GeoVax Expands Gedeptin Cancer Therapy Development to Additional Solid Tumor Types

GeoVax Labs, Inc. has announced the expansion of its oncology development strategy to include assessments of additional solid tumor targets for Gedeptin®, its gene-directed enzyme prodrug therapy. The clinical-stage biotechnology company is working with its oncology advisory team including the Winship Cancer Institute of Emory University to evaluate Gedeptin combinations with immune checkpoint inhibitors in preclinical models of several solid tumor types beyond head and neck cancer.

The expansion initiative builds on recent checkpoint inhibitor momentum and landmark KEYNOTE-689 results that demonstrated the transformative potential of neoadjuvant checkpoint therapy in head and neck cancer. GeoVax is specifically evaluating Gedeptin's mechanism - localized intratumoral cytotoxicity that also primes systemic immune responses - in tumor settings such as triple negative breast cancer and cutaneous malignancies. This strategic move addresses a critically important area of solid tumor cancer therapy and represents a major value-creation opportunity for the company.

David A. Dodd, Chairman and CEO of GeoVax, emphasized the importance of this expansion, stating that Gedeptin's tumor-debulking and immune-priming effects could potentially improve outcomes in a broader range of solid tumor cancers. The KEYNOTE-689 results provide important context, showing how immune-sensitizing strategies like Gedeptin are increasingly vital to maximizing checkpoint efficacy. The company views this expansion as addressing a critically important area of solid tumor cancer therapy.

GeoVax had previously announced updated plans for a Phase 2 clinical trial, AdPNP-203, which will evaluate the addition of intra-tumoral Gedeptin and intravenous fludarabine to recently approved neoadjuvant pembrolizumab as first-line treatment for head and neck squamous cell carcinoma patients eligible for curative surgery. The trial is designed to assess major pathological response and associated immunologic outcomes following two pre-surgical cycles of therapy, with trial initiation planned for the second half of 2026. More information about the company's clinical programs can be found at https://www.geovax.com.

The strategic rationale for expanding Gedeptin development includes checkpoint synergy, therapeutic expansion potential, and timely alignment with recent clinical advancements. Gedeptin directly debulks tumors and enhances immune visibility, positioning it as a potential force multiplier for checkpoint inhibitors. Success in these preclinical programs could support Gedeptin's clinical evaluation into additional solid tumors beyond its current focus on head and neck cancers.

Dr. Kelly T. McKee, Chief Medical Officer, noted that the preclinical efforts will provide in-vivo proof of concept for expanding Gedeptin-checkpoint inhibitor combination therapy into additional solid tumor types. This represents a natural evolution of the program that ensures the company remains positioned at the forefront of immuno-oncology innovation. The company anticipates early readouts from its preclinical modeling work, with results supporting the design of potential clinical trials in selected solid tumor indications.

GeoVax is also pursuing potential collaborative discussions, with expectations of partnership or collaboration opportunities relative to both clinical development and potential commercialization of Gedeptin. The company's lead clinical program in oncology evaluates Gedeptin as a novel oncolytic solid tumor gene-directed therapy, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. Gedeptin has been granted Orphan Drug Designation for oral and pharyngeal cancers, highlighting its potential significance in treating these challenging conditions.