VAX-31 - (OPUS-1)

September 3, 2026: Vaxcyte (NASDAQ: PCVX) announced leadership hires and updated timing for a key catalyst in its pneumococcal vaccine program. The company appointed Luis Jodar, Ph.D., as Chief Medical Officer and David McAvoy, J.D., as Chief Legal Officer.

For VAX-31, a 31-valent pneumococcal conjugate vaccine candidate for prevention of invasive pneumococcal disease and pneumonia, Vaxcyte said topline safety, tolerability and immunogenicity data from the adult Phase 3 OPUS-1 pivotal noninferiority trial are now expected by the end of October 2026, narrowed from prior guidance of Q4 2026. The company said the OPUS Phase 3 adult program consists of three fully enrolled trials—OPUS-1, OPUS-2, and OPUS-3—with 6,191 adults dosed in total, including about 3,500 who received VAX-31, and that the studies were finalized in consultation and alignment with the FDA to support potential licensure.

Upcoming milestones cited: OPUS-2 and OPUS-3 Phase 3 safety, tolerability and immunogenicity data are expected in the first half of 2027, and the company referenced a planned BLA submission for VAX-31.

Other pipeline status mentioned: VAX-31 is also in a Phase 2 infant study; VAX-24 has reported positive Phase 2 results in adults and infants; VAX-A1 is in a Phase 1 adult study; VAX-XL is earlier stage; and VAX-GI is a Shigella vaccine candidate.