ATLANTA, GA – GeoVax Labs, Inc. (Nasdaq: GOVX) has announced the completion of key milestones across manufacturing, regulatory, clinical, and preclinical areas, 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 MVA vaccines, which are critical for government preparedness and future procurement opportunities.
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."
Among the notable progress, a comparative nonclinical immunogenicity study evaluated GEO-MVA against the licensed MVA vaccine, Imvanex®, using both binding and neutralizing antibody assays. The results showed that GEO-MVA generated robust orthopoxvirus-specific immune responses. "These findings further strengthen our confidence in GEO-MVA as we prepare to initiate our pivotal immune-bridging study later this year," Dodd added.
The completion of these integrated milestones has substantially de-risked the GEO-MVA program. Key accomplishments include the successful manufacture, fill, packaging, and release of GMP clinical product for the pivotal study, meeting a crucial requirement for clinical development. Regulatory alignment has been achieved through the European Medicines Agency (EMA) Scientific Advice, supporting an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine. Clinical operations are advanced, with CRO engagement and site identification underway for the targeted 500-participant study. Preclinical immunogenicity data, including neutralizing antibody responses, support the immune-bridging strategy. Additionally, GeoVax continues active discussions with government agencies and international preparedness organizations regarding future procurement and long-term supply requirements.
The planned Phase 3 study will compare immune responses generated by GEO-MVA with those of MVA-BN using established neutralizing antibody endpoints. Results are expected in mid-2027. This immune-bridging approach, aligned with EMA guidance, is designed to facilitate a more capital-efficient and expedited regulatory pathway, potentially making GEO-MVA a strategic asset for biosecurity and orthopoxvirus preparedness.
GeoVax's development of GEO-MVA addresses a critical global need for expanded MVA vaccine supply, particularly in light of mpox outbreaks and ongoing smallpox preparedness efforts. The company believes that having an additional, reliable source of MVA vaccine will support government and international public health organizations in their biosecurity initiatives.
For more information about GeoVax and its programs, visit GeoVax's website. The company also provides additional CEO commentary via this video.
