Thursday, August 10, 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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GeoVax Continues To Make Clinical and Preclinical Progress. GeoVax Labs reported a 2Q23 loss of $5.9 million or $(0.22) per share and reviewed progress made during the quarter. The company continues to enroll patients in the Gedeptin Phase 1/2 trial in head and neck cancer, as well as its CM04S1 Phase 2 clinical trials in immunocompromised patients and as a second-generation booster against COVID-19.
Interim Gedeptin Data Was Presented. As discussed in our July 11 Research Note, GeoVax presented interim data from the Phase 1/2 trial testing Gedeptin in head and neck cancer. The presentation included the first 8 patients out of the planned enrollment of 10 patients. Gedeptin achieved Stable Disease in 5 out of 7 evaluable patients, according to RECIST 1.1 criteria. Laboratory measurements showed evidence of successful delivery of the gene, its activation, and immunological markers that were consistent with the expected tissue response.
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