PDS Biotech Announces Amended Protocol for Phase 3 Trial of PDS0101 in Head and Neck Cancer

Progression-Free Survival Added as Interim Primary Endpoint to Support 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 immunotherapy PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. The amendment includes progression-free survival (PFS) as an interim primary endpoint, which could potentially enable a shorter timeline to regulatory submission and accelerated approval, while median overall survival (mOS) remains the primary endpoint for full approval.

Why it matters

The addition of PFS as an interim primary endpoint provides a potential pathway to accelerate the development and approval of PDS0101, a promising targeted immunotherapy for the rapidly growing population of patients with HPV16-positive recurrent and/or metastatic head and neck cancer, an area of high unmet medical need.

The details

The amended protocol allows PDS Biotech to potentially seek accelerated approval for PDS0101 based on an interim analysis of PFS, while the trial will continue to evaluate the primary endpoint of mOS for full approval. This change is intended to shorten the duration of the VERSATILE-003 trial and make it more cost-efficient, while maintaining the focus on survival and safety as the key measures for full regulatory approval.

  • PDS Biotech filed the amended protocol with the FDA, and after the standard 30-day wait period without objection, the company is proceeding with the amended trial.

The players

PDS Biotechnology Corporation

A late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, including the development of PDS0101 (Versamune® HPV) for HPV16-positive head and neck squamous cell cancers.

Frank Bedu-Addo, PhD

President and Chief Executive Officer of PDS Biotech.

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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, PDS Biotech is proceeding with the amended Phase 3 VERSATILE-003 trial, which now includes progression-free survival as an interim primary endpoint to potentially support accelerated approval of PDS0101.

The takeaway

The amended protocol for the VERSATILE-003 trial represents an important step forward in PDS Biotech's efforts to accelerate the development and approval of PDS0101, a targeted immunotherapy that could address the significant unmet need for new treatment options in HPV16-positive head and neck cancers.