The Ebola Virus. Handout/Getty Images News/Getty
Amazingly, a nine-person San Diego company called Mapp may have the best shot yet at ending the deadly Ebola epidemic. They've developed an experimental drug called ZMAPP that has been rushed into use as the virus spreads. Their extraordinary story reveals opportunities for innovation and entrepreneurship in the biotechnology sector.
Fact #1: They are a tiny company
Possibly the most amazing thing about the ZMAPP story is that it was developed by a completely obscure and tiny company and not a pharmaceutical giant like Merck or GlaxoSmithKline. The New York Times reports that the firm was started in 2003 by Dr. Larry Zeitlin and Kevin J. Whaley, two researchers who had begun working together at Johns Hopkins University many years ago on ways of using crops to produce immune system proteins to treat diseases in people.
Fact #2: The experimental drug is not approved for human use
ZMAPP was still in development, slated for human trials in 2015, when the Ebola crisis hit. Until that point, it had only been tested in monkeys and showed some promise there. In August, it was used to treat Kent Brantly and Nancy Writebol, two doctors who had been infected with Ebola while treating patients in West Africa. Both doctors recovered.
The Morning Consult, a website that covers questions pertaining to regulation and industry, questions how the doctors got the drug, looking askance at the stated private deal brokered by Samaritan's Purse, the nonprofit employing Dr. Brantley and Mapp. Were other forces at play, the author wonders?
Fact #3: The FDA's "animal rule" may provide a regulatory fast-track for ZMAPP
While drug regulation in the United States is quite labyrinthine, characterized by a series of clinical trials that can take years, the FDA did create an "animal efficacy rule" in 2002 in part to help speed the development and testing of drugs to reduce or prevent life-threatening conditions caused by exposure to lethal toxic agent (bioterrorism). It's possible that this rule may help a drug like ZMAPP get to market more quickly.
Fact #4: Mapp produces this drug with the help of tobacco plants
An article in the New York Times explains that ZMAPP is the result of a long process of developing and engineering antibodies that start in mice exposed to a key Ebola protein. The antibodies that the mice produce against the virus are genetically modified to better resemble human antibodies. Interestingly enough, as part of the production process, the gene for each antibody produced is introduced into the leaves of a tobacco plant.
While "monoclonal antibodies" like these, typically used in the treatment of cancer and other diseases, are normally grown in animal cells, the tobacco plants are used in this process because they are cheaper and will potentially allow more of the antibody to be produced in less time.
Fact #5: It's actually quite something to produce drugs with genetically engineered crops
The Times notes that this type of plant modification is not practiced at large scale, because of the worry of cross-contamination. Instead, these plants are grow inside of buildings and their cultivation is funded, in part, by the U.S. Department of Defense.
If the Ebola crisis worsens, Mapp may turn to other production facilities to ramp up their production of ZMAPP.
Opportunities in Biotechnology
Mapp's story highlights the exploding opportunities in the emergent field of biotechnology, or the use of living systems or organism to make useful products. In this case, the product is a theraputic treatment for Ebola, but the biotechnology sector comprises solutions in a number of sectors including agriculture, biofuels and even industrial chemical production.