PDS Biotechnology announces presentation of Phase 2 data on PDS0101 at ASCO

PDS Biotechnology "announced an upcoming poster presentation of preliminary data from its ongoing Phase 2 VERSATILE-002 clinical trial at the American Society of Clinical Oncology, ASCO, Annual Meeting taking place June 3-7, 2022 in Chicago and online. VERSATILE-002 is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech's proprietary Versamune technology, in combination with Merck's anti-PD-1 therapy KEYTRUDA. The combination is being evaluated in checkpoint inhibitor-naive and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma. The data being presented at ASCO will detail preliminary safety and efficacy data for CPI-naive patients at a prespecified interim analysis point. In the VERSATILE-002 clinical trial, patients are being treated with KEYTRUDA(R) 200 mg by IV infusion every three weeks, plus subcutaneous injection of PDS0101 for the first 4 treatment cycles and again on Cycle 12; KEYTRUDA treatment continues for up to 35 cycles, or until disease progression or demonstrated intolerance to therapy."