GeoVax Labs, Inc. (Nasdaq: GOVX) announced on September 14, 2026, that it has entered into a Memorandum of Agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to access clinical trial sample testing services through the CEPI Centralised Laboratory Network. The agreement supports GeoVax's planned pivotal Phase 3 immune-bridging study of GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate targeting mpox and smallpox.
The CEPI Centralised Laboratory Network is the largest global group of laboratories dedicated to harmonizing immunological assessments of vaccines against infectious diseases with epidemic and pandemic potential. By using standardized assays and reporting procedures, the network minimizes variability in trial readouts, helping researchers and regulators consistently evaluate vaccine performance. For GeoVax, this independent evaluation is a critical step toward building confidence in GEO-MVA among regulators, public-health organizations, governments, and potential strategic partners.
"Independent evaluation is an important step toward building confidence in GEO-MVA among regulators, public-health organizations, governments and potential strategic partners," said David Dodd, Chairman and Chief Executive Officer of GeoVax. "Our agreement with CEPI provides access to a highly respected global laboratory network capable of testing and characterizing immune responses associated with GEO-MVA."
The agreement also advances GeoVax's broader strategy to diversify MVA vaccine supply. Recent global mpox outbreaks have highlighted the risks of constrained vaccine supply and the need for multiple qualified sources of manufacturing capacity. GeoVax believes that sustainable preparedness requires not only adequate stockpiles but also resilient supply chains that can serve different regions. If successful, GEO-MVA could become an additional source of mpox vaccine, reducing dependence on a single manufacturing infrastructure.
Under the agreement, clinical samples provided by GeoVax will be evaluated using assays specific to orthopoxviruses, the family to which mpox and smallpox belong. The independent, standardized immunological data generated will inform GeoVax's ongoing clinical development and future regulatory interactions. The agreement also allows CEPI to share anonymized summaries of sample-testing results with the World Health Organization (WHO), Gavi, the Vaccine Alliance, and others to further its mission to transform the world's response to epidemic and pandemic threats.
"CEPI's Centralised Laboratory Network was set up during the COVID-19 pandemic to help reduce clinical testing differences that can emerge from independent laboratory review to instead ensure easy access and alignment to key data that could support vaccine approvals," said Dr. Amy Shurtleff, Director of Laboratory Research and Innovation Department at CEPI. "It has rapidly expanded since then, with vaccine developers around the world using the service to evaluate thousands of their samples produced during trials of promising vaccine candidates against other deadly pathogens, including mpox. Our new agreement with GeoVax enables the company to access validated, high-quality mpox testing tools that could fast-track its promising GEO-MVA mpox vaccine through development and give the world further options to fight this harmful, recurring disease."
GeoVax expects to initiate its approximately 500-participant pivotal Phase 3 immune-bridging study in the fourth quarter of 2026, with results expected in mid-2027. The company will cover the full testing costs associated with the research carried out by CEPI's network; CEPI has not provided specific funding for the development of GEO-MVA.
The agreement matters because it could accelerate the development of a second qualified MVA-based mpox vaccine, offering a capital-efficient regulatory pathway and expanding global supply. The independent validation by CEPI's network may also facilitate broader acceptance and faster approval, ultimately enhancing global preparedness against orthopoxvirus threats. For more information, visit GeoVax's website and CEPI's website.
