PDS Biotechnology Corporation (PDSB)’s Versamune HPV Surpasses Survival Benchmarks in Recurrent Head and Neck Cancer Trial

PDS Biotechnology Corporation (NASDAQ:PDSB) unveiled compelling new data on its Versamune HPV (PDS0101) immunotherapy at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The company’s latest abstracts reveal that patients with HPV16-positive recurrent/metastatic head and neck cancer (HNSCC) treated with PDS0101 and pembrolizumab achieved a median overall survival (mOS) of 39.3 months, more than double the previously published 15-month mOS for pembrolizumab alone. Patients with lower CPS scores also saw significant survival benefits.

The ongoing Phase 3 VERSATILE-003 trial by PDS Biotechnology Corporation, enrolling 351 patients, aims to confirm these results, with overall survival as its primary endpoint. Additionally, early findings from a Phase 2 “window of opportunity” study showed that two cycles of Versamune HPV, alone or with pembrolizumab, led to stable disease or partial response in all patients, with the combination therapy achieving a 50% reduction in circulating tumor DNA.

These results highlight Versamune HPV’s potential to set a new standard of care for HPV16-positive HNSCC, offering renewed hope for patients facing this aggressive cancer. PDS Biotechnology Corporation will present these findings on June 2, 2025, in Chicago.