Vaxcyte provides update on development of VAX-31 pneumococcal vaccine

Vaxcyte (PCVX) provided updates on the continued advancement of VAX-31, the company’s next-generation 31-valent pneumococcal conjugate vaccine, or PCV, candidate, across its adult and infant clinical programs. For the VAX-31 adult indication, the first participants have been dosed in a Phase 3 trial evaluating VAX-31 when administered concomitantly with a licensed seasonal influenza vaccine in pneumococcal-naive adults aged 50 years and older – the OPUS-2 trial. Additionally, Vaxcyte plans to initiate a separate Phase 3 trial in Q1 evaluating VAX-31 in adults who have previously received a pneumococcal vaccine – the OPUS-3 trial -. For the VAX-31 infant indication, the company has completed enrollment in its Phase 2 dose-finding study evaluating VAX-31 in healthy infants. Vaxcyte expects to report topline safety, tolerability and immunogenicity data from both OPUS-2 and OPUS-3 Phase 3 studies in the first half of 2027, supporting planned BLA submission. Topline OPUS-1 data is expected in Q4. The VAX-31 Adult Phase 3 clinical studies were designed in consultation and alignment with the FDA. As for the VAX-31 infant indication, Vaxcyte completed enrollment of its Phase 2 dose-finding study evaluating VAX-31 for prevention of invasive pneumococcal disease and expects to announce topline data from primary immunization series and booster Dose either sequentially or together by the end of the first half of 2027.