The United States Patent and Trademark Office has issued U.S. Patent No. 12,453,760 to GeoVax Labs, providing composition-of-matter and method-of-use protection for the company's Gedeptin® gene therapy platform in combination with targeted delivery approaches for solid tumors. This patent, which extends through 2045, covers enhanced therapeutic usage of the therapy across multiple solid tumor types, with head and neck cancer specifically mentioned.
The 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 for difficult-to-treat solid tumors.
GeoVax 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. This approach 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.
Key advantages of the therapy 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. 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.
For more information about the company's clinical trials and updates, visit www.geovax.com. The patent protection through 2045 provides extended exclusivity for GeoVax's platform as the company advances clinical development across multiple solid tumor indications.
