Vaxcyte Advances Adult and Infant Programs for VAX-31, a Potential Best-in-Class, Next-Generation Pneumococcal Conjugate Vaccine

Core Insights - Vaxcyte has initiated dosing of the first participants in a Phase 3 study for VAX-31, a 31-valent pneumococcal conjugate vaccine, evaluating its administration alongside a seasonal influenza vaccine in adults aged 50 and older [1][3] - The company plans to start another Phase 3 trial (OPUS-3) in early 2026 for adults previously vaccinated with pneumococcal vaccines [1][3] - Vaxcyte expects to report topline safety, tolerability, and immunogenicity data from both OPUS-2 and OPUS-3 studies in the first half of 2027, supporting a planned Biologics License Application (BLA) submission [1][4] VAX-31 Adult Indication - The OPUS-2 trial will enroll approximately 1,300 participants and is designed to evaluate the safety, tolerability, and immunogenicity of VAX-31 when administered with a seasonal influenza vaccine [7][10] - The OPUS-3 trial will involve around 720 adults with a history of prior pneumococcal vaccination, assessing the safety and immunogenicity of VAX-31 [10][12] - A total of approximately 6,000 adults are expected to be enrolled across the adult Phase 3 studies, with about 3,400 receiving VAX-31 [6][5] VAX-31 Infant Indication - Vaxcyte has completed enrollment of 905 healthy infants in a Phase 2 dose-finding study for VAX-31, which aims to expand coverage against pneumococcal disease [14][19] - The vaccine is designed to increase protection against invasive pneumococcal disease (IPD) from approximately 69% to 92% in children under five years of age [14][21] - Topline data from the infant study is expected by the end of the first half of 2027 [19] Manufacturing and Commercial Supply Chain - The company plans to initiate the buildout of a custom fill-finish line in North Carolina in early 2026, as part of a long-term commitment of up to $1 billion in U.S. manufacturing and services [2][15] - Vaxcyte is establishing a dedicated local presence in North Carolina, focusing on chemistry, manufacturing, and controls (CMC) activities [15][2] Anticipated Key Milestones - The OPUS-3 Phase 3 trial is set to begin in the first quarter of 2026 [18] - Topline data from the OPUS-1 trial is expected in the fourth quarter of 2026 [18] - Data from the OPUS-2 and OPUS-3 trials will be announced in the first half of 2027 [18][19]