PDS Biotechnology Corporation (NASDAQ: PDSB) announced that the Phase 2 VERSATILE-002 trial results were published in the September 17, 2026 issue of JAMA Oncology. The study enrolled 88 patients with HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma across 26 oncology centers in the United States, the United Kingdom and Ireland.
In the immune checkpoint inhibitor‑naïve cohort with PD-L1 CPS ≥1 (n=53), median overall survival reached 39.3 months. The objective response rate for this group was 36%, with five complete responders identified by investigator review and six by central review.
Safety data showed that 13.8% of patients experienced Grade 3 or higher treatment‑related adverse events, including one Grade 4 event occurring one year after PDS0101 therapy. No Grade 5 treatment‑related adverse events were reported. The company noted that no head‑to‑head trials have been conducted comparing the PDS0101‑pembrolizumab combination to standard treatments.
The trial was led by Dr. Jared Weiss of the Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill. The study population had a mean age of 64.5 years, was 94.7% male and 92.0% White. PDS Biotechnology also disclosed that NantWorks, LLC received a one‑year exclusive right to negotiate an exclusive license to PDS0101 after a PIPE financing of up to $22.3 million led by Nant Capital.
