Talaris Therapeutics Announces First Patient Dosed in Phase 3 Clinical Trial of FCR001 in Living Donor Kidney Transplant Recipients

- Enrollment continues with multiple trial sites now opening across the U.S. -

BOSTON, MA & LOUISVILLE, KY, USA I July 22, 2020 ITalaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, today announced that the first patient has been dosed in the FREEDOM-1 Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients. The 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.

“We are proud to have begun dosing in Talaris’ pivotal FREEDOM-1 trial, and grateful to the clinicians, patients and wider kidney transplant community who have joined in our efforts to advance this potentially transformative therapy,” said Scott Requadt, Chief Executive Officer of Talaris. “We are rapidly expanding our network of trial sites, with five sites now active and a planned 10 sites active by the end of this year. We look forward to ramping up enrollment across the U.S. as we work to offer living donor kidney transplant patients the potential of a future free from chronic immunosuppression.”

The FREEDOM-1 trial is expected to enroll 120 adult LDKT recipients at multiple sites across the U.S. To date, the trial has been initiated at five clinical Centers of Excellence: Northwestern Memorial Hospital (Chicago, Ill.); Scripps Clinic (La Jolla, Calif.); Duke University Medical Center (Raleigh, N.C.); MedStar Georgetown University Hospital (Washington, D.C.); and University of Nebraska Medical Center (Omaha, Neb.).

“The ability to induce durable, drug-free immune tolerance to a transplanted organ would be transformative for the thousands of patients who undergo living donor kidney transplant each year,” said Joseph R. Leventhal, M.D., Ph.D., Interim Chief of Organ Transplantation and Fowler McCormick Professor of Surgery at Northwestern University Feinberg School of Medicine, and a principal investigator for the FREEDOM-1 trial. “In our earlier studies of FCR001, we’ve seen promising long-term safety and efficacy, with some patients now off all immunosuppression more than 10 years post-transplant — findings which we now hope to reproduce in a larger group of patients in this Phase 3 trial.”

More information about the FREEDOM-1 trial can be found at: https://freedom1study.com/

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. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients, FREEDOM-1, is now enrolling patients; more information can be found at: http://freedom1study.com/

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 auto-immune and immune-mediated disorders. Talaris was founded on technology discovered and developed by Dr. Suzanne Ildstad and operates its own cell processing facility in Louisville, KY. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA and maintains corporate offices in Boston, MA and Louisville, KY. www.TalarisTx.com.

SOURCE: Talaris Therapeutics

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