Vaxcyte Reports Positive Topline Data from OPUS-1, the Pivotal Adult Phase 3 Trial of VAX-31, the Company’s 31-Valent Pneumococcal Conjugate Vaccine Candidate
Key Highlights
- ➤VAX-31 met all primary immunogenicity endpoints across adults aged 18-49 and 50-plus
- ➤VAX-31 achieved superiority for three unique serotypes and cross-reactive serotype 20B
- ➤VAX-31 safety profile was similar to PCV20 and PCV21 across all studied ages
- ➤OPUS-2 and OPUS-3 Phase 3 results expected in first half of 2027
- ➤Planned VAX-31 BLA submission targeted for first half of 2028
Expert Statements
Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte
“We believe these positive OPUS-1 results provide clinical validation of our site-specific, carrier-sparing platform’s potential to deliver broader-spectrum pneumococcal vaccines while maintaining the magnitude of immune responses.”
Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte
“VAX-31 met all prespecified primary immunogenicity endpoints across all age groups studied in this pivotal Phase 3 trial, providing the clinical cornerstone for our planned Biologics License Application.”
Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte
“We believe VAX-31’s combination of broader coverage and robust immune responses, demonstrated in a trial inaugurating a more stringent noninferiority standard, sets a new benchmark for the class and gives us confidence in its potential for approval.”
Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte
“We look forward to announcing results from OPUS-2 and OPUS-3 in the first half of 2027, to be followed by a manufacturing consistency study, as we work toward making this vaccine broadly available to help protect adults from the consequences of pneumococcal disease.”
James Wassil, Chief Scientific Officer and Chief Operating Officer of Vaxcyte
“These OPUS-1 results strengthen our confidence in VAX-31’s potential to provide broader protection against invasive pneumococcal disease and pneumococcal pneumonia.”
James Wassil, Chief Scientific Officer and Chief Operating Officer of Vaxcyte
“Given current U.S. epidemiology, with the serotypes unique to PCV21 accounting for a larger share of adult disease, we expect the comparison of VAX-31 to PCV21 to be a particular focus of FDA review.”
James Wassil, Chief Scientific Officer and Chief Operating Officer of Vaxcyte
“PCV20 remains an important immunogenicity comparator for VAX-31, including for serotypes 4 and 19F, which are not contained in PCV21.”
Luis Jodar, Ph.D., Chief Medical Officer of Vaxcyte
“Important gaps remain in adult pneumococcal disease coverage, and OPUS-1 highlights VAX-31’s potential to address them.”
Luis Jodar, Ph.D., Chief Medical Officer of Vaxcyte
“Today’s adult PCVs differ in the serotypes they cover, requiring tradeoffs between coverage of currently circulating disease-causing serotypes and preserving coverage of historically important serotypes.”
Luis Jodar, Ph.D., Chief Medical Officer of Vaxcyte
“VAX-31 is designed to bring both into a single 31-valent vaccine, with the potential to provide incremental coverage of 13-36% of invasive pneumococcal disease(5) and 19-31% of pneumococcal pneumonia(6) compared with currently available adult PCVs.”
VAX-31 Met All Prespecified Primary Endpoints Across Age Groups Studied Compared to Prevnar 20(®) (PCV20) and/or Capvaxive(®) (PCV21)
Prespecified Co-Primary Immunogenicity Endpoints: In Adults 50 and Older, All 28 VAX-31 Serotypes Shared with PCV20 and/or PCV21 Met Noninferiority Criterion at >0.667 Threshold; All Three Serotypes Unique to VAX-31 and Cross-Reactive Serotype 20B Met Superiority Criterion
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