GeoVax Labs, Inc. announced the issuance of U.S. Patent No. 12,453,760 by the United States Patent and Trademark Office, providing composition-of-matter and method-of-use protection for the company's Gedeptin platform in combination with targeted delivery approaches for solid tumors. The patent, which extends through 2045, covers enhanced therapeutic usage of the gene-directed enzyme prodrug therapy across multiple solid tumor types, including head and neck cancer. This patent issuance strengthens GeoVax's intellectual property estate for Gedeptin and supports ongoing clinical development plans.
David A. Dodd, Chairman and Chief Executive Officer of GeoVax, stated that the patent marks an important milestone in advancing and protecting the company's oncology pipeline, underscoring commitment to progressing Gedeptin both as monotherapy and in combination with other oncology treatments. The company is preparing for a Phase 2 clinical trial evaluating Gedeptin as a first-line therapy in combination with pembrolizumab (Keytruda) in resectable head and neck cancer, aligning with recent shifts toward neoadjuvant checkpoint strategies. Additional preclinical programs are assessing Gedeptin across other tumor types including breast and cutaneous cancers.
Gedeptin is a gene-directed enzyme prodrug therapy designed for targeted use in solid tumors, delivered via a non-replicating adenoviral vector encoding purine nucleoside phosphorylase followed by systemic fludarabine. The therapy generates localized cytotoxic activity within tumors while minimizing systemic toxicity and has demonstrated safety and disease control in a multi-center Phase 1/2 trial in patients with advanced head and neck cancer. The therapy has received FDA Orphan Drug Designation for oral and pharyngeal cancers.
The company plans to advance Gedeptin into a Phase 2 trial in combination with pembrolizumab as a neoadjuvant regimen for resectable head and neck squamous cell carcinoma, supported by recent clinical data validating immune checkpoint inhibitors in perioperative settings. Additional preclinical work is underway to assess Gedeptin combinations across other solid tumors. For more information about the company's clinical trials and updates, visit https://www.geovax.com.
Key advantages of the Gedeptin platform include localized tumor-selective cytotoxicity, tumor-agnostic expansion potential across multiple solid tumors, synergistic potential with checkpoint inhibitors, favorable safety profile, orphan drug designation, and strong patent protection through 2045. The patent protection comes as GeoVax continues development of its lead clinical program GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, along with vaccines targeting Mpox and smallpox.
