Date: 2014-12-22
Type of information: Grant
Company: NewLink Genetics (USA - IO) Merck&Co (USA - NJ)
Investors: Biomedical Advanced Research and Development Authority (USA)
Amount: $30 million
Funding type: grant
Planned used: The contract will support the manufacturing and development activities of the investigational rVSV-EBOV (Ebola) vaccine candidate, including clinical development through a new 330-person Phase Ib study. The vaccine candidate was initially developed by the Public Health Agency of Canada (PHAC), and is now being developed under an exclusive licensing and collaboration agreement between NewLink Genetics and Merck. The rVSV-EBOV (Ebola) vaccine candidate is currently being evaluated in Phase I clinical studies in humans. Pending the results of Phase I trials underway, the US National Institutes of Health has announced plans to initiate, in early 2015, a large randomized, controlled Phase II/III study to evaluate the safety and efficacy of this and another investigational Ebola vaccine candidate. This vaccine platform is based on attenuated strains of vesicular stomatitis virus, a common animal virus, that has been modified to express an Ebola virus protein and which is non-pathogenic in primates and mice. This vaccine was initially developed by the Public Health Agency of Canada (PHAC) with a significant portion of the funding coming from the CBRN Research and Technology Initiative, a federal program led by Defence Research and Development Canada, the research arm of Canada\'s Department of National Defence, which funded work at the PHAC\'s National Microbiological Laboratory resulting in the creation of the experimental vaccine, rVSV-ZEBOV-GP (BPSC1001). In 2010, PHAC signed a licensing arrangement with BioProtection Systems (BPS), a wholly-owned subsidiary of NewLink Genetics, as the sole licensee for these vaccines and the underlying technology.Dec 22, 2014.
Others: * On December 22, 2014, NewLink Genetics Corporation and Merck & Co announced that the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services (HHS) has awarded NewLink Genetics\' wholly-owned subsidiary, BioProtection Systems, as the prime contractor in a $30 million contract to support the manufacturing and development activities of its investigational rVSV-EBOV (Ebola) vaccine candidate, including clinical development through a new 330-person Phase Ib study.
Therapeutic area: Infectious diseases
