“Completing enrollment in the ICI naïve arm is an important milestone in the VERSATILE-002 Phase 2 trial and the ongoing development of PDS0101 in combination with KEYTRUDA® as a potential treatment for recurrent and/or metastatic HPV16-positive head and neck cancer,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “HPV-driven HNSCC is a growing problem, and there is a large unmet medical need to develop an HPV-targeted immunotherapy. Preliminary data reported at ASCO 2022 and highlighted at our October 2022 Head and Neck Cancer KOL Roundtable suggest that PDS0101 in combination with KEYTRUDA® may lead to improved outcomes in ICI naïve, recurrent or metastatic HNSCC patients. We now look forward to reporting updated data from the VERSATILE-002 trial at ASCO 2023 as the next step towards a planned global confirmatory randomized, controlled trial investigating the combination of PDS0101 and KEYTRUDA® in this same patient population.”
