GeoVax Labs, Inc. (Nasdaq: GOVX) announced today the completion of key manufacturing, regulatory, clinical, and preclinical milestones for its GEO-MVA vaccine candidate, which is being developed for protection against mpox and smallpox. These advancements set the stage for the initiation of a pivotal Phase 3 immune-bridging study, planned for the fourth quarter of 2026.
The company stated that it has successfully manufactured, filled, packaged, and released GMP clinical product for use in the upcoming trial, fulfilling a critical requirement for clinical development. Regulatory alignment has been achieved through scientific advice from the European Medicines Agency (EMA), supporting an expedited immune-bridging pathway that will compare GEO-MVA with the licensed MVA-BN vaccine (Imvanex). Clinical operations have also advanced, with contract research organization engagement and clinical site identification complete, enabling a targeted 500-participant study to commence as scheduled.
In preclinical immunogenicity studies, GEO-MVA generated robust orthopoxvirus-specific immune responses, including neutralizing antibodies, when compared with MVA-BN. These data support the planned immune-bridging strategy and bolster confidence in the vaccine’s potential.
David A. Dodd, Chairman and CEO of GeoVax, emphasized the significance of these milestones: “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.”
The company also highlighted ongoing commercial and procurement planning, noting active discussions with government agencies and international preparedness organizations regarding future procurement opportunities and long-term MVA vaccine supply requirements. This aligns with GEO-MVA’s goal to expand global manufacturing capacity for non-replicating MVA vaccines, addressing critical needs for biosecurity and orthopoxvirus preparedness.
GeoVax expects to report results from the Phase 3 study in mid-2027. The study is designed to compare immune responses generated by GEO-MVA with those of MVA-BN using established neutralizing antibody endpoints. If successful, GEO-MVA could become a strategic preparedness asset, providing an additional reliable source of MVA vaccine for governments and public health organizations.
For more information about the milestones and the planned study, GeoVax’s CEO provides additional context in a video available at this link.
The completion of these milestones is a significant step forward in addressing the global need for expanded orthopoxvirus vaccine supply. With an expedited regulatory pathway and encouraging preclinical data, GEO-MVA is positioned to advance into pivotal clinical evaluation. The company’s focus on manufacturing readiness and regulatory alignment underscores its commitment to bringing this vaccine to market efficiently.
GeoVax is a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and solid tumors. Its priority program, GEO-MVA, is being developed under an expedited regulatory pathway with plans to initiate a pivotal Phase 3 trial in the second half of 2026. The company also continues to develop Gedeptin®, a gene-directed enzyme prodrug therapy for oncology, and maintains a global intellectual property portfolio.
