PDSB - PDS Bio expands mid-stage study of PDS0101 + Keytruda in head and neck cancer

PDS Biotechnology ([[PDSB]] -3.3%) announces the protocol amendment to expand its Phase 2 VERSATILE-002 study to include patients, in an additional arm, who have failed prior checkpoint inhibitor ((CPI)) therapy (CPI refractory patients).The study is designed to evaluate PDS0101 in combination with Merck' (MRK) Keytruda (pembrolizumab) in the treatment of advanced human papillomavirus ((HPV))-associated head and neck cancer. VERSATILE-002 was initially opened to checkpoint inhibitor naive HPV16-associated head and neck cancer patients in first line treatment of recurrent or metastatic cancer.The additional study arm will evaluate the objective response to the combination among ~40 patients with advanced head and neck cancer who have failed multiple treatments, including checkpoint inhibitor therapy.Objective response is measured by radiographic tumor responses. In the expansion arm, the first 21 patients will be evaluated for safety and objective response before the arm progresses to full enrollment.

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PDS Bio expands mid-stage study of PDS0101 + Keytruda in head and neck cancer