FCR-001

Unassigned

New Medicines

Transplant rejection in living donor kidney transplant recipients

Information

New molecular entity
Talaris Therapeutics
Talaris Therapeutics

Development and Regulatory status

None
None
Phase III Clinical Trials
Yes
Nov 19Has orphan drug status and Regenerative Medicine Advanced Therapy (RMAT) status for prevention of renal transplant rejection in the US [2].
Oct 19PIII clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients starts [1].

Category

An allogeneic haematopoietic stem cell-based therapy, which includes facilitating cells from a donor. The cell therapy demonstrated induction of immune tolerance, or bone marrow chimerism, after transplantation.
In 2018/19, there were 935 living donor kidney transplants [3].
Transplant rejection in living donor kidney transplant recipients
Intravenous

Trial or other data

Dec 20PIII FREEDOM-1 study is recruiting and remains on course to complete primary outcome data collection in Apr 23 [6].
Oct 19PIII trial NCT03995901 (FREEDOM-1) is due to complete collection of primary outcome data in Apr 23 [5].
Oct 19PIII trial NCT03995901 (FREEDOM-1) is an open-label, randomized clinical trial comparing FCR001 to a standard of care (tacrolimus and mycophenolate-based) regimen for living donor kidney transplant recipients. It is expected to enroll 120 adults in the US. Its primary endpoint is the proportion of those free from immunosuppression at 24 months post-transplant [1].
Apr 19Talaris releases results from a PII study to evaluate the efficacy of FCR 001 in induction of donor specific tolerance in recipients of living kidney transplants by donor FCRx infusion (NCT00497926). The open-label, trial enrolled 60 patients in the US. By Sep13, 15 renal transplant recipients had been treated, and six of these had been able to discontinue immunosuppressant drugs without loss of new blood cells formed from transplantation. Withdrawal of immunosuppressants in a further two patients is anticipated. Results from the study showed that FCR 001 demonstrated ability to durably free a significant proportion of living donor kidney transplant recipients from all chronic immunosuppression by 12 months after their transplant, without rejection of their transplanted organ [2].