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. This collaboration is significant because it provides independent, standardized evaluation of immune responses, which is critical for regulatory acceptance and for establishing GEO-MVA as a qualified additional source of MVA vaccine supply amid recurring global mpox outbreaks.
The CEPI Centralised Laboratory Network is the largest global group of laboratories dedicated to harmonizing immunological assessment of vaccines against epidemic and pandemic threats. 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 testing is essential to build confidence among regulators, public-health organizations, and potential partners. As David Dodd, Chairman and CEO of GeoVax, stated, "Independent evaluation is an important step toward building confidence in GEO-MVA among regulators, public-health organizations, governments and potential strategic partners." He added that the larger objective is to create resilient MVA supply, reducing dependence on a single manufacturing infrastructure.
GeoVax expects to initiate its approximately 500-participant Phase 3 study in the fourth quarter of 2026, with results anticipated in mid-2027. The trial will compare immune responses generated by GEO-MVA with those from the licensed MVA-BN comparator, following Scientific Advice from the European Medicines Agency. The independent data from CEPI's network will inform regulatory interactions and support GeoVax's strategy to expand global access to MVA vaccines.
Dr. Amy Shurtleff, Director of Laboratory Research and Innovation at CEPI, noted that the network was established during the COVID-19 pandemic to reduce testing differences and has since expanded to evaluate thousands of samples for various 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," she said. The agreement also allows CEPI to share anonymized summaries with the World Health Organization and Gavi, the Vaccine Alliance, furthering global preparedness efforts.
The implications of this agreement extend beyond GeoVax's development program. Recent mpox outbreaks have exposed the risks of constrained vaccine supply and the need for diversified manufacturing capacity. By adding GEO-MVA as a potential second qualified MVA vaccine, global health systems could become more resilient. GeoVax will cover all testing costs, and CEPI has not provided specific funding for GEO-MVA's development. For more information, visit www.geovax.com and CEPI.net.
