Award from U.S. Department of Defense to Advance Marburg Virus Vaccine Candidate Development

NEW YORK — NOVEMBER 12, 2019 — IAVI announced today the award of $35.7M from the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense (DoD) to develop a recombinant vesicular stomatitis virus (VSV) vector Marburg virus vaccine candidate. This award builds on IAVI’s expertise in VSV vector technology that it has developed through its own VSV HIV vaccine candidate and VSV Lassa fever vaccine candidate, which are in preclinical development. The Marburg virus vaccine candidate, licensed by IAVI from the Public Health Agency of Canada, demonstrated strong protection from the deadly disease in non-human primate studies.

Kevin Wright, Senior Research Associate, IAVI Design and Development Laboratory in Brooklyn, New York. Photo credit: IAVI

Marburg virus is a public health threat that has a high case fatality rate, and it is a potential bioterrorism threat. The World Health Organization has identified Marburg virus disease, along with other viral hemorrhagic fevers, as a priority for research and development because of its epidemic potential and because there are insufficient countermeasures to prevent and treat it. The U.S. Centers for Disease Control has classified Marburg virus as a Category A bioterrorism threat – a high-priority agent that poses a risk to national security.

Mark Feinberg, M.D., Ph.D., president and CEO of IAVI, said, “IAVI looks forward to applying more than a decade of our experience in viral vector vaccines to hasten the development of this viral hemorrhagic fever vaccine candidate, and we are grateful to the U.S. Department of Defense for its support of this critical work. Beyond Marburg virus disease, we are hopeful that this innovative vaccine science could potentially be used in a range of vaccines for emerging infectious diseases.”

The Marburg virus vaccine candidate rVSVΔG-MARV-GP is based on the same VSV platform as Merck’s Ebola Zaire virus vaccine candidate that was tested during the 2014-2016 Ebola outbreak and is currently being used in the Ebola outbreak in the Democratic Republic of the Congo. As a vaccine vector, VSV delivers a gene from the target pathogen designed to lead to a long-lasting immune response in the recipient. Data from an efficacy trial in Guinea of the Ebola Zaire virus vaccine candidate indicates that vaccine efficacy is as high as 100%.¹

Much of the preclinical work on the Marburg virus vaccine candidate will be performed by scientists at IAVI’s Vaccine Design and Development Laboratory (DDL) in Brooklyn, New York, which is home to IAVI’s VSV vaccine preclinical development. With its facilities and expertise, the DDL conducts the applied research required to advance promising experimental vaccines from the lab to a stage at which they can meet the regulatory agency guidance associated with production of a clinical trial candidate. In addition, critical work to validate the key assays needed to measure immune responses in clinical trials will be done at the IAVI Human Immunology Laboratory, based at Imperial College London.

“By continuing to build on our years of expertise with the VSV platform and partnering with innovative institutions, we will strengthen our ability to conduct end-to-end product development for this promising platform and get closer to our vision to deliver effective vaccines to the people who need them most,” said Swati Gupta, Dr.P.H., M.P.H., vice president of research integration and innovation at IAVI.

IAVI has assembled a group of international experts from leading institutions around the globe to advance this vaccine candidate. These experts include an innovative manufacturing partner, Batavia Biosciences, based in Leiden, Netherlands; members of the Viral Hemorrhagic Fever Consortium with its decades of experience researching Lassa, Marburg, and Ebola viruses; preclinical investigators working on cutting-edge immunological assays; and experienced clinical trial sites in the U.S. and Africa.

IAVI’s expertise in VSV vector technology emerges from its work on other VSV vector vaccine candidates. IAVI’s VSV HIV vaccine candidate has been made possible by many supporters, including the Bill & Melinda Gates Foundation, the Danish Ministry of Foreign Affairs, the Irish Department of Foreign Affairs and Trade, the Japanese Ministry of Finance, the Louis & Rachel Rudin Foundation, the Netherlands Ministry of Foreign Affairs, the Norwegian Agency for Development Cooperation, the Starr Foundation, the U.K. Department for International Development, the U.S. National Institutes of Health (NIH), and the World Bank, and through the generous support of the American people from the United States Agency for International Development (USAID). IAVI’s VSV Lassa fever vaccine candidate is supported by CEPI, the Coalition for Epidemic Preparedness Innovations.

About IAVI’s Partners in the Marburg Vaccine Candidate Development Program
IAVI’s research partners in this vaccine program are investigators at the Center for Global Infectious Disease Research; La Jolla Institute for Immunology; Ragon Institute of MIT, MGH, and Harvard; Tulane University; and University of Texas Medical Branch. The manufacturing partner is Batavia Biosciences. Clinical research partners in the U.S. and Africa are George Washington University, KAVI-Institute of Clinical Research (Kenya), Kenema Government Hospital (Sierra Leone), MRC/UVRI and LSHTM Uganda Research Unit, National Public Health Institute of Liberia, and Projet San Francisco (Rwanda). Merck & Co., Inc., is a scientific advisor.

About the Defense Threat Reduction Agency
The Defense Threat Reduction Agency enables the Department of Defense, the United States Government, and international partners to counter and deter weapons of mass destruction (WMD) and improvised threat networks.

Countering WMD and improvised threats is a global problem that requires DTRA’s unique global presence and execution capabilities. As a Combat Support Agency, DTRA provides various forms of support to the Combatant Commands (CCMDs) and the military services with both defensive and offensive capabilities. The agency is uniquely prepared to address some of the most immediate, consequential, and non-conventional weapon threats to national security through leveraging and expanding collaboration with interagency and international partners.

As the DoD’s research and development leader focused on WMD and improvised threats, DTRA facilitates innovation through combining traditional research with unconventional means to develop and quickly field solutions to the most complex, deadly and urgent threats facing the United States and the rest of the world.

DTRA has over 2,000 uniformed military personnel and DoD civilians working on every continent except Antarctica. The agency has thousands of global engagements in more than 100 countries and in addition to multiple locations stateside and overseas, the agency has liaisons in many embassies.

¹Henao-Restrepo AM, Camacho A, Longini IM, Watson CH, Edmunds WJ, Egger M, Carroll MW, Dean NE, Diatta I, Doumbia M, Draguez B. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!). Lancet. 2017 Feb 4;389(10068):505-18.