SAB Biotherapeutics, Inc. (SAB), a leading biopharmaceutical development company, announced today it has produced a new human antibody therapeutic to treat the deadly Middle East respiratory syndrome coronavirus (MERS-CoV) utilizing its novel DiversitAb™ production platform. MERS-CoV was first identified in Saudi Arabia in 2012; the World Health Organization has identified it as a “threat to global health.”
Until now, there have been no treatments for this disease. Additionally, to date, the ability to treat emerging threats has been limited by lengthy development timelines. SAB’s DiversitAb platform leverages transchromosomic cattle (Tc Bovine™) that have been genetically designed to produce large amounts of human antibodies (immunoglobulin G) in response to an immunogenic antigen.
Research efforts showcasing the effectiveness of the treatment were led by global infectious disease experts at the Naval Medical Research Center (NMRC) and MERS-CoV expert, Matthew B. Frieman, PhD, Associate Professor of Microbiology and Immunology at the University of Maryland, School of Medicine (UM, SOM), and are published in today’s online edition of Science Translational Medicine.
“These results are very promising,” says Dr. Frieman. “This gives us a potential way to attack MERS and provides evidence that using transgenic cows can rapidly produce therapeutics.”
This research is a collaboration with the UM, SOM, NMRC and Novavax, a biotech company that provided the vaccine that triggered the antibody production.
SAB’s platform has also yielded positive results in a 2014 proof-of-concept study with Hantavirus and Ebola in laboratory tests.
“New emerging diseases are spreading quickly to various parts of the world,” said Dr. Eddie Sullivan, president and CEO of SAB. “As we complete successful studies, we’re realizing the potential broad application and significance of the DiversitAb platform in addressing these threats.”
Human testing will confirm whether passive immunization with these antibodies can treat infected individuals. SAB is currently working with the National Institutes of Health (NIH) to submit an initial new drug application for Phase I Clinical Trials to the U.S. Food and Drug Administration (FDA) in the first quarter of 2016.
Reference: Human polyclonal immunoglobulin G from transchromosomic bovines inhibits MERS-CoV in vivo. Luke, Thomas; Frieman, Matthew B., et al: Sci Translational Med, 17 Feb 2016, Vol 8 Issue 326 326ra21.
SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls, S.D. is an established, biopharmaceutical company that is leading the science and manufacturing of immunoglobulin therapies. Utilizing some of the most advanced antibody science in the world, SAB is delivering the world’s first large scale platform to create fully human immunoglobulins. This natural production platform holds the promise of treatment of public health problems, rare conditions, long-term diseases and global pandemic threats.
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