US Gov’t Grants NewLink Genetics $25 Million to Develop Merck’s Ebola Vaccine

The Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services (HHS) has issued a $24.8 million contract to a subsidiary of NewLink Genetics Corporation, an Ames, Iowa-based biopharmaceutical company focused on immuno-oncology therapeutics, to support the advanced development of an investigational Ebola Zaire vaccine candidate, rVSV∆G-ZEBOV GP, designated as V920.

The award includes an additional $51 million of contract options that may be exercised by BARDA. BARDA previously awarded $76.8 million in contracts for the development of V920. The new funding is in support of manufacturing-facility readiness, manufacturing-process qualification activities, and additional clinical trials to support regulatory approval of the V920 vaccine.

Merck & Co. has the exclusive worldwide license for the research, development, manufacturing,and distribution of the rVSV∆G-ZEBOV GP (Ebola Zaire) vaccine. In July 2016, the US Food and Drug Administration granted the V920 breakthrough therapy designation. The European Medicines Agency has also granted the vaccine candidate priority medicines status.

The rVSV∆G-ZEBOV GP (Ebola Zaire) vaccine candidate was originally engineered by scientists at the Public Health Agency of Canada and was subsequently licensed to NewLink Genetics. In late 2014, Merck licensed the vaccine from NewLink Genetics to help accelerate the development of this vaccine candidate. Merck is responsible for and involved in the research, development, manufacturing, distribution, and regulatory efforts in support of V920.

Source: NewLink Genetics Corporation

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