PDS Biotech Plans To Pursue Expedited Approval Pathway for PDS0101 In The Treatment Of HPV16-Positive Head And Neck Cancer

PDS Biotechnology Corporation, a late-stage immunotherapy company committed to transforming how the immune system targets and destroys cancer cells, announced that it has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss an expedited approval pathway for PDS0101, its lead immunotherapy candidate for the treatment of HPV16-positive head and neck cancer.

This request follows a recent review of the final data from the VERSATILE-002 trial, which showed strong clinical outcomes. Based on these results, PDS Biotech has also proposed an amendment to its ongoing VERSATILE-003 Phase 3 trial. The amendment aims to reduce the number of enrolled patients while maintaining statistical validity and to add progression-free survival (PFS) as an earlier primary endpoint alongside median overall survival (mOS). Achieving the PFS endpoint could enable an accelerated approval submission to the FDA. Pending regulatory review of this proposed amendment, the VERSATILE-003 trial will be temporarily paused.

Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, expressed optimism about the latest trial findings. He stated that the final survival data and durable clinical responses from the VERSATILE-002 study are particularly encouraging, noting that this is the first time a trial in recurrent or metastatic head and neck cancer has reported a median overall survival (mOS) of nearly 40 months. He explained that while the current Phase 3 study uses mOS as the primary endpoint and PFS as a secondary endpoint, this design extends the trial’s overall duration. By shifting PFS to an earlier primary endpoint, PDS Biotech hopes to accelerate the timeline for bringing this potential therapy to patients.

Dr. Kirk Shepard, Chief Medical Officer of PDS Biotech, added that the rising incidence of HPV16-positive head and neck cancer underscores the need for faster regulatory progress. He emphasized that the company’s goal is to pursue the most efficient and cost-effective path to approval, ensuring that patients have access to a well-tolerated treatment option that does not rely on chemotherapy. He also confirmed that patients currently enrolled in the VERSATILE-003 trial will continue receiving PDS0101 treatment during the temporary pause.

PDS0101 is designed to stimulate a strong and targeted immune response against HPV16-positive cancer cells, which are responsible for a significant subset of head and neck cancers. The company’s efforts to collaborate with the FDA on an accelerated approval pathway reflect its broader mission to deliver effective immunotherapy options for patients with limited treatment choices. With the FDA meeting request underway and promising data from the VERSATILE-002 trial, PDS Biotechnology continues to advance toward its goal of offering a new, life-extending treatment for patients battling HPV-related cancers.