KU research, startup company at forefront of exosome isolation in cancer research

By Lindsey Slater  – Director of Communications

You may have never heard of an exosome, but research involving these vesicles has boomed. Exosomes have a variety of clinical applications, like targeted drug delivery or liquid biopsies. A Lawrence company is on the forefront of technology that tackles the challenging process of isolating exosomes for research.

Clara Biotech’s co-founder, Dr. Mei He, started working with exosomes in cancer research using ultracentrifugation.

“She saw the potential, but also saw the major limitations in the methods available for isolating exosomes from samples,” said Jim West, CEO of Clara Biotech. “Through research grants from the NIH and USDA, she was able to develop the platform that Clara Biotech is developing today.”

He is a research associate and assistant professor in the School of Engineering at the University of Kansas and serves as the Chief Science Officer of Clara Biotech. He’s lab is located in the MultiDisciplinary Research Building on KU’s West Campus, across the street from the company’s home in the Bioscience and Technology Business Center.

“Being at the BTBC is great,” West said. “The support from the staff in numerous areas has been immensely helpful. We’ve met some great companies we wouldn’t have otherwise, and it has given us a great foundation to build our business from.”

Clara Biotech was founded in 2015 by scientists, including Dr. He, who spent much of their careers contending with the difficulties that exist in exosome research. The company’s creation came from the need to address sample preparation, a major limitation. Clara Biotech’s exosome isolation platform, called ExoSS, simplifies the process of exosome sample preparation through improved quality, yield and reliability.

In April 2018, Clara Biotech was awarded a Phase I SBIR from the National Cancer Institute at the National Institutes of Health. Later that same year, the company executed an exclusive patent license from the University of Kansas.

The patented chemistry is the company’s proprietary bead technology, which significantly increases the affinity of antibody-bead interactions.

“Clara Biotech is a great example of how university research can be spun out of the academic setting and into the commercial realm with tangible and significant benefit for the public good,” said G.R. Underwood, president of the BTBC. “Clara’s exosome isolation platform has the potential to not only enable revolutionary discoveries from therapeutics to clinical applications, but also for creating and sustaining a number of high-paying jobs.”

2019 was a big year for Clara Biotech – they launched their Exosome Isolation Lab Service, completed their first paid customer pilot projects, secured their first investor, was a top company at the Pure Pitch Rally, came in first place at the Velocity Lee’s Summit Pub Pitch Crawl and completed its first project with a major player in the pharmaceutical industry.

“The company has completed significant customer validation activities, and we look forward to providing a platform any company can use to develop and bring high quality exosome products to market,” West said.

Clara Biotech will be launching its reagent product in the summer, which will give them a major product in the market. The company is also developing an exosome marketplace, working on contracts to do large volume processing, getting Good Manufacturing Practice (GMP) systems in place, and developing its lab-tool automatic platform.

West, a dual alumnus from KU, has utilized interns from the university, and being located on West Campus has been a vital connection for Clara Biotech to find resources and opportunities, and to build relationships.

Clara Biotech says its platform is virtually limitless in its application, and ExoSS is scalable in both the academic and industrial worlds.