PDS halts work on phase 3 cancer therapy to focus on colorectal contender

Now accepting nominations for the Fierce Innovation Awards - Submit your application today Biotech PDS halts work on phase 3 cancer therapy to focus on colorectal contender By James Waldron Aug 13, 2026 9:55am PDS Biotechnology colorectal cancer immunotherapy Oncology PDS Biotechnology has called time on its phase 3 head and neck cancer therapy to channel resources to a drug in phase 2 development for metastatic colorectal cancer. The New Jersey biotech had been evaluating Versamune HPV, an HPV-specific T cell-stimulating immunotherapy also known as PDS0101, in combination with Keytruda in the late-stage Versatile-003 trial of 350 patients with HPV16-positive head and neck squamous cell carcinoma. A phase 2 study of PDS0101 last year had linked the PDS0101-Keytruda combo to median overall survival of 39.3 months in the tough-to-treat head and neck cancer setting.

But PDS CEO Frank Bedu-Addo, Ph.D., told shareholders in an Aug. 11 letter that following a “comprehensive review of our development portfolio, capital allocation priorities and long-term strategy,” the biotech had decided to prioritize its tumor-targeted IL-12 immunocytokine PDS0301 instead. Back in March, the company announced data from a National Cancer Institute-led phase 2 study of PDS0301 in patients with metastatic colorectal cancer.

At the time, PDS noted an objective response rate of 77.8% at six months among the nine patients treated with PDS0301 in the first stage of the trial. Since then, Bedu-Addo has touted PDS0301’s potential to “complement a broad range of current and emerging oncology therapies,” such as RAS pathway inhibitors, bispecific antibodies, antibody-drug conjugates and radioligand therapies. The company is already assessing the therapy’s potential in recurrent prostate cancer, metastatic castration-resistant prostate cancer, Kaposi sarcoma and HPV16-positive cancers, the CEO noted.

Bedu-Addo told shareholders this week that the company believes “the best path to creating long-term shareholder value is to prioritize the advancement of PDS0301 … while pursuing strategic partnership opportunities for PDS0101.” That means internal investment in PDS0101 will be halted, including the discontinuation of the Versatile-003 trial. “We believe the strength of the phase 2 clinical results allows us to preserve the potential value of PDS0101 through a strategic partnership,” Bedu-Addo added in the letter. PDS had $5.6 million in cash as of the end of June, according to this morning’s second-quarter earnings release.

PDS Biotechnology colorectal cancer immunotherapy Oncology Biotech