On October 20, 2020 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that the Phase 2 clinical trial of PDS0101 in combination with standard of care chemoradiotherapy (CRT) for treatment of locally advanced cervical cancer is now open (Press release, PDS Biotechnology, OCT 20, 2020, View Source [SID1234570260]).
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This Phase 2 trial is being led by Ann H. Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D., Resident in Radiation Oncology at The University of Texas MD Anderson Cancer Center. The trial will investigate the anti-tumor efficacy and safety of the PDS0101-CRT combination, and their correlation with critical biomarkers of immune response, in approximately 35 patients.
"We are excited to have initiated this Phase 2 human study of PDS0101 administered with the current standard of care. We believe that the demonstrated potential of PDS0101 to activate the immune system to induce tumor-targeting T-cells provides strong potential to present improved treatments to patients with cervical cancer," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech.
Dr. Lauren Wood, PDS Biotech’s Chief Medical Officer, will serve as PDS Biotech’s intermediary. The study is being performed pursuant to an Investigator Initiated Study Agreement between PDS Biotech and MD Anderson.