GeoVax Completes Key GEO-MVA Milestones, Paving Way for Pivotal Phase 3 Study

GeoVax Labs, Inc. (Nasdaq: GOVX) has announced the completion of key manufacturing, regulatory, clinical, and preclinical milestones for its GEO-MVA vaccine program, setting the stage for the initiation of a pivotal Phase 3 immune-bridging study scheduled for the fourth quarter of 2026. The company aims to expand global manufacturing capacity for non-replicating MVA vaccines, which are critical for mpox and smallpox preparedness.

According to David A. Dodd, Chairman and CEO of GeoVax, these milestones represent a significant inflection point, systematically executing the activities required to support successful study completion and eventual regulatory registration and commercialization. The company recently completed a comparative nonclinical immunogenicity study evaluating GEO-MVA alongside the licensed MVA vaccine, Imvanex®, using both binding and neutralizing antibody assays. The study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses, strengthening confidence in the program.

Key milestones include manufacturing readiness, with GMP clinical product successfully manufactured, filled, packaged, and released for use in the pivotal study. Regulatory alignment was achieved with the European Medicines Agency (EMA), supporting an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine. Clinical operations have advanced through CRO engagement and site identification, supporting the planned initiation of a 500-participant study. Preclinical immunogenicity data provided neutralizing antibody results that support the immune-bridging strategy. Additionally, GeoVax is actively discussing future procurement opportunities with government agencies and international preparedness organizations.

The planned Phase 3 study will compare immune responses generated by GEO-MVA with those of the licensed MVA-BN vaccine using established neutralizing antibody endpoints. Results are expected in mid-2027. The company believes these integrated milestones have substantially de-risked the program, positioning it for advancement into pivotal clinical evaluation.

GeoVax is developing GEO-MVA to expand global access to MVA vaccine supply, scalable production capabilities, and a capital-efficient regulatory pathway. The company believes GEO-MVA has the potential to become an important strategic preparedness asset, providing governments and international public health organizations with an additional, reliable source of MVA vaccine to support biosecurity and orthopoxvirus preparedness.

The completion of these milestones comes as the company prepares to initiate the pivotal study, underscoring the importance of GEO-MVA in addressing critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. For more information on GeoVax and its programs, visit GeoVax's website.