GeoVax Labs, Inc. (GOVX) – Positive Data From CM04S1 Phase 2 and Preclinical Trials


Monday, September 25, 2023

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor 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®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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GEO-CM04S1Phase 2 Clinical and Preclinical Data Show Efficacy. GeoVax announced publication of initial Phase 2 data from the CM04S1 trial in immunocompromised patients that showed significant immune responses. A poster presentation at a medical meeting showed preclinical data on CM04S1 efficacy against multiple variant strains. We believe both publications support our expectations that CM04S1 can effectively stimulate both humoral and cellular immunity.

Initial Responses Seen In Immunocompromised Patients. GeoVax announced the publication of initial data from its Phase 2 trial for GEO-CM04S1 in immunocompromised patients with hematological malignancies in the journal Vaccines. The data showed both humoral and cellular immune responses in patients with reduced immune function that have difficulty responding to vaccination. The immune markers were superior or comparable to historical cohorts from healthy patients receiving the Pfizer mRNA vaccine.


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