PDS Biotechnology to present updated data from VERSATILE-002 study

PDS Biotechnology announced the presentation of updated data from the VERSATILE-002 study at the 2023 ASCO Annual Meeting being held June 2-6 in Chicago. VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, in adults with human papilloma virus16 positive, unresectable recurrent or metastatic head and neck squamous cell carcinoma. VERSATILE-002 is investigating two patient populations of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group, which is the focus of the ASCO poster presentation, has not been previously treated with an immune checkpoint inhibitor, also known as the ICI naive cohort, and is PD-L1 positive, and the second group of patients has failed treatments including ICI therapy. "We are pleased to present updated data from the VERSATILE-002 clinical trial," stated Lauren V. Wood, M.D., PDS Biotech’s Chief Medical Officer and a co-author of the study. "The incidence of HPV-positive head and neck cancers is growing rapidly, and there is currently a lack of effective targeted therapies to address this population. The ASCO meeting provides an opportunity to share promising early data with the clinical and scientific community that shows how PDS0101 combined with KEYTRUDA can potentially address this unmet medical need."