Versamune HPV (PDS0101)

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PDS Biotech Unveils Updated Positive Data From VERSATILE-002 Trial and Additional Trials Evaluating Versamune® HPV to Treat Head and Neck Cancers at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
GlobeNewswire· 2025-06-02 12:00
Core 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]
PDS Biotech Announces Positive Extended Follow-Up Data for VERSATILE-002 and Additional Trials Evaluating Versamune® HPV to be Presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Globenewswire· 2025-05-22 21:26
Core Insights - PDS Biotechnology Corporation is advancing its lead immunotherapy program, Versamune HPV, in combination with pembrolizumab for the treatment of recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) [2][8] Group 1: Clinical Trial Results - In Phase 2 trials, the median overall survival (mOS) for patients with a Combined Positive Score (CPS) ≥20 is reported at 39.3 months, while for CPS ≥1, it is 30.0 months [1][6] - The ongoing Phase 3 trial (VERSATILE-003) is currently enrolling patients, with a total of 351 patients expected to be accrued [5][6] - The VERSATILE-002 trial shows promising results, with a median follow-up of 18.4 months, indicating one of the longest follow-up periods for this patient population [6] Group 2: Presentation and Publication - Three abstracts summarizing Versamune HPV studies will be presented at the 2025 ASCO Annual Meeting, scheduled for May 30-June 3, 2025 [2][4] - The VERSATILE-002 trial results will be presented by Dr. Jared Weiss, while Dr. Katharine Price will present the ongoing VERSATILE-003 trial details [6] Group 3: Company Overview - PDS Biotechnology is focused on transforming cancer treatment through immunotherapy, particularly targeting HPV16-positive cancers [8] - The company is also developing a triple combination therapy that includes PDS01ADC, an IL-12 fused antibody drug conjugate, alongside standard immune checkpoint inhibitors [8]