BOSTON & LOUISVILLE, Ky.--(BUSINESS WIRE)--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, is presenting today new data from its Phase 2 trial of FCR001 in living donor kidney transplant (LDKT) recipients in a poster at the 2019 American Transplant Congress in Boston. These data indicate that the induction of tolerance achieved with FCR001 was associated with significantly improved quality of life measures for transplant recipients.
FCR001 is an investigational, allogeneic cell therapy that is being developed to induce or restore patients’ immune tolerance by establishing a stable, chimeric immune system comprised of both donor and recipient cells. Phase 2 data have shown that FCR001 can durably free a significant proportion of LDKT recipients from all chronic immunosuppression by about 12 months after their transplant, without rejection of their transplanted organ.
The recently completed quality of life study compared 13 patients in the Phase 2 trial to 12 patients who would have met the Phase 2 trial inclusion criteria but were transplanted under standard of care therapy. Patients were administered three validated quality of life questionnaires. Compared to those receiving standard of care, patients tolerized with FCR001 reported superior quality of life in the form of lower levels of psychological stress, anxiety and depression, and increased overall mental health. They also reported lower levels of pain and greater overall health. The poster, entitled “Quality of Life in Tolerant Living Donor Kidney Transplants vs. Standard of Care,” is on display on Sunday, June 2, from 6:00-7:00pm (board #251).
“These data complement the safety and efficacy of FCR001 observed in our Phase 2 trial,” said Chief Executive Officer Scott Requadt. “The negative impacts of chronic immunosuppression following a life-saving transplant, such as the high pill burden, lifestyle constraints and psychological stress, represent serious, daily and often underappreciated challenges for the vast majority of transplant recipients. It’s not surprising that inducing durable immune tolerance to a donated organ can not only result in improved long-term health for LDKT recipients — including better kidney function and lower cardiovascular risk — but can also potentially lead to a significantly better quality of life. At Talaris we are working to enable patients to live their fullest lives post-transplant.”
Talaris also presented at the 2019 American Transplant Congress two posters containing preclinical data on its Facilitating Cell platform:
- “JAK Inhibitor as a Novel Conditioning Approach to Establish Mixed Chimerism and Prevent Type 1 Diabetes Non-myeloablatively”: Saturday, June 1, 2019, 5:30-7:30pm, Board #43
- “Prevention of Diabetes in the NOD Mice Reconstituted with Bone Marrow Cells from Allogeneic CD4 Knockout, CD8 Knockout or B-Cell Knockout B6 Mice”: Tuesday, June 4, 2019, 6:00-7:00pm, Board #61
Finally, in an oral presentation entitled “Ten Year Follow-Up of a Phase 2 Clinical Trial to Induce Tolerance in Living Donor Renal Transplant Recipients,” the company will share longer term follow up data from the Phase 2 trial of FCR001. The presentation is Tuesday, June 4, 2019 at 4:30pm at the John B. Hynes Convention Center Veterans Auditorium (Publication #522).
About FCR001
FCR001 is an investigational, allogeneic cell therapy being developed by Talaris to induce durable immune tolerance in patients who receive a transplanted organ or to restore tolerance to self in patients with certain severe auto-immune or immune-mediated disorders. Talaris is initiating in 2019 a pivotal study of FCR001 to induce durable immune tolerance in living donor kidney transplant recipients. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.
About Talaris Therapeutics
Talaris Therapeutics, Inc., formerly Regenerex, 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.
