GeoVax Labs, Inc. 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 (sMVA) process, for developing COVID-19 vaccines, including GEO-CM04S1 (CM04S1), a multi-antigenic SARS- CoV-2 investigational vaccine expressing the spike and nucleocapsid antigens of the SARS-CoV- 2 virus. Orthopoxviruses include Mpox (monkeypox), smallpox, and other viruses that cause disease in humans. Modified Vaccinia Ankara (MVA) is the vaccine currently used and stockpiled in the U.S. Strategic National Stockpile for immunization against the Mpox and smallpox viruses.

GeoVax previously demonstrated that an experimental HIV vaccine, utilizing MVA as the vaccine vector, protected non-human primates challenged with a lethal dose of the Mpox virus. Vaccines of this format should not require repeated modification and updating. A recent presentation of unpublished data from the open-label portion of the Phase 2 trial of CM04S1 (ClinicalTrials.gov Identifier: NCT04977024) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment) indicates that 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.