Vaxcyte (PCVX) Leerink Global Healthcare Conference 2026 summary

Company vision and technology

• Focus on leveraging cell-free protein synthesis for novel and improved vaccines, enabling production of proteins not possible with conventional methods.

• Site-specific conjugation technology underpins the pneumococcal conjugate vaccine franchise, enabling broader spectrum vaccines and durable T-cell mediated immunity.

• Carrier-sparing conjugates allow for broader coverage by metering protein carrier amounts, leading to the development of 24-valent and 31-valent pneumococcal vaccines.

Clinical development and trial updates

• VAX-31, a 31-valent pneumococcal conjugate vaccine, is the primary focus, with a comprehensive phase III program underway, including the pivotal OPUS-1 study.

• OPUS-1 compares VAX-31 to 20-valent and 21-valent standard of care vaccines, with results expected in Q4 2024; two additional phase III studies (OPUS-2 and OPUS-3) will read out in H1 2025.

• OPUS-2 evaluates VAX-31 with high-dose flu vaccine; OPUS-3 assesses immune response in subjects previously vaccinated with lesser valent PCVs, with a minimum six-month interval since prior vaccination.

• Manufacturing consistency study is being finalized, with BLA submission targeted by end of 2025 and potential approval and launch in 2026-2027.

Clinical results and regulatory considerations

• Phase II VAX-31 data showed unprecedented immune responses, outperforming standard of care on 18 of 20 common serotypes and expanding coverage to 31 serotypes.

• Regulatory non-inferiority margin for adults was raised to 0.67, reflecting higher expectations for immune response; a few misses on non-inferiority are acceptable if overall coverage is superior.

• In infants, higher doses of protein carrier in VAX-24 and VAX-31 studies improved immune responses, especially for relevant serotypes; a handful of misses is still considered best-in-class due to broad coverage.

• Regulatory precedent allows for some serotype misses if antibody titers remain high and coverage is expanded.