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Mayo Clinic Exploring PDS Biotech's PDS0101, Merck's Keytruda in HPV-Associated Oropharyngeal Cancer

NEW YORK – PDS Biotech on Tuesday announced the start of a study of its immunotherapy PDS0101 as a single agent and in combination with Merck's Keytruda (pembrolizumab) in patients with human papillomavirus-16-associated oropharyngeal cancer.

Researchers at the Mayo Clinic are leading the study, which is exploring PDS0101 with or without Keytruda as a neoadjuvant treatment for patients before they undergo transoral robotic surgery with curative intent. The trial will evaluate whether PDS0101 by itself or combined with a checkpoint inhibitor induces HPV-specific anti-tumor responses, including tumor shrinkage and pathologic regression, and decreases circulating tumor DNA.

"This upcoming trial not only broadens our addressable patient population of those affected by the increasing incidence of HPV-associated oropharyngeal cancer, but also allows us to better understand the activity of PDS0101 alone or in combination with Keytruda in earlier stages of disease," Lauren Wood, PDS Biotech's chief medical officer, said in a statement.

PDS developed PDS0101 using its T-cell activating platform Versamune and designed it to induce CD8 cytotoxic T-cell responses and target HPV16 antigens on cancer cells. The company is also exploring PDS0101's activity in other HPV-associated cancers, including anal, cervical, penile, vaginal, and vulvar cancers.

This month, PDS began a Phase II study, called VERSATILE-002, of PDS0101 and Keytruda in HPV16- and PD-L1-positive recurrent or metastatic head and neck cancers.

PDS, based in Florham Park, New Jersey, is developing three other cancer drugs based on its Versamune platform. Those agents are in preclinical phase for TARP-associated, MUC1-associated, and TRP2-associated cancers.