Atlanta, GA — May 6, 2026 — Leads & Copy —
GeoVax Labs, Inc. (Nasdaq: GOVX) has initiated operational execution activities to support its planned Phase 3 immunobridging clinical study for GEO-MVA, its Modified Vaccinia Ankara (MVA) vaccine candidate targeting mpox and smallpox.
This milestone marks GeoVax’s transition from strategic program positioning to active clinical-stage execution, following prior regulatory alignment with the European Medicines Agency (EMA) supporting an expedited development pathway.
GeoVax confirmed that multiple core execution workstreams are underway, including:
Clinical Operations: A global contract research organization (CRO) has been selected.
Trial Infrastructure Activation: Clinical site identification and activation planning progressing in alignment with study requirements.
Manufacturing Readiness: Clinical trial material manufactured and fill/finish product has been completed and released for clinical use.
Regulatory Execution Alignment: Ongoing implementation of EMA-guided immunobridging strategy designed to support an efficient path to authorization.
The planned Phase 3 immunobridging arm of the clinical trial is expected to enroll approximately 500 participants and evaluate neutralizing antibody responses relative to the approved MVA-based comparator vaccine. The company says this study design intentionally provides rapid clinical validation, further de-risking the program in addition to the expedited development pathway.
“We are now executing against a clearly defined clinical and regulatory pathway for GEO-MVA,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Our focus has shifted decisively to operational execution of the Phase 3 program. The EMA’s guidance provides a structured and efficient pathway centered on immunobridging, and we are advancing accordingly.”
Dodd added, “Our objective is to move efficiently through study initiation and execution, positioning GEO-MVA to support global preparedness needs while advancing toward potential regulatory authorization. Our study plan is structured to provide the immunobridging study results within 8-12 weeks following trial initiation.”
The EMA-supported immunobridging approach is designed to:
Leverage established MVA platform experience
Focus on quantitative neutralizing antibody endpoints
Enable a streamlined development pathway relative to traditional efficacy trials
GeoVax believes this approach supports a clear and actionable pathway from development toward potential commercialization.
GEO-MVA is being advanced as a potential second-source MVA-based vaccine, addressing ongoing global demand for orthopoxvirus vaccines and reducing reliance on a single supplier.
Public health agencies and governments continue to emphasize the importance of resilient and diversified vaccine supply, particularly in the context of evolving mpox dynamics and preparedness requirements.
GEO-MVA is GeoVax’s candidate vaccine for protection against mpox and smallpox based on the Modified Vaccinia Ankara (MVA). The program is advancing under an expedited regulatory pathway supported by EMA scientific advice, which enables potential regulatory approval based on a single immune bridging study demonstrating non-inferiority to an approved MVA vaccine.
Following successful completion of the planned study, GEO-MVA is expected to advance toward regulatory submission and potential commercialization as an additional source of MVA vaccine supply for global preparedness and biodefense programs.
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness.
In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings.
GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities.
Source: GeoVax Labs, Inc.
