Batavia Biosciences would like to congratulate IAVI on their press release, as today they’ve announced volunteers in Monrovia, Liberia have been vaccinated with IAVI’s novel vaccine candidate against Lassa fever virus (LASV) in a Phase I clinical trial, named IAVI C102, supported by the Coalition for Epidemic Preparedness Innovations (CEPI).
‘LASV causes significant annual outbreaks of an acute viral illness called Lassa fever, which is endemic in many parts of West Africa. Outbreaks in Guinea, Liberia, Nigeria, Sierra Leone, South Africa, and Togo have resulted in nearly 6,000 suspected cases and more than 180 deaths since early 2022, according to reports by the World Health Organization (WHO).’
IAVI’s LASV vaccine candidate was manufactured by Batavia in Leiden, The Netherlands. As a contract-development and manufacturing organization focused on delivering sustainable, low-cost manufacturing solutions in the field of infectious disease and cancer, we intend to continue to strengthen our partnership with IAVI and continue to develop an end-to-end platform for more flexible, low-cost production of epidemic preparedness vaccines.
Congratulations to everyone involved in helping reduce human suffering from infectious diseases
Link to IAVI Press Release
Mutual expertise drives innovations to address supply issues for vaccines for outbreak pathogens
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 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 is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV, tuberculosis, and emerging infectious diseases. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more at iavi.org.
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, 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.
Grant from the Bill & Melinda Gates Foundation will support Univercells and partner Batavia Biosciences to develop a cost-effective manufacturing process and proceed towards the successful commercialization of measles and rubella vaccines.
BRUSSELS, BELGIUM – JUNE, 13 2019
Univercells announced today that it has been awarded a $14.3 million grant by the Bill & Melinda Gates Foundation to increase the availability of measles and rubella (M&R) vaccines in low- and middle-income countries (LMICs). Univercells will adapt the process design of its proprietary NevoLine™ platform to deliver affordable M&R vaccines. This novel manufacturing platform has already proven success with its initial application for Sabin inactivated polio vaccine (sIPV), supported by a $12M Grand Challenges grant awarded by the Bill & Melinda Gates Foundation.
Viral infectious diseases, such as measles and rubella, still represent a significant global health burden despite preventability via vaccination. Effective vaccination programs in LMICs are impaired by a substantial gap of affordable vaccines. Conventional vaccine manufacturing requires high capital and operating costs and does not provide a sustainable or cost-effective solution for the future. Univercells will leverage its NevoLine bioproduction platform to sustainably supply measles and rubella vaccines at an affordable cost by minimizing equipment and facility related capital investment together with lower operating costs.
Under the terms of the agreement, Univercells will develop a NevoLine platform for the measles and rubella processes and initiate clinical validation. As part of this project, Univercells’ partner Batavia Biosciences will adapt its highly intensified production process to the M&R vaccines and manufacture GMP material. Univercells will also explore utilizing novel vaccine delivery technologies under evaluation by the foundation. Combining innovations could further reduce costs, facilitate the execution of immunization campaigns and improve accessibility of critical vaccines.
“We are very honored to receive this grant and work once again with the Bill & Melinda Gates Foundation to increase affordability of the measles-rubella vaccine, another critical vaccine especially in view of the recent outbreaks worldwide”, said Hugues Bultot, CEO and co-founder of Univercells. “We are dedicated to delivering a portfolio of viral vaccines such as inactivated polio, measles and rubella and other undersupplied vaccines to further increase the availability of these life-saving products.”
José Castillo, CTO and co-founder of Univercells added “This second project with the foundation confirms the trust built upon our breakthrough technology. It enables Univercells to demonstrate the potential of our NevoLine manufacturing platform to be a game-changer for global health”.
Leiden, the Netherlands, May 14, 2019 – Batavia Biosciences announced today that it will work together in a consortium including the European Vaccine Initiative and Stanford University, icddr,b, and headed by the University of Tokyo, to develop an epidemic preparedness vaccine against the Nipah virus. For this purpose, the University of Tokyo received a $31 million grant from the Coalition for Epidemic Preparedness (CEPI) – which finances and coordinates the development of vaccines against infectious disease – to use its Measles vector technology to develop and stockpile a Nipah vaccine.
