GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company, announced today the completion of key manufacturing, regulatory, clinical, and preclinical milestones for its GEO-MVA vaccine candidate. These milestones support the planned initiation of a pivotal Phase 3 immune-bridging study scheduled for the fourth quarter of 2026. The announcement marks a significant step forward in the development of GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine designed to protect against mpox and smallpox.
David A. Dodd, Chairman and CEO 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."
Among the completed milestones, GeoVax successfully manufactured, filled, packaged, and released GMP clinical product for use in the upcoming study. The company also aligned its development strategy with the European Medicines Agency (EMA) through Scientific Advice, supporting an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine. Clinical operations have advanced through CRO engagement and clinical site identification, with the targeted 500-participant study expected to begin in Q4 2026.
In a notable preclinical achievement, a comparative nonclinical immunogenicity study evaluated GEO-MVA alongside the licensed MVA vaccine, Imvanex®, using binding and neutralizing antibody assays. The study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses, further bolstering confidence in the vaccine's potential. These data support the planned immune-bridging clinical strategy, which will compare immune responses generated by GEO-MVA with those of MVA-BN using established neutralizing antibody endpoints.
"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," Dodd added.
The development of GEO-MVA is aimed at expanding global manufacturing capacity for non-replicating MVA vaccine, addressing government preparedness programs and future procurement opportunities for this critically needed mpox/smallpox vaccine. In parallel with clinical development, GeoVax continues active discussions with government agencies and international preparedness organizations regarding future procurement and long-term supply requirements.
The company expects to report results from the Phase 3 study in mid-2027. This announcement is particularly significant given the ongoing global need for reliable and scalable orthopoxvirus vaccines. The completion of these milestones could position GeoVax as a key player in biodefense and public health preparedness, offering an additional source of MVA vaccine to governments and international health organizations.
For more information on GeoVax and its programs, visit www.geovax.com. To hear additional commentary from CEO David Dodd, watch the video here.
