GeoVax is advancing vaccine technologies designed to address critical preparedness, health security, and biodefense priorities. The Company's lead infectious disease program, GEO-MVA®, is a next-generation MVA-based vaccine candidate for mpox and smallpox that is being advanced under an expedited regulatory pathway toward potential commercialization. GEO-MVA is intended to support expanded orthopoxvirus vaccine supply, strengthen supply-chain resilience, and provide an additional source of MVA-based vaccine availability for public health and preparedness stakeholders worldwide.
Building upon the flexibility of its MVA platform, GeoVax is also developing vaccine candidates targeting hemorrhagic fever viruses, including Ebola Zaire, Ebola Sudan, and Marburg. These programs reflect the broader potential of the Company's technology to address emerging infectious disease threats and support future preparedness and outbreak response initiatives. Through GEO-MVA and its expanding infectious disease portfolio, GeoVax is working to strengthen vaccine infrastructure and advance solutions for some of the world's most significant biological threats.
GEO-MVA
GeoVax is advancing GEO-MVA, a Modified Vaccinia Ankara (MVA)-vaccine candidate for the prevention of mpox and smallpox infection. GEO-MVA is being developed to support expanded global vaccine supply, strengthen preparedness infrastructure, and provide an additional source of MVA-based vaccine availability for public health and biodefense needs.
The program is currently GeoVax's highest development priority and is advancing under an expedited regulatory pathway supported by scientific advice from the European Medicines Agency (EMA).
Mpox and Smallpox (GEO-MVA)
MVA was originally developed for use as a smallpox vaccine more than 30 years ago. MVA is the preferred vaccine for individuals with compromised immune systems as these individuals would be put at significant risk if administered the initial-developed smallpox vaccine. It is also approved as the vaccine for other orthopox vaccines, including Mpox. As such, an added potential benefit of our vaccines is that in those regions where Mpox or smallpox are of concern, vaccines built on an MVA vaccine platform will likely provide protection against both.
MVA is the vaccine currently used and stockpiled in the U.S. Strategic National Stockpile for immunization against the Mpox and smallpox viruses.
In response to the global need to address the continued emerging threat from Mpox and the unique opportunity offered by MVA-based vaccines, GeoVax recently acquired rights from the NIH covering preclinical, clinical and commercial uses of the NIH-MVA against Mpox or smallpox viruses. The Company is now clarifying the development and regulatory pathways towards expanding the public health options available to reduce and manage the risk of Mpox worldwide.
Hemorrhagic Fever Virus Vaccines (Ebola Zaire, Ebola Sudan and Marburg)
Ebola (EBOV), formerly designated as Zaire ebolavirus), Sudan (SUDV), and Marburg viruses (MARV) are the most virulent species of the Filoviridae family, causing hemorrhagic fever illnesses with up to a 90% fatality rate in humans. The first EBOV outbreaks occurred in remote villages in Central Africa, near tropical rainforests. The 2014–2016 outbreak in West Africa was the largest and most complex Ebola outbreak since the virus was first discovered in 1976. There were more cases and deaths in this outbreak than all others combined. It also spread between countries, starting in Guinea then moving across land borders to Sierra Leone and Liberia. MARV outbreaks have been reported in Angola, Democratic Republic of the Congo, Kenya, South Africa (in a person with recent travel history to Zimbabwe) and Uganda. In December 2019, FDA approved the first live recombinant Ebola vaccine for prevention of Ebola disease by Zaire virus. This rVSV-ZEBOV showed safety concerns in Phase 1 trials and by virtue of being replication competent could pose threats to immunocompromised individuals, such as those infected with HIV living in West Africa where recent Ebola epidemics started.
To address the unmet need for a product that can respond to future hemorrhagic fever outbreaks, we are developing vaccines utilizing our GV-MVA-VLP™ platform. As previously noted, the MVA vector itself is considered safe, having originally been developed for use in immunocompromised individuals as a smallpox vaccine. We expect our vaccines may protect at-risk individuals against EBOV, SUDV and MARV, and the GeoVax GV-MVA-VLP™ approach could offer a unique combination of advantages to achieve breadth and safety of a pan-filo vaccine. In addition to protecting historically higher-risk populations in Africa, it is also intended to prevent the spread of disease to the U.S. and globally, and for preparedness against terrorist release of any of biothreat pathogens in the U.S. and globally.
Our initial preclinical studies in rodents and nonhuman primates for our MVA-VLP-EBOV vaccine candidate have shown significant levels of protection against lethal doses of EBOV. Recent studies in lethal challenge guinea pig models demonstrated that GeoVax vaccines MVA-VLP-SUDV and MVA-VLP-MARV conferred 100% protection from death. These vaccines were subsequently evaluated in a rigorous cynomolgus macaque infectious challenge model. Vaccination protected nonhuman primates from viremia, weight loss and death following challenge with a dose of Sudan or Marburg virus that is lethal in nonvaccinated animals. Evaluation of immune responses following vaccination demonstrated presence of both neutralizing antibodies and functional T cells, indicating a breadth of responses that combine for optimal protection. The nonhuman primate studies conducted in collaboration with NIAID and the U.S. Department of Defense (DoD) have been completed and clinical development programs are being defined with these same partners with a focus on potentially developing products for the U.S. Strategic National Stockpile.
Zika Virus
Zika disease is an emerging infectious disease caused by the Zika virus (ZIKV) and has been linked to an increase in microcephaly in infants and Guillain-Barre syndrome (a neurodegenerative disease) in adults. ZIKV is a member of the Flaviviridae family, which includes medically important pathogens such as dengue fever, yellow fever, Japanese encephalitis, tick-borne encephalitis, and West Nile viruses. Public health officials recommend avoiding exposure to ZIKV, delaying pregnancy, and following basic supportive care (fluids, rest, and acetaminophen) after infection.
To address the unmet need for a ZIKV vaccine, we are developing novel vaccine candidates constructed using our MVA platform. MVA has an outstanding safety record, which is particularly important given the need to include women of child-bearing age and newborns among those being vaccinated.
Initial preclinical studies in rodents using GEO-ZM02 vaccine candidate demonstrated 100% single-dose protection against a lethal dose of ZIKV delivered directly into the brain. In rhesus macaques, vaccination with GEO-ZM02 induced immune responses that effectively controlled the virus replication despite the fact the vaccine is not designed to induce ZIKV neutralizing antibodies.
In January 2023, GeoVax announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for Patent Application No. 17/000,768 titled, “Method for Generating a ZIKV Immune Response Utilizing a Recombinant Modified Vaccinia Ankara Vector Encoding the NS1 Protein.” Preclinical studies demonstrated a single dose of GEO-ZM02 provided 100% protection against a lethal dose of Zika virus.