GEDEPTIN TECHNOLOGY OVERVIEW
Gedeptin is a novel patented technology for the treatment of solid tumors using a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In September 2021, GeoVax entered into an assignment and license agreement with PNP Therapeutics, Inc. (PNP), granting GeoVax exclusive worldwide rights to develop and commercialize Gedeptin. The Gedeptin technology was developed with funding support from the National Cancer Institute (NCI), part of the NIH. GeoVax’s license to Gedeptin includes the rights to expand its use to all human diseases and/or conditions including, but not limited to, other solid tumors.
NEXT PHASE OF DEVELOPMENT
GeoVax is advancing Gedeptin® into the next stage of clinical development through a planned Phase 2 study evaluating the therapy in combination with an immune checkpoint inhibitor for the treatment of resectable head and neck squamous cell carcinoma (HNSCC). The study is designed to assess Gedeptin’s ability to enhance anti-tumor immune responses prior to surgery, with endpoints expected to include major pathological response (MPR), immune activation biomarkers, and event-free survival.
The planned clinical strategy reflects the growing role of neoadjuvant immunotherapy in solid tumors and is intended to build upon the safety profile and anti-tumor activity observed in prior clinical studies. GeoVax believes this approach may provide a differentiated pathway for improving patient outcomes by combining localized tumor destruction with systemic immune activation.
The Company has initiated key planning activities supporting the Phase 2 program, including protocol development, manufacturing readiness, regulatory engagement, and clinical site selection.
