March 5, 2020

 

Mutual expertise drives innovations to address supply issues for vaccines for outbreak pathogens

IAVI Scientist Working at IAVI DDL in Brooklyn, New YorkOlivia Wallace, Senior Research Associate, IAVI Design and Development Laboratory, Brooklyn, New York

NEW YORK — MARCH 5, 2020 — IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, and Batavia Biosciences, a contract development and manufacturing organization focused on delivering sustainable manufacturing solutions in the field of infectious disease and cancer, today announced their partnership to accelerate the development of vaccines for emerging infectious diseases (EIDs).

By working with Batavia Biosciences to leverage their state-of-the-art manufacturing approach for highly intensified, modular vaccine production, IAVI intends to develop an end-to-end platform for flexible, low-cost production of epidemic preparedness vaccines, including vaccines against a group of viruses that cause hemorrhagic fevers and other emerging viral disease threats. Importantly, collaborating on these vaccines and developing the platform will also enable these two institutions to accelerate the development of a vaccine candidate to address the rapidly growing coronavirus disease (COVID-19) outbreak.

IAVI’s viral hemorrhagic fever vaccine candidates currently in development are to prevent disease caused by Lassa virus, Marburg virus, and Ebola Sudan virus. These agents are high-priority public health threats with high case fatality rates, as well as potential bioterrorism threats. IAVI licensed the vaccine technology underlying these vaccine candidates from the Public Health Agency of Canada (PHAC). The vaccine candidates, named rVSVΔG-LASV-GPC, rVSVΔG-MARV-GP, and rVSVΔG-SUDV-GP, respectively, are based on a recombinant vesicular stomatitis virus (VSV) vector and were developed by scientists at PHAC’s National Microbiology Laboratory. This same platform was used to produce Merck’s highly efficacious1 Ebola Zaire virus vaccine, Ervebo®, recently approved by the European Commission, the U.S. FDA, and regulators in several African countries and prequalified by the World Health Organization. Ervebo® was originally developed by PHAC scientists and advanced through clinical testing and approval by Merck & Co., Inc.

Today’s agreement builds on IAVI’s expertise in VSV vector technology that it has developed through its own VSV HIV vaccine candidate, another program on which IAVI and Batavia have collaborated for some time. Through this HIV vaccine program, IAVI has gained over a decade of experience in the development and production of viral vector vaccines, with a particular recent focus on the VSV vector approach that will be applied to develop the viral hemorrhagic fever candidates described above.

Mark Feinberg, M.D., Ph.D., IAVI president and CEO, said, “We need new partnership models and new, more flexible ways to respond to emerging infectious diseases. While the recent approval of the Ebola Zaire vaccine is a great achievement, we must be prepared for future outbreaks. We need to be creative about how we get there, and partnering with Batavia helps us achieve our shared vision of a suite of VSV-based vaccines and a secure and sustainable manufacturing solution to produce vaccines for emerging infectious diseases.”

Menzo Havenga, Ph.D., Batavia Biosciences president and CEO, said, “We are very excited to partner with IAVI and to provide cost-effective manufacturing solutions to combat disease threats that have plagued humanity far too long such as those posed by viral hemorrhagic diseases.”

The goal is to have a stable and affordable supply of vaccines for outbreak pathogens through flexible manufacturing solutions. Traditional vaccine manufacturing methods are designed for continuous, long-term production of high volumes of individual vaccines, which requires substantial investments in large-scale fixed facilities. This model is not economically practical to produce vaccines that are needed intermittently in relatively small quantities, such as for stockpiles for outbreak pathogens.

To address this challenge, a more sustainable manufacturing approach is required, and Batavia Biosciences is developing state-of-the-art, highly intensified vaccine manufacturing processes that can be applied in small footprint, low-cost, modular manufacturing facilities. Such processes are being developed for rVSVΔG-based vaccines with the goal of establishing a single rVSVΔG platform manufacturing solution. The advantage of such an approach is that it enables a rapid response and delivery of vaccines against new and emerging outbreaks as well as quickly offering surge capacity as needed to respond to larger outbreaks.

IAVI previously announced an award of $37.5M from the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense (DoD) to support further development of the Marburg vaccine candidate. DTRA works to enable the DoD, the U.S. government, and international partners to counter potential bioterrorism threats. IAVI’s VSV Lassa fever vaccine candidate is supported by CEPI, the Coalition for Epidemic Preparedness Innovations.

Much of the preclinical work on the vaccine candidates is being done 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 IAVI’s Human Immunology Laboratory at Imperial College London.

IAVI has assembled a group of international experts from leading institutions around the globe to advance these vaccine candidates. In addition to Batavia, these experts include 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 VSV HIV vaccine candidate has been made possible by many supporters, including the Bill & Melinda Gates Foundation, the Danish Ministry of Foreign Affairs, the government of Canada, Irish Department of Foreign Affairs and Trade, the Government of Japan in partnership with the World Bank, 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 through the generous support of the American people from the United States Agency for International Development (USAID).


About Batavia Biosciences
Batavia Biosciences significantly contributes to ease human suffering from infectious diseases and cancer by improving the success rate in the translation of candidate medicines from discovery to the clinic. We offer our novel technologies and in-depth know-how in order to help our partners to complete preclinical phases in biopharmaceutical product development at higher speed, reduced costs, and increased success. The company focuses on the early stages of product development including cell line generation, upstream process development (mammalian & microbial), purification development, product characterization, and clinical manufacturing. Headquartered in Leiden, the Netherlands, with a subsidiary in Woburn, Massachusetts, and offices in Hong Kong, Batavia Biosciences is privileged to have strong strategic partners worldwide. For more information visit the website.


About the Public Health Agency of Canada
The Public Health Agency of Canada empowers Canadians to improve their health. In partnership with others, its activities focus on preventing disease and injuries, promoting good physical and mental health, and providing information to support informed decision making. It values scientific excellence and provides national leadership in response to public health threats. We are a federal institution that is part of the Health portfolio.


About IAVI’s Partners in the Ebola Sudan and Marburg Vaccine 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 Center for Family Health Research/Projet San Francisco (Rwanda). Merck & Co., Inc., is a scientific advisor.

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.

 

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