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PDS Biotech Initiates VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent/Metastatic Head and Neck Cancer in Collaboration with Merck
VERSATILE-002 Trial for First Line Treatment of Recurrent/Metastatic Head and Neck Cancer with Combination PDS0101-KEYTRUDA® is Now Open and Recruiting
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"VERSATILE-002 Trial for First Line Treatment of Recurrent/Metastatic Head and Neck Cancer with Combination PDS0101-KEYTRUDA® is Now Open and Recruiting Patients\nFLORHAM PARK, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced that its VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 and KEYTRUDA® (pembrolizumab) for the first-line treatment of head and neck cancer that has returned or spread is now open. The trial is being conducted in collaboration with Merck.\n The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomized trial that plans to enroll approximately 100 patients across 25 sites in the U.S. The University of Tennessee Medical Center is the first site to open. The studies to be performed at the UT Medical Center will be led by Principal Investigator Dr. Timothy Panella, M.D. The clinical study will evaluate the efficacy and safety of PDS0101, PDS Biotech’s lead Versamune®-based immunotherapy targeting human papillomavirus (HPV)-associated cancers, in combination with KEYTRUDA® (pembrolizumab), Merck's checkpoint inhibitor, in the first-line treatment of patients with HPV16-positive head and neck cancer that has returned or spread. KEYTRUDA® was approved by the FDA in June 2019 as first-line treatment for recurrent or metastatic head and neck cancer. VERSATILE-002 will study if combining PDS0101 with KEYTRUDA® is more effective than what has been previously shown with KEYTRUDA® alone. The main efficacy endpoint in this study is shrinkage of the tumor referred to as the objective response rate (ORR) at nine months following the initiation of treatment with the combination. “The launch of the VERSATILE-002 Phase 2 trial demonstrates our commitment to developing a safe and effective treatment option that builds upon the current standard of care for patients with this aggressive cancer and further strengthens our collaboration with Merck,” commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Though the COVID-19 pandemic impacted our initial timeline, we are pleased to open up this trial to patients.” Dr. Lauren V. Wood, Chief Medical Offi...