• 80% Survival in Nonhuman Primates Observed in a Lethal Challenge Model

Atlanta, GA, April 05, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of encouraging data from recent nonhuman primate studies of GeoVax’s vaccine candidate (GEO-MM01) against Marburg virus, during the 23rd Annual World Vaccine Congress taking place in Washington, DC.

The data were presented by Dr. Jason Comer, Associate Professor, Sealy Institute for Vaccine Sciences, University of Texas Medical Branch (UTMB), in a presentation titled “Preclinical Capabilities at the University of Texas Medical Branch: Evaluating Candidate Vaccines and Immunotherapeutics against Sudan Ebola Virus,” during the session on Emerging and Re-Emerging Diseases. Dr. Comer’s presentation focused on UTMB’s services for regulated, nonclinical studies, and included data from recent studies conducted on behalf of GeoVax. Following encouraging results showing complete protection from Marburg virus challenge in guinea pigs, GeoVax’s vaccine efficacy studies targeting Marburg virus and Sudan Ebola virus disease were contracted to UTMB through the National Institute of Allergy and Infectious Disease (NIAID) Preclinical Services.

Of particular interest, immunization with GeoVax’s vaccine candidate (GEO-MM01) conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus. Vaccination protected nonhuman primates from viremia, weight loss and death following challenge with a lethal Marburg virus dose. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a breadth of responses that combine for optimal protection.

Mark Newman, Ph.D., GeoVax Chief Scientific Officer, commented, “We are highly encouraged by the results of these studies of GEO-MM01. This vaccine candidate deserves further evaluation, and we are currently developing our plans to advance GEO-MM01 into good manufacturing practices and Phase 1 clinical trials.”

David Dodd, GeoVax Chairman and CEO added, “GeoVax is committed to providing vaccines that address many of the most threatening infectious threats, such as Marburg, worldwide.  Utilization of our MVA-based vaccine candidates also provide the added potential to provide protection against such additional infectious threats such as MPox (“Monkeypox”), which is critically important in many regions throughout the world.”

The work conducted by UTMB built upon earlier studies demonstrating that guinea pigs vaccinated with GEO-MM01 were 100% protected against death and disease caused by the Angola strain of Marburg virus. The vaccine induced immune responses were characterized by Marburg virus-specific binding and neutralizing antibodies as well as other effector functions like antibody-dependent phagocytosis. The Angola strain is the most virulent strain of Marburg Virus characterized by up to a 90% fatality rate in humans and a successful vaccination approach is of paramount public health importance.

About Marburg Virus

Marburg virus (MARV) is a hemorrhagic fever virus of the Filoviridae family, which also includes Ebola virus, and causes severe human disease with up to a 90% fatality rate. The Marburg virus is transmitted to people from fruit bats, and human-to-human transmission occurs through direct contact with bodily fluids, or contaminated surfaces and materials. MARV is rated by the World Health Organization as a Risk Group 4 Pathogen. In the United States, the NIH/National Institute of Allergy and Infectious Diseases ranks it as a Category A Priority Pathogen and the Centers for Disease Control and Prevention lists it as a Category A Bioterrorism Agent. MARV typically appears in sporadic outbreaks throughout Africa. Equatorial Guinea and Tanzania recently reported their first-ever Marburg virus disease outbreaks in February 2023 and March 2023 respectively. In total, 37 cases have been recorded of which 32 were fatal. The outbreak risk remains high, with potential spread to Cameroon and Gabon as cross-border movements are frequent. The virus continues to pose potential public health and biodefense threats. There are currently no licensed vaccines or therapeutics against the diseases caused by MARV.

About GeoVax

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 two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 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. 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. For more information, visit our website: www.geovax.com.

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