Vaxcyte announces anticipated milestones

VAX-24 Adult Program: Topline safety, tolerability and immunogenicity data from the Phase 2 study in adults 65 and older are anticipated in the first half of 2023. Final results with the 6-month safety data from the two Phase 2 adult studies are anticipated in the first half of 2023. Following the receipt of the final safety reports from the two adult Phase 2 studies, regulatory interactions to inform the Phase 3 program are anticipated in the second half of 2023. Topline safety, tolerability and immunogenicity data from the Phase 3 non-inferiority study in adults are expected in 2025. VAX-24 Pediatric Program: The infant IND application submission and the Phase 2 study initiation are both anticipated in first half of 2023. Topline safety, tolerability and immunogenicity data from the infant Phase 2 study following the primary 3-dose immunization series are expected by 2025. The study design will include a primary immunization series consisting of three doses followed by a subsequent booster dose. VAX-XP Adult Program: The IND application submission for VAX-XP is anticipated in the second half of 2023. Topline safety, tolerability and immunogenicity data from a Phase 1/2 study in adults are expected in 2024. VAX-A1: Vaxcyte continues to advance development of VAX-A1, a novel conjugate vaccine designed to prevent infections caused by Group A Strep bacteria, and expects to provide guidance for its anticipated IND application submission to the FDA by the end of 2022. VAX-PG: Vaxcyte expects to nominate a final vaccine candidate for VAX-PG, its novel therapeutic vaccine designed to treat periodontal disease, by the end of 2022.