PDS Biotech Announces Adoption of Amended Protocol for Phase 3 VERSATILE-003 Trial Incorporating Progression Free Survival (PFS) as Primary Endpoint for Interim Analysis and Potential Accelerated Approval

On February 20, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes 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 ("FDA"). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Survival and safety will continue to anchor full approval, and we remain confident in the path we’ve outlined and in our commitment to advancing a promising targeted immunotherapy for the rapidly growing population of patients with HPV16-positive recurrent and/or metastatic head and neck cancer."

(Press release, PDS Biotechnology, FEB 20, 2026, View Source [SID1234662820])