PDSB - PDS Biotech gets UK drug regulator nod to start trial of PDS0101/Keytruda combo

PDS Biotechnology (NASDAQ:PDSB) said that the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) accepted its clinical trial application (CTA) to start a study, called VERSATILE-002, of PDS0101 in combination with Merck's (MRK) Keytruda (pembrolizumab). The company said the MHRA is among several regulatory agencies that it is seeking approval from to expand the trial into several sites outside the U.S. "The reported preliminary safety data of PDS0101 in combination with pembrolizumab is highly encouraging, and we are pleased that European patients will be able to enroll in this promising clinical study of an HPV-targeted immunotherapy with standard of care, pembrolizumab," said Chris Curtis, CEO of U.K.-based charity group The Swallows.

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PDS Biotech gets UK drug regulator nod to start trial of PDS0101/Keytruda combo