Core Insights - PDS Biotechnology Corporation is seeking an expedited approval pathway from the FDA for its immunotherapy PDS0101 targeting HPV16-positive head and neck cancer, projected to be the most prevalent type of head and neck cancer in the US by the mid-2030s [1][2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative cancer treatments, particularly through its lead program PDS0101, which is being developed in combination with standard immune checkpoint inhibitors [4] Clinical Trials - The VERSATILE-002 trial has shown promising results, reporting a median overall survival (mOS) of 39.3 months and a median progression-free survival (PFS) of 6.3 months, leading to a proposed amendment in the ongoing VERSATILE-003 trial to include PFS as an earlier primary endpoint [1][2][3] - The VERSATILE-002 trial is an open-label, multi-center Phase 2 study evaluating the safety and efficacy of PDS0101 in combination with pembrolizumab for patients with unresectable, recurrent, or metastatic HPV16-positive head and neck cancer [3] Regulatory Strategy - The company plans to meet with the FDA to discuss changes to the current trial protocol, aiming to shorten the trial duration by making PFS an earlier primary endpoint, which could facilitate an accelerated approval submission [1][2]