Merck obtained exclusive rights to the experimental Ebola vaccine candidate being advanced by a subsidiary of NewLink Genetics in return for joining NewLink in researching, developing, manufacturing, and distributing rVSV-EBOV, the companies said today.
The value of the collaboration was not disclosed.
Merck will be granted exclusive rights to the rVSV-EBOV vaccine candidate—which has been developed by Canadian and U.S. researchers—as well as any follow-on products arising from the collaboration with NewLink, the companies said.
“Merck's vaccine development expertise, commercial leadership and history of successful strategic alliances make it an ideal partner to expedite the development of rVSV-EBOV and, if demonstrated to be efficacious and well-tolerated, to make it available to individuals and communities at risk of Ebola virus infection around the world,” Charles J. Link, Jr., M.D., NewLink’s founder, chairman, CEO, and CSO, said in a statement.
NewLink subsidiary BioProtection Systems has been advancing rVSV-EBOV under a license from its initial developer, the Public Health Agency of Canada (PHAC). Scientists from PHAC’s National Microbiology Laboratory created the vaccine, with a significant portion of development funding to date coming from the CBRN (Chemical, Biological, Radiological, and Nuclear) Research and Technology Initiative, a federal program led by Defence Research and Development Canada.
Late last month, The Welcome Trust awarded an international consortium a grant of £3.1 million ($4.9 million) to fund trials of rVSV-EBOV, which uses an attenuated version of live vesicular stomatitis virus (VSV).
rVSV-EBOV is now being assessed in Phase I trials involving a total 335 healthy volunteers—20 in Germany, followed by 100 each in Gabon and Kenya, then 115 in Switzerland. In the U.S., Phase I trials are now underway at the Walter Reed Army Institute of Research and the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). Those trials are focused on dosage safety and immunogenicity comparison of single-injection and prime-boost regimens.
Additional Phase I studies are underway or planned to be launched in Switzerland, Germany, Kenya, and Gabon in a World Health Organization (WHO)-coordinated effort, and in Canada by the Canadian Immunization Research Network. The Canadian government has donated to the WHO 800 vials of rVSV-EBOV.
Pending results of the ongoing Phase I trials, the NIH has said it will launch in early 2015 a Phase III study to evaluate the safety and efficacy of the rVSV-EBOV vaccine, as well as another experimental Ebola vaccine co-developed by NIAID and GlaxoSmithKline.