GeoVax Labs, Inc. (GOVX) – Clinical Trial Expansion Continues With A Stream Of Milestones

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Tuesday, October 31, 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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Site Expansion Should Increase Rate Of Enrollment. GeoVax announced the additional of new clinical sites in the Phase 2 trial for CM04S1, its COVID-19 vaccine to protect patients who are immunocompromised due to treatment for hematological malignancies. Patients who receive treatments including allogenic/autologous stem cell transplant or CAR-T therapy have difficulty responding to the available COVID-19 vaccines, leaving them vulnerable.

Site Expansion Should Increase Speed of Enrollment.  The trial is designed to compare the safety and immunogenicity of CM04S1 directly against the mRNA vaccines from Pfizer and Moderna. The trial began at the City of Hope Medical center in California and will begin treating patients at Wake Forest Baptist Medical Center (North Carolina), University of Massachusetts Medical Center, and Fred Hutchinson Cancer Research (Washington). Patient enrollment at these sites should increase the enrollment rate and number of patients in the study, providing greater statistical significance with shortened time to results.

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