PDSB - PDS Biotech to further advance mid-stage trial for head and neck cancer after early win

PDS Biotechnology (NASDAQ:PDSB) announced it plans to fully enroll the VERSATILE-002 trial for PDS0101 in head and neck cancer after the Phase 2 study achieved its preliminary objective response benchmarks. The trial is designed to study PDS0101 in combination with Merck’s (NYSE:MRK) Keytruda across two groups of head and neck cancer patients with HPV16 mutations and whose cancer has returned or spread. According to the trial design, the study was expected to advance to full enrollment subject to the achievement of the objective response, meaning radiographic tumor responses in at least four or more of the first 17 patients who were not treated with checkpoint inhibitors. The company is currently evaluating the effect of the combination therapy in the second group who have failed prior therapy with checkpoint inhibitors. Read: VERSATILE-002 trial was launched in 2020.

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PDS Biotech to further advance mid-stage trial for head and neck cancer after early win