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01/10/2019 10:13

Sabin Vaccine Institute Receives $20.5 Million From BARDA With Potential of up to $128 Million to Develop Ebola Sudan and Marburg Vaccines


WASHINGTON, Oct. 01, 2019 (GLOBE NEWSWIRE) -- The Sabin Vaccine Institute (Sabin) today announced a funding award of $20.5 million with options for an additional $107.5 million from the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services. Under the terms of this agreement, the full program is expected to advance development of clinical-stage monovalent vaccines against Ebola Sudan and Marburg viruses through Phase 2 clinical trials.



Ebola Sudan and Marburg are among the worlds deadliest viruses, causing hemorrhagic fever with subsequent death in an average of 50 percent of cases.1,2 A closely related strain, Ebola Zaire, has caused more than 2,000 deaths in the past year during the ongoing outbreak in the Democratic Republic of Congo (DRC),3 leading the World Health Organization to declare it a Public Health Emergency of International Concern.4 With Ebola Sudan and Marburgs own history of outbreaks and their potential for future devastating outbreaks, preventative measures are overdue to protect civilian populations, military personnel, first responders, healthcare workers and laboratory workers, both in the United States and abroad, against these emerging infectious diseases.


Vaccines are the most effective shield we can use against Ebola and Marburg viruses, both of which have a long history of deadly outbreaks, said Sabin Chief Executive Officer Amy Finan. In the years ahead, we hope to make available the reliable protection every man, woman and child needs to defend themselves against these life-threatening diseases.


The BARDA funding will enable Sabin to advance the investigational Ebola Sudan and Marburg vaccines using the ChAd3-based platform recently licensed under an agreement between GSK and Sabin. Building on the immunogenicity and safety demonstrated in recent Phase 1 clinical trials by the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, Sabin aims to advance the ChAd3 vaccines in pursuit of licensure and stockpiling. Under the terms of the agreement, the initial $20.5 million award supports process development and non-clinical activities. Additional non-clinical studies, as well as manufacturing of clinical material and Phase 2 clinical trials in the United States and Africa, may be supported by $107.5 million in additional funding.


This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C000555. 


Learn more about Sabins Ebola Sudan and Marburg program.


Citations:
[1] WHO fact sheet, Ebola virus disease, accessed August 28, 2019 available at: https://www.who.int/news-room/fact-sheets/detail/ebola-virus-disease
[2] WHO fact sheet, Marburg virus disease, accessed August 28, 2019 available at: https://www.who.int/news-room/fact-sheets/detail/marburg-virus-disease
[3] WHO, Ebola in the Democratic Republic of the Congo Health Emergency Update, accessed August 28, 2019 available at: https://www.who.int/emergencies/diseases/ebola/drc-2019
[4] WHO press release, Ebola outbreak in the Democratic Republic of the Congo declared a Public Health Emergency of International Concern, accessed August 28, 2019 available at: https://www.who.int/news-room/detail/17-07-2019-ebola-outbreak-in-the-democratic-republic-of-the-congo-declared-a-public-health-emergency-of-international-concern


About the Sabin Vaccine Institute


The Sabin Vaccine Institute, a non-profit organization founded in 1993, is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Sabins R&D strategy focuses on continuing the development of candidate vaccines that have demonstrated early scientific value and target disease primarily impacting the world's most vulnerable populations, but have little commercial value. The Blavatnik Family Foundation and the David E.I. Pyott Foundation provided seed funding to launch Sabins ChAd3 Ebola program. In past years, Sabin received more than $110 million for vaccine R&D programs from public and philanthropic funding sources, including the Bill & Melinda Gates Foundation, European Commission, Dutch Ministry of Foreign Affairs, Global Health Innovative Technology Fund and the Michelson Medical Research Foundation.


Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on Twitter, @SabinVaccine.


About the GSK-Sabin ChAd3 Transaction


In August 2019, GSK and Sabin entered agreements for Sabin to advance the development of the prophylactic candidate vaccines against Ebola Zaire, Ebola Sudan and Marburg viruses. Under the agreements, Sabin exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013. The candidate vaccines, based on GSKs proprietary ChAd3 platform, were further developed by GSK, including the Phase 2 development for the Ebola Zaire vaccine. The ChAd3-based vaccines have demonstrated strong safety profiles and encouraging immunogenicity results after being administered to more than 5,000 adults and 600 children in 13 different clinical trials to date.


About Ebola Sudan and Marburg


Ebola Sudan and Marburg are members of the Filoviridae virus family and are commonly referred to as filoviruses. Both can cause severe hemorrhagic fever in humans and nonhuman primates. No therapeutic treatment of the hemorrhagic fevers caused by filoviruses has been licensed to date.


Marburg and Ebola viruses are transmitted to humans by infected animals, particularly fruit bats. Once a human is infected, the virus can spread to others through close personal contact or contact with bodily fluids. Isolation of infected people is currently the centerpiece of filovirus control.


Marburg was the first filovirus to be recognized in 1967 when a number of laboratory workers, including some in Marburg, Germany, developed hemorrhagic fever. Ebola was identified in 1976 when two simultaneous outbreaks occurred in northern Zaire (now the DRC) in a village near the Ebola River and southern Sudan. The outbreaks involved what eventually proved to be two different species of Ebola virus; both were named after the nations in which they were discovered.


Media Contact:
Zach Barehmi
1-321-946-6927
zach.barehmi@porternovelli.com




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