From inside SAB’s new ‘pharm,’ game-changing biopharmaceuticals are coming

Oct. 30, 2018

This paid piece is sponsored by South Dakota Biotech.

The cattle that live on 80 acres just outside Canton are unlike any anywhere in the world.

The animals, approaching a herd of 40, are all genetically identical and genetically engineered so they no longer produce bovine antibodies but instead produce human antibodies.

It’s science decades in the making from Sioux Falls-based SAB Biotherapeutics – a company that set out to produce human polyclonal antibodies at scale and that now sits on the verge of bringing its technology into human patients where it has the potential to address a wide variety of diseases.

“The thing that’s really unique about SAB is that we can produce polyclonal antibodies, which is the natural way our bodies fight disease, outside of human donors,” CEO Eddie Sullivan said. “That’s something that is unique in the world. No one can do that.”

Inside the pharm

The cattle provide the platform for SAB to achieve it. And it all starts at the pharm, which officially opened today.

Here, cattle are not raised for milk or meat but instead so SAB can collect their plasma.

That plasma is filled with antibodies, produced once the cows are vaccinated for various diseases.

“We vaccinate the animals approximately one time per month and collect plasma three times per month,” said Todd Stahl, executive director of animal management for SAB, who oversees the pharm.

“The vaccinates we use are all attenuated, or killed products, so it’s similar to us getting a flu shot. All the vaccines we use are safe for the animals and can’t cause disease in either animals or humans.”

The pharm includes a nursery, a surgery space where calves are born by Caesarean section, a grower building where calves move at about 3 months old, and a production building, where they move at about 6 months old and where their plasma will be collected.

There’s also space for feed storage, a shop and offices.

A specialized team cares for the cows, bringing years of experience and accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International.

“We treat these animals very special,” Stahl said. “They have twice the square footage a typical agricultural animal would have. In the winter, they don’t go outside. We keep it at 50 or 55 degrees. During the summer, we have the ability to air condition the barns. They’re observed two to three times a day, including weekends and holidays. If I were a cow, this is where I’d want to live.”

The pharm is a biosecure space, so precautions are taken to ensure visitor cleanliness and limit any outside hazards to the animals.

“We’re not concerned with anything getting out into the environment. We’re more concerned with anything coming into the environment,” Stahl said.

Opening the pharm is a significant step for SAB, Sullivan said.

“This is a great opportunity for us to move to the next level as a company and produce these antibodies at scale,” he said. “And just to give you some idea, just 20 percent of the production capacity of that pharm can produce the antibodies needed for influenza. The entire worldwide need could be produced by just 20 percent of the production capacity of that pharm.”

The pharm is unique statewide, said Joni Johnson, executive director of South Dakota Biotech, the state affiliate of the international BIO organization.

“There’s nowhere in South Dakota like this,” she said. “But even more significantly, there’s no company in the bioscience industry doing what SAB is doing. It’s hard to even describe how significant it is that this sort of science is being achieved and now taken into large-scale production in South Dakota. The potential ramifications of this company are enormous for our state.”

Scaling up

SAB has increased its staff by almost  30 percent in two months. There now are three dozen people helping develop products and advance them through clinical trials.

“We have a staff here at SAB that is second to none, and the amount of work we’ve been able to produce in just the last four years is incredible,” Sullivan said. “We’ve been able to produce over 12 products, most of which at the current time are in the infectious diseases area. We know we can help a lot of people with a lot of different diseases.”

One of those new employees is Dr. Tom Luke, chief medical officer, who was introduced to SAB through a collaboration at his former employer, the U.S. Naval Medical Research Center.

“I used to have the greatest job in the world, but I think I’ve got the greatest job in the world right now,” said Luke, who relocated from the East Coast to help guide SAB through its clinical trials.

“There has never been a platform, at least in my experience, that has been able to do so much so quickly with such an adaptive platform.”

In the past, creating a polyclonal antibody response against a disease condition could be done only two ways, he explained.

The first option was to find patients who had been exposed to the disease, collect their plasma and produce purified antibodies.

“That’s very difficult and very expensive and sometimes not even possible to do,” he said.

The other option was to take a horse or rabbit, immunize the animal against the target, collect its plasma and produce the antibodies. But because they were animal-derived antibodies and not human-derived, “there is very often the potential of having a severe reaction,” he said.

When SAB produced a cow with human antibody response, it created a first-of-its-kind approach, Luke said.

“And it’s very, very exciting,” he said. “There is no target at this point in time that I have seen that I do not think that SAB Biotherapeutics and their bovine platform cannot address. If you say viral diseases, I say yes. If you say bacterial diseases, I say yes. If you say parasitic diseases, I say yes. If you say cancers, I say yes. If you say autoimmune diseases like MS or type 1 diabetes, I say yes.”

SAB’s next steps include continuing with clinical trials to test its treatments for MERS-CoV and severe hospitalized influenza. Earlier this year, a study published in The Journal of Infectious Diseases found SAB’s anti-Ebola immunotherapy provided 100 percent protection against a lethal dose of Ebola in animals.

Targeted products in development include immunotherapies in type 1 diabetes and oncology.

SAB will be an anchor tenant in the USD Discovery District in Sioux Falls, where it will relocate its corporate headquarters.

“To see us reach this clinical stage is very exciting to me, and one of the reasons I am motivated every day to get up and begin a new day,” Sullivan said. “Things are happening very, very quickly.”

From inside SAB’s new ‘pharm,’ game-changing biopharmaceuticals are coming

“There has never been a platform, at least in my experience, that has been able to do so much so quickly.” The science being done at SAB Biotherapeutics could be huge, not just for South Dakota but for human disease. We got a rare look at where it all will start.

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