The U.S. Department of Health and Human Services said today it would provide its expertise and as much as $42.3 million to help San Diego-based Mapp Biopharmaceutical accelerate development and testing of ZMapp, the biotech’s experimental Ebola drug.
With just nine employees, Mapp Bio lacks the resources to respond to the Ebola crisis unfolding in Western Africa, co-founder and CEO Kevin Whaley said at an event last week in San Diego. The biotech, founded in 2003 to address the public health needs of mothers and children in developing countries, was looking for government help, Whaley said.
In a statement today, the federal health agency said it would provide $24.9 million to Mapp Bio through an initial, 18-month contract. The company will make a small amount of ZMapp for early stage clinical safety studies and for non-clinical animal studies needed to demonstrate its safety and effectiveness.
The effort is intended to advance ZMapp toward FDA approval, and includes subject-matter expertise and technical support to accelerate drug manufacturing and to address regulatory and other non-clinical concerns. The health agency’s assistant secretary for preparedness and response can extend the contract up to a total of $42.3 million.
There are no approved vaccines or drugs for treating Ebola. The NIH was expected to begin human safety trials this week on a vaccine that was co-developed with GlaxoSmithKline, this week, and a second trial is set to begin in October under the auspices of the National Institute of Allergy and Infectious Diseases.
The virus causes flu-like symptoms, including a headache and fever, then escalates to vomiting, diarrhea, and bleeding. Scientists say the virus replicates so rapidly that a patient’s immune system is basically in a race against death.
The strain responsible for the outbreak in West Africa has killed about half of the 3,069 suspected and confirmed cases of Ebola in four countries: Guinea, Liberia, Nigeria, and Sierra Leone. The World Health Organization warned last week that the virus could infect as many as 20,000 people before it can be brought under control.
Mapp Bio was working in relative obscurity before the Ebola outbreak in West Africa went from a public health emergency to a global health crisis. Tom Frieden, the director for the Centers of Disease Control and Prevention, said that in recent weeks the outbreak has become the world’s first Ebola epidemic, and it is “spiraling out of control.”
ZMapp combines three antibodies that bind to proteins on the Ebola virus. Scientists believe that the antibodies, which are produced in the leaves of tobacco plants, prevent the virus from entering human cells to replicate and trigger an immune response that destroys the viruses.
The drug had never been tested in humans, but Mapp Bio provided all of the available samples of ZMapp it had produced earlier this year for the emergency treatment of seven healthcare workers in West Africa. Four people who received the drug survived, including the American missionaries Kent Brantley and Nancy Writebol. But two others died.
“While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy,” said Dr. Nicole Lurie, the Department of Health and Human Services’ assistant secretary for preparedness and response.
On Friday, scientists reported that in one preclinical trial, ZMapp had cured all 18 lab monkeys infected with Ebola, including those suffering fever and hemorrhaging that were hours from death.
