GEO-CM04S1 Demonstrates Superior Protection in Immunocompromised Populations; Fully Aligned with HHS Priorities for Durable, Broad-Spectrum Immunization
ATLANTA, GA - May 20, 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 in response to the U.S. Department of Health and Human Services' (HHS) anticipated changes to COVID-19 vaccine recommendations.
According to recent reports, HHS is preparing to limit blanket vaccine guidance in favor of a risk-based approach focused on older adults and those with chronic health problems. This pivot away from one-size-fits-all vaccine recommendations underscores the urgent need for next-generation immunization strategies - precisely the role that GeoVax's multi-antigen COVID-19 vaccine, GEO-CM04S1, is designed to fulfill.
"As public health strategy shifts toward protecting those most vulnerable, the demand increases for vaccines that work where others fall short," said David Dodd, Chairman and CEO of GeoVax. "GEO-CM04S1 delivers broad, durable immunity even in immunocompromised patients - a population estimated at over 40 million adults in the U.S. that are inadequately served by the current authorized, single-antigen mRNA vaccines."
GEO-CM04S1: Purpose-Built for the New Vaccine Paradigm
GEO-CM04S1 is based on the Modified Vaccinia Ankara (MVA) platform and expresses both Spike (S) and Nucleocapsid (N) proteins - offering multi-antigen protection against SARS-CoV-2. This broader design induces both antibody and T cell responses, essential for robust, durable protection against continually evolving COVID-19 variants and is especially critical in populations with weakened immune systems.
Recent interim results from a Phase 2 clinical trial in patients with chronic lymphocytic leukemia (CLL) demonstrated a superior T cell response rate versus a leading mRNA vaccine. The trial's independent Data Safety Monitoring Board recommended and implemented continuing enrollment in the GEO-CM04S1 arm while halting the underperforming mRNA comparator arm.
Aligned with the New HHS Biosecurity Vision
GEO-CM04S1 is fully aligned with the new strategic direction from HHS Secretary Kennedy, who has called for a focus toward multi-antigen vaccine technologies that can deliver durable, variant-adaptive immunity while prioritizing safety and domestic production.
GeoVax's MVA vaccines offer:
Multi-antigen breadth: Including both S and N antigens for protection across variants.
Durability: Sustained antibody and T cell immunity - even in immunocompromised individuals.
Safety: MVA is non-replicating and approved for use in vulnerable groups such as transplant patients, pregnant women, and children.
Domestic advanced manufacturing: Using an avian continuous cell line platform that eliminates reliance on specialized pathogen-free eggs and a slow vaccine manufacturing process, enabling scalable U.S.-based vaccine production aligned with President Trump's recent Executive Order on pharmaceutical onshoring.
"The HHS call for broader, more resilient vaccine solutions is well-founded," Dodd added. "GEO-CM04S1 is not only scientifically advanced but strategically aligned with our nation's public health and biosecurity goals."
Multiple Trials Support Path to Licensure
GEO-CM04S1 is currently in three active Phase 2 trials, evaluating its use among:
Immunocompromised blood cancer patients in preparation for stem cell transplantation or CAR-T therapy (in comparison to mRNA-based vaccine),
Immunocompromised patients with Chronic Lymphocytic Leukemia (in comparison to mRNA vaccine), and
Healthy adults, previously vaccinated with a mRNA vaccine as a more robust, more durable booster following mRNA vaccination.
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.
