NewLink Genetics said today it will receive $20 million from Merck & Co. for achieving a key clinical development milestone in their collaboration to co-develop the experimental Ebola vaccine candidate rVSV-EBOV—namely the launch of a large-scale clinical trial.

Earlier this month, NIH announced the launch of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), a Phase II/III study in which approximately 27,000 healthy men and women aged 18 years and older are being assessed for their response following assignment at random to placebo or any of two Ebola vaccine candidates—rVSV-EBOV, and cAd3-EBOZ.

cAd3-EBOZ was co-developed by scientists at NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) and GlaxoSmithKline (GSK), and is being manufactured by GSK Biologicals.

In addition to healthy adults in the general population, the trial will seek volunteers from groups at particular risk of Ebola infection, including health care workers, communities with ongoing transmission, contact tracers and members of burial teams, the NIH said.

“We hope that the initiation of large scale clinical trials in Africa represent another step forward toward finding a solution for this difficult, global problem. This milestone payment will help us continue our significant investment into vaccines for infectious diseases, including Ebola in collaboration with Merck,” Charles J. Link, Jr., M.D., NewLink’s founder, chairman, CEO, and CSO, said today in a statement announcing the milestone.

Merck obtained exclusive rights to rVSV-EBOV from NewLink in November in return for joining NewLink in researching, developing, manufacturing, and distributing the vaccine. In addition to the up-to-$20 million milestone payment, Merck also agreed to pay NewLink $30 million upfront, according to a NewLink regulatory filing. NewLink also said it was eligible for tiered royalties on sales of the vaccine “in certain markets, subject to certain conditions.”

In December, NewLink subsidiary BioProtection won a $30 million contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) toward supporting manufacturing and development activities of rVSV-EBOV.

Earlier trials of rVSV-EBOV have been funded by The Wellcome Trust, which in October awarded an international consortium a grant of £3.1 million ($4.8 million) toward those studies. rVSV-EBOV has also been assessed in Phase I trials in Germany, Gabon, Kenya, and Switzerland, in a World Health Organization (WHO)-coordinated effort, as well as in a Phase I trial in the U.S. by the Walter Reed Army Institute of Research and NIAID.

BioProtection Systems has been advancing rVSV-EBOV under a license from its initial developer, the Public Health Agency of Canada (PHAC). NewLink said PHAC will be entitled to a payment in connection with the milestone; the amount was not disclosed.

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.

A third Ebola vaccine candidate began Phase I clinical trials in January—a prime-boost Ebola vaccine regimen that combines AdVac® technology from Crucell Holland, part of Johnson & Johnson’s Janssen Pharmaceutical Cos., and Bavarian Nordic’s MVA-BN® Filovirus vaccine candidate. The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics.

J&J said at the time that more than 400,000 regimens of the prime-boost vaccine had been produced with Bavarian Nordic for use in large-scale clinical trials by April 2015, with a total of 2 million regimens available through the course of 2015. The companies said they had the ability to quickly scale up to 5 million regimens, if required, over a 12- to 18-month period.

Janssen has formed several consortia with global research institutions and non-government organizations (NGOs). The consortia are being funded through more than €100 million (about $113.8 million) in grants from the Ebola+ program of the Innovative Medicines Initiative.








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