PDS Biotechnology Corporation (PDS), a private clinical stage immuno-oncology company developing novel immunotherapies, has entered a clinical trial collaboration agreement with a subsidiary of Merck (known as MSD outside the United States and Canada) to evaluate the combination of PDS's lead Versamune-based immunotherapy, PDS0101, with Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), in a phase II clinical trial. The planned clinical 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.

"We are honored to collaborate with Merck – one of the world's leading cancer immuno-oncology companies – on this innovative, investigational combination cancer treatment for head and neck cancer patients," said Dr. Frank Bedu-Addo, CEO of PDS. "This collaboration is supported by our recent Phase IIa human clinical 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."

Details of the collaboration were not disclosed.

Keytruda is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Versamune is a registered trademark of PDS Biotechnology Corporation, North Brunswick, NJ, USA.

Versamune is a synthetic T-cell activating nanoparticle platform that overcomes a key obstacle facing cancer immunotherapy by facilitating efficient presentation of cancer proteins recognized by the immune system to powerful tumor-attacking immune cells called killer T-cells.  This process trains the body's T-cells to recognize and attack the cancer.  The Versamune platform has also demonstrated the ability to induce the immunological stimuli locally within the lymph nodes to recruit T-cells, and to enhance both the proliferation and potency of the trained T-cells.  Thirdly, Versamune has also been demonstrated to significantly reduce the population of immune suppressive cells within the tumors in preclinical models, thus facilitating effective killing of the cancer cells.  Efficient activation of each of the above mechanisms by Versamune in order to effectively treat cancer is being actively studied in human clinical trials.

PDS0101 is a combination of Versamune with harmless multi-epitope peptides derived from cancer-causing proteins of the HPV virus which are recognized by the immune system.  PDS plans to evaluate PDS0101 in multiple HPV-advanced cancer and HPV pre-cancer Phase IIb clinical trials.

PDS is a clinical stage immuno-oncology company committed to the development of simpler, safer and more effective immunotherapies.