Vaxcyte’s stock has skyrocketed as its invasive pneumococcal disease (IPD) and pneumococcal pneumonia vaccine has met its endpoints in a Phase III trial, teeing the drug up for regulatory approval.
The OPUS-1 pivotal trial (NCT07284654) enrolled 3,572 adults to evaluate VAX-31’s safety, tolerability and immunogenicity. The vaccine was compared to Pfizer’s Prevnar 20 and Merck’s Capvaxive, which are approved higher-valent pneumococcal conjugate vaccines.
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In the prespecified individual comparator analysis, VAX-31 met the noninferiority criterion for 20 of 20 serotypes shared with Prevnar 20, and 17 of 19 shared with Capvaxive. Compared to Capvaxive, while serotypes 3 and 12F missed the LBCI >0.667 noninferiority criterion, they met the historical LBCI >0.5 threshold.
Beyond all the serotypes in common with both comparator drugs, for the three unique serotypes and cross-reactive serotype 20B, VAX-31 met all the serotype OPA GMR comparisons per the prespecified superiority criterion.
For the primary immunobridging endpoint, VAX-31 met the noninferiority criterion for all 32 serotype OPA GMR comparisons in adults aged 18-49 compared to adults aged 50-64.
In the study, VAX-31 was well tolerated and demonstrated a safety profile similar to PCV20 and PCV21 at all ages studied. The majority of reactions were generally mild-to-moderate, with the majority resolving within 48 hours of vaccination, and with no meaningful differences observed across the cohorts.
Dr Luis Jodar, CMO of Vaxcyte, said: “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. 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 and 19-31% of pneumococcal pneumonia compared with currently available adult PCVs.”
Following the data announcement, Vaxcyte’s stock rose significantly in the pre-market, opening at $87.21 on 5 October, a 54.4% rise from a 2 October close of $56.48.
VAX-31 is a 31-valent pneumococcal conjugate vaccine (PCV) candidate that targets 31 serotypes of Streptococcus pneumoniae bacteria, making it broader than current standards like Prevnar 20 (20 strains) and Capvaxive (21 strains).
The data from OPUS-1 will allow Vaxcyte to start a planned filing of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA).
There are other studies of the drug, including the data from the Phase III OPUS-2 and OPUS-3, with data anticipated in the first half of 2027, and a Phase II trial in infants, in which data is expected by the end of the first half of 2027.
Analysts from Leerink said that VAX-31delivered “highly impressive” data in OPUS-1 that could create a “new competitive moat for future adult pneumococcal vaccine competitors”.
According to a GlobalData report, in the 16 major pharmaceutical markets (16MM: Australia, Brazil, Canada, Urban China, France, Germany, India, Italy, Japan, Mexico, Russia, South Africa, South Korea, Spain, UK, and the US), epidemiologists estimated that more than 148 million pneumococcal vaccinations were delivered in adults in 2023, with this figure projected to rise to more than 171 million delivered in adults in 2028. GlobalData is the parent company of Clinical Trials Arena.
