Vaxcyte, Inc. (NASDAQ: PCVX) is seeing a significant rise in its shares this morning, climbing 35.85% to $109.71 during the pre-market session. This increase comes after the PCVX revealed positive topline results from a recent Phase 1/2 clinical research.
Vaxcyte Reported Encouraging Research Results for VAX-31
Vaxcyte has released positive topline findings from a Phase 1/2 study assessing the immunogenicity, safety, and tolerability of VAX-31, a 31-valent pneumococcal conjugate vaccine. The vaccine was tested on 1,015 healthy adults 50 years of age and older with the goal of preventing invasive pneumococcal disease (IPD). Based on compelling evidence, Vaxcyte has chosen to proceed with VAX-31’s development to a Phase 3 adult investigation.
In the Phase 1/2 study, VAX-31 demonstrated a safety profile comparable to Prevnar 20 (PCV20) across all doses examined. The vaccine exhibited strong opsonophagocytic activity (OPA) immune responses for all 31 serotypes at each dose level. Notably, VAX-31 met or surpassed the non-inferiority criteria for OPA responses in all 20 serotypes common with PCV20 at the middle and high doses.
PCVX Observed Impressive Immune Response
At the middle dose, VAX-31 showed a geometric mean ratio (GMR) exceeding 1.0 for 13 of the 20 serotypes and achieved statistically superior immune responses for five of these serotypes compared to PCV20. For the 11 additional serotypes unique to VAX-31, all three dose levels met the superiority criteria. Vaxcyte intends to finalize the VAX-31 dose selection before starting the adult Phase 3 program.
Future Plans and Public Health Impact
The encouraging results from the Phase 1/2 study underscore Vaxcyte’s site-specific, carrier- The high case-fatality rates, antibiotic resistance, and meningitis associated with IPD might meet the public health demand for increased prevention. By mid-2025, Vaxcyte intends to start the major Phase 3 investigation for VAX-31; topline data are anticipated in 2026.
PCVX business will proceed with more Phase 3 trials and file a biologics license application pending these results. VAX-31 is anticipated to significantly improve coverage against more than 95% of circulating IPD strains in adults 50 and older, potentially setting a new standard in pneumococcal vaccination.
