PDS Biotechnology(US:PDSB) GlobeNewswire·2025-06-02 12:00Core Insights - The median overall survival (mOS) for first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) remains at 30.0 months, indicating durability in clinical responses [1][7] - HPV16-positive HNSCC is identified as a rapidly increasing and severe medical need in the US, with over 50% of HNSCC cases being HPV16-positive [2][3] - PDS Biotechnology's VERSATILE-003 is the only ongoing Phase 3 clinical trial specifically targeting HPV16-positive HNSCC [1][3] Company Overview - PDS Biotechnology Corporation is a late-stage immunotherapy company focused on transforming immune responses to target and kill cancers, particularly HPV16-positive HNSCC [1][11] - The company is developing its lead investigational immunotherapy, Versamune HPV (PDS0101), in combination with standard-of-care immune checkpoint inhibitors [11] Clinical Trial Insights - The VERSATILE-002 trial reported a median overall survival of 30.0 months for patients treated with PDS0101 and pembrolizumab, with a follow-up period of 22.1 months [6][7] - The trial included 53 patients, with a disease control rate of 77.4% and an objective response rate of 35.8% [8] - The lower limit of the 95% confidence interval for mOS improved from 18.4 months in 2023 to 23.9 months, suggesting a positive trend in survival outcomes [7] Comparative Analysis - PDS Biotechnology's approach differs from other ongoing Phase 3 trials by exclusively targeting HPV16-positive HNSCC, while other trials focus on predominantly HPV-negative populations [3][4] - HPV-positive HNSCC is recognized as a distinct disease requiring targeted treatment strategies, as traditional therapies have shown limited efficacy [4][9] Regulatory Insights - The FDA has recommended the development of a companion diagnostic for identifying HPV16-positive patients in the ongoing VERSATILE-003 trial [5]