GeoVax is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancers using novel proprietary platforms. GeoVax’s most advanced product candidates include a next-generation COVID-19 vaccine, a gene-directed enzyme prodrug therapy for solid tumor cancers, and a vaccine against Mpox and smallpox. Additional preclinical research and development programs include vaccines targeting hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan and Marburg), and Zika virus.
Our corporate strategy is to advance, protect, and leverage our vaccine/immunotherapy technologies to enable the development of preventive and therapeutic solutions for infectious diseases and cancer. Our goal is to progress our product candidates through human clinical trials and pursue regulatory approval and commercialization via internal development or external licensing and partnerships. We also work collaboratively with academic, governmental, and industry partners to advance and validate our pipeline.
Our programs are in various stages of development. Key updates for our lead programs are outlined below:
| ● | GEO-CM04S1 – COVID-19 Vaccine Candidate: |
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| o | GEO-CM04S1 is undergoing multiple Phase 2 clinical studies: |
| ■ | One trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating its use in immunocompromised patients with hematologic malignancies (e.g., following stem cell transplant or CAR-T therapy). Published data from this study’s safety lead-in showed GEO-CM04S1 induced both neutralizing antibody and T cell responses in this high-risk population. |
| ■ | A second trial (NCT04639466) is assessing GEO-CM04S1 as a heterologous booster following primary mRNA vaccination. Interim results have shown statistically significant increases in neutralizing antibodies across multiple SARS-CoV-2 variants, including Omicron XBB 1.5. |
| ■ | A third, investigator-initiated trial (NCT05672355) is evaluating GEO-CM04S1 versus an mRNA-based vaccine in patients with chronic lymphocytic leukemia (CLL). The mRNA vaccine arm was discontinued following an interim safety and efficacy review; the GEO-CM04S1 arm continues. |
| o | In June 2024, GeoVax received a development award through the Rapid Response Partnership Vehicle (RRPV), funded by the Biomedical Advanced Research and Development Authority (BARDA), to support advancement of GEO-CM04S1 into a Phase 2b study. On April 11, 2025, we received formal notice from Advanced Technology International (ATI) that BARDA elected to terminate the contract for convenience, consistent with its terms. |
| ● | Gedeptin® -- Gene-Directed Enzyme Prodrug Therapy (GDEPT): |
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| o | Gedeptin has successfully completed a Phase 1/2 clinical trial (NCT03754933) in patients with advanced head and neck squamous cell carcinoma (HNSCC). This trial was funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. |
| o | Planning activities are underway for a Phase 2 trial to evaluate the addition of intra-tumoral Gedeptin® and intravenous fludarabine to recently approved neoadjuvant pembrolizumab as first-line treatment of patients with head and neck squamous cell carcinoma eligible for curative surgery. Trial initiation is targeted for 2026. |
| ● | GEO-MVA – Mpox/Smallpox Vaccine Candidate: |
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| o | GEO-MVA is a Modified Vaccinia Ankara (MVA)-based vaccine candidate intended for protection against Mpox and smallpox. MVA is the strain recommended by both the World Health Organization (WHO) and U.S. Centers for Disease Control and Prevention (CDC) for these indications and is currently used in the U.S. Strategic National Stockpile. |
| o | Following scientific advice from the European Medicines Agency (EMA) in May 2025, we intend to proceed directly to a Phase 3 trial, bypassing traditional Phase 1 and 2 studies, subject to final protocol and regulatory alignment. The Phase 3 study is expected to initiate in 2026. |
| o | A cGMP clinical drug substance batch of GEO-MVA has been successfully produced to support clinical development. |
| ● | Other Product Development Programs: |
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| o | Additional research and development activities continue for vaccine candidates targeting filoviruses (Ebola Zaire, Ebola Sudan, and Marburg) and Zika virus, as well as potential applications of the GEO-MVA and Gedeptin platforms in broader infectious disease and oncology indications |
| ● | Manufacturing Platform – Continuous Avian Cell Line: |
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| o | GeoVax is developing a continuous avian cell line manufacturing platform for production of its Modified Vaccinia Ankara (MVA)-based vaccines. This platform will enable scalable, high-yield production of vaccine candidates under current Good Manufacturing Practice (cGMP) conditions. Thus far, initial process development steps in support of cGMP production of GEO-MVA in the continuous avian cell line have been achieved Unlike traditional egg-based production methods, continuous cell line manufacturing offers greater efficiency, reproducibility and flexibility, supporting rapid response capabilities for emerging infectious diseases and biothreats. This approach is aligned with U.S. and international priorities for modernizing vaccine manufacturing and ensuring supply chain resilience |
