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EQS-News: GeoVax, Inc.
/ Key word(s): Science
Company Advances to Active Clinical Execution, Supporting Potential Accelerated Path Toward Regulatory Authorization ATLANTA, GA - May 6, 2026 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today announced that it has initiated operational execution activities in support of 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. Execution Activities Now Underway GeoVax confirmed that multiple core execution workstreams are underway:
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. This study design intentionally provides rapid clinical validation, further de-risking the program in addition to the expedited development pathway. From Defined Pathway to Active Execution “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.” Positioned for Efficient Clinical Advancement The EMA-supported immunobridging approach is designed to:
GeoVax believes this approach supports a clear and actionable pathway from development toward potential commercialization. Addressing a Critical Global Need 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. About GEO-MVA 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. About GeoVax 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. For more information, visit www.geovax.com. Forward-Looking Statements This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Company Contact: Media Contact: View the original release on www.newmediawire.com News Source: GeoVax, Inc.
06.05.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group. |
| Language: | English |
| Company: | GeoVax, Inc. |
| United States | |
| ISIN: | US3736782000 |
| EQS News ID: | 2322634 |
| End of News | EQS News Service |
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2322634 06.05.2026 CET/CEST