PDS Biotech Trial Shows Promise for HPV16-Positive Cancer Patients

PRINCETON, N.J., Sept. 22, 2026 /CourierPR/ -- PDS Biotechnology Corporation, a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, has announced the publication of results from a Phase 2 trial evaluating its HPV16-targeted immunotherapy, PDS0101, in combination with pembrolizumab in the September 17, 2026, issue of JAMA Oncology.

The trial, led by Dr. Jared Weiss, MD, of the Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, evaluated the efficacy and safety of PDS0101 in combination with pembrolizumab in participants with HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study, which was open-label and non-randomized, was conducted at twenty-six oncology centers across the US, UK, and Ireland.

Key findings from the trial included a 39.3-month median overall survival (mOS) for first-line (1L) immune checkpoint inhibitor (ICI)-naïve patients. The trial enrolled 88 patients with histologically confirmed R/M HPV16-positive diseases, with 87 receiving treatment and comprising the safety population. Of these, 75 were in the modified Intention-to-Treat (mITT) population used for efficacy analyses: 53 were ICI-naïve with PD-L1 CPS ≥1, and 22 were ICI-resistant. The trial found that 62.3% of the ICI-naïve participants in the mITT cohort had low CPS of 1-19, and 37.7% had high CPS ≥ 20. In the overall CPS ≥ 1 population, the mOS was 39.3 months (95% CI, 23.9 to NE). The best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months.

Objective response rate (ORR) for CPS ≥ 1 was 36%, with 5/53 being complete responders by investigator review and 34% of which 6/53 were complete responders by central review. The published ORR for the overall population with CPS ≥ 1 when treated with standard of care pembrolizumab is 19%. The treatment was well-tolerated, with 13.8% Grade ≥3 treatment-related adverse events (TRAEs), 1 Grade 4 event one year after PDS0101 therapy, and no Grade 5 TRAEs.

The Company continues to prioritize PDS0301 in metastatic colorectal cancer (mCRC) while pursuing a partnership strategy for PDS0101. The trial evaluated PDS0101, its HPV16-targeted immunotherapy, in combination with pembrolizumab, a program that has been ongoing for some time. The trial was published in JAMA Oncology, a peer-reviewed journal of the American Medical Association, in the September 17, 2026, issue.

PDS Biotechnology Corporation intends to pursue strategic partnerships or other externally funded opportunities for the Phase 3 development of PDS0101. The Company's lead development program, PDS0301, is an investigational tumor-targeted interleukin-12 (IL-12) immunocytokine designed to deliver IL-12 preferentially to the tumor microenvironment, with the goal of enhancing anti-tumor immune activity while limiting systemic exposure. The Company is focused on advancing PDS0301 in indications where its tumor-targeted mechanism may help address and overcome mechanisms of resistance to immunotherapy.

PDS Biotechnology Corporation is a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer. The Company owns the Versamune® cancer vaccine platform, including PDS0101, which has been evaluated in HPV16-positive cancers. The Company intends to pursue strategic partnerships or other externally funded opportunities for the Phase 3 development of PDS0101.