Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial of FCR001 in Living Donor Kidney Transplant Recipients

Pivotal trial to evaluate the safety and efficacy of novel, investigational cell therapy intended to durably free living donor kidney transplant recipients from immunosuppression

BOSTON & LOUISVILLE, Ky.--(BUSINESS WIRE)-- Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today announced the initiation of FREEDOM-1, the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients. This pivotal trial will evaluate the safety and efficacy of a single dose of FCR001, the company’s investigational cell therapy designed to durably free LDKT recipients from immunosuppression without rejection of their transplanted organ.

FREEDOM-1 is an open-label, randomized clinical trial comparing FCR001 to a standard of care (tacrolimus and mycophenolate-based) regimen for LDKT recipients. The trial is expected to enroll 120 adult LDKT recipients at multiple sites across the U.S. Its primary endpoint is the proportion of LDKT recipients free from immunosuppression at 24 months post-transplant. The trial will also evaluate the safety of FCR001 donors in the trial. The trial has begun enrolling patients at its first clinical site, Northwestern Memorial Hospital, and additional trial sites will be announced in coming months.

“Living donor kidney transplants save lives. However, they have a downside: the lifelong regimen of immunosuppressive drugs that organ transplant recipients must take elevates their risks of hypertension, high cholesterol, type 2 diabetes, sleep and CNS disorders, infections and certain cancers. Moreover, immunosuppressive drugs are, themselves, toxic to the kidney, leading to declining kidney function over time. On average, a transplanted kidney only lasts between 12-15 years, and many kidney transplant recipients will require multiple transplants over their lifetime,” said Scott Requadt, Chief Executive Officer of Talaris. “In our Phase 2 clinical trial, FCR001 demonstrated the capability to durably free a high percentage of LDKT recipients from immunosuppression and improve their overall quality of life post-transplant, findings which we now hope to reproduce in a larger group of patients in this Phase 3 trial as we advance this potentially transformative therapy.”

In Talaris’ groundbreaking Phase 2 study of FCR001, 26 of 37 (70%) LDKT recipients of FCR001 were able to be weaned off all immunosuppression treatments, with 100% durability to date. These results were equally robust regardless of the degree of HLA mismatch (spanning 0/6 to 6/6) between the donor and the recipient. Additionally, a subset of seven patients with an underlying autoimmune kidney disease who were able to withdraw from immunosuppression therapy have had no sign of recurrence of that autoimmune disease.

“Transplant surgeons have for decades searched for a way to establish durable immune tolerance to a donated organ, due to the risks and lifestyle limitations imposed by immunosuppression therapy,” said Joseph R. Leventhal, M.D., Ph.D., Fowler McCormick Professor of Surgery at Northwestern University Feinberg School of Medicine and a principal investigator for the Phase 2 and Phase 3 trials of FCR001. He also is the director of kidney transplantation at Northwestern Medicine. “FCR001 has shown great promise toward achieving this goal, with all tolerized patients in the Phase 2 study remaining off immunosuppression. It’s gratifying as a physician to be part of a clinical trial for a therapy that has the potential to change the landscape of living donor kidney transplants and, importantly, improve outcomes for patients.”

More information about the FREEDOM-1 trial can be found at: https://www.clinicaltrials.gov/ct2/show/NCT03995901

About FCR001
FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics to induce or restore patients’ immune tolerance. FCR001 builds on over 30 years of research by the company’s founder, Dr. Suzanne Ildstad, into the means by which durable immune tolerance can be induced in a patient who receives a transplanted organ or can be restored in patients with certain immune-mediated or blood disorders. The lead indication for FCR001 is to induce durable immune tolerance in living donor kidney transplant recipients. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

About Talaris Therapeutics
Talaris Therapeutics, Inc. is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. Talaris operates its own cell processing facility in Louisville, KY and maintains corporate offices in Boston, MA and Louisville, KY. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA. www.TalarisTx.com.

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