Both patients were treated with ZMapp, which is the result of a collaboration between Mapp Biopharmaceuticals, San Diego-based LeafBio, Toronto-based Defyrus, the US government and the Public Health Agency of Canada.
The CDC (Centers for Disease Control) said in comments Monday that the treatment “could be used in the future as production of the serum is increased. Looks like it might be a useful therapy.”
The Ebola outbreak is the worst in history, with over 700 killed by the virus in West Africa. There are no approved treatments for Ebola and funding is one of the main constraints in bringing new treatments to trial.
ZMapp was first identified as a drug candidate in January and has not been clinically evaluated in humans, though it has proved successful in non-human primates infected with Ebola. Composed of three monoclonal antibodies, the treatment is manufactured by contract manufacturer Kentucky Bioprocessing (KBP).
David Howard, a spokesman for Reynolds American Services, which owns KBP, told BioPharma-Reporter.com that back in 2007, Mapp Bio engaged KBP to be a post-exposure treatment. “Mapp developed the protein and KBP has taken the protein and will inject it into tobacco plants, which produce or serve as a photocopier to produce the proteins and then they target, extract and purify it to create the compound,” Howard said, noting that the treatment has rapid growth potential and can be produced quickly.
“KBP is working closely with Mapp to increase production, and though not approved as a drug, we anticipate adhering to normal protocols on the compound later this year,” Howard said, referring to the clinical trials that the treatment will undergo later this year.
The US FDA said it’s ready to work with companies and investigators treating Ebola patients who are in dire need of treatment, an FDA spokeswoman told Bloomberg News.
According to Barry Bratcher, KBP’s COO, the plant-based system allows for considerable efficacy while the company’s automated facility in Owensboro, Kentucky keeps the treatment cost-effective and cuts down on the production time.
“Our facility can produce these proteins in two weeks at a substantial reduction in cost to other production methods,” said Bratcher. “This advanced method of manufacturing allows us to address needs quickly and inexpensively.”
The National Institutes of Health (NIH) has awarded a five-year grant of up to $28 million to establish a new center for excellence to find an antibody “cocktail” to fight the deadly Ebola virus. The project, which involves researchers from 15 institutions, will be led by Erica Ollmann Saphire, professor at The Scripps Research Institute
North Carolina-based BioCryst Pharmaceuticals and Canada’s Tekmira Pharmaceuticals are also developing Ebola treatments and vaccines against Ebola. The US FDA, however, put Tekmira’s trials on hold last month after seeking to ensure that higher doses of the drug were safe.
NewLink Genetics Corporation, through its wholly owned subsidiary BioProtection Systems Corporation, also announced on Tuesday a letter contract worth $1m with the US Defense Threat Reduction Agency (DTRA) for studies that will bring an Ebola vaccine licensed from the Public Health Agency of Canada closer to human clinical trials. The letter contract will fund Investigational New Drug (IND)-enabling pre-clinical toxicology studies and includes the manufacture of clinical materials.