There is currently no effective medical countermeasure against the Nipah virus and therefore it is listed as one of the main priorities of the WHO. The virus is prevalent in Southeast Asia and the Indian subcontinent and causes illness ranging from fever and headache, to acute respiratory illness, and even fatal encephalitis. The Nipah virus is also known to cause severe disease in domestic pigs, resulting in significant regional economic loss. “The need for effective medical intervention strategies against this virus is huge and therefore, we are very excited to be working with the consortium in developing a Nipah vaccine”, says Dr. Menzo Havenga, President & CEO of Batavia Biosciences.
As partner in the consortium, Batavia will receive $9.6 million to deliver a low-cost manufacturing process that can be easily applied for stockpiling of the Nipah vaccine.
Dr. Christopher Yallop, Chief Operations and Scientific Officer at Batavia Biosciences elaborates: “We will deploy our High Intensity Process technology in combination with the NevoLine™ production technology (Univercells; Belgium) to develop a manufacturing process, deliver GMP drug product for clinical trials, and transfer the process to a Developing Country Vaccine Manufacturer for stockpiling purposes. We are excited that after years of developing our highly intensified manufacturing platform, we are now taking the next step to strengthen global health initiatives.”
About Batavia Biosciences
Batavia Biosciences significantly contributes to the easing of human suffering from infectious diseases 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, 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.
About the Nipah virus
Nipah virus belongs to the Paramyxoviridae family of viruses, genus Henipavirus, alongside Hendra virus. Nipah is a zoonotic disease, meaning it passes from animals to humans. The natural hosts of the virus are fruit bats of the genus Pteropus. Nipah virus can be spread through contact with infected persons or animals.
Nipah virus infection can cause severe, rapidly progressive illness that affects the respiratory system and the central nervous system, including inflammation of the brain (encephalitis). Symptoms begin between five and 14 days after infection, and include fever, altered mental state, cough and respiratory problems.
People are advised to avoid contact with ill pigs and bats in countries where Nipah virus is known to occur. They are also advised to avoid drinking raw date palm sap, which can be infected with bodily fluids from bats. There are currently no vaccines or therapeutics against Nipah virus approved for use in humans.
About the University of Tokyo
The University of Tokyo was established in 1877 as the first national university in Japan. UTokyo is Japan’s leading university and one of the world’s top research universities. The vast research output of some 6,000 researchers is published in the world’s top journals across the arts and sciences. Our vibrant student body of around 15,000 undergraduate and 15,000 graduate students includes over 2,000 international students.
Find out more at http://www.u-tokyo.ac.jp/en/ or follow us on Twitter at develop-vector-based-vaccine-nipah-virus/ @UTokyo_News_en.
Brussels, Belgium, December 15, 2016 – Univercells announced today that it has been awarded a $12 million grant by the Bill & Melinda Gates Foundation for the development of a breakthrough vaccine manufacturing platform with the objective of radically lowering costs and increasing vaccine availability and affordability in developing countries. The development will be performed by a consortium which also includes Batavia Biosciences and Natrix Separations.
Hugues Bultot, CEO and co-founder of Univercells said: “We are extremely honoured to partner with the Gates Foundation to significantly increase global access to priority vaccines by lowering their manufacturing cost”.
Vaccines are a powerful contributor to the improvement of global health, with corresponding economic and societal value in averted costs, productivity gains and poverty reduction. A number of factors limit complete global immunization coverage, including prohibitive costs for procuring and distributing vaccines in lower income countries. A substantial reduction in the cost of manufacturing vaccines could help enable affordable, equitable and sustainable immunization on a global scale.
Under the terms of the agreement, the consortium will develop a manufacturing platform that integrates continuous processing with extremely high process intensification. This combination allows miniaturization of commercial manufacturing to the point where it can be performed in locally deployed, self-contained, small footprint, low-cost micro-facilities. The platform will leverage Univercells’ process intensification and integration capabilities and technologies; Natrix’s novel single-use chromatography membrane platform; and Batavia’s vaccine development and manufacturing capabilities. The initial target is to establish a micro-facility for inactivated polio vaccine (sIPV) that can deliver 40 million doses of trivalent vaccine per year at a manufacturing cost of less than $0.15 per dose. The platform concept can be applied to any viral vaccine and the reduced scale and simplified operations that it delivers will lower the hurdles for vaccine manufacturers in developing countries while maintaining high safety and containment.
José Castillo, CTO and co-founder of Univercells, stated: “We are excited about this partnership with the Bill & Melinda Gates Foundation. With Batavia Biosciences and Natrix Separations, our consortium integrates considerable experience, know-how and innovative but proven technologies that tremendously increase manufacturing productivity. As a result, we expect our integrated platform to be a real game-changer for global health.”