GeoVax Expands Gedeptin® Development to Additional Solid Tumor Indications

GeoVax Labs, Inc. 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 closely with its oncology advisory team including the Winship Cancer Institute of Emory University to evaluate the combination of Gedeptin with immune checkpoint inhibitors in preclinical models of several solid tumor types.

These models are designed to validate Gedeptin's mechanism of localized intratumoral cytotoxicity that also primes systemic immune responses in tumor settings beyond head and neck cancer, including triple negative breast cancer and cutaneous malignancies. The company 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 of patients with head and neck squamous cell carcinoma eligible for curative surgery.

The strategic rationale for this expansion includes checkpoint synergy, therapeutic expansion potential, and timely alignment with recent clinical developments. 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. The KEYNOTE-689 trial demonstrated the transformative potential of neoadjuvant checkpoint therapy in head and neck cancer, underscoring the urgency of expanding combination approaches such as Gedeptin plus Keytruda into additional tumor types.

David A. Dodd, Chairman and CEO of GeoVax, commented that the expansion of Gedeptin development beyond head and neck cancer addresses a critically important area of solid tumor cancer therapy and represents a major value-creation opportunity. By leveraging the strengths of oncology advisors and validated checkpoint inhibitor backbones, the company aims to evaluate whether Gedeptin's tumor-debulking and immune-priming effects can potentially improve outcomes in a broader range of solid tumor cancers.

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

In parallel, the company is targeting initiation of its Phase 2 clinical trial of Gedeptin in combination with Keytruda for head and neck cancer in the second half of 2026. Potential collaborative discussions continue, with expectation of some form of partnership or collaboration relative to both clinical development and potential commercialization of Gedeptin. Gedeptin has been granted Orphan Drug Designation for oral and pharyngeal cancers and represents a significant advancement in gene-directed enzyme prodrug therapy approaches to cancer treatment.