GeoVax Shifts Gedeptin® Strategy to Neoadjuvant Combination Trial After KEYNOTE-689 Success
GeoVax Labs, Inc. announces a strategic pivot in its Gedeptin® clinical development program towards a neoadjuvant therapy combination with pembrolizumab for head and neck squamous cell carcinoma, following promising KEYNOTE-689 Phase 3 trial results.
GeoVax Labs, Inc. has announced a strategic shift in its Gedeptin® clinical development program, focusing now 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 in the wake of the landmark KEYNOTE-689 Phase 3 trial results, which showed significant improvements in event-free survival (EFS) with 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. The trial aims to evaluate major pathological response (MPR) and associated immunologic and biomarker outcomes, alongside event-free survival over a one-year period. GeoVax believes that Gedeptin’s tumor-targeting, immune-sensitizing mechanism could enhance the efficacy of checkpoint monotherapy by boosting immune activation within the tumor microenvironment.
Dr. Kelly McKee, GeoVax's Chief Medical Officer, emphasized the transformative potential of neoadjuvant checkpoint inhibition in head and neck cancer treatment, highlighting the hope that integrating Gedeptin could improve local tumor clearance and event-free survival, particularly for high-risk or PD-L1-low patients. David Dodd, GeoVax's Chairman and CEO, underscored the strategic nature of this shift, expressing confidence in Gedeptin’s localized cytotoxic mechanism to enhance therapeutic outcomes when combined with systemic checkpoint inhibition.
The rationale behind this combination strategy is supported by the observation that while the neoadjuvant component of immunotherapy in KEYNOTE-689 drove significant benefits, many patients still face local or distant relapse, indicating a need for more intensive perioperative strategies. Gedeptin’s dual cytotoxic and immune-priming mechanism positions it as an ideal partner to checkpoint inhibitors, potentially converting 'cold' tumors into 'hot' immunogenic targets.