GeoVax Announces Expansion of Next-Generation COVID-19 Vaccine Rights to Include Omicron Variants and Use Against Orthopoxviruses

GeoVax Labs, a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, 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.

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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. 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 (monkeypox), smallpox, and other viruses that cause disease in humans.

Potential Benefit of the Additional Indications

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 (publication accessible here). Further, in August 2022, COH published results demonstrating that both their proprietary sMVA (synthetic MVA) and CM04S1 (referred to as “COH04S1” in the publication, accessible here) elicited robust orthopoxvirus-specific binding and neutralizing antibody responses. The authors conclude that CM04S1 and sMVA represent unique vaccine candidates to control the unforeseen global Mpox outbreak.

CM04S1, which can induce strong antibody and T cell responses against the variants of the SARS-CoV-2 virus, also offers the possibility of protection against Mpox and smallpox diseases, further differentiating CM04S1 as compared to current mRNA-based COVID-19 vaccines. Such attributes may be especially important in vulnerable patient populations, such as the immune-compromised, as well as in geographic areas where both diseases are endemic. Such a vaccine may offer a simplified vaccine regimen for protection against diseases associated with SARS-CoV-2 and orthopoxviruses.

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David Dodd, GeoVax’s Chairman and CEO, commented, “We are delighted to have secured these expanded rights to the COH sMVA technology for further development and commercial use together with our ongoing COVID-19 vaccine program. This provides a compelling opportunity to leverage our MVA-based vaccine expertise and help expand the global public health supply options available for the worldwide public health threats posed by SARS-CoV-2, Mpox and smallpox.”

Mr. Dodd continued, “We are pleased with the continued encouraging results of our COVID-19 vaccine, especially related to addressing the critical needs of the high-risk immunocompromised patient populations. GeoVax is focusing on the clinical development of this vaccine for use in patients with special medical limitations or needs, specifically the immunocompromised populations. These individuals may be unable to raise or maintain protective antibody responses after receipt of first-generation mRNA vaccines, contributing to reduced vaccine efficacy. This includes patients suffering from and/or being treated for numerous malignancies and autoimmune disorders, transplant patients, dialysis patients, and potentially the aging population.”

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