EQS-News: GeoVax Highlights Growing Urgency for Diversified Mpox Vaccine Supply as Global Outbreaks Expand

European Medicines Agency Supports Streamlined Development Pathway for GEO-MVA Vaccine Candidate via a Single Phase 3 Immuno-bridging Trial

ATLANTA, GA - July 16, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today issued a statement underscoring the increasing urgency of expanding global Mpox vaccine access, as recent data from the Airfinity July 2025 Mpox Report highlight significant new outbreaks and rising global transmission of Clade I and Clade II Mpox.

The company previously announced favorable Scientific Advice from the European Medicines Agency (EMA) supporting the company’s proposed expedited development pathway for GEO-MVA. EMA confirmed that a single Phase 3 immuno-bridging trial, combined with proposed preclinical data, would be sufficient to support a Marketing Authorisation Application (MAA) via the centralized procedure. Immuno-bridging studies allow for vaccine approval by demonstrating comparable immune responses, rather than requiring traditional large-scale efficacy trials, thereby reducing development time while maintaining regulatory rigor.  GeoVax is now accelerating engagement with global and regional health authorities as Mpox re-emerges with more virulent and transmissible strains in vulnerable populations.

“The global Mpox situation is expanding in both scope and severity, especially with the silent spread of Clade I in China, Europe, and the United States,” said David Dodd, Chairman and CEO of GeoVax. “The increasing number of breakthrough infections, pregnancy-related complications, and international importation threats make the need for second-source MVA-based vaccines not only strategic, but urgent. We are encouraged by EMA’s endorsement of a streamlined regulatory approach, which enables us to accelerate clinical development and scale-up planning for GEO-MVA.”

Global Spread of Clade I Mpox Highlights Need for Vaccine Diversification

The Airfinity report shows:

• Clade I Mpox cases now span all continents, with new detections confirmed in China, United Kingdom, Italy and the U.S., including wastewater tracing.
• Local Clade I transmission in China raises concern of sustained spread in one of the world’s most populous regions.
• Travel-linked cases from Ethiopia and the Democratic Republic of the Congo (DRC) indicate high exportation risk to G7 countries, including the U.S. and France.
• New data from the DRC confirmed vertical transmission of Mpox - meaning the virus was passed from mother to child during pregnancy - prompting renewed calls for next-generation vaccines with broader safety data and global availability.

GEO-MVA Positioned as Scalable, Strategic Alternative

GeoVax’s GEO-MVA vaccine candidate is being positioned as a second source MVA-based vaccine to address emerging global needs with:

• EMA Scientific Advice concurrence on the company’s proposed expedited development pathway offering a near-term alternative MVA supply option.
• Planned transition to a modernized AGE1 continuous cell-line-based manufacturing system, offering the potential for scalable, lower-cost, and U.S.-based production.

“As the global MVA vaccine stockpile is stretched and a single supplier model becomes increasingly untenable, GEO-MVA offers both immediate and long-term solutions to expand access, improve durability, and restore resilience to the world’s Mpox vaccine infrastructure,” added Dodd.

GeoVax is actively engaging with global stakeholders, including the World Health Organization (WHO), Africa CDC, and Gavi, as well as the U.S. Administration for Strategic Preparedness and Response (ASPR) to explore advance purchase agreements, regional partnerships, and manufacturing alliances to enable rapid deployment of GEO-MVA in current and emerging hotspots.

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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. 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@geovax.com 

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