Vaxcyte Inc（PCVX）資訊與事件PCVXVaxcyte Inc

Vaxcyte Expects OPUS-1 Trial Data in Q4 2023

"With the VAX-31 OPUS-1, OPUS-2 and OPUS-3 Phase 3 trials and the VAX-31 Phase 2 infant study fully enrolled, we expect a series of meaningful clinical study readouts across our adult and infant pneumococcal conjugate vaccines franchise over the next 12 months," said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. "We are on track to deliver the topline data from the OPUS-1 noninferiority trial in the fourth quarter of this year. Following, we expect to announce the results of the OPUS-2 and OPUS-3 trials in the first half of 2027, which along with a manufacturing consistency study, would enable our planned Biologics License Application submission and potential U.S. commercial launch."

Vaxcyte Doses First Participant in Phase 1 Study of VAX-A1 Vaccine

Vaxcyte announced that the first participant was dosed in the Phase 1, first-in-human study evaluating VAX-A1, the company's investigational prophylactic vaccine candidate for the prevention of disease caused by Group A Streptococcus, in healthy adults aged 18 to 40 years. The company expects to announce topline data from the study in the second half of 2027.

Company Completes OPUS-3 Enrollment, Anticipates Q4 Data Release

The company said, "With the recent completion of OPUS-3 enrollment, our OPUS-1, OPUS-2 and OPUS-3 adult Phase 3 trials are now fully enrolled, and we remain on track to deliver data from these studies beginning with the expected OPUS-1 topline readout in the fourth quarter. Our OPUS Phase 3 program was designed to establish not only a best-in-class pneumococcal conjugate vaccine (PCV), but also a new standard by which other pneumococcal vaccines will be judged. Based on the unprecedented results from our VAX-31 Phase 1/2 study in adults and the advantages of our carrier-sparing platform, we designed the OPUS-1 noninferiority trial as a head-to-head comparison against both Prevnar 20 (PCV20) and Capvaxive (PCV21) with the potential to deliver a 14-34% increase in coverage against invasive pneumococcal disease (IPD) and a 19-31% increase in coverage against pneumococcal pneumonia relative to the current standard-of-care PCVs in U.S. adults. Following the anticipated OPUS-1 data in the fourth quarter, we expect to announce the results of the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027, maintaining the timeline for our planned Biologics Application License (BLA) submission and potential U.S. commercial launch."