GeoVax Labs, a clinical-stage biotechnology company, has outlined its substantial scientific and financial progress in developing next-generation vaccines and therapies for COVID-19 and cancer. The company’s strategic focus includes advancing its GEO-CM04S1 COVID-19 vaccine, Gedeptin cancer therapy, and GEO-MVA vaccine platform for Mpox and Smallpox prevention.
In a pivotal development, GeoVax received a nearly $400 million award from BARDA for Project NextGen to advance its GEO-CM04S1 vaccine through a Phase 2b clinical trial. The company has confirmed target sites for a 10,000-participant randomized study comparing the vaccine’s efficacy, safety, and immunogenicity against an FDA-approved mRNA COVID-19 vaccine.
The company’s COVID-19 vaccine efforts have shown promising initial results, including statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants. A key focus remains addressing the critically underserved immunocompromised patient population, where current mRNA vaccines provide inadequate protection.
In oncology, GeoVax is preparing to launch a Phase 2 clinical trial of Gedeptin in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. The therapy, designated as an FDA Orphan Drug, represents a potential treatment for multiple solid tumor indications with an estimated market potential of $15 billion.
The company is also advancing its GEO-MVA vaccine platform for Mpox and Smallpox, with clinical evaluations expected to begin in late 2025. Successfully manufacturing a clinical batch under current Good Manufacturing Practice standards, GeoVax aims to provide a scalable and cost-effective vaccine production process that reduces reliance on foreign manufacturers.
Financially, GeoVax reported a net loss of $25.0 million for 2024, compared to $26.0 million in 2023. The company generated $4.0 million in government contract revenues and continues to strengthen its intellectual property portfolio with over 130 granted or pending patents across 23 different families.
Strategic initiatives include establishing a presence in the United Kingdom to advance manufacturing partnerships, European collaborations, and technology licensing opportunities. These efforts underscore GeoVax’s commitment to addressing emerging global health challenges and developing innovative medical solutions.
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