Drug intelligence / Profile preview

FCR001

Development stage
Phase 2
Lead developer
Tourmaline Bio
Modality
Stem Cell Therapies → Cell Therapies
Administration
Intravenous
01

Overview

**FCR001** is an investigational, cryopreserved donor-derived facilitated allogeneic hematopoietic stem-cell therapy developed to establish durable mixed donor-recipient hematopoietic chimerism and donor-specific immune tolerance. The product is manufactured from mobilized peripheral blood obtained from the living organ donor and contains CD34-positive hematopoietic stem and progenitor cells, facilitating cells, and a controlled dose of alpha-beta T cells. It is administered after nonmyeloablative conditioning in conjunction with living-donor kidney transplantation, with the therapeutic objective of eliminating chronic maintenance immunosuppression while preserving graft function. Talaris Therapeutics discontinued its FREEDOM-1 and FREEDOM-2 kidney-transplant trials in February 2023 because of slow enrollment; ImmunoFree subsequently acquired rights to FCR001 and the transplant-tolerance business. ([tts2022.org](https://tts2022.org/images/sponsor_logos/Talaris/TAL2112663A_1-pager_Overall_Clinical_Trial_Program_updated_21July2022.pdf))

Other names
Talaris cell therapyFacilitating Cell-based Therapy

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