INFECTIOUS DISEASE PROGRAMS

GEO-MVA – Mpox and Smallpox Vaccine

The 2022 global mpox outbreak highlighted vulnerabilities in worldwide orthopoxvirus preparedness, including significant pressure on available vaccine inventories and dependence on a limited number of manufacturing sources.

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.

Regulatory Pathway and Accelerated Development Strategy

The GEO-MVA 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). The EMA agreed with the Company’s proposed immunobridging strategy utilizing an approved MVA comparator vaccine. Key elements of the pathway include:

  • Single pivotal Phase 3 immunobridging study
  • Established immunogenicity endpoints
  • Streamlined clinical development plan
  • Potential centralized European regulatory submission

This pathway provides a defined and efficient route toward potential regulatory authorization and commercialization.

Phase 3 Clinical Trial Planning

GeoVax has initiated activities supporting implementation of the pivotal Phase 3 immunobridging study. The planned study is expected to enroll approximately 500 participants and evaluate neutralizing antibody responses relative to an approved MVA vaccine. The objective is to demonstrate non-inferiority using established immunobridging endpoints accepted by regulatory authorities. Trial initiation is expected during the second half of 2026.

See MVA Technology Overview for more information about GeoVax’s MVA vaccine platform and plans to transition to an advanced high-capacity manufacturing process for MVA-based vaccines.

Hemorrhagic Fever Virus Vaccines (Ebola Zaire, Ebola Sudan and Marburg)

Although not currently under active development, using its MVA vaccine platform, GeoVax has developed vaccine candidates targeting several of the world’s most serious viral hemorrhagic fever pathogens, including Ebola Zaire, Ebola Sudan, and Marburg viruses. These pathogens continue to present significant global health security and biodefense concerns due to their potential for severe disease, high mortality rates, outbreak potential, and lack of broadly available vaccine solutions.

GeoVax has generated encouraging preclinical data across multiple filovirus vaccine programs. In animal studies, vaccine candidates targeting Ebola Zaire, Ebola Sudan, and Marburg viruses have demonstrated protective immune responses and survival benefits following viral challenge. These studies have shown the induction of both neutralizing antibodies and cellular immune responses, which are considered important components of protection against filovirus infection.

Recent outbreaks of Ebola and Marburg viruses have reinforced the continuing need for advanced vaccine technologies capable of supporting rapid outbreak response and long-term preparedness objectives. GeoVax believes vaccine platforms that combine established safety, manufacturing flexibility, and applicability across multiple infectious disease threats may play an important role in strengthening global health security infrastructure.

Beyond their potential public health applications, these programs support GeoVax’s broader strategy of leveraging its MVA platform to address high-consequence infectious diseases with relevance to preparedness, biodefense, and emerging biological threats.

While GEO-MVA remains GeoVax’s primary infectious disease development priority, the Company’s hemorrhagic fever vaccine portfolio represents an important strategic extension of its MVA platform. GeoVax continues to evaluate opportunities to advance these programs through government collaborations, strategic partnerships, and preparedness-focused initiatives aimed at addressing future outbreak and health security needs.