PDS Biotech Submits Phase 3 Protocol to FDA for Initiation of VERSATILE-003 Clinical Trial
Tuesday, August 15, 2023
PDS Biotechnology Corporation, a company engaged in clinical-stage immunotherapy research, has recently put forward updated documentation to the U.S. Food and Drug Administration (FDA). The submission includes an enhanced Chemistry, Manufacturing, and Controls (CMC) package and a Phase 3 multicenter registrational protocol as part of the Investigational New Drug (IND) application process. The purpose of this submission is to assess the potential of combining PDS0101, the company's experimental drug, with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of recurrent or metastatic human papillomavirus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC). The Phase 3 trial, referred to as VERSATILE-003, seeks to evaluate the safety and effectiveness of this combination therapy.
The design of the Phase 3 trial adheres to FDA guidance, incorporating essential elements to support a possible future Biologics License Application (BLA). The trial is projected to commence in the fourth quarter of 2023 and is expected to involve approximately 90-100 clinical sites across the globe.
VERSATILE-003 is designed as a randomized study, where a comparator group receiving KEYTRUDA® monotherapy is compared to a group receiving the combination of PDS0101 and KEYTRUDA®. The study focuses on patients with recurrent or metastatic HPV16-positive HNSCC who have not previously undergone immune checkpoint inhibitor treatment. The primary endpoint of VERSATILE-003 is overall survival (OS).
Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech, emphasized the significance of this regulatory submission. She highlighted the positive interim results from the ongoing VERSATILE-002 Phase 2 trial, where PDS0101 is combined with KEYTRUDA® for HPV16-positive head and neck squamous cell carcinoma (HNSCC). These interim results, presented at a medical conference, demonstrated promising survival rates and manageable side effects.
PDS0101, the company's lead candidate, is an innovative immunotherapy designed to trigger targeted T cell responses against HPV-positive cancers. Administered via subcutaneous injection, it has shown potential in generating effective immune responses against HPV16. The drug has exhibited promise in terms of controlling disease progression and enhancing survival rates, both when used alone and in combination with other therapies. Importantly, combining PDS0101 with other treatments seems to avoid compounding treatment-related toxicity.
The submission of this Phase 3 protocol marks a significant milestone in PDS Biotech's endeavor to establish the efficacy of combining PDS0101 with KEYTRUDA® for treating recurrent or metastatic HPV16-positive HNSCC. This step reflects the company's commitment to advancing its clinical development efforts.
