PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint

Core Viewpoint - PDS Biotechnology Corporation has submitted an amended protocol for its Phase 3 VERSATILE-003 trial, aiming for accelerated approval of its immunotherapy PDS0101 by changing the primary endpoint to progression-free survival (PFS) [1][2][3] Group 1: Clinical Trial Updates - The amendment to the VERSATILE-003 trial allows for an earlier evaluation of PFS with significant statistical power, which could support accelerated approval [1][2] - Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by the FDA [1] - The submission follows a constructive Type C meeting with the FDA in December 2025, discussing the accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer [2] Group 2: Company Insights - PDS Biotechnology is focused on transforming how the immune system targets and kills cancers, with a pivotal clinical trial for advanced HPV16-positive head and neck squamous cell cancers [4] - The lead investigational targeted immunotherapy, PDS0101 (Versamune HPV), is being developed in combination with a standard-of-care immune checkpoint inhibitor and a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate [4] - The company expresses confidence in the potential to accelerate regulatory submission based on discussions with the FDA [3]