Confirms Single Phase 3 Immuno-Bridging Trial Sufficient to Evaluate Efficacy and to Support a Marketing Authorization Application (MAA) For Vaccination against Mpox and Smallpox
ATLANTA, GA - June 16, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today announced that it has received positive Scientific Advice (SA) from the European Medicines Agency (EMA) for GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine for the prevention of Mpox and smallpox. The SA supports the suitability of GeoVax’s clinical and nonclinical development strategy. This feedback from EMA provides clear regulatory alignment and enables an efficient pathway toward potential approval, eliminating multiple development steps commonly required for vaccines.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) confirmed the adequacy of GeoVax’s proposed non-clinical immuno-bridging and toxicity studies to support progression to a Phase 3 study and MAA, assuming no unexpected findings occur. They also confirmed Phase 1 and Phase 2 trials could be omitted and that a single, robustly designed Phase 3 immuno-bridging trial against the approved MVA vaccine (Imvanex), if successful, would be sufficient to support an MAA for GEO-MVA via the centralized procedure. The CHMP also agreed with the Company’s proposed immunogenicity endpoints in order to demonstrate non-inferiority. GeoVax believes this guidance represents a potentially significant acceleration in the regulatory approval timeline.
“This positive guidance from EMA represents a major milestone in the global advancement of GEO-MVA and opens a strategic path toward regulatory approval in Europe,” said David Dodd, Chairman and CEO of GeoVax. “At a time when the world is dependent on a single supplier for the MVA-based Mpox and smallpox vaccine, the approval of GEO-MVA would represent an additional, expanded source of vaccine and strengthen global health resilience.” Dodd continued, “The timing of this regulatory development is particularly critical. Just last week, the World Health Organization issued its fourth declaration of Mpox as a Public Health Emergency of International Concern (PHEIC), citing the ongoing spread of both Clade I and II Mpox viruses across 25 African countries as well as the continued risk of geographical expansion. The emergence of the highly virulent Clade 1 across Africa, Europe, Asia and the U.S. – along with wastewater detection in multiple U.S. states - highlights the urgent need to expand vaccine availability and accelerate new options like GEO-MVA. We believe our MVA platform offers a critical alternative to current vaccine solutions, especially when paired with our progressing next-generation MVA manufacturing capabilities. EMA’s clear and constructive guidance significantly streamlines the regulatory pathway for GEO-MVA, bringing us closer to potentially meeting urgent global and domestic needs for Mpox and smallpox preparedness.”
The EMA’s agreement with GeoVax’s proposed immune-bridging strategy to support an MAA filing comes as public health authorities face mounting pressure to diversify vaccine supply amid escalating Mpox transmission and strained global stockpiles.
Dodd emphasized, “GEO-MVA addresses both immediate and long-term needs. In the short-term, it expands vaccine availability using the current Chicken Embryo Fibroblast (CEF) production method. GeoVax plans to shift to its next-generation AGE1 manufacturing platform is anticipated to provide scalable, cost-effective production within the U.S. and self-sufficiency in regions such as Africa. The global need for additional Mpox vaccine manufacturers is critical and we are committed to working with global regulators to ensure access, transparency, and manufacturing resilience.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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
Investor Relations Contact:
geovax@precisionaq.com
212-698-8696
Media Contact:
Jessica Starman
media@elev8newmedia.com
