May 28. 2020

Sioux Falls-based SAB Biotherapeutics has confirmed that its treatment in development specifically for the virus that causes COVID-19 has produced antibodies that neutralized the virus in a way that’s four times as potent as using plasma from recovered patients.

SAB has used its proprietary technology to produce fully human polyclonal antibodies targeting the virus without the need for human plasma donors.

The Sioux Falls company today announced data that demonstrated SAB-185, its COVID-19 treatment being developed, has shown it produces highly potent neutralizing antibodies to the virus SARS-CoV-2 in the lab that are four times higher than the most potent human convalescent plasma serum sample evaluated.

SAB started manufacturing SAB-185 on May 25 to support the next phase of clinical development for its potential COVID-19 therapeutic, still on track to begin human trials in early summer.

“These data indicate this human polyclonal antibody therapeutic has potent neutralizing activity against live SARS-CoV-2. The neutralizing titers of SAB-185 are significantly higher than those of the most potent plasma of recovered COVID-19 patients we’ve been able to source,” said Dr. William Klimstra, associate professor of microbiology and molecular genetics, associate professor of immunology and member of the Center for Vaccine Research at the University of Pittsburgh.

“We are still in the early stages of evaluating SAB-185, but the preliminary results are promising. My laboratory is conducting a series of studies to bring SAB-185 into clinical trials as soon as possible.”

As a fully human polyclonal antibody, SAB’s novel therapeutic candidate for COVID-19 deploys the same natural immune response to fight the disease as recovered patients but with a much higher concentration of targeted antibodies.

The data also suggests SAB’s therapeutic may be effective against current and mutating strains of the virus.

“In just seven weeks, we’ve accelerated development of a specifically targeted natural human polyclonal therapeutic, without the need for human serum, and generated large volumes of highly potent neutralizing antibodies to SARS-CoV-2, to produce clinical lots of our COVID-19 therapeutic candidate, SAB-185,” said Eddie Sullivan, president, CEO and co-founder of SAB Biotherapeutics.

“Consistent with data across SAB’s platform in other indications, these data suggest that our potential COVID-19 therapeutic may remain effective even as SARS-CoV-2 continues to evolve.”

SAB-185, which was developed from the original Wuhan strain sequences, demonstrated highly potent neutralizing titers to the mutated Munich strain of the virus, which is believed to be the most prevalent strain in the U.S., he added.

“These data give us great confidence as we begin manufacturing clinical product and prepare to move forward in the regulatory pathway to provide a potential solution to combat COVID-19.”

Manufacturing is being done in Sioux Falls, where SAB is headquartered at Sanford Research. SAB’s approach leverages genetically engineered cattle to produce fully human antibodies and enables a scalable and reliable production of targeted, higher potency neutralizing antibody product than has been previously possible, the company said in a statement.

Since the company moved its headquarters to Sioux Falls nearly two decades ago, many local investments partners have helped support its growth. They include the Sioux Falls Development Foundation, South Dakota Equity Partners and several private investors.

“We have received tremendous support from our local community and the biotech industry which is meaningful to us but also critical as we acknowledge that this support extends beyond SAB Biotherapeutics and contributes in a significant way to strengthening research infrastructure and to growing a vibrant biotech industry here in our region,” Sullivan said.

“As we work to rapidly develop a potential treatment for COVID-19 with our therapeutic candidate on track to initiate clinical trials early this summer, we know that there is still much work ahead and several crucial milestones to accomplish. The broad potential impact of our science and the continued confidence of our investors serves as further validation of these efforts and bolsters us on our pathway forward.”

Data from SAB’s clinical trials in MERS coronavirus and other infectious disease targets also has demonstrated that the approach can be used both as a treatment and prophylaxis, or preventatively.

“SAB Biotherapeutics has a successful pre-clinical track, having developed more than a dozen effective antibodies from our DiversitAb platform in response to emerging infectious diseases during outbreaks of Ebola, Zika, Dengue, Hantavirus and others,” Sullivan said. “A highly potent, polyclonal antibody therapy for COVID-19 could prove critical in combating this pandemic as it could potentially treat severely ill patients and provide protective antibodies for front-line responders, mission-critical staff and high-risk populations such as the elderly and immune-compromised.”

The SAB team in Sioux Falls has been working literally around the clock, including over the Memorial Day weekend, to begin manufacturing.

“While our team at SAB Biotherapeutics has been committed to advancing our novel, breakthrough technology to address emerging diseases prior to this pandemic, I’ve never been more impressed with their dedication and abilities to mobilize across work streams and expedite efforts with precision, unified with a mission to advance the development of an antibody therapeutic candidate for COVID-19,” Sullivan said.

“Now with the confirmation our antibodies are highly potent in neutralizing the virus and clinical production underway, we’re seeing these efforts begin to come to fruition in the midst of this devastating pandemic.”

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