Joseph Leventhal, Cell-Based Therapy for Organ Transplantation
About 123,000 Americans are on the organ transplant waiting list. Successful solid organ transplantation currently requires the lifelong use of medications to suppress the immune system in order to prevent transplant rejection. Drug-based immunosuppression significantly increases the risk of infection and cancer, and it’s very expensive. In addition, the immunosuppressive drugs that guard against organ rejection can have side effects that damage the transplanted organ.
Since the early 2000s, the research of Joseph Leventhal, MD, interim chief of organ transplantation and Fowler McCormick Professor of Surgery at the Feinberg School of Medicine, has focused on developing a method to minimize the need for drug-based immunosuppression in organ transplant recipients and individuals with autoimmune disease.
Through TRACT (T-Reg Adoptive Cell Transfer) Therapeutics, he and co-founder Gretchen Johnson are testing a T-cell-based therapy called T Reg Cell, a personalized product made from naturally occurring regulatory T cells, the patient’s own, expanded ex vivo to clinically significant quantities, and then infused back into the patient. This work has shown promise for both easing moderate to severe Crohn’s disease in animal models and raising the chances of success in kidney and other organ transplants in Phase 1 human testing.
An initial 2013 grant supported his studies in living donor kidney transplant recipients, which ran from through 2016 and enabled Leventhal to develop a protocol for producing clinical-grade human Tregs, and to launch the Phase 1 trials. Based on the promising results of these studies, in 2019, TRACT raised $15 million and started Phase 2 for the kidney transplant trial and Phase 1 for Crohn’s disease. They look to focus subsequent studies on liver transplant patients. TRACT has grown to five staff members and has secured a contract manufacturer.
The incremental successes of TRACT suggest much promise, but Leventhal knows that doesn’t guarantee success. “The entrepreneurial biotech landscape is littered with the remains of many early-phase companies,” he said. “I feel fortunate that I was able to identify a partner, do the capital raise, and be in a position to move this technology forward.”