Talaris Therapeutics Announces Initiation of Phase 2 Clinical Trial of FCR001 in Delayed Tolerance Induction

FREEDOM-2 trial will evaluate the potential for the company’s investigational allogeneic cell therapy, FCR001, to induce durable immune tolerance in patients who have previously received a kidney from a living donor

BOSTON, MA, USA I October 29, 2021 ITalaris Therapeutics, Inc., (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced the initiation of the company’s Phase 2 FREEDOM-2 study. Northwestern University is the first FREEDOM-2 clinical site to have been activated and has now begun screening for eligible patients. Additional sites are expected to be activated in 2022. This trial will explore the safety and efficacy of the company’s investigational allogeneic cell therapy, FCR001, to induce immune tolerance to a transplanted kidney in patients who received the transplant from a living donor up to a year prior to administration of FCR001.

“This trial exploring the efficacy of FCR001 in the delayed tolerance setting is an important step toward potentially offering an alternative to long-term immunosuppression as the standard of care for organ transplant recipients today,” said Nancy Krieger, M.D., Chief Medical Officer at Talaris. “We believe that this innovative approach could allow us to broaden the opportunity to apply this novel therapy in larger patient populations by expanding the options for previously transplanted patients whose donor is still available.”

FREEDOM-2 (NCT# NCT01649388) is a single-arm, open-label, multicenter study exploring the preliminary efficacy and evaluating the safety of FCR001, the company’s investigational allogeneic cell therapy, in living donor kidney transplant recipients 3-12 months following transplantation. The study consists of a one-time treatment administered with non-myeloablative conditioning, after which patients are followed for five years, with a primary analysis performed at 24 months.

“As a physician, I believe the possibility of inducing immune tolerance to a previously-transplanted organ would be transformative,” said Joseph R. Leventhal, M.D., Ph.D., Fowler McCormick Professor of Surgery at Northwestern University Feinberg School of Medicine, and the principal investigator for the FREEDOM-2 trial. “I look forward to leading this important study and to the insights it will bring to improve patient care.”

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 biopharmaceutical company developing investigational, one-time, allogeneic cell therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders. Talaris maintains corporate offices in Boston, MA, and its cell processing facility in Louisville, KY.

SOURCE: Talaris Therapeutics

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