GeoVax Labs, Inc. (Nasdaq: GOVX) has entered into a Memorandum of Agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to utilize the CEPI Centralised Laboratory Network for independent testing of clinical trial samples from its planned pivotal Phase 3 immune-bridging study of GEO-MVA, the company's Modified Vaccinia Ankara (MVA)-based vaccine candidate targeting mpox and smallpox. The agreement, announced on September 14, 2026, represents a significant step in the development of GEO-MVA and underscores the importance of independent evaluation in building confidence among regulators, public-health organizations, and potential strategic partners.
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 standardized assays and reporting procedures, the network minimizes variability in trial readouts, helping researchers and regulators consistently evaluate vaccine performance. For GeoVax, access to this network supports its broader strategic objective: establishing GEO-MVA as an additional qualified source of MVA-based mpox vaccine supply. Recent global mpox outbreaks have highlighted the risks of constrained vaccine supply and the need for diversified vaccine capacity. GeoVax believes that sustainable preparedness requires not only adequate stockpiles but also multiple qualified sources of supply and manufacturing capacity capable of serving different regions.
"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." Dodd continued, "But the larger objective extends beyond development of 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, 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."
Under the agreement, clinical samples provided by GeoVax will be evaluated through the CEPI Centralised Laboratory Network using assays specific to orthopoxviruses, the family of viruses 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 laboratory network will provide independently generated and standardized immunological data that will inform GeoVax's ongoing clinical development and future regulatory interactions.
"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."
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 diseases like mpox. 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.
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. Following Scientific Advice from the European Medicines Agency (EMA), GeoVax is pursuing an immune-bridging development strategy that is intended to compare immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator. The company believes GEO-MVA has the potential to become an important strategic preparedness asset by providing governments and international public health organizations with an additional, reliable source of MVA vaccine to support biosecurity and orthopoxvirus preparedness.
CEPI is an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. Central to CEPI's pandemic-beating plan is the '100 Days Mission' to develop safe, effective and accessible vaccines against new threats in just 100 days. Learn more at CEPI.net. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.
