31-valent Pneumococcal Conjugate Vaccine Cleared to Launch Clinical Trial

 Vaxcyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's adult Investigational New Drug application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).

Vaxcyte expects to initiate the VAX-31 Phase 1/2 clinical study in 2023 and announce topline results 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, in a press release on October 19, 2023.

"Given that 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."

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.

Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media, and sinusitis.

In the U.S., approximately 320,000 people get pneumococcal pneumonia yearly, estimated to result in about 150,000 hospitalizations and 5,000 deaths. Pneumococci also cause over 50% of all cases of bacterial meningitis in the U.S.

As of October 20, 2023, numerous licensed pneumococcal vaccines and candidates are conducting clinical trials.