GeoVax Secures U.S. Patent for Enhanced Gedeptin Therapy in Solid Tumors

GeoVax Labs, Inc., a clinical-stage biotechnology company, announced the issuance of U.S. Patent No. 12,453,760 by the United States Patent and Trademark Office. The patent, titled "Enhanced Therapeutic Usage of a Purine Nucleoside Phosphorylase or Nucleoside Hydrolase Prodrug," provides composition-of-matter and method-of-use protection for GeoVax's Gedeptin platform in combination with targeted delivery approaches for solid tumors, including head and neck cancer. This newly issued patent, which extends through 2045, enhances the company's intellectual property estate for Gedeptin and its use across a range of solid tumor cancers, consolidating GeoVax's position in targeted gene therapies and supporting ongoing clinical development plans.

David A. Dodd, Chairman and Chief Executive Officer of GeoVax, stated that the patent issuance marks an important milestone in advancing and protecting the company's oncology pipeline. He emphasized the commitment to progressing Gedeptin both as a monotherapy and in synergistic combination with other oncology treatment approaches to deliver meaningful options for patients with difficult-to-treat solid tumors. The company is actively 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 and followed by systemic fludarabine, Gedeptin generates localized cytotoxic activity within tumors while minimizing systemic toxicity. The therapy has demonstrated safety and disease control in a multi-center Phase 1/2 trial in patients with advanced head and neck cancer and has received FDA Orphan Drug Designation for oral and pharyngeal cancers. GeoVax 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.

The patent protection strengthens GeoVax's position as it develops novel vaccines against infectious diseases and therapies for solid tumor cancers. The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as a primary vaccine for immunocompromised patients, a booster vaccine in patients with chronic lymphocytic leukemia, and a more robust COVID-19 booster among healthy patients who previously received mRNA vaccines. In oncology, the lead clinical program evaluates Gedeptin, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation. For more information about clinical trials and updates, visit https://www.geovax.com.