PRINCETON, N.J. — September 18, 2025 — Leads & Copy — PDS Biotechnology Corporation (Nasdaq: PDSB) announced a sub-analysis from its VERSATILE-002 Phase 2 clinical trial, revealing that a combination therapy achieved 29.5 months of Median Overall Survival (mOS) in patients with low PD-L1 expression (CPS 1-19) suffering from HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (1L R/M HNSCC).
The trial evaluated PDS0101 (Versamune® HPV) combined with Keytruda®.
Prof. Kevin Harrington, M.D., from The Institute of Cancer Research, London, noted the potential for a well-tolerated treatment option without chemotherapy.
According to Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, the multifunctional T cell immune response of PDS0101 treatment may improve survival in a difficult-to-treat patient population, overcoming limitations of immune checkpoint inhibitor therapy.
The sub-analysis of patients with low PD-L1 expression (n=32) showed a mOS of 29.5 months, compared to published mOS of 10.8 months with Keytruda® monotherapy and 12.3 months with Keytruda® plus chemotherapy.
The company previously announced mOS results of 39.3 months for the full study population on August 25, 2025.
Investor Contact: Mike Moyer, LifeSci Advisors, Phone +1 (617) 308-4306, Email: mmoyer@lifesciadvisors.com
Media Contact: David Schull, Russo Partners, Phone +1 (858) 717-2310, Email: david.schull@russopartnersllc.com
Source: PDS Biotechnology
