GeoVax Advances Gedeptin® in Neoadjuvant HNSCC Treatment Strategy

GeoVax Labs, Inc., a clinical-stage biotechnology company, has announced a strategic pivot in its Gedeptin® clinical development program, focusing on its use as a neoadjuvant therapy in combination with pembrolizumab for primary, resectable head and neck squamous cell carcinoma (HNSCC). This shift is inspired by the promising results of the KEYNOTE-689 Phase 3 trial, which showcased significant improvements in event-free survival (EFS) with perioperative pembrolizumab in similar patients. The new Phase 2 trial, AdPNP-203, aims to evaluate the efficacy of combining intra-tumoral Gedeptin®, intravenous fludarabine, and pembrolizumab, targeting major pathological response (MPR) and enhancing immune activation within the tumor microenvironment. GeoVax's approach seeks to address the limitations of checkpoint monotherapy, offering hope for high-risk or PD-L1-low patients. The trial is slated to begin in 2026, marking a significant step forward in the treatment of HNSCC.

GeoVax's Gedeptin® is a gene-directed enzyme prodrug therapy (GDEPT) that targets tumor cells selectively, aiming to reduce toxicity and enhance immune visibility. With Orphan Drug Designation for oral and pharyngeal cancers, Gedeptin represents a promising advancement in cancer therapy. GeoVax's broader strategy includes developing vaccines against infectious diseases and therapies for solid tumor cancers, with ongoing clinical trials for a next-generation COVID-19 vaccine and a vaccine targeting Mpox and smallpox. The company's innovative approach to combining localized cytotoxic mechanisms with systemic checkpoint inhibition could revolutionize cancer treatment paradigms.