NewLink Genetics announced that the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services (HHS) has exercised its $21.6m option to support continued development of the investigational rVSV-ZEBOV-GP (Ebola) vaccine candidate.
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These funds will be used to conduct clinical bridging studies to further assess the vaccine’s safety, immunogenicity and efficacy in populations different from the original testing region.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. ("Merck") (known as MSD outside the United States and Canada), holds the license for research, development, manufacturing and commercialization of the rVSV-ZEBOV-GP (Ebola) vaccine candidate.
NewLink Genetics was initially awarded a $30m contract by BARDA in December 2014, with a 25-month base period ending January 31, 2017.
To date, NewLink Genetics has received close to $53m in BARDA funding. This newly executed option brings the total to $74.6m and extends the performance period until October 11, 2017.
NewLink Genetics chairman, CEO and chief scientific officer Charles J. Link said: "BARDA is providing pivotal support and commitment to accelerated development of this Ebola vaccine candidate.
"NewLink Genetics and our partner Merck are dedicated to bringing an Ebola vaccine to patients in need. This additional funding provides resources to build on the substantial progress that has been made in gathering data critical to moving this vaccine candidate forward."
Originally developed by the Public Health Agency of Canada (PHAC), rVSV-ZEBOV-GP was subsequently licensed to a subsidiary of NewLink Genetics. In late 2014, Merck licensed the vaccine from NewLink Genetics to apply Merck’s vaccine expertise to help accelerate the development of this vaccine candidate. Clinical studies of the vaccine candidate are ongoing.