GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company, 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 partnership matters because it provides independent, standardized evaluation of immune responses, which is critical for regulatory acceptance and for establishing GEO-MVA as a potential 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 supports a broader strategic objective: building the scientific evidence needed to position GEO-MVA as a second qualified source of MVA-based mpox vaccine, reducing dependence on a single manufacturing infrastructure and enabling production capacity closer to at-risk populations.
“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 CEO 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.” Dodd added that the larger objective extends beyond another mpox vaccine: “The global preparedness community needs resilient MVA supply. 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.”
Under the agreement, clinical samples from GeoVax will be evaluated using assays specific to orthopoxviruses, the family that includes mpox and smallpox. The independent nature of the testing is particularly important as GeoVax advances GEO-MVA toward its pivotal Phase 3 study. Results will provide independently generated and standardized immunological data to inform 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, including mpox.
“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 Centralised Laboratory Network. CEPI has not provided specific funding for the development of GEO-MVA. For more information, visit www.geovax.com and CEPI.net.
