GeoVax Expands Gedeptin® 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 the combination of Gedeptin with immune checkpoint inhibitors in preclinical models of several solid tumor types.

The company is validating Gedeptin's mechanism of localized intratumoral cytotoxicity that also primes systemic immune responses in tumor settings beyond head and neck cancer, specifically targeting triple negative breast cancer and cutaneous malignancies. This expansion builds on the company's previously announced 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 strategic rationale for this expansion includes three key factors: checkpoint synergy, therapeutic expansion potential, and timely alignment with recent clinical advancements. Gedeptin's ability to directly debulk tumors and enhance immune visibility positions it as a potential force multiplier for checkpoint inhibitors. Success in these preclinical programs could support Gedeptin's clinical evaluation into additional solid tumors, while the KEYNOTE-689 trial demonstrated the transformative potential of neoadjuvant checkpoint therapy in head and neck cancer.

David A. Dodd, Chairman and CEO of GeoVax, emphasized the importance of this expansion, stating that it addresses a critically important area of solid tumor cancer therapy and represents a major value-creation opportunity. The company aims to demonstrate that Gedeptin's tumor-debulking and immune-priming effects can potentially improve outcomes in a broader range of solid tumor cancers. More information about the company's development programs can be found at https://www.geovax.com.

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, ensuring the company remains positioned at the forefront of immuno-oncology innovation. The KEYNOTE-689 results provide important context for how immune-sensitizing strategies like Gedeptin are increasingly vital to maximizing checkpoint efficacy.

GeoVax anticipates early readouts from its preclinical modeling work, with results supporting the design of potential clinical trials in selected solid tumor indications. 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. Gedeptin has been granted Orphan Drug Designation for oral and pharyngeal cancers and represents a significant advancement in gene-directed enzyme prodrug therapy approaches.

The expansion of Gedeptin development into additional solid tumor types could have substantial implications for cancer treatment, particularly for patients with difficult-to-treat cancers who may benefit from combination approaches that enhance the effectiveness of existing checkpoint inhibitors. This strategic move positions GeoVax to potentially address multiple cancer indications with a single therapeutic platform, leveraging the growing body of evidence supporting combination immunotherapy approaches.