other material
confidence high
sentiment positive
materiality 0.70
PDS Biotech initiates VERSATILE-003 Phase 3 trial for Versamune HPV in head and neck cancer
PDS Biotechnology Corp
- Phase 3 trial VERSATILE-003 now open to patient enrollment for HPV16-positive head and neck cancer.
- Trial to enroll ~350 patients at 2:1 ratio; primary endpoint is overall survival.
- First-ever Phase 3 trial in HPV16-positive head and neck cancer.
- Versamune HPV already has FDA Fast Track designation based on Phase 2 data.