GeoVax to Advance Gedeptin® Into First-Line Therapy Neoadjuvant Combination Trial Following Landmark KEYNOTE-689 Results

GeoVax Labs, Inc. has announced a strategic shift in its Gedeptin® clinical development program, focusing on evaluating Gedeptin as a neoadjuvant therapy in combination with pembrolizumab for patients with primary, resectable head and neck squamous cell carcinoma (HNSCC). This decision comes after the landmark results of the KEYNOTE-689 Phase 3 trial, which showed significant improvement in event-free survival with the addition of perioperative pembrolizumab in resectable, locally advanced HNSCC patients.

The new Phase 2 trial, AdPNP-203, will assess the combination of intra-tumoral Gedeptin®, intravenous fludarabine, and pembrolizumab in patients eligible for curative surgery, aiming to evaluate major pathological response and event-free survival over a one-year period. GeoVax believes that Gedeptin’s tumor-targeting, immune-sensitizing mechanism can enhance the effectiveness of checkpoint monotherapy by boosting immune activation within the tumor microenvironment.

Dr. Kelly McKee, Chief Medical Officer at GeoVax, stated that the KEYNOTE-689 results validate the potential of neoadjuvant checkpoint inhibition to transform head and neck cancer treatment. The company aims to improve local tumor clearance and event-free survival, particularly for high-risk or PD-L1-low patients, by integrating Gedeptin into this emerging standard.

David Dodd, Chairman and CEO of GeoVax, emphasized the strategic nature of this shift, highlighting Gedeptin’s localized cytotoxic mechanism as a means to enhance therapeutic outcomes in resectable HNSCC when combined with systemic checkpoint inhibition. The trial initiation is planned for 2026, marking a significant step forward in the treatment of head and neck cancer.