The Democratic Republic of the Congo is likely to approve the use of Zmapp “in the coming days” to treat patients affected by the country's Ebola outbreak, the World Health Organization said Friday.
President Larry Zeitlin told BioCentury that Mapp Biopharmaceutical Inc. (San Diego, Calif.) has a stockpile of emergency use doses of Zmapp and will be "very willing" to provide the product to the country. He declined to disclose how many doses are in the stockpile. Zmapp, which comprises three mAbs targeting Ebola glycoproteins GP1 and GP2, is in the Phase I/II PREVAIL II trial.
WHO said it will begin administering Ebola vaccine rVSV-ZEBOV (V920) from Merck & Co. Inc. (NYSE:MRK) in the DRC as early as Monday. A second shipment of the vaccine will arrive on Saturday, bringing the total doses delivered to the DRC to 7,540. Merck has a stockpile of more than 300,000 emergency use dose equivalents (BioCentury Extra, May 17).
The organization will start vaccinating people who have come into contact with confirmed cases, and then move to contacts of contacts. It plans on around 150 vaccinations for every confirmed case. As of Friday, there have been 45 reported cases, of which 14 have been confirmed.
WHO now estimates it will cost $26 million over a three-month period to respond to the outbreak, up from its $18 million estimate on May 13 (see BioCentury Extra, May 14).
In 2016, data from PREVAIL II published in the New England Journal of Medicine in 2016 showed ZMapp plus standard of care led to reduced mortality rates compared with SOC alone (22% vs. 37%). Mapp licensed two of Zmapp's mAbs from Defyrus Inc. (Toronto, Ontario), and the third mAb from U.S. Army Medical Research Institute of Infectious Diseases.
Last September, Mapp received about $46 million in a grant from the Biomedical Advanced Research and Development Authority (BARDA) to advance Zmapp to licensure by FDA.
rVSV-ZEBOV was originally developed by the Public Health Agency of Canada, which retains non-commercial rights under a 2010 deal granting NewLink Genetics Corp. (NASDAQ:NLNK) rights to the product. Merck has exclusive, worldwide rights to develop, commercialize and manufacture the vaccine from NewLink under a 2014 deal (see BioCentury Extra, Nov. 24, 2014).