GeoVax Completes Key Milestones for Pivotal Phase 3 GEO-MVA Study

GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and solid tumors, has announced the completion of key manufacturing, regulatory, clinical, and preclinical milestones for its GEO-MVA vaccine program. These milestones support the initiation of a pivotal Phase 3 immune-bridging study scheduled for the fourth quarter of 2026. The company has successfully manufactured and released GMP clinical product, aligned its development strategy with the European Medicines Agency (EMA) for an expedited immune-bridging pathway, advanced clinical operations through CRO engagement and site identification, and generated encouraging preclinical immunogenicity data. Notably, a comparative nonclinical study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses, including neutralizing antibodies, compared to the licensed MVA-BN vaccine (Imvanex®).

The GEO-MVA vaccine is being developed to expand global manufacturing capacity for non-replicating MVA vaccines, addressing government preparedness programs and future procurement for mpox and smallpox. The planned 500-participant immune-bridging study will compare immune responses of GEO-MVA with MVA-BN, with results expected in mid-2027. GeoVax is also in active discussions with government agencies and international preparedness organizations for future procurement opportunities. David A. Dodd, Chairman and CEO, emphasized that these integrated milestones have substantially de-risked the program, positioning it for pivotal evaluation and potential commercialization. The company also highlighted its parallel efforts in oncology, including Gedeptin®, a gene-directed enzyme prodrug therapy for solid tumors, and maintains a global intellectual property portfolio. For more information, visit www.geovax.com.

GeoVax's CEO provides additional context in a video available at https://www.youtube.com/watch?v=oxB4C1MPzm0. The company's forward-looking statements caution about risks and uncertainties, including clinical trial outcomes, regulatory approvals, and capital requirements. The original release can be viewed on NEWMEDIAWIRE.