PDS Biotechnology Corporation (PDS Biotech) is set to host a Key Opinion Leader (KOL) event on December 17, 2024, to discuss the growing prevalence and pathology of HPV16-positive head and neck squamous cell carcinoma (HNSCC). The primary focus will be on the company's upcoming VERSATILE-003 Phase 3 clinical trial, evaluating Versamune-HPV in combination with pembrolizumab for the first-line treatment of recurrent and/or metastatic HPV16-positive HNSCC.
The panel will feature leading experts in the field, including Dr. Francis Worden from the University of Michigan Rogel Cancer Center and Dr. Kevin Harrington from The Institute of Cancer Research, United Kingdom. The event will be moderated by Dr. Kirk Shepard, Chief Medical Officer of PDS Biotech.
Expert Insights on HPV16-Positive HNSCC
Dr. Worden, a renowned expert in HPV-positive oropharyngeal cancer, has co-authored over 190 peer-reviewed articles and is involved in multiple clinical trials for HNSCC, including the VERSATILE-002 trial. Dr. Harrington served as the principal investigator for the KEYNOTE-048 trial, which led to FDA approval of pembrolizumab for first-line treatment of recurrent/metastatic HNSCC. He also presented results from the VERSATILE-002 trial at the European Society of Medical Oncology Congress earlier this year.
VERSATILE-003 Phase 3 Trial Details
The VERSATILE-003 trial aims to evaluate the efficacy and safety of Versamune-HPV, PDS Biotech's lead investigational targeted immunotherapy, in combination with pembrolizumab, a standard-of-care immune checkpoint inhibitor. This trial is designed as a pivotal study to potentially advance the treatment landscape for patients with advanced HPV16-positive head and neck cancers. The trial will provide critical data on the combination therapy's ability to improve outcomes in this patient population.
PDS Biotech is also exploring a triple combination therapy that includes Versamune-HPV, PDS01ADC (an IL-12 fused antibody-drug conjugate), and a standard-of-care immune checkpoint inhibitor, further expanding their approach to targeting and eliminating cancers.
