Sioux Falls company developing potential treatment for coronavirus

SAB Biotherapeutics, a Sioux Falls clinical-stage biopharmaceutical company that developed a first-of-its-kind therapeutic approach, is rapidly working to develop what its CEO said could be the first treatment specifically designed to target the new coronavirus known as SARS-CoV-2, the virus responsible for COVID-19.

SAB’s DiversitAb™ platform, which leverages genetically designed cattle, produces large amounts of fully human polyclonal antibodies in response to a disease such as COVID-19 in a short amount of time.

As it waits on word if funding will be available to scale up its technology, SAB has started preliminary work on both reagent antibodies for a test diagnostic and therapeutic antibodies to treat the virus.

“We have been in constant contact with federal agencies on what we’re doing and when we will have information available,” CEO Eddie Sullivan said.

And they’re listening, he said.

“Under-the-radar in Sioux Falls, South Dakota, SAB is in the thick of it. Isn’t that the Midwestern way? To be understated but really hard at work?”

Prior parallels

While SAB’s platform technology ultimately could address a multitude of diseases, it mostly has been used to date on infectious diseases similar to COVID-19.

Using its platform technology, it developed human antibodies more than a decade ago to the past Severe Acute Respiratory Syndrome, or SARS-CoV-1. COVID-19, which is stands for “Coronavirus 2019,” is the disease resulting from the virus SARS-CoV-2.

Then in 2016, SAB was awarded up to $5.3 million from the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services to test its therapeutic for another type of coronavirus, Middle East respiratory syndrome coronavirus, or MERS-CoV.

The phase one clinical trial sponsored by the National Institutes of Health, National Institute of Allergy and Infectious Disease showed SAB’s treatment is safe; the phase two/three trial is planned to prove that it’s also effective.

The challenge is that there aren’t many MERS patients at any given time – it’s mostly transmitted from camels to humans – so while the trial is planned in the Middle East, it requires available patients.

“We do know when we produce antibodies, it neutralizes the virus because of our experience with MERS,” Sullivan said. “So we know how to target our antibodies for this new coronavirus.”

SAB has “the most advanced immunotherapy for a coronavirus (MERS) that exists in the world,” he continued.

“So we have a tremendous amount of historical information and data about how we can potentially respond to this new coronavirus. That has allowed us to have some very directed strategies about how we bring this all together in order to respond.”

Addressing coronavirus

Because of its previous collaborations, SAB has been able to access enough information about SARS-CoV-2 that it can start to produce antibodies for it, Sullivan said.

“I want to communicate particularly to our local community that SAB does not work with the virus itself,” he said. “We work with subunits of the virus that are noninfectious.”

SAB has reagent antibodies available from its work both with SARS and MERS that “appears to be useful” for diagnostic tests for SAS-CoV-2, or COVID-19, and is making that available to federal agencies, Sullivan said.

“And we will make some SARS-CoV-2, or COVID-19, specific antibody available for reagents and controls and diagnostic tests for this disease,” Sullivan said. “The SARS-CoV-2-specific antibody diagnostic we will have available next month.”

At the same time, SAB has started working on a therapeutic. Because of the process involved, it will take until this summer before a treatment is available for evaluation by federal agencies, Sullivan said.

“All other therapeutics they’re starting to test are drugs already on the market, where they’re trying to see if it works against this disease,” he said.

“We likely will have the first one developed specific to this disease.”

SAB also likely will have the only treatment that uses human polyclonal antibodies, he added.

“Our antibodies work within the patient’s own immune system to both neutralize the virus and activate the other components of the immune system that are important to helping the body fight the disease. We know that polyclonal antibodies work because that’s the way our bodies naturally fight disease.”

The only other way found to offer the same treatment would be by using plasma from people who have recovered from the disease to produce antibodies – a process with multiple challenges. Using SAB’s specialized cattle as plasma donors specific for the purpose of creating antibodies, “uses a controlled environment that has already been proven to be safe in the MERS-CoV trial,” he said.

SAB’s treatment approach also is able to accommodate mutations in the virus, he said.

“SAB has shown our antibodies are effective even when antivirals or monoclonal antibodies have become ineffective due to virus or pathogen mutation,” Sullivan said.

“We think that’s one of the very compelling reasons that polyclonal antibodies should in fact be the primary line of defense against some of these viral targets, and that’s why we are so adamant about putting our technology forward as the best solution for a rapid response that won’t allow the virus to become resistant to the therapeutic.”

A novel, quickly spreading disease is exactly the type of challenge SAB’s biotechnology is ideally suited to address, said Joni Johnson, executive director of South Dakota Biotech, the state affiliate of the international BIO organization.

“The state of South Dakota, the community of Sioux Falls and a deep pool of local investors have believed in SAB’s technology and potential for years,” Johnson said.

“This could be the time that the world gets to see what we’ve known all along — this is a game-changing company that has the potential to help untold numbers of people.”

What’s next

At this point, SAB is not involved in developing a vaccine to prevent the coronavirus, Sullivan said.

“We do not consider ourselves in competition with vaccine developers. We are for treating the disease. So we’re a therapeutic not a vaccine,” he said.

For now, SAB is doing its preliminary work “on our own,” Sullivan said. “We believe that we have an obligation to leverage our unique capabilities to rapidly respond to this public health threat. However, we also have an obligation to our investors and building the business.

“So, at some point, it will require additional external funding in order to continue.”

Last week, the federal government approved $8.3 billion in emergency spending related to coronavirus, which can help support development of tests and therapeutics through companies such as SAB.

“The funding agencies have to go through their process and make their decision as to which technologies they want to move forward with,” Sullivan said. “So that decision-making process is out of our hands, but we’re providing all the information we have available on our technology in order to make a decision.”

SAB has been recognized by the U.S. government and the World Health Organization for its ability to respond quickly to emerging disease threats.

“But the speed at which we can move is not just up to us. I need to make sure that’s understood,” Sullivan said.

“We can move relatively rapidly. We’re looking at having a candidate therapeutic available sometime this summer for evaluation and perhaps to move quickly into the clinic. But it takes time to produce the candidate product and make sure all the regulatory components are put in place. It’s not like you see in the movies where days later you have an antidote you can distribute around the world. It takes time, but we absolutely believe we are capable of producing a therapeutic response to this virus faster than anyone, and that’s what we are putting into place now.”

The international BIO organization has put together a Business Resource Center for COVID-19 that includes help with business continuity planning, travel policies and other resources to address supply chain disruption. Click here to learn more.
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