FCR001

Talaris Therapeutics Announces First Patient Dosed in Phase 3 Clinical Trial of FCR001 in Living Donor Kidney Transplant Recipients

Retrieved on: 
Wednesday, July 22, 2020
Biotechnology, Other Health, Health, Pharmaceutical, Clinical trials, Medical specialties, Clinical medicine, Medicine, Immunology, Transplantation medicine, Biotechnology, Stem cells, Regenerative biomedicine, Organ transplantation, Kidney transplantation, Immunosuppression, Cell therapy, FCR001, Talaris Therapeutics

Talaris Therapeutics, Inc. , a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, today announced that the first patient has been dosed in the FREEDOM-1 Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.

Key Points: 
  • Talaris Therapeutics, Inc. , a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, today announced that the first patient has been dosed in the FREEDOM-1 Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.
  • We look forward to ramping up enrollment across the U.S. as we work to offer living donor kidney transplant patients the potential of a future free from chronic immunosuppression.
  • More information about the FREEDOM-1 trial can be found at: https://freedom1study.com/
    FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics to induce or restore patients immune tolerance.
  • FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

FDA Approves Talaris Therapeutics’ IND for Its Allogeneic Cell Therapy FCR001 to Be Evaluated in Patients With a Severe Form of Scleroderma

Retrieved on: 
Wednesday, July 8, 2020
Research, FDA, Genetics, Clinical trials, Stem cells, Cardiology, Biotechnology, Health, Science, Autoimmune disease, RTT, FCR001, Talaris Therapeutics

Approval of this IND allows Talaris to initiate a Phase 1/2a trial at sites across the U.S., including Duke University and the University of Michigan.

Key Points: 
  • Approval of this IND allows Talaris to initiate a Phase 1/2a trial at sites across the U.S., including Duke University and the University of Michigan.
  • Were very eager to study the tolerogenic potential of FCR001 for patients with severe autoimmune disease, said Scott Requadt, Chief Executive Officer of Talaris.
  • FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics to induce or restore patients immune tolerance.
  • FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

Update on Talaris’ Phase 2 Study of FCR001 in Living Donor Kidney Transplant Recipients to be Presented at ATC Virtual Congress

Retrieved on: 
Friday, May 29, 2020
Biotechnology, Pharmaceutical, Health, Clinical trials, Medicine, Medical specialties, Clinical medicine, Organ transplantation, Transplantation medicine, Kidney transplantation, Immunosuppression, Therapy, TK cell therapy, FCR001, Talaris Therapeutics

The data show that 26 of 37 (70%) of LDKT recipients of FCR001 were able to be weaned off all of their immunosuppression treatments.

Key Points: 
  • 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.
  • 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.

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

Retrieved on: 
Wednesday, November 13, 2019
Biotechnology, FDA, Health, Pharmaceutical, Clinical trials, Medical specialties, Medicine, Kidney diseases, Clinical medicine, Kidney transplantation, Glomerulosclerosis, Kidney disease, Focal segmental glomerulosclerosis, Alport syndrome, IgA nephropathy, Nephrology, Kidney failure, Biotechnology, FDA, Health, Pharmaceutical, Clinical trials, Medical specialties, Medicine, Kidney diseases, Clinical medicine, Kidney transplantation, Glomerulosclerosis, Kidney disease, Focal segmental glomerulosclerosis, Alport syndrome, IgA nephropathy, Nephrology, Kidney failure, FCR001, Talaris Therapeutics

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 companys Phase 2 trial.

Key Points: 
  • 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 companys Phase 2 trial.
  • Various auto-immune diseases including IgA nephropathy, focal segmental glomerulosclerosis (FSGS) and Alport syndrome 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.
  • Twelve subjects in Talaris Phase 2 trial experienced kidney failure as a result of an auto-immune disease.