SAB: First MERS treatment appears safe in clinical trial

Jan. 10, 2018

The anti-MERS immunotherapy developed by Sioux Falls biotech company SAB Biotherapeutics Inc. appears safe in phase 1 clinical trials, the company announced.

Results of the study, which was sponsored, funded and conducted by National Institutes of Health, were published in The Lancet Infectious Diseases.

 Currently, there are no approved vaccines or treatments for Middle East respiratory syndrome,  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 percent, according to the World Health Organization.

“This is the first study to show the safety of a potential treatment for MERS,” said Dr. John H. Beigel, 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 Sullivan, 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 that have been genetically designed to produce human antibodies 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,” Sullivan added. “We have the ability to develop antibody treatments against a variety of infectious diseases in a much faster time frame, 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 and then purified to isolate the antibodies becoming the therapeutic treatment.

In the study, 28 volunteers were treated with SAB-301 and 10 received 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.

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.”

It’s the second successful human clinical trial announced by SAB in the past month.

SAB Biotherapeutics announces successful human trial

SAB: First MERS treatment appears safe in clinical trial

The anti-MERS immunotherapy developed by Sioux Falls biotech company SAB Biotherapeutics Inc. appears safe in phase 1 clinical trials, the company announced.

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