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 involving 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.