GeoVax Labs, Inc. (Nasdaq: GOVX) has entered a Memorandum of Agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) that grants the company access to the CEPI Centralised Laboratory Network for independent testing of clinical trial samples. The arrangement 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 agreement matters because it introduces independent, standardized immunological evaluation into a late-stage vaccine program at a time when global mpox outbreaks have exposed vulnerabilities in vaccine supply chains.
The CEPI Centralised Laboratory 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 methods and validated assays across network scientists, the possibility of variability in trial readouts is minimized, helping researchers and regulators consistently evaluate vaccine performance. For GeoVax, this independent evaluation is intended to build confidence among regulators, public-health organizations, governments, and potential strategic partners. "Independent evaluation is an important step toward building confidence in GEO-MVA," 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 broader strategic objective extends beyond developing another mpox vaccine. Dodd noted that the global preparedness community needs resilient MVA supply. Data produced by CEPI's network could pave the way for an additional qualified supply source if GeoVax is successful in testing and licensure, reducing dependence on a single manufacturing infrastructure and enabling production capacity closer to affected populations. Recent mpox outbreaks have underscored the risks of constrained vaccine supply, and GeoVax believes sustainable preparedness will require multiple qualified sources of supply and manufacturing capacity capable of serving different regions.
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 nature of the testing is particularly important as GeoVax advances GEO-MVA toward its pivotal Phase 3 study. Results generated through CEPI's network will provide independently generated and standardized immunological data to inform ongoing clinical development and future regulatory interactions. "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," said Dr. Amy Shurtleff, Director of Laboratory Research and Innovation Department at CEPI.
The agreement also provides a framework under which CEPI may share anonymized summaries of sample-testing results with the World Health Organization, Gavi, the Vaccine Alliance and others to further CEPI's mission to transform the world's response to epidemic and pandemic threats. GeoVax will cover the full testing costs, and CEPI has not provided specific funding for GEO-MVA development. 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 is pursuing an immune-bridging strategy following Scientific Advice from the European Medicines Agency, comparing immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator.
The collaboration reflects a growing emphasis on independent, harmonized laboratory assessment as a foundation for regulatory and public-health decisions. For CEPI, which launched the Centralised Laboratory Network during the COVID-19 pandemic, the agreement adds another vaccine developer to a network that has already served over 60 developers and processed more than 120,000 samples. For GeoVax, the deal represents a step toward establishing GEO-MVA as a potential additional source of MVA-based mpox vaccine supply. More information is available at www.geovax.com and CEPI.net.
