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 initiate in the fourth quarter of 2026. These milestones mark a significant inflection point for the program, as the company prepares for regulatory registration and ultimate commercialization.
“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,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “We have systematically executed the manufacturing, regulatory, clinical, and scientific activities required to support successful study completion, preparing for regulatory registration and ultimate commercialization.”
Of special note, the company recently completed a comparative nonclinical immunogenicity study evaluating GEO-MVA alongside the licensed MVA vaccine, Imvanex®, using both binding antibody and neutralizing antibody assays. The study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses. These findings further strengthen confidence in GEO-MVA as the company prepares to initiate the pivotal immune-bridging study later this year. Together with manufacturing progress and favorable regulatory interactions, these data support the advancement of GEO-MVA into pivotal clinical evaluation.
With GMP clinical product available and released, an expedited regulatory pathway established, clinical operations progressing, and encouraging preclinical immunogenicity data in hand, the company believes completion of these integrated milestones has substantially de-risked GEO-MVA and positioned the program to advance into the Phase 3 study. GEO-MVA is being developed to expand global manufacturing capacity for non-replicating MVA vaccine, supporting government preparedness programs and future procurement opportunities for this critically needed mpox/smallpox vaccine.
Key development milestones include manufacturing readiness, with GMP clinical product successfully manufactured, filled, packaged, and released for use in the pivotal study. Regulatory alignment has been achieved through consultation with the European Medicines Agency (EMA) Scientific Advice, supporting an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine. Clinical readiness has advanced through CRO engagement and clinical site identification, supporting planned initiation of the targeted 500-participant study in the fourth quarter of 2026. Preclinical immunogenicity data from the comparative study generated neutralizing antibody responses that support the planned immune-bridging strategy. Additionally, commercial and procurement planning is underway, with active discussions with government agencies and international preparedness organizations regarding future procurement opportunities and long-term MVA vaccine supply requirements.
GeoVax expects initiation of its targeted 500-participant immune-bridging clinical study during the fourth quarter of 2026. The study is designed to compare immune responses generated by GEO-MVA with those of the licensed MVA-BN vaccine using established neutralizing antibody endpoints. The company expects to report results in mid-2027. Additional CEO commentary is available in a video at https://www.youtube.com/watch?v=oxB4C1MPzm0.
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 by providing governments and international public health organizations with an additional, reliable source of MVA vaccine to support biosecurity and orthopoxvirus preparedness. For more information, visit GeoVax's website.
