Medgene’s revolution

A Brookings-based company borne from South ÌÇÐÄÊÓÆµ State University research is helping veterinarians and producers make headway in the endless battle against animal disease.
Animal disease remains one of the biggest threats to not only the agriculture industry, but to human health worldwide. While vaccines may be the best tool in defeating disease, the traditional method in developing a vaccine is costly and time-consuming. Often, vaccines get on the market long after the damage is done.
A Brookings-based animal health company, Medgene, is leading a revolution in the development of veterinary vaccines that is turning the tide in the endless battle against animal disease.
Challenging norms
Alan Young is a professor in SDSU's Department of Veterinary and Biomedical Sciences. His decorated academic career has been marked by stops at the renowned Basel Institute, Harvard University's Medical School, and a nearly unmatched level of experience in immunology studies.
In the mid-2000s, Young was working on U.S. Department of Homeland Security-funded research for emerging and zoonotic diseases. Rift Valley fever, a mosquito-borne viral disease, had devastated sheep herds in Africa with almost 100% mortality, and the available traditional vaccines couldn't provide long-term immunity.
Because traditional vaccines, made using either a "live" version of the virus or a "killed" inactivated version of the virus, weren't successful in protecting sheep herds, Young knew he had to challenge conventional development methods. He began targeting proteins in the insect cells to stimulate an immune reaction.
The results were eye-opening. Not only was the system successful in defeating Rift Valley fever, it also significantly reduced the chance of side effects.
Around this time, former SDSU President David L. Chicoine '69 noticed a surprising lack of technology commercialization stemming from SDSU's research enterprise. He saw firsthand the impressive discoveries and inventions by professors, but they weren't making it much farther than the lab. Ideally, Chicoine thought, these discoveries would be serving as the technological foundation for startup companies.
Chicoine gathered a group of local businessmen and formed a Sioux Falls-based venture capital firm named "South ÌÇÐÄÊÓÆµ Innovation Partners." They then recruited a South ÌÇÐÄÊÓÆµ native, Mark Luecke, to direct the firm's business and serve as its CEO.
Luecke's goal for the firm was to commercialize university research and expertise by partnering with business-minded professors to bring their discoveries into the marketplace. With SDSU's strong agricultural college, he focused his efforts on finding agricultural technologies that had potential in growing and emerging industries. He reviewed around 2,000 invention disclosure forms before meeting with Young and a select few other professors in 2011.
The meeting was a resounding success. Young was exactly the type of professor Luecke was looking for.
"Dr. Young has a keen understanding of what is important to make business work," Luecke said. "There's not a lot of professors out there like him."
Young had previously been writing small business innovation research grants with another local company. After being introduced to Luecke, the duo began writing similar grants and Medgene was born.
"We were very successful at first and were awarded grants from a number of top federal agencies," Luecke said. "We were working on those grants together and looking for the right opportunity to center Medgene's mission around."

Proactive moves
In spring 2013, porcine epidemic diarrhea was first detected in the United States. The foreign animal disease, believed to have come from China, devastated swine herds across the country and caused significant economic damage to U.S. producers. Despite a vaccine being developed, it wasn't approved by the U.S. Department of Agriculture until 8 million piglets were dead.
This had become a recurring theme with animal disease in the U.S., and the USDA understood something had to change. In 2015, the agency issued Veterinary Services Memorandum 800.213. The seven-page document opened a regulatory pathway for animal health companies to address emerging diseases.
"The USDA recognized that we can't let emerging diseases spread, but when someone has a technical solution for it, regulations get in the way," Luecke explained.
Medgene's opportunity had arrived. The insect cell protein expression system, or baculovirus-based protein platform, that Young used to develop the Rift Valley fever vaccine could now be utilized to create new vaccines through this pathway.
"We've been able to do things within this new regulatory framework that we haven't been able to do before," Young explained. “Not because technically we didn't have an idea about how to do them, but because there was no pathway to get from here to there."
Medgene’s technology and growth
Medgene's campus is located on the northeastern edge of Brookings, just north of the Dacotah Bank Center. What started as a four-person team has grown to over 100 employees, many of whom are SDSU graduates. One of the lead researchers is an SDSU grad, and the company routinely takes on SDSU students as interns.
"We end up hiring a number of undergraduates and graduates from South ÌÇÐÄÊÓÆµ State," Luecke said. "That's been fantastic."
The company, just 14 years old, is quickly becoming a nationally recognized leader in animal bioscience and has shipped out over 1 million vaccine doses. The company currently has vaccines available for swine, cattle, deer and companion animals.
