PDS Biotech submitted a protocol amendment to the U.S. FDA for its Phase 3 VERSATILE-003 clinical trial.
The amendment changes the PFS endpoint to a primary endpoint, potentially leading to accelerated approval of PDS0101.
Positive final results from the VERSATILE-002 trial supported the protocol amendment.
Primary Endpoint Change
The protocol amendment for VERSATILE-003 shifts the PFS endpoint to the primary endpoint for accelerated approval.
Constructive FDA Meeting
The FDA meeting in December 2025 opened a potential pathway to accelerate the regulatory submission of PDS0101.
Promising Trial Results
Results from VERSATILE-002 trial showed promising median overall survival and durable Progression Free Survival, supporting the protocol amendment.
- The inclusion of PFS as a primary endpoint can potentially shorten the trial duration of VERSATILE-003.
- The dialogue with the FDA indicates a pathway for accelerated regulatory submission based on the protocol amendment.
PDS Biotech's submission of the amended protocol marks a significant milestone towards potentially accelerating the approval process of PDS0101. The positive dialogue with the FDA and promising trial results provide a strong foundation for the Company's future developments in immunotherapy.