Vaxcyte Says FDA OK's IND Application Of VAX-31 For Prevention Of Invasive Pneumococcal Disease

(RTTNews) - Vaccine maker Vaxcyte, Inc. (PCVX) announced Thursday that the U.S. Food and Drug Administration (FDA) has cleared the Company's adult Investigational New Drug (IND) 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 healthy adults in the fourth quarter of this year and announce topline safety, tolerability and immunogenicity results in the second half of 2024.

The VAX-31 Phase 1/2 study, which will enroll approximately 1,000 adults aged 50 and older, is designed to enable us to understand the clinical potential of VAX-31 to improve upon the standard-of-care for adults by providing a broader-spectrum of protection.