UofL cell therapy startup acquired by publicly traded biotech firm UofL to lead planned clinical trial for COVID-19-related acute respiratory distress

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    Stuart K. Williams II, Ph.D.
    Stuart K. Williams II, Ph.D.

    LOUISVILLE, Ky. — A University of Louisville-born startup using innovative personalized cell therapies to help patients with pancreatitis and other conditions has been acquired by publicly traded biotech company, Orgenesis Inc. (NASDAQ: ORGS) in a roughly $15 million deal.

    The startup, Koligo Therapeutics Inc., led by a UofL alumnus, was launched in 2016 to develop and commercialize UofL research and technology for personalized therapies using a patient’s own cells. One UofL-developed therapy for pancreatitis already is on the market and another for COVID-19-related acute respiratory distress soon will enter a multi-site phase 2 clinical trial led by UofL.

    “These therapies have come a long way since that first ‘eureka’ moment in the lab at UofL,” said Stuart K. Williams II, Ph.D., a professor in the UofL Department of Physiology who co-invented the technologies, co-founded Koligo and now serves as its chief technology officer. “This acquisition supports expanded treatment of chronic pancreatitis patients and could further our cell-based treatments for COVID-19 patients throughout the United States.”

    The first therapy originated in UofL’s islet transplant program with co-inventors Williams, Michael Hughes, M.D., and Balamurugan Appakalai, Ph.D., with early grant funding from the Jewish Heritage Fund for Excellence. This therapy is now marketed as Kyslecel ™ to treat chronic and recurrent acute pancreatitis, which can cause pain, inflammation and diabetes as the pancreas degrades. The technology is available today in six U.S. hospitals and so far has been used to treat 38 patients.

    In the Kyslecel therapy, a surgeon removes the diseased pancreas and sends it to Koligo where the islets are extracted and preserved to make Kyslecel. The drug is then returned to the patient’s health care facility to be infused into the liver where the islets are expected to function and produce the insulin needed to regulate blood sugar. Williams said the goal for the next generation of islet cell therapies will be to deliver the islets via implant created using 3D-V, a UofL-developed bioprinting technology. 

    Koligo plans to test another therapy, KT-PC-301, in treating COVID-19-related acute respiratory distress syndrome (ARDS) in a forthcoming multi-site phase 2 randomized clinical trial, pending FDA review and clearance of an Investigational New Drug application.

    The planned trial, led by Mohamed Saad, M.D., chief of the UofL Division of Pulmonary, Critical Care and Sleep Disorders Medicine, is expected to enroll 75 COVID-19 patients. A list of other ongoing clinical trials at UofL is available here.

    ARDS can occur in critical cases of COVID-19 when the lungs swell and fill with fluid as the body tries to fight off the infection. KT-PC-301 is a cell therapy that is derived from a patient’s own fat tissue. A small amount of fat is collected from the patient and sent to Koligo to make KT-PC-301. The product is manufactured within hours and sent back to the hospital for intravenous administration. KT-PC-301 then migrates to the patient’s lungs to reduce inflammation.

    Matthew Lehman
    Matthew Lehman

    UofL licensed the Kyslecel and 3D-V technologies exclusively to Koligo through the UofL Commercialization EPI-Center, which works with startups and industry to commercialize research-born technology. Those licenses transfer to Orgenesis. UofL also maintains an equity stake in Koligo which has become an equity stake in Orgenesis after closing of that transaction.

    “We look forward to continuing our strong relationship with UofL, now with an even wider reach and global scale,” said Koligo Chief Executive Officer Matthew Lehman, who also is a former UofL McConnell Scholar and political science and history alumnus. “Together, Orgenesis and UofL will further develop these therapies that have real potential to save lives.”

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    Betty Coffman
    Betty Coffman is a Communications Coordinator focused on research and innovation at UofL. A UofL alumna and Louisville native, she served as a writer and editor for local and national publications and as an account services coordinator and copywriter for marketing and design firms prior to joining UofL’s Office of Marketing and Communications.