GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today announced the completion of key manufacturing, regulatory, clinical, and preclinical milestones for its GEO-MVA vaccine candidate, positioning the program for a pivotal Phase 3 immune-bridging study scheduled to begin in the fourth quarter of 2026.
These milestones mark a significant inflection point for GEO-MVA, which is being developed to expand global manufacturing capacity for non-replicating MVA vaccines, supporting government preparedness programs and future procurement opportunities for mpox and smallpox vaccination.
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."
Key achievements include successful manufacturing, filling, packaging, and release of GMP clinical product for the trial. Regulatory alignment was secured through EMA Scientific Advice, supporting an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine. Clinical operations are advanced with CRO engagement and site identification for the targeted 500-participant study.
Notably, a comparative nonclinical immunogenicity study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses, including neutralizing antibodies, when compared head-to-head with Imvanex® (MVA-BN). These data support the immune-bridging strategy and bolster confidence in the vaccine's potential.
The company is also engaging in active discussions with government agencies and international preparedness organizations regarding future procurement and long-term supply needs, underscoring the strategic importance of GEO-MVA for biosecurity.
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 Phase 3 trial is 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.
GeoVax is developing GEO-MVA to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. The company believes its vaccine 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.
For more information, visit GeoVax's website. A video with additional CEO commentary can be viewed here.
