GeoVax Labs, Inc. (Nasdaq: GOVX) has announced the completion of key manufacturing, regulatory, and preclinical milestones for its GEO-MVA vaccine candidate, setting the stage for a pivotal Phase 3 immune-bridging study scheduled to begin in the fourth quarter of 2026. The company said these achievements significantly de-risk the program and support its advancement toward regulatory registration and commercialization.
GEO-MVA is a Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. 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. The study is expected to enroll approximately 500 participants, with results anticipated in mid-2027.
David A. Dodd, Chairman and CEO of GeoVax, said, "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 milestones completed include the successful manufacturing, filling, packaging, and release of GMP clinical product for use in the study. The company also aligned its development strategy with the European Medicines Agency (EMA) through Scientific Advice, supporting an expedited immune-bridging pathway. Clinical operations have been advanced through CRO engagement and site identification, and a preclinical immunogenicity study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses comparable to the licensed vaccine.
In addition, the company continues discussions with government agencies and international preparedness organizations regarding future procurement and long-term supply requirements for MVA vaccines. This aligns with GeoVax's goal of expanding global manufacturing capacity for non-replicating MVA vaccines, which is critical for government preparedness programs.
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 completion of these milestones underscores the progress of GEO-MVA in addressing the critical global need for expanded orthopoxvirus vaccine supply and biodefense preparedness. GeoVax is developing GEO-MVA to provide an additional, reliable source of MVA vaccine for governments and international public health organizations.