"We are very proud to be partnering with nearly all the ’Top 40 U.S. Pork Powerhouses’ on a number of swine diseases," Luecke said. "We work with some of the largest veterinary clinics on both the beef and cattle side. We're also currently working with many of the small animal clinic consolidators."
The key to Medgene's success is its prescription platform technology. It was developed after years of testing and research from Young that stemmed from his Rift Valley fever vaccine work. The platform technology is highly complex, but Medgene uses a simple home technology — Keurig coffee makers — to describe its technology to the general public.
"The technology that you see is like the old adage: just the tip of the iceberg," Young explained. "What you see above the water is very basic. It was developed in 1985 by Max Summers. But below the water is the advanced technology we have implemented to make it work."
With a Keurig, different pods inserted into the machine can make different types of drinks, but the process to make the drink, regardless of the type of pod inserted, stays the same. For Medgene, its platform technology allows researchers to insert different genes into the platform’s sequence to make different vaccines, but the manufacturing process remains the same. The platform is preapproved by the USDA, so new vaccines do not need additional rounds of review.
This process is revolutionizing how vaccines are developed and how veterinarians can respond to new diseases. Traditional vaccine development for an animal disease can take roughly five years and over $5 million in research and development to get on the market. This makes it very difficult to respond to a rapidly mutating disease or foreign animal disease. By the time the vaccine gets approved, it’s usually too late.
But in the case of Medgene's technology, vaccines can be developed within weeks rather than years. The key is finding a protein construct that will generate an effective immune response. The faster that happens, the faster a vaccine can be developed. Medgene scientists utilize cutting-edge technology, like artificial intelligence, and advances in science, like bioinformatics, to ensure they are targeting the correct proteins and triggering the correct immune response.
"The bioinformatics technology that our group has is very exciting," Young said. "We can be very certain that when our vaccines go out the door, they are going to do what we want them to do."
Medgene is one of the only companies nationwide producing vaccines in this manner, and its ingenuity is earning the lab national recognition. When rabbit hemorrhagic disease emerged internationally as a major threat in 2020, the USDA reached out to Medgene for a solution. The only available vaccine for the disease was in Europe and was made by harvesting the livers of infected rabbits. Medgene was able to quickly make and produce a vaccine — all in a humane, animal-free process — that has proven to successfully protect rabbits from this death-sentence of a disease.
'A new day for animal health’
Medgene has grown enough that it is not only developing vaccines but is researching new ways to defeat disease. For example, the company is investigating how secondary bacterial infections from viruses can be defeated through its platform technology. This is an encouraging development in the ongoing, endless battle with animal disease that gives the company's slogan — "a new day for animal health"— real meaning.
But for Young, the most exciting developments at Medgene are vaccines against tick-born illnesses. In the cattle industry, ticks are a significant problem as they cause disease transmission, anemia, loss in productivity and damage to hides. To combat this, Medgene researchers had another unconventional idea. Rather than target the disease with a vaccine, they targeted the tick. This was something that no other pharmaceutical company had done. The results have been surprising — even to Young.
"We introduced a vaccine last year against one strain of tick, and it worked way better than even I imagined," Young said. "We don't know if it limits disease because that’s a much more difficult experimental thing to do, but it clearly must because it clears the ticks off the animal."
Now, Medgene is looking at this idea of vector-borne disease vaccines through a broader lens. In the U.S., tick-borne diseases are a challenge for cattle, but in places like Africa, tick-borne diseases pose a significant threat to both animals and humans.
"If you can shut down tick-borne disease in animals, you can stop it occurring in humans," Young explained. "It's really a one-health approach."
Medgene is not only making a name for itself domestically, it’s also gaining traction internationally. As Luecke explains, there are a number of countries around the world that have livestock populations and experience significant challenges with animal disease. Medgene's ability to solve problems — Luecke describes Medgene as a "solutions provider" — uniquely positions it to quickly solve country-specific animal disease challenges. This development has both Luecke and Young optimistic about the company's trajectory and future.
"We're shipping internationally now," Young said. "It's really grown to a level that I never really foresaw that it was going to get to."
Medgene's growth as a company is important as its "next generation" of vaccine technology may be even more crucial in the future. The increasing prevalence and global transmission of animal disease underlines just how difficult the battle is — and scientists believe animal disease outbreaks are becoming more common. But the platform technology, which allows Medgene to develop potential vaccines for emerging threats and diseases and are ready to be deployed as needed, may be the defense needed in controlling future animal disease outbreaks and protecting U.S. agriculture.
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