PDS Biotech Provides Data Update from Ongoing VERSATILE-002 Phase 2 Clinical Trial in Head and Neck Cancer

Core Insights - PDS Biotechnology Corporation is advancing its VERSATILE-002 Phase 2 clinical trial, focusing on the combination of Versamune® HPV and KEYTRUDA® for treating HPV16-positive head and neck squamous cell cancer (HNSCC) [1][3][6] Clinical Trial Updates - As of May 17, 2024, the trial has enrolled 53 patients, with updated survival data expected to be announced in Q3 2024 [2] - The median overall survival (mOS) for patients remains at 30 months, with a 95% confidence interval lower limit of 19.7 months [7][8] - The trial includes a three-arm registrational study for first-line treatment of HPV16-positive recurrent/metastatic HNSCC, featuring both double and triple combination therapies [3][6] Treatment Mechanism and Efficacy - The combination of PDS01ADC and Versamune® HPV is believed to effectively disrupt tumor defenses while generating targeted T-cells to attack tumors [10] - The company asserts that the current standard of care for recurrent/metastatic HNSCC has survival rates below 18 months, highlighting the potential of their investigational therapies [9]