GeoVax Labs, Inc. has 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 gene therapy platform in combination with targeted delivery approaches for solid tumors. The patent, which extends through 2045, covers enhanced therapeutic usage of the therapy across multiple solid tumor types including head and neck cancer.
The patent issuance represents a significant development in cancer treatment innovation, as it consolidates GeoVax's intellectual property position in the field of targeted gene therapies. This protection comes at a critical time as the company prepares for a Phase 2 clinical trial evaluating Gedeptin as a first-line therapy in combination with pembrolizumab (Keytruda) in resectable head and neck cancer. The timing aligns with recent shifts toward neoadjuvant checkpoint strategies in oncology treatment.
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. "It underscores our commitment to progressing Gedeptin, both as a monotherapy and in synergistic combination with other oncology treatment approaches as we work to deliver meaningful treatment options for patients with difficult-to-treat solid tumors," Dodd said.
Gedeptin is a gene-directed enzyme prodrug therapy designed for targeted use in solid tumors. The therapy utilizes a non-replicating adenoviral vector encoding purine nucleoside phosphorylase followed by systemic fludarabine, generating 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.
The patent protection supports GeoVax's expansion of the Gedeptin product platform across multiple tumor types. Additional preclinical programs are assessing Gedeptin across other tumor types, including breast and cutaneous cancers. The company's approach leverages several key advantages including localized tumor-selective cytotoxicity, tumor-agnostic expansion potential across multiple solid tumors, synergistic potential with checkpoint inhibitors, and a favorable safety profile.
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 the role of 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 www.geovax.com.
The patent issuance comes as GeoVax continues development across multiple therapeutic areas. The company's lead clinical program in infectious diseases is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials. In oncology, the Gedeptin program represents the company's lead clinical effort following completion of 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.
