PDS Biotechnology pauses phase 3 head-and-neck trial to prioritize colorectal cancer immunotherapy

PDS Biotechnology announced it is stopping work on its phase 3 head and neck cancer therapy, Versamune HPV (PDS0101), in order to reallocate resources to a different drug program.

The halted trial, called Versatile-003, was testing PDS0101 in combination with Keytruda in about 350 patients with HPV16‑positive head and neck squamous cell carcinoma. Earlier phase 2 data had linked the combo to a median overall survival of roughly 39 months.

The company is shifting focus to its tumor‑targeted IL‑12 immunocytokine, PDS0301, which is in phase 2 development for metastatic colorectal cancer. A National Cancer Institute‑led study reported an objective response rate of 77.8% at six months among nine patients in the first stage of the trial.

CEO Frank Bedu‑Addo said the change follows a comprehensive review of the portfolio, capital allocation priorities and long‑term strategy, emphasizing the potential of the colorectal candidate.