The recent U.S. Food and Drug Administration (FDA) approval of Keytruda® (pembrolizumab) for the treatment of resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) has significant implications for the development of combination therapies, including GeoVax Labs, Inc.’s Gedeptin®. This approval not only marks a pivotal advancement in the treatment of head and neck cancer but also validates the therapeutic approach behind GeoVax’s Gedeptin® development program, which seeks to combine the targeted cytotoxicity of Gedeptin® with the systemic immune activation provided by checkpoint inhibitors like pembrolizumab.

An editorial in the New England Journal of Medicine (NEJM) highlighted the study leading to the FDA’s approval as the first to demonstrate the benefits of PD-1 inhibition in the curative setting for HNSCC, suggesting a shift in neoadjuvant immunotherapy paradigms. GeoVax is leveraging this development by planning a Phase 2 clinical trial of Gedeptin® in combination with a checkpoint inhibitor for patients with locally advanced HNSCC scheduled for curative-intent surgery. The trial, expected to commence in 2026, will assess pathologic response, recurrence rates, and immunologic changes, aiming to optimize patient outcomes through a biomarker-driven approach.

David Dodd, Chairman and CEO of GeoVax, remarked on the significance of the FDA approval and NEJM publication, stating that it heralds a new era in curative-intent cancer therapy. The combination of Gedeptin® therapy with pembrolizumab is anticipated to not only enhance local tumor eradication but also to stimulate systemic anti-tumor immunity, potentially reducing both local and distant recurrence. Dr. Kelly McKee, GeoVax’s Chief Medical Officer, added that Gedeptin’s tumor-targeted cytotoxicity could improve the efficacy of immunotherapy, especially in the perioperative period, where priming anti-tumor immunity is crucial.

Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT), delivers a cytotoxic agent selectively within the tumor microenvironment, offering dual cytotoxicity and immune modulation with minimal systemic exposure. With Orphan Drug Designation from the FDA for the treatment of oral and pharyngeal cancers, Gedeptin® represents a promising avenue for enhancing the effectiveness of checkpoint inhibitors and overcoming tumor immune resistance in solid tumors.

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