PDS Biotechnology supports Oral, Head & Neck Cancer Awareness Month

PDS Biotechnology announced its support for Oral, Head & Neck Cancer Awareness Month in April and Oral, Head & Neck Cancer Awareness Week, April 16-22, both of which are organized by the Head & Neck Cancer Alliance. PDS Biotech recognizes the important role and dedication of patient organizations, such as the HCNA and the U.K.-based Swallows Head & Neck Cancer Support Group in not only raising awareness of oral, head and neck cancer, but also in providing advice, information and education to those impacted by the disease. PDS Biotech recently announced it is planning to initiate a randomized, controlled Phase 3 trial of the company’s lead clinical candidate, PDS0101, in combination with KEYTRUDA for the potential treatment of human papillomavirus 16-positive head and neck cancer. A growing number of head and neck cancers are caused by HPV and 90% of HPV-associated head and neck cancers in the US are reported to be caused by HPV16, as reported in a study published in the Journal of Clinical Medicine. PDS Biotech is currently running – VERSATILE-002 – a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 in combination with KEYTRUDA in adults with HPV16 recurrent or metastatic head and neck squamous cell carcinoma. Data reported at the American Society for Clinical Oncology Annual Meeting in 2022 indicated the combination therapy achieved an objective response rate of 41%, a clinical benefit rate of 77%, and an overall survival rate of 87% at nine months in 17 evaluable patients. Following the release of these data, the U.S. Food and Drug Administration granted the combination of PDS0101 and KEYTRUDA Fast Track designation.