Clinical phase vaccine developer Vaxcyte, Inc. (NASDAQ:PCVX) ~38% increase pre-market on Monday after the company released leading data from a phase 1/2 clinical demonstration study for its experimental 24-valent pneumococcal conjugate vaccine (PCV), VAX- 24.
According to Vascyte (PCVX), a trial in healthy adults aged 18-64 years showed that VAX-24 at a dose of 2.2 mcg achieved immunogenicity for all 24 serotypes of the causative agent, streptococcus pneumoniae (pneumococcus). bridge).
The phase 2 portion of the study included 771 healthy adults aged 50 – 64 years designed to test the 24-valent vaccine at three dose levels, 1.1mcg, 2.2mcg and 2.2mcg/4, 4mcg, against FDA-approved Prevnar 20 Vaccine (PCV20) developed by Pfizer (PFE).
Based on an immunological measure known as opsonophagtic cell activity (OPA) response, VAX-24 showed non-inferiority to PCV20 for 20 common serotypes, of which 16 achieved an immune response. stronger translation.
All three doses demonstrated superiority against all four serotypes unique to the experimental vaccine. These supplemental sera include 10 – 15% of the invading pneumococcal strains compared with current standard of care.
“Study results demonstrate that VAX-24 has the potential to provide broader coverage and a better immune response than standard of care,” said Vaxcyte CEO (Vaxcyte)PCVX) Grant Pickering commented.
The company intends to increase the dose to 2.2mcg for the Phase 3 program, where the initial management is is expected to begin in 2023.
FDA awarded Fast Track designation to VAX-24 to target adults aged 18 years and older.