GEO-CM04S1 Demonstrates Robust COVID-19 and Mpox Immunogenicity in Immunocompromised Patients and Healthy Adults
ATLANTA, GA - May 8, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against infectious diseases and solid tumor cancers, today recapped the presentation of clinical and translational data for its next-generation multi-antigen COVID-19 vaccine candidate, GEO-CM04S1, delivered at IMMUNOLOGY2025™, the Annual Meeting of the American Association of Immunologists (AAI), held May 3–7, 2025, in Honolulu, Hawaii.
The presentation, titled “Immunogenicity of Synthetic MVA-based Vaccine COH04S1 Against SARS-CoV-2 in Post-HCT/CAR-T Patients and Its Cross-Protective Potential Against Mpox” (Abstract Number: 9352), highlighted findings from an the initial segment of an ongoing Phase 2 clinical study in blood cancer patients receiving hematopoietic cell transplantation or CAR-T therapy that was conducted by investigators at City of Hope Medical Center with the next-generation multi-antigen COVID-19 vaccine COH04S1 (licensed by GeoVax as GEO-CM04S1), as well as studies with sera obtained from COH04S1-vaccinated healthy adults and non-human primates demonstrating induction of orthopox-specific and Mpox cross-reactive immune responses.
The study in blood cancer/cell transplant patients demonstrated robust, durable, and broad anti-SARS-CoV-2 immune responses following vaccination with COH04S1, including cross-reactive immunity against variants of concern such as Omicron XBB.1.5. Immune responses in healthy adult and non-human primates receiving COH04S1 were cross-reactive against Mpox virus and found comparable to those in humans receiving the currently licensed smallpox/Mpox vaccine (Jynneos). Further, sera from these vaccinated individuals were shown to protect against lung infection in susceptible mice challenged with Mpox virus.
These studies demonstrate the potential of GEO-CM04S1 to provide protection against both COVID-19 and Mpox.
“These findings underscore the differentiated potential of GEO-CM04S1 to serve dual roles as both a next-generation multi-antigen COVID-19 vaccine and a cross-protective agent against Mpox,” said Kelly T. McKee, Jr., M.D., Chief Medical Officer of GeoVax. “The ability to stimulate strong, broad, and durable immunity, particularly in immunocompromised individuals, represents a meaningful advancement over current vaccines. The added benefit of cross-reactive immunity against Mpox is especially important in regions where this virus is endemic, such as the Democratic Republic of the Congo and surrounding areas in Africa.”
About GEO-CM04S1
GEO-CM04S1 is a next-generation multi-antigen COVID-19 vaccine designed using a synthetic Modified Vaccinia Ankara (sMVA) vector platform. The vaccine expresses both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2, offering the potential for broader and more durable immune protection across current and emerging variants. GEO-CM04S1 is licensed from City of Hope and is currently being evaluated in three Phase 2 clinical trials:
- As a primary vaccine in immunocompromised patients such as those undergoing stem cell transplantation or CAR-T therapy in a randomized comparison to mRNA vaccines.
- As a booster vaccine for patients with chronic lymphocytic leukemia (CLL) in a randomized comparison to an mRNA vaccine.
- As a booster for healthy adults previously vaccinated with mRNA COVID-19 vaccines.
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
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