GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on developing vaccines and immunotherapies for high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA) vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the fourth quarter of 2026 to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness.
In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to destroy solid tumors through the localized generation of a potent cytotoxic agent within treated tumors while also enhancing immune checkpoint inhibitor activity against both treated and untreated tumors. Gedeptin has completed a multicenter Phase 1/2 clinical trial evaluating its use as a monotherapy in advanced head and neck cancer. GeoVax is advancing Gedeptin® into the next stage of clinical development through a planned Phase 2 study evaluating the therapy in combination with an immune checkpoint inhibitor for the treatment of resectable head and neck squamous cell carcinoma (HNSCC). The study is designed to assess Gedeptin’s ability to enhance anti-tumor immune responses prior to surgery, with expected endpoints including major pathological response (MPR), immune activation biomarkers, and event-free survival.
In addition, GeoVax is evaluating combination strategies for Gedeptin® in neoadjuvant and first-line settings, including combinations with other cancer treatment modalities.
At GeoVax, we are guided by the following strategic imperatives as we develop and grow our Company:
- Innovate – Pursue the development of unique, patented products addressing unmet medical needs
- Differentiate – Target populations underserved by existing products/standard of care
- Accelerate – Focus on expedited registration pathways
- Collaborate – Achieve worldwide distribution via business collaborations
