GeoVax Labs, Inc. (Nasdaq: GOVX) has announced the completion of critical development milestones for its GEO-MVA vaccine, a Modified Vaccinia Ankara (MVA)-based candidate targeting mpox and smallpox. These achievements span manufacturing, regulatory, clinical, and preclinical domains, setting the stage for the initiation of a pivotal Phase 3 immune-bridging study scheduled for the fourth quarter of 2026.
The company has successfully manufactured, filled, packaged, and released GMP clinical product for use in the upcoming study, fulfilling a key 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 will compare GEO-MVA with the licensed MVA-BN vaccine. Clinical operations are advancing with contract research organization (CRO) engagement and site identification for the targeted 500-participant trial.
A notable preclinical study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses, including neutralizing antibodies, comparable to those elicited by the licensed vaccine. These data bolster confidence in the immune-bridging strategy. "Completion of these milestones marks a significant inflection point for the GEO-MVA program," 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 GEO-MVA program is designed to expand global manufacturing capacity for non-replicating MVA vaccines, addressing government preparedness programs and future procurement opportunities. In parallel with clinical development, GeoVax is in active discussions with government agencies and international preparedness organizations regarding long-term supply requirements. The company expects to report results from the Phase 3 study in mid-2027.
These milestones collectively de-risk the GEO-MVA program, positioning it for pivotal evaluation. The initiation of the Phase 3 study later this year represents a significant step toward providing an additional, reliable source of MVA vaccine to support biosecurity and orthopoxvirus preparedness globally. For more information, visit GeoVax's website.
