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PDS Biotechnology Announces Principal Investigator and Independent Data Monitoring Committee for its Phase 2 Clinical Collaboration with Merck
Study evaluating PDS0101-KEYTRUDA® (pembrolizumab) Combination in First Line Treatment of Metastatic Head and Neck Cancer expected to be initiated in Q1 2020
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"Study evaluating PDS0101-KEYTRUDA® (pembrolizumab) Combination in First Line Treatment of Metastatic Head and Neck Cancer expected to be initiated in Q1 2020\nPRINCETON, N.J., Dec. 11, 2019 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced that Dr. Jared Weiss, an internationally recognized expert in the field of thoracic and head and neck cancers and Faculty at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, will be the Principal Investigator for the Company’s Phase 2 VERSATILE-002 study in collaboration with Merck. In addition, the Company has established an independent Data Monitoring Committee (DMC) that will be responsible for reviewing and evaluating patient safety and efficacy data in the upcoming Phase 2 study.\n Dr. Jared Weiss serves as the Section Chief of Thoracic and Head and Neck Oncology and has served as principal investigator on numerous industrial and investigator initiated immunotherapy clinical trials. He is the Vice President of Cancergrace.org, a global resource with the goal of increasing patient education and family information on cancer and is an advocate and board member of the Lung Cancer Initiative of North Carolina. Dr. Weiss holds a Doctor of Medicine from Yale University School of Medicine and a B.S. in neuroscience from Brown University. Dr. Weiss completed his residency in internal medicine at Beth Israel Deaconess Medical Center; and his medical oncology fellowship at the Hospital of the University of Pennsylvania. The combination study will evaluate the efficacy and safety of PDS Biotech’s lead Versamune®-based immunotherapy, PDS0101, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in the first-line treatment of patients with recurrent or metastatic human papillomavirus-16 (HPV16) positive head and neck cancer. The study is expected to be initiated in the next three to four months. “I look forward to working with PDS Biotech in collaboration with Merck on this Phase 2 study to evaluate the novel combination of PDS0101 and KEYTRUDA®,” commented Dr. Jared Weiss. “PDS0101’s unique ability to promote the in-vivo induction of high levels...