PDS Biotech announces Versamune® HPV ctDNA results: 100% clearance vs 50% CRT alone; Phase 3 HNSCC trial planned Q1 2025

PDS Biotechnology Corp

Versamune® HPV + CRT achieved 100% HPV16 ctDNA clearance at 3-4 months vs 50% with CRT alone in cervical cancer.
Undetectable ctDNA at 3-4 months linked to 93% 2-year recurrence-free survival vs 30% with detectable ctDNA.
Phase 3 VERSATILE-003 trial in HPV16-positive HNSCC to be initiated in Q1 2025.
Plans to discuss accelerated regulatory pathway (e.g., Breakthrough Therapy) with FDA based on ctDNA-survival correlation.
Median follow-up 23 months; 100% 36-month OS in patients receiving 5 doses of Versamune® HPV + CRT.

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