PDS Biotechnology Corporation announced on September 22, 2026, that results from a Phase 2 clinical trial have been published in the September 17, 2026, issue of JAMA Oncology. The study, titled "VERSATILE-002," evaluated PDS0101, a human papillomavirus 16 (HPV16)-targeted immunotherapy, in combination with pembrolizumab. The trial focused on patients with recurrent or metastatic head and neck squamous cell carcinoma.

The VERSATILE-002 trial was an open-label, non-randomized study conducted at 26 oncology centers across the United States, the United Kingdom, and Ireland. A total of 88 patients with histologically confirmed HPV16-positive recurrent/metastatic disease were enrolled, with 87 receiving treatment. The safety population consisted of 87 patients, while 75 were included in the modified Intention-to-Treat (mITT) population for efficacy analyses. This cohort included 53 patients who were immune checkpoint inhibitor (ICI)-naïve and 22 patients who were ICI-resistant.

Key efficacy findings for the ICI-naïve population with a PD-L1 Combined Positive Score (CPS) of at least 1 included a median overall survival (mOS) of 39.3 months. The press release notes that this figure is higher than the best published results for standard-of-care pembrolizumab or pembrolizumab plus chemotherapy, which is 17.9 months. The objective response rate (ORR) for the CPS ≥ 1 population was 36%, with 5 out of 53 complete responders identified by investigator review and 6 out of 53 by central review.

Safety data indicated that the combination treatment was generally well-tolerated. Among the 87 patients in the safety population, 13.8% experienced Grade ≥3 treatment-related adverse events (TRAEs). One Grade 4 event was reported one year after PDS0101 therapy, and no Grade 5 TRAEs occurred. The press release compares this safety profile to the published ORR for standard-of-care pembrolizumab, which is 19%.

In other company news, PDS Biotechnology recently announced the initial closing of a PIPE financing of up to $22.3 million led by Nant Capital. Additionally, the company granted NantWorks, LLC, an affiliate of Nant Capital, an exclusive right to negotiate an exclusive license to PDS0101. The company stated that it intends to pursue strategic partnerships or other externally funded opportunities for the Phase 3 development of PDS0101.