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Vaxcyte readies Phase 3 results for VAX-31 after Q2 update
The clinical-stage vaccine maker says all three Phase 3 trials for its VAX-31 pneumococcal candidate are fully enrolled, with OPUS-1 safety and immune data due in the fourth quarter of 2026.
Vaxcyte (NASDAQ: PCVX) reported second-quarter results that emphasize how its near-term outlook hinges on upcoming clinical data, with the three late-stage Phase 3 studies for its lead pneumococcal vaccine now fully enrolled.
The company said its VAX-31 program has dosed 6,191 adults in total, with about 3,500 receiving the candidate. The largest study, OPUS-1, includes head-to-head comparisons against Prevnar 20 and Capvaxive, and Vaxcyte expects safety, tolerability, and immune response results for OPUS-1 in the fourth quarter of 2026, followed by OPUS-2 and OPUS-3 data in the first half of 2027.
Vaxcyte also outlined its timeline for other parts of the pipeline, including a Phase 2 infant study of VAX-31 covering the primary series and a booster dose, with results due on a similar schedule. Separately, it said it dosed the first participants in a Phase 1 study of VAX-A1, aimed at preventing Group A Streptococcus, with topline data expected in the second half of 2027.
On the financial side, Vaxcyte reported net loss of $284.3 million for the quarter ended June 30, up from $166.6 million a year earlier. It attributed higher spending to a rise in R and D to $267.9 million from $194.2 million and an increase in G and A to $34.9 million from $32.0 million, while cash and investments totaled $2.5 billion as of June 30. The board also added Dr. Moncef Slaoui and Dr. John Markels to strengthen its vaccine leadership as results approach.
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