PDS Biotech Announces Amended Protocol for Phase 3 Trial

Progression Free Survival Added as Interim Primary Endpoint for Potential Accelerated Approval

Published on Feb. 28, 2026

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PDS Biotechnology Corporation announced the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial for its lead investigational targeted immunotherapy PDS0101 (Versamune® HPV). 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, while median overall survival (mOS) remains the trial's primary endpoint for full approval.

Why it matters

The inclusion of PFS as an interim primary endpoint provides a potential pathway to shorten the duration of the VERSATILE-003 trial and accelerate the timeline to regulatory submission, as well as making the trial more cost-efficient. This could help bring PDS0101, a promising targeted immunotherapy, to the rapidly growing population of patients with HPV16-positive recurrent and/or metastatic head and neck cancer more quickly.

The details

The amended protocol was filed with the U.S. Food and Drug Administration (FDA), and following the standard 30-day wait period without objection, the company is proceeding with the amended protocol. Survival and safety will continue to anchor full approval, and the company remains confident in the path outlined and its commitment to advancing PDS0101 for this patient population.

  • On February 20, 2026, PDS Biotechnology Corporation announced the adoption of the amended protocol for the Phase 3 VERSATILE-003 trial.

The players

PDS Biotechnology Corporation

A late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers.

Frank Bedu-Addo, PhD

President and Chief Executive Officer of PDS Biotech.

U.S. Food and Drug Administration (FDA)

The regulatory agency that oversees the approval of new drugs and therapies in the United States.

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What they’re saying

“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.”

— Frank Bedu-Addo, PhD, President and Chief Executive Officer (PDS Biotechnology Corporation)

What’s next

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 takeaway

The adoption of the amended protocol for the Phase 3 VERSATILE-003 trial, which includes progression-free survival as an interim primary endpoint, represents a potential pathway to accelerate the development and regulatory approval of PDS0101, a promising targeted immunotherapy for patients with HPV16-positive recurrent and/or metastatic head and neck cancer.