GeoVax Labs (GOVX) – Gedeptin To Begin Phase 2 Clinical Trial


Tuesday, January 21, 2025

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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GeoVax Starts The Year By Announcing Phase 2 Trial For Gedeptin. GeoVax has announced that a Phase 2 trial for Gedeptin, its gene therapy for delivering cytotoxic cancer drugs, is planned to start in 1H25. As we expected, the trial will test Gedeptin with a checkpoint inhibitor in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN).

Gedeptin Delivers A Gene To Activate The Cancer Drug In The Tumor. Gedeptin is based on the Gene-Directed Enzyme Prodrug Therapy (GDEPT) technology platform. It uses an adenovirus vector to deliver the E. coli PNP gene to cancer cells. Once inside the cells, the gene produces an enzyme that converts an inactive prodrug (fludarabine) into an active cytotoxic drug. This increases the drug’s potency inside the cancer cells while avoiding healthy tissue. Gedeptin has completed Phase 1/2 trials in advanced head and neck cancer and has been granted Orphan Drug Designation for oral and pharyngeal cancers.


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