Date: 2016-10-04
Type of information: Grant
Company: NewLink Genetics (USA - IO)
Investors: Biomedical Advanced Research and Development Authority (USA)
Amount: $24.8 million
Funding type: grant
Planned used: The funds will be used to support the advanced development of the investigational rVSV?G-ZEBOV GP (Ebola Zaire) vaccine candidate, designated 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. The rVSV?G-ZEBOV GP (Ebola Zaire) vaccine candidate was originally engineered by scientists at the Public Health Agency of Canada (PHAC) and was subsequently licensed to 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. Merck is responsible for and involved in the research, development, manufacturing, distribution and regulatory efforts in support of V920. Clinical studies of the vaccine candidate are ongoing.
Others: * On October 4, 2016, NewLink Genetics announced that the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services (HHS) has issued a $24.8 million contract to a subsidiary of NewLink Genetics to support the advanced development of the investigational rVSV?G-ZEBOV GP (Ebola Zaire) vaccine candidate, designated V920. The new award includes an additional $51 million of contract options which may be exercised by BARDA. BARDA has previously awarded $76.8 million in contracts for development of V920. Merck&Co has the exclusive worldwide license for research, development, manufacturing and distribution of the rVSV?G-ZEBOV GP (Ebola Zaire) vaccine. In July 2016, the two companies reported on two key regulatory milestones for V920. The FDA granted the V920 Breakthrough Therapy Designation, and the European Medicines Agency (EMA), PRIME (PRIority MEdicines) status.
Therapeutic area: Infectious diseases
