GEO-MVA Advancing as the Leading U.S.-Developed Mpox Vaccine Candidate
ATLANTA, GA - April 24, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today responded to the recent detection of Clade I Mpox viral particles in wastewater samples in Greenville, North Carolina - the first such identification in the state. This finding, disclosed by the North Carolina Department of Health and Human Services (NCDHHS), underscores the increasing threat posed by Clade I Mpox and the urgent need for expanded preparedness and Mpox vaccine availability.
This development aligns with concerns raised by the Centers for Disease Control and Prevention (CDC), which continues to monitor Clade I Mpox - a more virulent strain associated with higher transmissibility and a greater case fatality rate than Clade II. Four confirmed Clade I Mpox cases have been reported in the U.S. to date - in California, Georgia, New Hampshire, and New York.
"The detection of Clade I Mpox in North Carolina wastewater is a warning shot - silent transmission may be occurring even before clinical cases are reported," said David Dodd, Chairman and CEO of GeoVax. "We encourage public health authorities to act decisively to expand our Mpox vaccine supply and ensure rapid, scalable access to effective solutions."
GEO-MVA: A U.S.-Developed Vaccine Candidate at the Forefront of Biosecurity
During this week's World Vaccine Congress in Washington, D.C., GeoVax's GEO-MVA vaccine was the focus of several high-level discussions as the leading U.S.-developed vaccine candidate for Mpox/smallpox. GEO-MVA is advancing in development as a strategic complement to the existing global Mpox vaccine supply option, which is currently reliant on a single overseas-manufactured vaccine from a European supplier.
GeoVax has completed cGMP manufacturing of GEO-MVA and anticipates the availability of clinical vialed product soon. Clinical trials are expected to commence in the second half of 2025.
GEO-MVA directly aligns with the strategic recommendations issued by the CDC, WHO, and biodefense think tanks urging governments to reduce dependence on single suppliers and bolster domestic manufacturing capacity. "Our discussions at the World Vaccine Congress reaffirmed the critical need and role that GEO-MVA can fulfill as the first U.S.-supplied Mpox vaccine," said Dodd. "This is a pivotal opportunity to onshore our vaccine capabilities and protect Americans against future outbreaks."
Strengthening Pandemic Preparedness Through Early Detection and Vaccine Access
The wastewater detection in North Carolina was facilitated by the state's Wastewater Monitoring Network - a vital tool for identifying viral threats early. However, proposed federal funding cuts threaten the continuity of this critical infrastructure.
GeoVax urges state and federal policymakers to take decisive action by:
Expanding funding for surveillance systems that serve as early warning networks for viral emergence.
Supporting U.S.-based manufacturing and vaccine diversification to enhance biosecurity and preparedness.
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(R), 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.
