BIO member companies SAB Biotherapeutics, Inc. (SAB) and Novovax, Inc. teamed up with the University of Maryland School of Medicine and the Naval Medical Research Center to treat the deadly Middle East Respiratory Syndrome Coronavirus, known as MERS-CoV.
Headquartered in Sioux Falls, S.D., SAB Biotherapeutics, Inc. is an established, biopharmaceutical company that is leading the science and manufacturing of immunoglobulin therapies. Novavax, a clinical-stage vaccine company, is headquartered in Gaithersburg, MD and currently has vaccine candidates to treat a variety of infectious diseases including pandemic influenza and the Ebola virus.
Argus Leader covered the news of this collaboration:
…SAB developed the treatment using its DiversitAb platform, which leverages genetically engineered cattle to produce large amounts of human antibodies.
Until now there have been no treatments for MERS-CoV, which was identified in Saudi
Arabia in 2012 and has been called “a threat to global health” by the World Health Organization.
The SAB therapeutic has been shown to effectively treat the disease in laboratory testing and in a mouse model, according to the company. The next step will be human testing.
“We’re very pleased with the results and very encouraged we’ll be able to move forward and provide a solution to this very serious disease,” SAB president and CEO Eddie Sullivan said. “We did this with a broad coalition … and these folks were able to independently conduct these results and verify that our product has efficacy at least in the animal models against this disease.”
Research showing the effectiveness of the treatment was published in the current online edition of Science Translational Medicine. The research is a collaboration with the University of Maryland School of Medicine, the Naval Medical Research Center and Novavax, a biotech company that provided the vaccine that triggered the antibody production.
“These results are very promising,” said Matthew Frieman, associate professor of microbiology and immunology at the University of Maryland. “This gives us a potential way to attack MERS and provides evidence that using transgenic cows can rapidly produce therapeutics.”
The development has ““been a long time coming,” Sullivan said. “With this paper we were extremely cautious in everything we did to make sure we did it right and had a lot of collaboration, so it’s a great, great study.”
SAB’s platform also produced positive results in a 2014 proof-of-concept study with
hantavirus and Ebola in laboratory tests.
Human testing will confirm whether passive immunization with these antibodies can treat infected individuals. SAB is working with the National Institutes of Health to submit an initial new drug application for phase one clinical trials to the U.S. Food and Drug Administration.
“We would be hopeful we will be able to start clinical trials in the second quarter of this year,” Sullivan said. “We know the U.S. has an interest in an approved product against this disease.”
The U.S. trials would involve testing the drug in healthy volunteers. From there, SAB could move forward with human trials in countries such as Saudi Arabia, which are seeing patients with the disease.
SAB Biotherapeutics – SAB Biotherapeutics Produces New Human Antibody Treatment for MERS-CoV
University of Maryland School of Medicine – New study finds promising results for MERS treatment