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 when combined with targeted delivery approaches for solid tumors, including head and neck cancer. This intellectual property protection extends through 2045, enhancing the company's estate for Gedeptin and its application across a range of solid tumor cancers.

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. It underscores commitment to progressing Gedeptin both as a monotherapy and in synergistic combination with other oncology treatments, aiming 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. It is delivered via 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. 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.

Key advantages of Gedeptin include localized, tumor-selective cytotoxicity; tumor-agnostic expansion potential across multiple solid tumors; synergistic potential with checkpoint inhibitors; a favorable safety profile; orphan drug designation; and strong patent protection through 2045. The issuance of this patent consolidates GeoVax's leadership in targeted gene therapies and supports ongoing clinical development plans. For more information about the current status of clinical trials and other updates, visit www.geovax.com.

The implications of this patent issuance are significant for the oncology field, as it strengthens GeoVax's position in developing innovative treatments for solid tumors. By securing intellectual property through 2045, the company can potentially accelerate clinical development and partnerships, offering new hope for patients with cancers that have limited treatment options. The expansion of Gedeptin's application across multiple tumor types could lead to broader therapeutic impact, while the combination with checkpoint inhibitors like pembrolizumab may enhance treatment efficacy in resectable cancers. This development highlights ongoing advancements in gene therapy and targeted oncology approaches, potentially influencing future treatment paradigms and investment in biotechnology.