GeoVax Labs, Inc. (Nasdaq: GOVX) has announced the completion of several key development milestones for its GEO-MVA vaccine, a Modified Vaccinia Ankara (MVA)-based vaccine targeting mpox and smallpox. These milestones span manufacturing, regulatory, clinical, and preclinical areas, and are designed to support the initiation of a pivotal Phase 3 immune-bridging study scheduled for the fourth quarter of 2026.
The announcement comes as GeoVax seeks to expand global manufacturing capacity for non-replicating MVA vaccines, addressing government preparedness programs and future procurement needs. The company has successfully manufactured, filled, packaged, and released GMP clinical product for the upcoming study, fulfilling a critical requirement for clinical development. Regulatory alignment has been achieved through scientific advice from the European Medicines Agency (EMA), endorsing an expedited immune-bridging pathway that compares GEO-MVA with the licensed MVA-BN vaccine.
Clinical operations are advancing, with contract research organization (CRO) engagement and clinical site identification underway for the targeted 500-participant study. Preclinical immunogenicity data, including neutralizing antibody responses, have shown that GEO-MVA generates robust orthopoxvirus-specific immune responses comparable to MVA-BN, strengthening confidence in the immune-bridging strategy.
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." He added that the company has "systematically executed the manufacturing, regulatory, clinical, and scientific activities required to support successful study completion."
The GEO-MVA program is being developed to provide an additional, reliable source of MVA vaccine for biosecurity and orthopoxvirus preparedness. In parallel with clinical development, GeoVax is engaging in discussions with government agencies and international preparedness organizations regarding future procurement and long-term supply requirements.
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.
For more information on the development milestones and manufacturing readiness, GeoVax has released a video commentary from CEO David Dodd, available at https://www.youtube.com/watch?v=oxB4C1MPzm0.
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on vaccines and immunotherapies for infectious diseases and solid tumors. In addition to GEO-MVA, the company is developing Gedeptin®, a gene-directed enzyme prodrug therapy for enhancing immune checkpoint inhibitor activity, which has completed a Phase 1/2 trial in head and neck cancer.
