GeoVax Highlights Critical Role of Multi-Antigen COVID-19 Vaccines as Nimbus Variant Underscores Persistent and Evolving Public Health Threat
ATLANTA, GA - July 3, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today emphasized the urgent need for innovation in COVID-19 vaccination as the NB.1.8.1 variant - commonly known as 'Nimbus' - spreads rapidly across the globe.
Nimbus, a highly transmissible Omicron subvariant classified by the World Health Organization as a 'Variant Under Monitoring,' is now dominant in multiple U.S. states and surging across Europe and Asia. Though not more severe, its rapid spread and potential for immune escape reflect an increasingly clear reality: COVID-19 is not going away, and it will continue to evolve.
'The emergence of the Nimbus variant is a stark reminder that we need 'smarter' vaccines, not just newer ones,' said David Dodd, Chairman and CEO of GeoVax. 'Our GEO-CM04S1 vaccine was designed for this purpose and is built to potentially provide broader and longer-lasting protection, especially for the immunocompromised patients most at risk.'
GEO-CM04S1: Multi-Antigen Protection for the Immunocompromised
Unlike mRNA vaccines that rely solely on the Spike protein, GEO-CM04S1 delivers both Spike (S) and Nucleocapsid (N) antigens, stimulating an immune response that includes not only an antibody response, but also robust T-cell activity. This is believed to be critical for cross-variant protection and extended durability, particularly in individuals with weakened immune systems.
GEO-CM04S1 is currently being evaluated in two Phase 2 clinical trials, focused on populations at greatest risk from COVID-19 complications, including blood cancer patients scheduled to receive stem cell transplant therapy.
In one of the ongoing Phase 2 trials, the mRNA control arm was discontinued due to poor immunogenicity with the remainder of the trial only including GEO-CM04S1 which surpassed the immunogenicity target, reinforcing the limitations of monovalent vaccines and the important value of a multi-antigen vaccine approach in such high-risk patient populations.
'There are more than 40 million immunocompromised individuals in the U.S. alone,' said Dodd. 'They are underserved by the current, FDA-approved vaccine options that deliver only an antibody response and require a better solution with both breadth and longevity of protection.'
Public Vaccine Policy and Regulatory Changes Support Platform Diversification
Recent guidance from the U.S. Food and Drug Administration (FDA) calls for diversified vaccine platforms and risk-based regulatory pathways. Additionally, the CDC's narrowed 2025–2026 booster recommendations - now focused on adults 65+ and immunocompromised individuals - closely mirror GeoVax's clinical strategy and target population.
GEO-CM04S1 has been proposed under BARDA's Rapid Response Partnership Vehicle (RRPV) for surge manufacturing support and integration into long-term public health preparedness efforts. The proposal, 'Innovation in Clinical Manufacturing of MVA-Vectored COVID-19 Vaccines', was selected by the RRPV, pending funding availability.
'As public health moves toward more targeted, durable, and inclusive vaccination strategies, GEO-CM04S1 is positioned to deliver where first generation COVID-19 vaccines fall short,' Dodd added.
In addition to targeting today's variants, GEO-CM04S1 is structurally designed to adapt to future mutations and serve as a platform for multi-pathogen preparedness. As part of GeoVax's broader MVA-based portfolio, the platform underpins vaccine candidates for Mpox, smallpox, and hemorrhagic fever viruses, offering scale and flexibility across infectious disease threats.
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. 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.
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