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.
“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.”
Dodd continued, “Of special note, we 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 our confidence in GEO-MVA as we prepare to initiate our pivotal immune-bridging study later this year. Together with our manufacturing progress and favorable regulatory interactions, these data continue to support 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 these integrated milestones have 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 successful production, filling, packaging, and release of GMP clinical product; regulatory alignment 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 through CRO engagement and site identification for the planned 500-participant study; and preclinical immunogenicity data supporting the immune-bridging strategy. Additionally, the company continues active discussions with government agencies and international preparedness organizations regarding future procurement opportunities.
GeoVax expects initiation of the 500-participant immune-bridging clinical study in Q4 2026, designed to compare immune responses generated by GEO-MVA with those of MVA-BN using established neutralizing antibody endpoints. Results are expected in mid-2027.
“These milestones represent a critical step forward in our mission to provide a reliable and scalable MVA vaccine supply for global preparedness,” commented Dodd. “The completion of these integrated activities underscores our commitment to advancing GEO-MVA through pivotal development and toward potential registration.”
For more information on the GEO-MVA development milestones and planned Phase 3 study, watch the video commentary by CEO David Dodd at YouTube.
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.
