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GeoVax Labs announced the expansion of its rights under its exclusive license agreement with City of Hope, COH, a world-renowned cancer research and treatment organization, to include development and commercialization rights against orthopoxviruses in addition to SARS-CoV-2. The original license agreement with COH provides GeoVax exclusive worldwide rights to key patents, including the use of COH's proprietary synthetic MVA process, for developing COVID-19 vaccines, including GEO-CM04S1, a multi-antigenic SARS-CoV-2 investigational vaccine expressing the spike and nucleocapsid antigens of the SARS-CoV-2 virus. CM04S1 is currently being studied in two ongoing Phase 2 clinical trials. The amendment to the license announced today grants GeoVax an expanded field of use to develop vaccine products, such as CM04S1, which target the prevention, reduction, amelioration or treatment of COVID-19 to also include targeting the prevention, reduction, amelioration or treatment of diseases caused by a virus within the orthopoxvirus genus. Orthopoxviruses include Mpox, smallpox, and other viruses that cause disease in humans.

GeoVax Labs presented an update on the development of its SARS-CoV-2 vaccine, GEO-CM04S1, including preliminary data from an ongoing Phase 2 clinical trial, during the 23rd Annual World Vaccine Congress taking place in Washington, DC. The presentation, titled "COVID-19 Vaccine CM04S1; A Superior Viral Platform Alternative for Eliciting Durable T Cell Responses in Immunocompromised Hematologic Malignancy Patients," was delivered by Dr. Don Diamond, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating. Diamond's presentation included unpublished data from the open-label portion of the Phase 2 trial of CM04S1 in patients undergoing hematological cancer treatment. The preliminary analysis indicates CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines. CM04S1 continues to advance in a second Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population, the company said.

GeoVax Labs announced the presentation of data from recent nonhuman primate studies of GeoVax's vaccine candidate 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, 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 Preclinical Services. Of particular interest, immunization with GeoVax's vaccine candidate 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. 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.

GeoVax Labs announced the presentation of results from a clinical study of a combinational HIV therapy that included GeoVax's HIV vaccine candidate, MVA62B. The data were presented at the Conference on Retroviruses and Opportunistic Infections held February 19-22, 2023, in Seattle, Washington. The data were generated, in a clinical trial led by researchers at the University of California, San Francisco, to develop a combinational therapy aimed at reducing or eliminating viral replication in the absence of antiviral medications in HIV-positive individuals. The primary objectives of the proof-of-concept trial were to assess the safety and tolerability of the combinational therapy and to determine the viral load "set-point" during antiviral treatment interruption. Secondary objectives were to assess immune responses and changes in viral reservoir status. The clinical trial was led by Steven Deeks, M.D. of UCSF, a world leader in therapeutic approaches to HIV infections, and was one of the most comprehensive tests to date for the ability of synergistic approaches to control HIV infection. The studies were conducted with funding from amfAR, The Foundation for AIDS Research.