Shares of Vaxcyte, Inc. (Nasdaq: PCVX) fell 26% today after the company announced topline results from its Phase 2 dose-finding study of VAX-24 in infants, which compared the safety, tolerability, and immunogenicity of their vaccine candidate against Prevnar 20®. Despite the company’s positive portrayal of the study outcomes, the stock’s downturn reflects investor concerns.
The clinical-stage vaccine company, which aims to protect against bacterial diseases, highlighted that VAX-24 was well-tolerated and demonstrated a safety profile comparable to PCV20 across all doses studied. The vaccine candidate elicited substantial immune responses following the initial three-dose immunization series and interim booster dose IgG data showed robust memory responses. The company has chosen the VAX-24 Mid dose (2.2mcg) for an optimized dose formulation to advance to a potential Phase 3 program.
Vaxcyte also announced the development of VAX-XL, their third-generation PCV candidate, which is intended to expand the spectrum of coverage even further. The complete VAX-24 data set is expected by the end of 2025, with the VAX-31 Phase 2 study topline data anticipated in mid-2026. For the adult indication, the Phase 3 non-inferiority study for VAX-31 is expected to start in mid-2025 with topline data following in 2026.
The study found that post-dose 3, the VAX-24 Mid dose met target Phase 2 non-inferiority criteria on relative seroconversion rates and Geometric Mean Ratio (GMR) point estimates for the highest circulating serotypes. Additionally, all doses of VAX-24 generated robust opsonophagocytic assay (OPA) responses, which are correlated with effectiveness against invasive pneumococcal disease (IPD), across all serotypes.
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