First Treatment for MERS Appears Safe in NIH Phase I Clinical Trial

January 11, 2018

SAB Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical development company, announced its anti-MERS immunotherapy (SAB-301) appears safe in a Phase I Clinical Trial. Results of the study, sponsored, funded and conducted by National Institutes of Health (NIH) were published today in The Lancet Infectious Diseases.

Presently, there are no approved vaccines or treatments for Middle East respiratory syndrome (MERS)–a newly discovered, contagious and sometimes fatal respiratory illness, caused by a virus known as MERS coronavirus (MERS-CoV). Since the first confirmed case in Saudi Arabia in 2012, the illness has spread to 27 countries and more than 2,000 people, with a fatality rate approaching 40%, according to the World Health Organization.

“This is the first study to show the safety of a potential treatment for MERS,” said John H. Beigel, M.D., a medical affairs scientist affiliated with Leidos Biomedical Research, supporting the NIAID Division of Clinical Research, and lead investigator on the study. “SAB-301–an experimental treatment for MERS developed from cattle plasma–was safe, well tolerated by healthy volunteers and had the same half-life as human-derived antibodies.”

Using plasma collected from recovered patients has been a preferred and effective source of antibodies to combat the pathogens associated with recent global health concerns involving influenza, MERS, SARS and Ebola.

“Our novel immunotherapy platform goes back to nature with the use of human polyclonal antibodies–our own body’s army–to combat disease,” said Eddie J. Sullivan, PhD, SAB Biotherapeutics president and CEO. “The use of human convalescent plasma as a treatment has been proven effective, but short in supply. Conversely, about 10 of our animals could serve the current MERS need.”

SAB’s novel DiversitAb™ platform enables the rapid production of large amounts of targeted human polyclonal antibodies, leveraging transchromosomic cattle (Tc Bovine™) that have been genetically designed to produce human antibodies (immunoglobulin G) rather than bovine in response to an antigen. Animal antibodies have been made in rabbits, sheep and horses. However, SAB’s platform is the first to produce fully human antibodies in large animals.

“Our goal is to leverage our immunotherapy platform as a countermeasure against emerging infectious diseases,” added Sullivan. “We have the ability to develop antibody treatments against a variety of infectious diseases in a much faster timeframe, as few as three months, and in much greater volume than currently possible.”

To produce SAB-301, Tc Bovine were vaccinated with a MERS antigen provided by Novavax. Within a brief period of time, they produced significant amounts of fully human antibodies to combat the virus. Plasma was collected (in a similar manner as from human plasma donors), then purified to isolate the antibodies becoming the therapeutic treatment.

In the study, 28 volunteers were treated with SAB-301 and 10 with a placebo. Six groups of volunteers received different intravenous doses and were assessed six times over 90 days. Complaints were common among the treatment and placebo group including mild headache and cold symptoms.

Funding for the Phase I clinical manufacturing was provided by a $5.3 million contract from Biomedical Advanced Research and Development Authority (BARDA), including an allotment for Phase II. Pre-clinical data from studies conducted by global infectious disease experts at the Naval Medical Research Center, the University of Maryland, School of Medicine and NIH paved the way for the study.

With the trials in healthy candidates complete, Phase II trials are planned to evaluate the potency and dosing in patients suffering with MERS in endemic countries.

“We’re also advancing treatments for Ebola, influenza and Zika,” Sullivan said. “SAB is dedicated to partnering with government and other organizations to address current and future human health threats to ultimately save lives.”

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls, S.D. is a clinical stage, biopharmaceutical company leading the science and manufacturing of antibody therapeutics. Utilizing some of the most advanced antibody science in the world, SAB is delivering the world’s first large-scale platform to create immunoglobulins. This natural production platform holds the potential for treatment of public health problems, rare conditions, long-term diseases and global pandemic threats.

About the National Institutes of Health (NIH):

NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.