On December 15, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported the completion of enrollment in the first stage of the checkpoint inhibitor refractory group of its VERSATILE-002 Phase 2 study for the potential treatment of recurrent and/or metastatic human papillomavirus (HPV16)-positive head and neck cancer (Press release, PDS Biotechnology, DEC 15, 2022, View Source [SID1234625318]). 90% of HPV-associated head and neck cancers in the US are reported to be caused by HPV16, as reported in a study published in the Journal of Clinical Medicine.

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab (KEYTRUDA) in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients has failed treatments including checkpoint inhibitor therapy (CPI refractory).

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. During PDS Biotech’s recent Head and Neck Cancer Key Opinion Leader (KOL) Roundtable, Dr. Weiss highlighted data observed from 17 patients, including an objective response rate of 41%, clinical benefit rate of 77%, and an overall survival rate of 87% at nine months.

"We are very pleased to have completed enrollment among checkpoint inhibitor refractory patients in this first stage for this group in our VERSATILE-002 Phase 2 study," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "This important milestone follows continued positive progress with the Phase 2 study, including data presented at ASCO (Free ASCO Whitepaper) 2022 and updated at our recent Head and Neck Cancer KOL Roundtable demonstrating the potential of PDS0101 in combination with pembrolizumab as a treatment for recurrent or metastatic HPV16-positive head and neck cancer. Currently, there are no approved therapies for CPI refractory head and neck cancer, with patients typically surviving less than a year. Our intent with VERSATILE-002 is to investigate the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer."

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