The U.S. Biomedical Advanced Research and Development Authority (BARDA) has awarded a $30 million contract to a NewLink Genetics subsidiary toward supporting manufacturing and development activities of the Ebola vaccine candidate rVSV-EBOV the company is co-developing with Merck & Co.
The grant—awarded to NewLink subsidiary BioProtection Systems—is intended to cover the cost of clinical development through a new 330-person Phase Ib study, the companies reported.
“The current funding provided by BARDA is key to the rapid development of this Ebola vaccine candidate,” Charles J. Link, Jr., M.D., NewLink’s founder, chairman, CEO, and CSO, said in a statement. “These funds will support multiple facets of the accelerated Ebola vaccine program including the expansion of critical vaccine supplies and larger clinical studies.”
BioProtection Systems has been advancing rVSV-EBOV under a license from its initial developer, the Public Health Agency of Canada (PHAC). Merck obtained exclusive rights to rVSV-EBOV from NewLink, in return for joining NewLink in researching, developing, manufacturing, and distributing the Ebola vaccine. The value of the collaboration was not disclosed.
rVSV-EBOV has begun trials in the U.S., at NIH’s Clinical Center, and the Walter Reed Army Institute of Research Clinical Trials Center, as well as in Switzerland and Africa. The Swiss trial for all 59 volunteer patients was interrupted and placed on a temporary hold, a week before its scheduled end, as “a measure of precaution” following complaints by four of the volunteers complained of joint pains in their hands and feet, the University of Geneva Hospital said Dec. 11. The hold does not affect the other trial sites, which have continued with lower doses of the vaccine.
Scientists from PHAC’s National Microbiology Laboratory created rVSV-EBOV, 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.
Pending the results of Phase I trials unde rway, the NIH has announced plans to initiate in early 2015 a large randomized, controlled Phase II/III study to evaluate the safety and efficacy of rVSV-EBOV as well as another investigational Ebola vaccine candidate, ChAd3-EBOV, for which a clinical study was launched in October in Mali.
rVSV-EBOV is one of at least two clinical programs that have been launched toward development of Ebola treatments in 2014. The other is the program for ChAd3-EBOV, which has been developed by the Vaccine Research Center (VRC) of NIOH’s National Institute of Allergy and Infectious Diseases (NIAID), and is being manufactured by GlaxoSmithKline (GSK) Biologicals.
A third clinical program is expected to launch next month. Johnson & Johnson (J&J) has said it plans to start trials in January for a prime-boost Ebola vaccine regimen that combines AdVac® technology from Crucell Holland, part of J&J’s Janssen Pharmaceutical Cos., and Bavarian Nordic’s MVA-BN® Filovirus vaccine candidate.
Bavarian Nordic has committed to making available 1 million doses of MVA-BN over the coming year—with J&J saying that included 250,000 doses to be released by May for clinical trials. The vaccine was discovered through collaborative research with the NIH—whose NIAID is joining the companies in a partnership J&J announced back in September