Vaxcyte Starts 4,000-Participant Phase 3 VAX-31 Trial with $3B Cash Runway
Vaxcyte has launched its 4,000-subject Phase 3 OPUS-1 adult trial for the 31-valent pneumococcal vaccine, targeting adult BLA submission by end of next year under stricter non-inferiority margins agreed with FDA. The company holds over $3 billion cash pro forma after recent financing to fund global commercialization and market expansion.
1. Phase 3 OPUS-1 Launch
Vaxcyte has initiated OPUS-1, a 4,000-subject, randomized trial in adults aged 50 and older, comparing its 31-valent VAX-31 to Prevnar 20 and CAPVAXIVE with a dual non-inferiority and superiority design. The study protocol, developed in consultation with the FDA, aims to demonstrate comparator non-inferiority for shared serotypes and superiority for those absent in current vaccines, supporting an adult BLA by year-end 2027.
2. Coverage and Comparator Profile
VAX-31’s 31-valent formulation targets both legacy serotypes and newly emerging strains, seeking to overcome the 20-21 serotype limit of existing vaccines. Analytical plans include head-to-head non-inferiority assessments for serotypes common to all three vaccines, alongside superiority analyses for serotypes unique to VAX-31.
3. Financial Position and Strategy
After closing a recent financing, Vaxcyte holds more than $3 billion in cash on a pro forma basis, providing runway for global commercialization and strategic partnerships. The company also appointed its first chief commercial officer to refine international market plans, focusing on the estimated $8 billion adult pneumococcal vaccine opportunity.