Vaxcyte, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for VAX-24, its lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease. Vaxcyte expects to initiate the VAX-24 Phase 1/2 clinical proof-of-concept study in adults in the first quarter of 2022 and announce topline immunogenicity results by the end of the year. The company currently expect to deliver topline results from VAX-24 Phase 1/2 clinical study by the end of 2022, while also continuing to advance the rest of pipeline including VAX-XP, PCV candidate with an expanded breadth of coverage of greater than 30 strains.” The VAX-24 Phase 1/2 clinical proof-of-concept study is a randomized, observer-blind, dose-finding, controlled study designed to evaluate the safety, tolerability and immunogenicity of VAX-24 in healthy adults.

The Phase 1 portion of the study will evaluate the safety and tolerability of a single injection of VAX-24 at three dose levels administered to approximately 64 healthy adults 18 to 49 years of age. The Phase 2 portion will evaluate the safety, tolerability and immunogenicity of a single injection of VAX-24 at three dose levels compared to that of Prevnar 20™ in approximately 800 healthy adults 50 to 64 years of age.