Benzinga | Dec 6, 2021 08:32AM EST

PDS Biotech Announces The Reopening Of Recruitment In National Cancer Institute-Led Phase 2 Clinical Trial Of PDS0101-Based Combination

PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company's proprietary Versamune(r) T-cell activating technology, today announced the reopening of recruitment in the National Cancer Institute (NCI)-led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune(r)-HPV16) in combination with two investigational immune-modulating agents in advanced HPV cancers.

The suspension of recruitment was administrative in nature and was unrelated to any specific safety or efficacy concerns associated with the triple combination being studied. As a result, during the recruitment suspension, patients already enrolled in the study continued to receive scheduled treatment. The timing of clinical results from this trial is not expected to be affected by the pause in recruitment of new patients.

The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal, and vulvar cancers in patients who are na?ve to checkpoint inhibitors and have not responded to at least one standard of care therapy. Secondly in third line treatment of the above recurrent or metastatic HPV-positive cancers in patients who have not responded to at least two standard of care therapies including checkpoint inhibitor treatment.

"We are pleased that the NCI, part of the National Institutes of Health, quickly obtained IRB approval to resume recruitment in this important trial. We believe the interim data demonstrated that this combination has the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV16-positive cancers who have limited treatment options. Our approach of treating multiple types of cancer based on their molecular profiles rather than tissue location, may have the potential to provide safe Versamune(r)-based treatment options to an expanded population of patients suffering from multiple types of cancer and at different stages of disease," said Dr. Lauren V. Wood, PDS Biotech's Chief Medical Officer.

For patients interested in enrolling in this clinical study, please call NCI's toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website: https://trials.cancer.gov.