Key points:
- Vaxcyte announced VAX-24 met primary safety and tolerability objectives
- VAX-24 demonstrated a safety profile similar to Pfizer’s Prevnar 20
- Vaxcyte shares surged 57% premarket
Shares of California-based Vaxcyte, Inc (NASDAQ: PCVX) surged over 57% Monday morning after the company said its investigational 24-valent pneumococcal conjugate vaccine (PCV), VAX-24 met the primary safety and tolerability objectives.
The biotechnology company said VAX-24 demonstrated a safety profile similar to Pfizer’s Prevnar 20 for all doses studied.
The Phase 1/2 clinical proof-of-concept study evaluated the safety, tolerability, and immunogenicity of VAX-24, with all 24 Serotypes of VAX-24 at the conventional 2.2mcg PCV dose meeting or exceeding regulatory immunogenicity standards.
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“At this dose, VAX-24 met the standard opsonophagocytic activity (OPA) response non-inferiority criteria for all 20 serotypes common with PCV20, of which 16 achieved higher immune responses,” the company added.
Vaxcyte said it now intends to progress VAX-24 into a Phase 3 program.
Vaxcyte shares are currently trading at $32.35 following the over 57% jump. On Friday, the stock fell over 7%, closing the session at $20.58, putting it down over 13% in 2022.
“We are thrilled with these positive topline results from our Phase 1/2 proof-of-concept study, which met all of our objectives. The findings indicate a potential best-in-class profile for VAX-24 and validate our carrier-sparing approach to enable the development of broader-spectrum PCVs,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte.
“The study results demonstrate that VAX-24 has the potential to provide broader coverage and better immune responses relative to the standard-of-care. We believe this presents an opportunity to set a new bar for immunogenicity standards for pneumococcal vaccines.”