- Data reinforce potential of FCR001 to induce long-lasting immune tolerance to donated organ -
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, announced the presentation of updated data from long-term follow-up of its Phase 2 study of FCR001 in living donor kidney transplant (LDKT) recipients during an oral presentation at the ATC Virtual Congress on Saturday, May 30, 2020.
The data show that 26 of 37 (70%) of LDKT recipients of FCR001 were able to be weaned off all of their immunosuppression treatments. The degree of HLA mismatch (spanning 0/6 to 6/6) between the donor and the recipient did not affect either the safety or the efficacy of the therapy. Every tolerized patient has subsequently remained off all chronic immunosuppression, now with a minimum follow-up of three years for all trial subjects, median follow-up of over five years, and the longest follow-up of almost 11 years. Long-term subjects off immunosuppression have shown no evidence of immune defect, and can be safely and effectively vaccinated. The findings will be presented by Joe Leventhal, M.D., Ph.D., a professor of surgery in organ transplantation at Northwestern University Medical School, director of the living donor renal transplant program at Northwestern Memorial Hospital and lead investigator for the trial.
The following are specific details regarding the oral presentation:
Title: "Long-Term Follow-Up of a Phase 2 Clinical Trial to Induce Tolerance in Living Donor Renal Transplant Recipients"
Date: Saturday, May 30, 2020
Time: 3:15 p.m. ET
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://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.
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