(Photo by Sergey Pesterev on Unsplash)
11 January 2018. An experimental treatment for Middle East respiratory syndrome, or MERS, infections made from antibodies produced in cattle is shown in a clinical trial to be safe for patients. Results of the trial conducted at National Institutes of Health are reported in the 9 January issue of the journal The Lancet Infectious Diseases (paid subscription required).
The antibody-based treatments, code-named SAB-301, are made by SAB Biotherapeutics in Sioux Falls, South Dakota. The MERS virus was first spotted in 2012 in Saudi Arabia, and is believed to originally spread from camels. Symptoms often include shortness of breath, cough, and fever, but cases of pneumonia, organ failure, and gastrointestinal symptoms also developed. World Health Organization reports 2,122 cases of MERS in 27 countries in the Middle East and Asia, including Korea and Thailand, leading to 740 deaths. So far no treatments or preventive vaccines are available.
SAB-301 is made of antibodies derived from immunoglobulin G, produced by the immune system in response to an antigen, and found in blood and other bodily fluids. While technically possible to produce these antibodies from natural sources, quantities produced through these techniques are usually limited. SAB Biotherapeutics says it meets this challenge with a technology that produces human antibodies in genetically engineered cattle, but prevents harm to the animals.
SAB’s cattle are genetically modified to carry an artificial human chromosome containing immunoglobulin genes. The cattle produce human polyclonal antibodies, those addressing multiple targets, that generate a strong immune response. Initial lab tests show the antibodies destroyed various strains of the MERS viruses in cell cultures, and as reported in Science & Enterprise in February 2016, protected lab mice from the MERS virus.
The early-stage clinical trial enrolled 38 healthy volunteers, who were randomly assigned to received SAB-301 or a placebo. Of the total, 28 participants received various doses of SAB-301 based on body weight, while 10 received the placebo. All of the volunteers received the doses through intravenous infusions.
The NIH research team looked primarily for signs of adverse effects for 90 days following infusions, and while a large majority (82%) of those receiving SAB-301 reported an average of 2.3 adverse events, placebo recipients reported comparable numbers of effects, 3.3 events per person. Nearly all effects were considered mild: headaches, the presence of albumin in urine — an indicator of kidney disease, elevated creatine kinase — an indicator of muscle injury including cardiac muscles, and common cold. One serious event, a failed suicide attempt, also occurred with an SAB-301 recipient. Concentrations of SAB-301 in the blood of participants were comparable to equivalent concentrations reported in earlier tests with lab mice.
The authors conclude the treatments were safe and well-tolerated with the healthy participants. As important, the researchers believe generating antibodies with genetically engineered cattle offers a promising technology for quickly producing treatments for a number of diseases.
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