Talaris Therapeutics Presents Data Supporting Potential of FCR001 to Prevent Recurrence of Kidney-Related Autoimmune Disease in Kidney Transplant Recipients

BOSTON, Mass., and LOUISVILLE, Ky., Nov. 7, 2019 – 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 presented data demonstrating the potential of its cell therapy to resolve certain auto-immune diseases of the kidney.

The data, presented in a late-breaking poster at the 2019 American Society of Nephrology (ASN) Kidney Week conference, reflect an analysis of living donor kidney transplant recipients with auto-immune diseases of the kidney who underwent kidney transplant and treatment with Talaris’ cell therapy, FCR001, in the company’s Phase 2 trial.

Various auto-immune diseases — including IgA nephropathy, focal segmental glomerulosclerosis (FSGS) and membranous glomerulonephritis — degrade kidney function and can necessitate a kidney transplant. These conditions recur in a high percentage of cases post-transplant, potentially leading to an accelerated decline of the transplanted kidney. Therefore, repeated kidney transplants are often necessary for patients with these diseases.

Twelve subjects in Talaris’ Phase 2 trial experienced kidney failure as a result of an auto-immune disease. Within this cohort, seven patients were successfully tolerized with FCR001, including two with FSGS, which is a particularly aggressive kidney-related auto-immune condition. None of the seven successfully tolerized patients has to date had a detectable recurrence of their underlying auto-immune disease. Of the five other patients who displayed either transient or no immune chimerism, recurrence of the prior auto-immune disease was observed in two cases.

“We’re very excited by this demonstration of the potential of FCR001 to durably reset the immune system and halt auto-immune disease in patients in our Phase 2 trial. Many auto-immune diseases of the kidney are not resolved by a conventional kidney transplant, and therefore patients may require multiple transplants over the course of their lives. We’re hopeful that our cell therapy could interrupt this cycle of repeat transplants,” said Chief Executive Officer Scott Requadt. “Talaris plans to build upon these promising findings in an upcoming Phase 2 trial, in which we will evaluate the potential of FCR001 to treat certain severe auto-immune or immune-mediated disorders.”

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

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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