University of Louisville-Originated Investigational Allogeneic Cell Therapy Demonstrating Improved Patient Quality of Life for LDKTs

Talaris Therapeutics, a privately held biotechnology company developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, presented data from a Phase 2 trial of its investigational product FCR001 in living donor kidney transplant (LDKT) recipients in a poster at the 2019 American Transplant Congress in Boston as reported by Citizen Tribune.

What is FCR001?

An investigational, allogeneic cell therapy that was patented and incubated at the University of Louisville.  It is being developed to induce or restore patients’ immune tolerance by establishing a stable, chimeric immune system comprised of both donor and recipient cells.  Clinical data reveals the potential for FCR001 to durably free a significant proportion of living donor kidney transplant recipients from all chronic immunosuppression by 12 months after their transplant, without rejection of their transplanted organ

The Study

The Phase 2 FCR001 study is being conducted at two leading U.S. transplant centers. The recently completed quality of life study compared 13 patients in the Phase 2 trial to 12 patients who would have met the Phase 2 inclusion criteria but were transplanted under standard of care therapy. The patients were given three validated quality of life questionnaires. The FCR001 patients reported superior quality of life in the form of lower levels of psychological stress, anxiety and depression, as well as improved overall mental health.  Lower levels of pain and improved health were also reported. The poster for the study was titled “Quality of Life in Tolerant Living Donor Kidney Transplants vs. Standard of Care.”

Talaris will launch other Phase 2 studies evaluating the feasibility of FCR001 to treat select severe autoimmune or immune-mediated disorders,  not to mention to induce durable immune tolerance in other organ transplant settings.

The Sponsor 

CEO Scott Requadt noted “These data complement the safety and efficacy of FCR001 observed in our Phase 2 trial.” He continued “The negative impacts of chronic immunosuppression following a life-saving transplant such as the high pill burden, lifestyle constraints and psychological stress, represent serious daily and often underappreciated challenges for the vast majority of transplant recipients. It’s not surprising that inducing durable immune tolerance to donated organ can not only result in improved long-term health for LDKT recipients—including better kidney function and lower cardiovascular—but can also potentially lead to a significantly better quality of life. At Talaris we are working to enable patients to live their fullest lives post-transplant.”

The company was formerly known as Regenerex. It is a late-clinical stage biotech venture that was founded by the University of Louisville’s Dr. Suzanne Ildstad. It operates its own cell processing facility in Louisville, KY.  It is based by major investors including Blackstone Life Sciences.

Living Donor Kidney Transplants (LDKTs)

Kidney transplants are the most common organ transplant worldwide. There are over 6,400 LDKTs performed in the U.S. in 2018. Presently an organ transplant required the patient to take lifelong immunosuppression to stop rejection of their transplanted organ. Chronic immunosuppression brings significant to major side effects, an increased risk of infection and malignancy, and reduced quality of life.  Moreover, the toxicity of the drugs on the market to the kidney may lead to a degradation in kidney function. Kidney failure may result requiring a need for a transplant within 15 years.