately 64 healthy adults 50 to 64 years of age before the study progresses to phase 2.