GeoVax Labs, Inc. (Nasdaq: GOVX) has announced the completion of critical milestones across manufacturing, regulatory, clinical, and preclinical domains, setting the stage for the initiation of its pivotal Phase 3 GEO-MVA immune-bridging study, scheduled for the fourth quarter of 2026. This development marks a significant step forward in the company's efforts to expand global manufacturing capacity for non-replicating Modified Vaccinia Ankara (MVA) vaccines, which are essential for mpox and smallpox preparedness.
David A. Dodd, Chairman and CEO of GeoVax, emphasized the importance of these achievements: "Completion of these milestones marks a significant inflection point for the GEO-MVA program as we prepare to initiate our pivotal immune-bridging study later this year. We have systematically executed the manufacturing, regulatory, clinical and scientific activities required to support successful study completion, preparing for regulatory registration and ultimate commercialization."
Notably, a comparative nonclinical immunogenicity study evaluated GEO-MVA alongside the licensed MVA vaccine, Imvanex®, using both binding and neutralizing antibody assays. The results demonstrated that GEO-MVA induced robust orthopoxvirus-specific immune responses, reinforcing the company's confidence in the vaccine's potential. These data, combined with manufacturing progress and favorable regulatory interactions, support the advancement of GEO-MVA into pivotal clinical evaluation.
Key milestones completed include the successful manufacture, fill, packaging, and release of GMP clinical product for the Phase 3 study. Regulatory alignment was achieved through European Medicines Agency (EMA) Scientific Advice, endorsing an expedited immune-bridging pathway that compares GEO-MVA with the licensed MVA-BN vaccine. Clinical operations have progressed with CRO engagement and site identification, targeting a 500-participant study. Preclinical immunogenicity data, including neutralizing antibody responses, further validate the immune-bridging strategy.
In parallel, GeoVax continues active discussions with government agencies and international preparedness organizations regarding future procurement opportunities and long-term MVA vaccine supply requirements. The company expects to initiate the Phase 3 study in Q4 2026 and report results by mid-2027.
GeoVax is developing GEO-MVA to provide an additional, reliable source of MVA vaccine for governments and public health organizations, addressing biosecurity and orthopoxvirus preparedness needs. The company's broader pipeline includes Gedeptin®, a gene-directed enzyme prodrug therapy for solid tumors, which has completed a Phase 1/2 trial in head and neck cancer and is advancing into combination strategies.
For more information about GeoVax and its programs, visit GeoVax's website.
