Vaxcyte, Inc. (NASDAQ: PCVX) watched its shares jump early Monday, as the clinical-stage vaccine innovation company announced today that the first participants were dosed in the Phase 2 portion of its ongoing Phase 1/2 clinical study evaluating VAX-24 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults.
The initiation of the Phase 2 portion of the study in healthy adults 50 to 64 years of age occurred after the independent Data Monitoring Committee completed a prespecified review of Phase 1 safety and tolerability data and recommended that the study progress as planned.
The Company expects to announce topline safety, tolerability and immunogenicity results from both the Phase 1 and Phase 2 portions of the VAX-24 study by the end of 2022.
"Moving forward with the larger Phase 2 portion of the VAX-24 Phase 1/2 study is an exciting step toward delivering potential clinical proof-of-concept data for our lead, 24-valent PCV candidate," according to CEO Grant Pickering.
The Phase 1 portion of the study is evaluating the safety and tolerability of a single injection of VAX-24 at three dose levels and compared to Prevnar 20™ in 64 healthy adults 18 to 49 years of age.
The Phase 2 portion is evaluating the safety, tolerability and immunogenicity of a single injection of VAX-24 at three dose levels and compared to Prevnar 20™ in approximately 800 healthy adults 50 to 64 years of age.
PCVX shares rocketed 91 cents, or 3.8%, to $24.72.
