other material
confidence high
sentiment positive
materiality 0.85
Vaxcyte reports positive Phase 2 data for VAX-24 in adults 65+; met key immunogenicity criteria vs Prevnar 20
Vaxcyte, Inc.
- VAX-24 2.2mcg dose met OPA non-inferiority for 18 of 20 serotypes common with Prevnar 20 and superiority for all four unique serotypes.
- Robust immune responses across all 24 serotypes at all doses in adults 65+, confirming prior Phase 2 results in adults 50-64.
- Full six-month safety data from both adult studies showed VAX-24 safety and tolerability similar to PCV20 with no related serious adverse events.
- Prespecified pooled analyses (age 50+ and 60+) showed VAX-24 2.2mcg met OPA non-inferiority for all 20 common serotypes and superiority for four unique.
- Company plans End-of-Phase 2 meeting with FDA in H2 2023; topline Phase 3 data in adults expected in 2025.