GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and solid tumors, today announced the completion of key manufacturing, regulatory, clinical, and preclinical milestones supporting the initiation of its pivotal Phase 3 GEO-MVA immune-bridging study, scheduled to begin in the fourth quarter of 2026. This progress marks a significant inflection point for the program, as the company prepares for regulatory registration and eventual commercialization.
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." He also highlighted that a recently completed comparative nonclinical immunogenicity study demonstrated GEO-MVA generated robust orthopoxvirus-specific immune responses, further strengthening confidence in the vaccine.
The milestones include manufacturing readiness, with GMP clinical product successfully manufactured, filled, packaged, and released for use in the pivotal study. Regulatory alignment was achieved through European Medicines Agency (EMA) Scientific Advice, supporting an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine. Clinical readiness advanced through CRO engagement and site identification for the targeted 500-participant study. Preclinical immunogenicity data generated neutralizing antibody responses supporting the immune-bridging strategy. Additionally, GeoVax continues active discussions with government agencies and international preparedness organizations regarding future procurement opportunities.
GEO-MVA is being developed to expand global manufacturing capacity for non-replicating MVA vaccine, addressing government preparedness programs and future procurement needs for mpox and smallpox vaccines. The company expects to initiate the pivotal study in Q4 2026 and report results in mid-2027. This development is crucial as it addresses the global need for expanded orthopoxvirus vaccine supply and biodefense preparedness, with GEO-MVA potentially becoming a strategic asset for governments and public health organizations.
For more information about GeoVax and its programs, visit www.geovax.com.
