PDS Biotechnology Corp., a clinical stage biopharma company developing immunotherapies, has entered a clinical trial collaboration with a subsidiary of Merck to evaluate the combination of PDS’ lead Versamune-based immunotherapy, PDS0101, with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase II trial. The trial will evaluate the safety and efficacy of the combination in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection after failure with platinum-based chemotherapy. Further details were not disclosed.

“We are honored to collaborate with Merck on this innovative, investigational combination cancer treatment for head and neck cancer patients,” said Dr. Frank Bedu-Addo, chief executive officer of PDS. “This collaboration is supported by our recent Phase IIa data demonstrating that PDS0101 uniquely combined induction of high levels of active tumor-targeting T-cells with an excellent safety profile. If PDS0101’s strong human immunological responses and superior safety profile are confirmed by demonstration of clinical benefit for HPV-cancer patients in multiple upcoming Phase IIb trials, including this important alliance with Merck in combination with a checkpoint inhibitor, PDS will be uniquely positioned to meaningfully impact clinical outcomes across a wide range of patients with HPV-related cancers.”