As disease threats increase, S.D. veterinary vaccine business scales products, begins exporting

Brookings-based veterinary vaccine company Medgene was built for news like this.

Highly pathogenic avian influenza, or HPAI, which has been in the headlines too often in South Dakota affecting turkeys, layers and broilers, and even pheasants, now has been detected in dairy cows and their milk in Texas, Kansas and New Mexico, and goats in Minnesota.

“Whereas developments like these are understandably alarming, it presents yet another situation where our platform technology is capable of providing a solution,” said Mark Luecke, South Dakota Innovation Partners CEO, who co-founded Medgene with SDSU immunologist Dr. Alan Young more than a decade ago.

Medgene got its start by working with several federal agencies to develop a platform technology that would respond to emerging animal diseases affecting both animals and people.

At the risk of oversimplifying it, consider the work of this platform technology like a Keurig coffee maker.

The coffee maker itself represents the platform technology developed by Medgene.

Using that platform technology, Medgene can develop vaccines targeting a wide range of viruses that affect animals, including those that rapidly emerge like HPAI – the range of vaccines being comparable to the range of coffee blends in the Keurig pods, to continue the metaphor.

But to use the platform technology and develop vaccines that can be used by veterinarians and animal owners requires approval from the USDA, and 2023 was a milestone year for that.

“It was an important year for us because different platforms for different species require different approvals from the USDA,” Luecke indicated.

“We got two platform technologies approved for swine and two approved for cattle, and we have a conditional license for our first companion animal platform technology starting with rabbits.”

Medgene, which is South Dakota’s first and only licensed veterinary vaccine production facility, has seen substantial growth in recent years. In 2020, there were 25 employees that were focused mostly on research and development. That has grown to more than 70 working in research and development, vaccine production, supply chain and administration at the company campus in Brookings.

“There’s so much impressive work happening here,” said Joni Ekstrum, executive director of South Dakota Biotech. “The platform technology developed by Medgene has incredible potential that’s just now starting to come to fruition.”

In the coming month, the company will ship its first vaccine doses internationally to help livestock producers in South America prevent influenza.

“We’ve grown rapidly,” Luecke said. “One of the things that makes us unique on a global basis is that we’ve approached veterinary vaccines from the perspective of the platform technology, which allows us to rapidly make new vaccines as viruses change. The government has already approved its safety for use.”

Luecke credits Young, who serves as Medgene’s chief technology officer, with the vision that led to the company’s platform technology. Essentially, it involves genetically coding insect cells to produce a targeted protein sequence. The protein is then harvested and becomes part of the vaccine.

“The fact that we use insect cells is important because it’s free of any animal components. Our manufacturing process is 100 percent animal-free,” Luecke said. “Other vaccine companies are having challenges because their process requires ingredients of animal origin.”

Still, there were people who doubted whether Medgene’s approach could become a commercially relevant platform, he said.

“It takes one scientist, like Dr. Young, to challenge conventional thinking. Not only has he done that, but with his use of bioinformatics and artificial intelligence, he’s been able to make vaccines on this platform that no one thought was possible and animal owners desperately need,” Luecke said.

“He’s been a tremendous partner and a thought leader for the industry.”

Recently, the USDA has been so encouraged by Medgene’s platform that officials reached out to the company to develop a vaccine for an emerging disease in rabbits. Rabbit hemorrhagic disease emerged internationally as a major threat, and the USDA’s only recourse previously was a vaccine made in Europe by harvesting the livers of infected rabbits.

“That’s an inhumane and unsafe way to make a vaccine, so they approached us, and, of course, we said yes,” Luecke said. “We developed and tested it very quickly, got it into the marketplace, and it’s been remarkable. Testing showed that when we vaccinated rabbits, there were no deaths from the disease.”

The USDA also allowed Medgene to send experimental doses of a vaccine for pigs to swine producers dealing with a type of rotavirus that causes scours, or diarrhea, in piglets where an effective vaccine does not exist. The illness has caused significant economic losses for the industry.

“Again, the response has been incredible,” Luecke said. “We are very proud to be partnering with nearly all of the ‘Top 40 U.S. Pork Powerhouses’ on a number of swine diseases.”

There are broader implications to Medgene’s work for human health too.

“If you think about influenza, for example, it is a virus that moves back and forth between animals and humans,” Luecke said. “The vaccine constructs that we make are approved for use in animals, but they could be moved to a facility that is approved to make human vaccines.”

While it’s not something that Medgene currently is pursuing, the company’s research and development pipeline does extend beyond targeting viruses to also covering bacterial infections.

Medgene is working through safety studies to approve platform technologies for other species. During the COVID-19 pandemic, it developed and administered a vaccine for mink in some markets. The company had made a COVID-19 vaccine for other species, although the government ultimately opted not to pursue scaling it.

But that exemplifies the company’s competitive advantage: an ability to respond with vaccines for viruses that are identified within weeks to prevent further disease transmission.

“Medgene is going to continue growing because we represent a much-needed solution for animal owners and veterinarians trying to address these emerging disease threats,” Luecke said. “Unfortunately, viruses don’t stop changing. Every time you develop a vaccine to stop a virus, evolutionary biology causes it to change into something else. Our platform technologies are a disruptive approach to conventional animal health.”

That positions South Dakota well for growth, Ekstrum said.

“South Dakota increasingly is becoming a leader in animal bioscience thanks to outstanding work from companies like Medgene,” she said. “It can take time, but Medgene is proving what’s possible when you persevere and is absolutely positioned to do big things in the years ahead. We’re thrilled by their recent success and anticipate much more.”

To learn more about Medgene, click here.