Advanced HPV-16 Positive Head and Neck Cancer: PDS Biotech Enlists First Stage of Checkpoint Inhibitor Nave Patients

PDS Biotech incorporates the first stage of a checkpoint inhibitor-naive patient arm into a phase 2 clinical trial for advanced HPV-16 positive head and neck cancer.

FREMONT, CA: Clinical trials are a critical component of medical research that advances medical knowledge and patient treatment. They are critical for identifying novel therapies for diseases and new methods for detecting, diagnosing, and preventing disease development. Additionally, clinical trials assist physicians in determining if the adverse effects of new medication are tolerable when weighed against the possible benefits. PDS Biotechnology Corporation enrolls itself for the first stage of the checkpoint inhibitor naive arm of its VERSATILE-002 Phase 2 study to treat recurrent or metastatic human papillomavirus (HPV16)-associated head and neck cancer has been completed. The company is known for developing novel cancer therapies based on the company's proprietary Versamune® T-cell activating technology. Dr. Jared Weiss is the Lead Principal Investigator of VERSATILE-002. He is a Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina in Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center.

Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech, says, "Completion of enrollment among checkpoint inhibitor naive patients in this first stage of our VERSATILE-002 Phase 2 study in the CPI naive arm is an important milestone, and we would like to thank the patients for their participation in this clinical trial. Through their involvement, together with site Investigators and study staff, this trial will help us better understand the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer."

VERSATILE-002 is a study of two groups of individuals with HPV16-positive head and neck cancer who have had their disease recur or spread. The first group has never received a checkpoint inhibitor before (CPI naive). The second group of patients has been treated unsuccessfully numerous times, including checkpoint inhibitor therapy (CPI refractory). The clinical trial design defines the objective response as determined using RECIST 1.1 radiographic tumor responses (tumor reduction of 30 percent or more). If at least four of the initial 17 patients in the CPI naive arm show an objective response, the research will continue to the second stage and recruit the anticipated 54 patients in the CPI naive arm. Merck & Co. is collaborating on the experiment.