PDS Biotech Announces Circulating Tumor DNA Results for Versamune® HPV in IMMUNOCERV Trial Published in Clinical Cancer Research

Core Insights - Versamune HPV shows potential as a broadly effective treatment for HPV16-associated cancers, with a Phase 3 trial for HPV16-positive head and neck squamous cell carcinoma (HNSCC) planned for Q1 2025 [1][2][3] Group 1: Clinical Trial Results - The trial demonstrated that Versamune HPV combined with chemoradiation (CRT) led to greater and earlier clearance of HPV16-positive cancer cells from the bloodstream in patients with locally advanced cervical cancer [2][3] - 100% of patients with locally advanced HPV16 cervical cancer treated with Versamune HPV + CRT had no detectable HPV16 circulating tumor DNA (ctDNA) at 3-4 months, compared to 50% of patients receiving standard CRT [1][4] - Undetectable HPV ctDNA at 3-4 months was associated with improved 2-year recurrence-free survival (RFS) of 93% versus only 30% in patients with detectable HPV ctDNA [1][4] Group 2: Patient Outcomes - The median follow-up period was 23 months, with a strong correlation between HPV ctDNA clearance at 3-4 months and better 2-year RFS (92.9% vs. 30%, P = 0.0067) [4] - The strongest predictor of RFS was HPV ctDNA clearance at 3-4 months, achieving a concordance index score of 0.83 [4] - The 36-month overall survival (OS) rate was reported as 100% for 8 patients who received 5 doses of Versamune HPV + CRT, and an 84.4% OS rate for 17 patients who received at least 2 doses of Versamune HPV + CRT [5] Group 3: Future Plans and Regulatory Pathway - The company plans to initiate discussions with the U.S. Food and Drug Administration regarding the potential for an accelerated regulatory pathway, such as Breakthrough Therapy designation in cervical cancer [3] - The findings suggest that the reduction of ctDNA levels may also apply to other HPV16-positive cancers like HNSCC, which is included in the VERSATILE-003 Phase 3 clinical trial [3]