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Trial Underway for Seasonal Flu Antibody Therapy

Cattle

(Stefanie Drenkow-Lolies, Pixabay)

30 July 2020. A participant in an early-stage clinical trial received the first dose of an experimental synthetic antibody produced in cattle to treat seasonal influenza. The study is testing the safety of the influenza immunotherapy code-named SAB-176 developed by SAB Biotherapeutics, a biotechnology company in Sioux Falls, South Dakota.

SAB Biotherapeutics is a developer of immunotherapies for infectious diseases and autoimmune disorders that act like antibodies found in human blood plasma. The company’s technology, called DiversitAb, designs synthetic forms of these antibodies, which are humanized and scaled-up for production in larger quantities by genetically engineered cattle. The cattle produce polyclonal antibodies that the company says address multiple targets and invoke a strong immune response. The company raises and houses the engineered cattle on a ranch they call their “pharm.”

The virus causing flu outbreaks has two main types known as influenza A and B. Influenza A viruses emerge as different strains from the composition of proteins on their surface, called hemagglutinin and neuraminidase, abbreviated to H and N. The various influenza A strains are made up of combinations of 18 H and 11 N proteins. The continuous mutation of flu viruses, particularly influenza A, makes the disease difficult to contain from year to year. Centers for Disease Control and Prevention says the 2019-2020 flu season affected as many as 56 million people in the U.S. resulting in up to 740,000 hospitalizations and 62,000 deaths.

SAB-176, says the company, is designed to overcome limitations of current treatments for severe cases of influenza. SAB Biotherapeutics says the polyclonal antibody is a synthetic human immunoglobulin G, or IgG therapy that addresses four viral influenza strains, covering both A and B types. The company designed SAB-176 for people hospitalized with severe influenza cases that can also help protect high-risk individuals, such as the elderly or those with compromised immune systems. SAB Biotherapeutics says preclinical studies demonstrate SAB-176’s potency in neutralizing various influenza strains.

“SAB-176 is a novel immunotherapy designed to address the unmet need for the treatment of seasonal influenza,” says Eddie Sullivan, president and CEO of SAB Biotherapeutics in a company statement released through BusinessWire. “SAB-176’s unique properties allow for adaptation to future emerging and mutating seasonal strains, an attribute that has also been shown to be of high importance in other viral diseases, particularly in light of the Covid-19 pandemic and the emerging public health crisis.”

The clinical trial is enrolling 27 healthy volunteers to test SAB-176, looking primarily for adverse effects indicating safety issues. Participants are randomly assigned to receive one of four intravenous dosage levels of SAB-176 or a placebo, and are monitored for 90 days. In addition to tracking adverse effects, the study team is measuring concentrations of SAB-176 antibodies in blood serum, as well as evidence of an immune response in participants.

The company says the trial is now underway with a participant receiving the first dose of SAB-176. The study is expected to finish in early 2021, with results helping decide on dosage levels in a mid-stage trial to follow.

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