GeoVax Labs, Inc. (Nasdaq: GOVX) announced on September 14, 2026, that it has entered 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 independent evaluation is expected to provide standardized immunological data that could bolster regulatory submissions and help position GEO-MVA as an additional qualified source of MVA-based vaccine supply.
Under the agreement, clinical samples from GeoVax's trial will be evaluated by CEPI's network using assays specific to orthopoxviruses, the family that includes mpox and smallpox. CEPI's network is the largest global group of laboratories dedicated to harmonizing the immunological assessment of vaccines against infectious diseases with epidemic and pandemic potential. By using the same validated methods and reporting procedures across network scientists, variability in trial readouts is minimized, enabling researchers and regulators to consistently evaluate vaccine performance. This independent, standardized testing is particularly important as GeoVax advances GEO-MVA toward its pivotal Phase 3 study, with results expected to inform ongoing clinical development and future regulatory interactions.
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 study follows Scientific Advice from the European Medicines Agency (EMA) and is designed to compare immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator. The agreement also provides a framework under which CEPI may share anonymized summaries of sample-testing results with the World Health Organization (WHO), Gavi, the Vaccine Alliance and others to further CEPI's mission to transform the world's response to epidemic and pandemic threats, including mpox.
Recent global mpox outbreaks have underscored the risks of constrained vaccine supply and the importance of expanding MVA vaccine capacity. GeoVax believes sustainable preparedness will increasingly require not only adequate vaccine stockpiles but also multiple qualified sources of supply and manufacturing capacity capable of serving different regions. The company's larger objective extends beyond developing another mpox vaccine. "The global preparedness community needs resilient MVA supply," said David Dodd, Chairman and Chief Executive Officer of GeoVax. "We believe that the data produced by CEPI's network could pave the way for an additional qualified supply source of mpox vaccine supply if we are successful in testing and licensure, reducing dependence on a single manufacturing infrastructure and ultimately enabling production capacity that can be deployed closer to the populations it is intended to protect."
Dr Amy Shurtleff, Director of Laboratory Research and Innovation Department at CEPI, noted that the Centralised Laboratory Network was set up during the COVID-19 pandemic to help reduce clinical testing differences and ensure alignment to key data that could support vaccine approvals. "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," she said. "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 will cover the full testing costs associated with the research carried out by CEPI's Centralised Laboratory Network. CEPI has not provided specific funding for the development of GEO-MVA. The agreement represents a strategic step for GeoVax as it seeks to build independent scientific evidence necessary to establish GEO-MVA as a potential additional source of MVA-based mpox vaccine supply. For more information about GeoVax, visit https://www.geovax.com. Details about CEPI and its Centralised Laboratory Network are available at https://CEPI.net.
