PDS Biotechnology Corporation recently held a conference call to update stakeholders on their clinical strategy, particularly focusing on the VERSATILE-002 Phase II trial of Versamune HPV in combination with KEYTRUDA (pembrolizumab) for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The company has had productive discussions with the FDA, receiving support for both a triple and a double combination therapy approach.
Key highlights from the meeting include:
-
Clinical Response: The VERSATILE-002 trial has shown improved clinical responses, with a notable percentage of patients experiencing deep and durable responses. Median overall survival data continues to mature, demonstrating impressive results.
-
Statistical Design Revision: Based on the more mature data, the company revised the clinical endpoints in the statistical design of the trial protocol. This revision is aimed at improving the potential for a successful trial.
-
Triple Combination Proposal: PDS Biotech proposed a three-arm trial, including a double-combination treatment arm and a third arm featuring their triple combination of Versamune HPV, PDS01ADC, and pembrolizumab. The FDA expressed support for both the double and triple combinations.
-
Regulatory Alignment: The FDA agreed to proceed with the VERSATILE-003 trial, a revised two-arm, double-combination trial, before the end of the year. This decision was made considering the strength of the VERSATILE-002 data, the potential of the double-combination, and the goal to be the first to market.
-
Preparatory Work: The company has contracted a contract research organization (CRO) to manage the Phase III clinical trial for VERSATILE-003, and preparatory activities are underway. A broad KOL support is noted, with investigators from the VERSATILE-002 study involved. A significant number of target sites have expressed interest in participating in the trial.
The focus now is on initiating the VERSATILE-003 trial with the double-combination approach, while the PDS01ADC dose optimization study will proceed separately, adhering to FDA recommendations. The company believes that the double-combination, which has received fast-track designation from the FDA, has the potential to significantly advance the treatment of HPV16-positive head and neck cancer.
