GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company, has announced the completion of key development milestones for its GEO-MVA vaccine, which targets mpox and smallpox. These milestones encompass manufacturing, regulatory, clinical, and preclinical aspects, setting the stage for a pivotal Phase 3 immune-bridging study scheduled to begin in the fourth quarter of 2026.
David A. Dodd, Chairman and Chief Executive Officer of GeoVax, stated, "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."
Key achievements include the successful manufacturing, filling, packaging, and release of GMP clinical product for the upcoming study. Regulatory alignment has been achieved with the European Medicines Agency (EMA), supporting an expedited immune-bridging pathway that compares GEO-MVA with the licensed MVA-BN vaccine. Clinical operations have advanced with CRO engagement and site identification for the planned 500-participant study.
Preclinically, a comparative immunogenicity study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses, including neutralizing antibodies, when compared to Imvanex® (MVA-BN). This data bolsters confidence in the immune-bridging strategy. Additionally, GeoVax is in active discussions with government agencies and international preparedness organizations regarding future procurement opportunities.
Dodd added, "With GMP clinical product available and released, an expedited regulatory pathway established, clinical operations progressing and encouraging preclinical immunogenicity data in hand, we believe completion of these integrated milestones has substantially de-risked GEO-MVA and positions the program to advance into the Phase 3 study."
The 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. GEO-MVA is being developed to expand global manufacturing capacity for non-replicating MVA vaccines, addressing government preparedness programs and future procurement needs for mpox and smallpox vaccines.
This announcement is significant as it moves GEO-MVA closer to potential regulatory approval and commercialization, providing an additional reliable source of MVA vaccine to support biosecurity and orthopoxvirus preparedness. For more information, visit GeoVax's website.
