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Covid-19 Antibody Therapy Prepares for Trial

Cattle
(Stefanie Drenkow-Lolies, Pixabay)

16 Apr. 2020. A biotechnology company producing synthetic antibodies in cattle, without human blood, to treat Covid-19 infections is advancing the therapy toward a clinical trial. SAB Biotherapeutics Inc. in Sioux Falls, South Dakota received a $9.4 million contract from Biomedical Advanced Research Development Authority, or BARDA, part of the U.S. Department of Health and Human Services, and Department of Defense, extending work already underway for DoD.

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.”

SAB Biotherapeutics has a track record with coronaviruses, including design of a treatment for Middle East respiratory syndrome, or MERS, infections, a coronavirus outbreak that began in 2012. In January 2018, Science & Enterprise reported on results from an early-stage clinical trial conducted at National Institutes of Health showing the company’s antibody treatment for MERS is safe for patients. The company is also developing a treatment for severe cases of influenza needing hospitalization, in clinical trials as well.

SAB’s current work on Covid-19, code-named SAB-185, is funded by the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, or JPEO – CBRND. For this agency, the company designed synthetic antigens from deactivated SARS-CoV-2 viruses responsible for Covid-19 infections, then vaccinated genetically-engineered cattle to produce polyclonal antibodies for Covid-19 treatments.

The SAB technology, says the company, is expected to produce larger quantities of neutralizing antibodies in a consistent quality than has been possible so far. An added advantage is the company’s approach removes the need to first identify people who recovered from Covid-19 infections and ask for blood donations as a source of convalescent antibodies.

The new funding from JPEO – CBRND and BARDA supports completion of preclinical tests of SAB-185 and production of antibodies in sufficient quantities for a clinical trial as early as this summer. The additional funds also enable SAB to quickly engage collaborators for clinical studies that provide evidence for FDA review.

“The current pandemic,” says SAB Biotherapeutics CEO Eddie Sullivan in a company statement, “is shining a light on the direct need for new and innovative therapies in addition to being prepared to react quickly for global health security. This initiative is solidifying a place for targeted human polyclonal antibodies in the immunotherapy space, showcasing the power of the native human biological immune response.”

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