2023-04-17 07:57:46 ET
- Vaxcyte ( NASDAQ: PCVX ) shares added ~10% Monday pre-market after announcing positive mid-stage results for its pneumococcal vaccine VAX-24 targeted at the prevention of invasive pneumococcal diseases (IPD) such as meningitis and bacteremia.
- Citing results from its Phase 2 VAX-24 study for older adults, Vaxcyte ( PCVX ) said that the 24-valent pneumococcal conjugate vaccine (PCV) candidate was reactive against 24 serotypes (ST) of the causative agent at all doses studied.
- The trial for 207 healthy adults aged 65 and older was designed to evaluate a single injection of VAX-24 at three dose levels (1.1mcg, 2.2mcg, and 2.2mcg/4.4mcg) against Pfizer's ( PFE ) Prevnar 20 (PCV20) .
- The data indicated that VAX-24 met Opsonophagocytic Activity (OPA) response at 2.2mcg against 24 STs and met the OPA response for non-inferiority criteria in terms of 18 of 20 STs common with PCV20.
- Vaxcyte ( PCVX ) also disclosed full six-month safety results from VAX-24 and its Phase 1/2 study in those aged 18 – 64, noting that in the former study, one participant who received VAX-24 suffered a sudden cardiac death which investigators classified as unrelated to VAX-24.
- "The data from both studies demonstrate VAX-24 safety and tolerability results similar to PCV20 and across cohorts, including older adults evaluated in this most recent study who are at increased risk for complications from IPD," Chief Operating Officer of PCVX Jim Wassil remarked.
- Read: Seeking Alpha analyst Bret Jensen argues that "VAX-24 will determine Vaxcyte's ( PCVX ) near and medium term future."
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Vaxcyte spikes after mid-stage data for pneumococcal vaccine