PDS Biotech Amends Phase 3 Trial Protocol to Enable Accelerated Approval Pathway
PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial, adding progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101 in HPV16-positive head and neck cancer.
On February 20, 2026, PDS Biotechnology Corporation adopted a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes progression-free survival (PFS) as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer.
Median overall survival (mOS) remains the trial's primary endpoint for full approval, consistent with the Company's prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration. Following the FDA's standard 30-day wait period since filing of the amended protocol to the Investigational New Drug (IND) Application, without objection, the Company is proceeding with the amended protocol.
The chief executive officer stated that including PFS as an interim primary endpoint provides a potential pathway to shorten the duration of VERSATILE-003 and accelerate the timeline to regulatory submission, as well as making the trial more cost efficient. Survival and safety will continue to anchor full approval.
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech's lead investigational targeted immunotherapy PDS0101 (Versamune® HPV) is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.