GeoVax Advances GEO-MVA Toward Pivotal Phase 3 Study Implementation 25.08.2026, 14:41 Uhr von EQS News Jetzt kommentieren: 0

Selections of CRO and European Clinical Sites Represent Significant Milestones Toward Initiation of the GEO-MVA Immunobridging Study

ATLANTA, GA - August 25, 2026 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and solid tumor cancers, today announced that it has selected the contract research organization (CRO) and European clinical trial sites planned to support the critical immunobridging portion of GEO-MVA-301, the Company’s pivotal Phase 3 clinical program evaluating GEO-MVA as a vaccine against mpox and smallpox.

The selections represent another important operational readiness milestone as GeoVax advances preparations for the European immunobridging study. The randomized, double-blind study is designed to compare the immunogenicity and safety of GEO-MVA with the licensed MVA vaccine in healthy adults.

The selected European clinical sites have extensive experience conducting late-stage vaccine studies and were evaluated for their ability to support timely recruitment across the study’s required adult age groups, intensive immunogenicity sampling, participant retention and high-quality clinical execution. GeoVax has also established contingency site capacity intended to provide additional recruitment flexibility if required.  The immunobridging study is designed to be completed within 8-12 weeks, initiated in Q4 2026, with results announced by mid-2027.

“Selection of our CRO and European clinical sites moves GEO-MVA another important step from development planning toward clinical execution,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “We now have critical components of the pivotal study infrastructure identified and aligned, and the program is increasingly taking shape as an execution-ready clinical program.”

Dodd continued, “These milestones are particularly important because they reflect progress across multiple workstreams - not simply clinical-site selection. Manufacturing readiness, regulatory planning, clinical operations, comparator strategy and site preparation are being brought together around a defined pivotal development pathway. We believe these activities position us to move efficiently toward study initiation as the remaining requirements are completed.”

A Focused Pivotal Development Strategy

The immunobridging study is planned to enroll 500 healthy adult participants at European clinical sites and evaluate whether immune responses generated by GEO-MVA are non-inferior to those generated by the licensed MVA comparator vaccine.  GeoVax expects meeting the non-inferiority criteria will form the basis for approval by the European Medicines Agency (EMA), providing eligibility for GEO-MVA procurement.

The study will evaluate neutralizing antibody responses and seroconversion against vaccinia and mpox viruses, together with additional immunogenicity and safety measures. Enrollment is planned across multiple adult age groups to support a representative clinical dataset.

The study design incorporates an initial safety lead-in cohort, followed by enrollment of the remaining immunobridging study participants. The CRO and site-selection process emphasized capabilities considered important for efficient execution of the pivotal program, including:

• Experience conducting Phase 2 and Phase 3 vaccine trials;
• Demonstrated ability to timely recruit healthy adult volunteers; Experience managing registration-enabling clinical programs;
• Established clinical and regulatory infrastructure in Europe;
• Ability to support intensive immunogenicity sampling and rigorous safety oversight; and
• Recruitment capacity and contingency planning designed to protect program timelines.

“Our objective has been to systematically remove the operational dependencies between GEO-MVA and initiation of the pivotal study,” Dodd said. “With each readiness milestone, the program becomes more tangible: the clinical pathway is defined, the vaccine has been manufactured, and we are now putting the clinical execution infrastructure in place. There is still work ahead, including regulatory and financing requirements, but the pieces necessary to execute the program are increasingly coming together.”

About GEO-MVA

GEO-MVA is GeoVax’s MVA-based vaccine candidate being developed for prevention of mpox and smallpox. GEO-MVA is a highly attenuated, replication-deficient poxvirus vaccine derived from the same original MVA lineage as currently licensed MVA vaccines. The planned GEO-MVA-301 pivotal program is designed to evaluate the immunogenicity and safety of GEO-MVA relative to an approved MVA comparator vaccine and, if successful, support regulatory submissions seeking marketing authorization.

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 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:
info@geovax.com
678-384-7220

Media Contact:
Jessica Starman
media@geovax.com