Highlights Critical Role of Multi-Antigen GEO-CM04S1 in Protecting Vulnerable Populations
ATLANTA, GA - May 27, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today announced its strong support for the U.S. Food and Drug Administration (FDA) advisory panel's updated COVID-19 vaccine recommendations. The new guidance prioritizes protection for older adults and individuals with chronic health conditions, moving away from a universal vaccination strategy and signaling a more focused public health approach - one that GeoVax believes that it is well equipped to support through its multi-antigen COVID-19 vaccine, GEO-CM04S1. The advisory panel's recommendations follow details on how the FDA is changing the type of evidence it will accept from vaccine manufacturers to approve updated COVID-19 vaccines as outlined in an editorial published last week in the New England Journal of Medicine.
GeoVax's COVID-19 candidate, GEO-CM04S1, is designed to address the precise needs of high-risk populations, including those identified in the new FDA guidance. Developed on the Modified Vaccinia Ankara (MVA) platform, GEO-CM04S1 delivers multiple antigens - specifically, both the spike (S) and nucleocapsid (N) proteins of SARS-CoV-2 - to induce broad, durable immune responses, including both antibody and T-cell immunity. This approach is believed to enhance protection, especially in individuals with compromised immune systems, such as those undergoing cancer treatment, organ transplant recipients, and others whose response to current mRNA vaccines may be suboptimal.
"GEO-CM04S1 embodies the next generation of COVID-19 vaccines - vaccines that offer layered immune protection and are purpose-built for the most vulnerable individuals," said David Dodd, Chairman and CEO of GeoVax. "The FDA's new guidance underscores the urgency of advancing vaccine solutions tailored for those at greatest risk. Our clinical data thus far appear to demonstrate that GEO-CM04S1 delivers a more comprehensive immune response, and we believe it is uniquely suited to fulfill the mission articulated by the FDA and the U.S. Department of Health and Human Services (HHS)."
The FDA's updated recommendations mirror recent priorities set forth by HHS and the National Science and Technology Council (NSTC), which have called for a pivot toward vaccine technologies that provide durable, variant-resistant protection. This policy evolution reflects growing concerns about waning immunity, limited breadth of response, and manufacturing vulnerabilities associated with single-antigen platforms.
GeoVax's alignment with these priorities is reflected not only in its COVID-19 vaccine design but also in its commitment to domestic manufacturing and pandemic preparedness. GEO-CM04S1 is currently being evaluated in multiple Phase 2 clinical trials. Interim results from a Phase 2 trial in patients with chronic lymphocytic leukemia (CLL) demonstrated superior T-cell responses relative to an FDA-approved mRNA vaccine, prompting the study's independent Data Safety Monitoring Board to halt the comparator arm and continue enrollment exclusively with GEO-CM04S1.
"The future of pandemic response lies in broad, durable, and accessible solutions that meet the needs of real-world patients, not just the healthy and immunocompetent," added Dodd. "We're building a vaccine portfolio that we believe will meet this challenge, and we are encouraged by the FDA's and HHS's recognition of the need for more sophisticated vaccine approaches."
With over 40 million immunocompromised adults in the U.S. and an annual global need estimated to be in excess of 400 million, GeoVax believes GEO-CM04S1, with an estimated market potential exceeding $30 billion, is uniquely positioned to potentially capture a significant market opportunity while advancing the public health mission. Its MVA-based COVID-19 approach enables expression of multiple antigens with a well-established safety profile, making it especially well-suited for vulnerable and immunocompromised populations.
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.
