GeoVax Labs, Inc. (Nasdaq: GOVX) has announced the completion of key milestones across manufacturing, regulatory, clinical, and preclinical areas for its GEO-MVA vaccine candidate, positioning the program for a pivotal Phase 3 immune-bridging study scheduled to begin in the fourth quarter of 2026. The announcement marks a significant step forward in the company's efforts to address global needs for mpox and smallpox vaccines.
The company has successfully manufactured, filled, packaged, and released GMP clinical product for use in the upcoming trial, fulfilling a critical requirement for clinical development. Regulatory alignment has been achieved through Scientific Advice from the European Medicines Agency (EMA), supporting an expedited immune-bridging pathway that compares GEO-MVA with the licensed MVA-BN vaccine. Clinical operations are advancing with CRO engagement and site identification for the planned 500-participant study.
Notably, a comparative nonclinical immunogenicity study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses, including neutralizing antibodies, when compared with Imvanex® (MVA-BN). These data reinforce confidence in the vaccine's potential and support the immune-bridging strategy. '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,' said David A. Dodd, Chairman and CEO of GeoVax. 'We have systematically executed the manufacturing, regulatory, clinical and scientific activities required to support successful study completion, preparing for regulatory registration and ultimate commercialization.'
The company is also engaging in active discussions with government agencies and international preparedness organizations regarding future procurement opportunities, underscoring the strategic importance of GEO-MVA in expanding global MVA vaccine supply. The vaccine is being developed to provide an additional reliable source for biosecurity and orthopoxvirus preparedness.
With these milestones completed, GeoVax believes the program has been substantially de-risked. The company expects to initiate the Phase 3 study in Q4 2026 and report results in mid-2027. For more information, visit GeoVax's website.
