Company’s Advanced Manufacturing Proposal Supports National Biosecurity Goals and Executive Action on Domestic Pharmaceutical Supply Chains
ATLANTA, GA - May 6, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against infectious diseases and solid tumors, today voiced strong support for the Executive Order signed by President Trump on May 5, 2025, aimed at restoring a robust U.S. pharmaceutical manufacturing base and reducing America’s reliance on foreign supply chains.
The Order directs the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and other agencies to streamline approvals for domestic pharmaceutical manufacturing, reduce foreign dependence, and fast-track U.S. supply chain resilience - a mission long championed by GeoVax. These actions align directly with GeoVax’s commitment to strengthening U.S. biosecurity through domestic, scalable vaccine production technologies.
David Dodd, Chairman and CEO of GeoVax, stated, “We commend the Administration’s leadership in restoring America’s pharmaceutical manufacturing independence. The COVID-19 pandemic and Mpox outbreaks exposed the fragility of foreign-dominated supply chains, particularly in vaccine manufacturing. GeoVax has taken a lead in addressing these risks with our U.S.-based GEO-MVA vaccine program and our advanced manufacturing process designed for national resiliency.”
Advancing U.S.-Based Biomanufacturing Through the RRPV
In alignment with the Executive Order, GeoVax’s advanced MVA manufacturing strategy has already been recognized by the U.S. Department of Health and Human Services (HHS) through the BARDA-funded Rapid Response Partnership Vehicle (RRPV). GeoVax’s proposal - “Innovation in Clinical Manufacturing of MVA-Vectored COVID-19 Vaccines” - was selected for funding (pending availability) and is designed to establish a next-generation U.S.-based MVA manufacturing process using a continuous avian cell line (AGE1) to replace traditional egg-based systems.
GeoVax’s proposed AGE1-based process is tailored to eliminate the lengthy production cycles, limited scalability, and foreign sourcing issues that plague current vaccine manufacturing infrastructure. The process is designed to:
- Replace supply chain-intensive egg-based production.
- Enable rapid, high-volume MVA vaccine output.
- Operate within existing GMP-compliant U.S. infrastructure.
- Shorten deployment timelines from years to months.
- Anticipated to significantly reduce production costs.
GeoVax’s advanced MVA manufacturing process directly addresses key gaps cited in the Executive Order, including long permitting timelines, foreign dependence for active pharmaceutical ingredients (APIs), and lack of domestic surge capacity - significantly reducing production timelines and enabling rapid scale-up during pandemics or biodefense emergencies.
Dodd added, “The President’s Executive Order sends a clear signal: the United States must regain control of its vaccine manufacturing capacity and capability. GeoVax stands ready to help fulfill that directive. Our advanced MVA manufacturing process can be implemented rapidly to deliver on the President’s call for pharmaceutical independence and national resiliency. It reduces dependence on a single foreign supplier, shortens production timeframes from months to weeks, and can be housed within existing U.S. infrastructure.”
Complementing National Preparedness with Proven Vaccine Technologies
GeoVax’s MVA process is central to its pipeline of multi-antigen vaccines, including GEO-CM04S1 for COVID-19 and GEO-MVA for Mpox and smallpox. These vaccines address critical shortcomings in first-generation products - offering improved durability, T-cell immunity, and safety for immunocompromised populations. The company is currently conducting three Phase 2 clinical trials for GEO-CM04S1 and preparing for clinical advancement of GEO-MVA in the second half of 2025.
GeoVax’s commitment to multi-antigen vaccine development is also closely aligned with current HHS leadership priorities. In a recent interview, the HHS Secretary emphasized a shift in federal focus away from single-antigen vaccines toward more robust, multi-antigen strategies for respiratory illnesses. GeoVax’s MVA-based vaccines - GEO-CM04S1 and GEO-MVA - are purpose-built to meet this demand, offering broader immune protection, increased durability, and enhanced efficacy in vulnerable populations.
With bipartisan momentum toward re-shoring essential health infrastructure, GeoVax stands ready to partner with HHS, BARDA, and other federal agencies to fulfill the Executive Order’s vision of a self-reliant pharmaceutical manufacturing ecosystem.
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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