Crystal Research Associates has issued a 13-page Company Update on clinical-stage biotechnology company, GeoVax Labs, Inc. (GOVX-NASDAQ).
Snapshot of GeoVax
GeoVax Labs, Inc. (“GeoVax” or “the Company”) is a clinical-stage biotechnology company developing novel therapies and vaccines, respectively, for cancers and many of the world’s most threatening infectious diseases. The Company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, which recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate, GEO-CM04S1, is a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. GEO-CM04S1 is being evaluated in three Phase 2 clinical trials: (1) as a primary COVID-19 vaccine for immunocompromised patients versus mRNA vaccines; (2) as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines; and (3) as a more robust, durable booster versus mRNA vaccines in immunocompromised patients with chronic lymphocytic leukemia (CLL). GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
Key Points
- On June 18, 2024, GeoVax and the U.S. Department of Health and Human Services (HHS) announced an award through the Rapid Response Partnership Vehicle (RRPV) to advance the development of its dual-antigen next-generation COVID-19 vaccine, GEO-CM04S1, in a Phase 2b clinical trial. The RRPV is funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the HHS.
- GeoVax will sponsor a 10,000-participant, randomized, double-blind Phase 2b study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with an FDA-approved mRNA COVID-19 vaccine. Preparations for the study are underway, and BARDA will fully fund the study's execution through its Clinical Studies Network.
- The direct award to GeoVax of approximately $24.3 million (with potential to increase to $45 million), will fund the manufacturing of clinical materials and support the Phase 2b trial, including regulatory activities. BARDA has also allocated approximately $343 million from the Project NextGen program through its Clinical Studies Network for a contract research organization (CRO) to conduct the clinical trial with GeoVax’s vaccine. In total, the value of the award exceeds $360 million with the potential to increase to over $380 million.
- Funding for this award comes from Project NextGen, a $5 billion initiative by HHS to develop innovative vaccines and therapeutics offering broader and more durable protection against COVID-19 than first-generation vaccines. BARDA is supporting the development of new vaccines and therapeutics to better address waning immunity and resistance to current and future SARS-CoV-2 strains. GeoVax’s vaccine candidate aligns with many of BARDA's priorities, including broader protection among variants of concern (VOC) and a longer duration of protection.
- This project is funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number: 75A50123D00005.
- In its most recent quarterly report issued last month (May 2024), GeoVax announced that it had released the first lot of GEO-CM04S1, marking a successful manufacturing scale-up with Oxford Biomedica, formerly known as ABL Europe. The Company also completed patient enrollment for a Phase 1/2 trial of Gedeptin® for advanced head and neck cancer, with trial completion expected by the third quarter and plans for a Phase 2/3 trial underway. Regulatory and advancement plans were further outlined for its MVA vaccine for Mpox and Smallpox. The Company maintains over 115 granted or pending patents across twenty-four families.
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