San Diego Business Journal

Mapp Biopharmaceutical, the local Ebola drugmaker that’s brewing antibody cocktails in tobacco plants, took another step toward combating the deadly virus last month when the U.S. and Liberian governments joined forces to begin testing the effectiveness of Mapp’s experimental drug in humans.

Besides the whole “growing biologics in tobacco plants” thing, Mapp is like most biotechs in San Diego. It operates out of a tiny rental space in Sorrento Mesa with fading carpets and plain walls. The scientists double as top executives, and nearly all working capital comes from government grants. One difference between Mapp and the few hundred other life science startups in the region is that Mapp is a bit of a biotech celebrity.

The world’s largest-ever Ebola outbreak drew international attention to the company last year when the tiny lab partnered with an array of organizations — including infectious-disease officials in Canada, the U.S. Army and The Scripps Research Institute in La Jolla — to develop the medication ZMapp.

Under emergency authorization, ZMapp was used to treat nine Ebola-infected patients in the United States, Africa and Western Europe, including the first two U.S. medical missionaries in Liberia who were infected in July 2014, Dr. Kent Brantly and Nancy Writebol. Both were subsequently treated on U.S. soil — and survived.

When these cases were reported in detail in the New England Journal of Medicine, the authors cautioned that due to the combination of experimental drugs administered during treatment and a slew of other variable factors, they were unable to conclude how much, if at all, the ZMapp treatment influenced the patients’ survival. Until now, the drug has not been tested in human clinical trials.

“Although ZMapp has been used to treat several Ebola-infected patients in recent months, we cannot determine if the drug actually benefitted those patients because it was not administered within the context of a clinical trial,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease (NIAID). “This clinical trial will help us determine if ZMapp and other treatments are safe and effective for use in the current devastating outbreak in West Africa, as well as in future outbreaks.”

Liberia has suffered the most deaths during the outbreak of Ebola, which as of last Monday had infected 23,913 people and killed 9,714. Almost all the cases have been in West Africa, according to the Centers for Disease Control and Prevention.

ZMapp is composed of three proteins called monoclonal antibodies. The drug combination is designed to prevent the progression of the Ebola virus within the body by targeting the main surface protein of the Ebola virus.

In September, Mapp and its commercial arm Leaf Bio Inc. received a $25 million grant from the U.S. Biodefense Advanced Research and Development Authority (BARDA) to produce enough bulk product to initiate potential Phase 1 studies and the current Phase 2 trial. The antibodies are produced in tobacco plants at Kentucky Bioprocessing Inc., a subsidiary of Reynolds American Inc. BARDA’s own manufacturing network provided the final product.

The new study, which will be conducted in the U.S. and Liberia, will be led by representatives of the National Institute of Allergy and Infectious Disease and the Ebola Incident Management System in Monrovia, Liberia.

NIAID announced that the randomized trial would include up to 200 patient volunteers with confirmed Ebola virus infections.

The two-arm study will compare supportive standard of care with or without three intravenous infusions of ZMapp spaced three days apart. This is the same dosing regimen of ZMapp published in Nature that protected 18 of 18 monkeys when given up to five days after experimental infection.

Ebola isn’t Mapp’s only area of interest. The company was recently awarded $225,000 in a joint Small Business Innovation Research grant from the National Institutes of Health for the initial development of a new immunotherapy for brain cancer.

The grant will fund the collaboration between Mapp and Nascent Biotech Inc. for the use of tobacco plants as an adjunct expression system for Nascent’s drug candidate Pritumumab — a monoclonal antibody for the treatment of brain cancer.

Co-founder and CEO Kevin Whaley was not available for comment.

MAPP BIOPHARMACEUTICAL INC.

CEO: Kevin Whaley

Revenue: Declined to disclose

No. of local employees: Nine

Investors: National Institutes of Health, BARDA

Headquarters: Sorrento Mesa

Year founded: 2003

Company description: Biopharmaceutical company seeking prevention and treatment of infectious diseases, focusing on unmet needs in global health and biodefense

Key factors for success: International spotlight and wide media coverage of Ebola outbreak may lead to additional funding and support