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.
Contacts
Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617)
903-8783