GeoVax Labs, Inc. (Nasdaq: GOVX) has announced the completion of key milestones for its GEO-MVA vaccine program, setting the stage for a pivotal Phase 3 immune-bridging study scheduled to begin in the fourth quarter of 2026. The company has achieved significant progress across manufacturing, regulatory, clinical, and preclinical fronts, substantially de-risking the program as it moves toward potential registration and commercialization.
David A. Dodd, Chairman and CEO of GeoVax, stated, “Completion of these milestones marks a significant inflection point for the GEO-MVA program. We have systematically executed the manufacturing, regulatory, clinical and scientific activities required to support successful study completion.” The company highlighted a recent comparative nonclinical immunogenicity study that demonstrated GEO-MVA generated robust orthopoxvirus-specific immune responses comparable to the licensed MVA vaccine, Imvanex®.
Key milestones completed include successful manufacturing and release of GMP clinical product, alignment with the European Medicines Agency (EMA) on an expedited immune-bridging pathway, and advancement of clinical operations through CRO engagement and site identification. The planned 500-participant study will compare immune responses of GEO-MVA with MVA-BN using neutralizing antibody endpoints, with results expected in mid-2027.
GeoVax is also actively engaging with government agencies and international preparedness organizations regarding future procurement opportunities for MVA vaccines, underscoring the strategic importance of expanding global manufacturing capacity for orthopoxvirus preparedness. The company believes GEO-MVA could serve as a critical asset for biosecurity and public health.
The completion of these milestones positions GeoVax to initiate the pivotal study, which could support regulatory submission and eventual widespread availability of an additional MVA vaccine source. With the global need for mpox/smallpox vaccines remaining high, this program addresses a critical public health gap.
