Wednesday, November 20, 2024
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.
Refer to the full report for the price target, fundamental analysis, and rating.
CM04S1 Continues In Phase 2 As DSMB Determines mRNA Vaccine Arm Failed Primary Endpoint. CM04S1 is in Phase 2 testing as a COVID-19 booster against an approved mRNA vaccine in patients with chronic lymphocytic leukemia (CLL). An interim analysis conducted by an independent Data Safety Monitoring and Review Board (DSMB) determined that the mRNA arm did not meet its specified primary endpoint, but the trial will continue with the CM04S1 arm.
Study Tests CM04S1 In Immunocompromised Patients. The Phase 2 study enrolled patients that are immunocompromised due to CLL and its therapies, which often leaves them unable to mount a sufficient immune response and vulnerable to COVID-19 infection. The trial was designed to determine the immune response with Pfizer’s mRNA vaccine as the control and comparator arm. Patients were randomized at 1:1 into two arms, receiving either two injections of CM04S1 three months apart or the mRNA vaccine.
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