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Talaris Therapeutics, Inc. Announces Promising Phase 2 Data of Novel, Allogeneic Cell Therapy in Living Donor Kidney Transplant Recipients

– FCR001 established durable immune tolerance in 70% of patients

– Results support initiation of Phase 3 registration study later this
year

BOSTON & LOUISVILLE, Ky.–(BUSINESS WIRE)–Talaris
Therapeutics, Inc.
, formerly Regenerex, a privately held
biotechnology company developing transformative cell therapies that have
the potential to eliminate the burden of chronic immunosuppression for
organ transplant recipients, today announced full results of its Phase 2
trial of FCR001 in living donor kidney transplant (LDKT) recipients. The
therapy’s strong durability of benefit and safety profile support the
initiation of a Phase 3 clinical trial in LDKT later this year.

The company also announced today the
completion of a $100 million Series A financing
from a syndicate of
leading life sciences investors.

FCR001, an investigational, allogeneic cell therapy that was patented
and incubated at the University of Louisville, is being developed to
induce or restore patients’ immune tolerance by establishing a stable,
chimeric immune system comprised of both donor and recipient cells.
Clinical data have shown the potential for FCR001 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.

In a groundbreaking Phase 2 study of FCR001 conducted at two leading
transplant centers in the United States, 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. Every tolerized patient has
subsequently remained off all chronic immunosuppression, with median
follow-up since transplant of approximately five years and longest
follow-up of almost 10 years. In addition, of the seven LDKT patients
with a prior auto-immune disease that led to their kidney failure and
who were successfully tolerized with FCR001, none has to date had a
recurrence of their underlying auto-immune disease. FCR001 has received
a Regenerative Medicine Advanced Therapy (RMAT) designation from the
U.S. Food and Drug Administration.

“Talaris is committed to eliminating the need for chronic
immunosuppression following a life-saving organ transplant. These
promising Phase 2 data support our belief that FCR001 has potential to
dramatically improve outcomes for patients,” said Chief Executive
Officer Scott Requadt. “We hope to reproduce these findings in a Phase 3
trial to be initiated later this year.”

The company plans to launch additional Phase 2 studies to evaluate the
potential of FCR001 to treat certain severe auto-immune or
immune-mediated disorders, as well as to induce durable immune tolerance
in other organ transplant settings.

“As a transplant surgeon, I have seen firsthand the life-saving benefits
of organ transplantation, as well as the challenges patients face due to
their lifelong dependence on immunosuppressive drugs,” said Dr. Suzanne
Ildstad, Chief Scientific Officer and Founder. “We are excited and
gratified for this opportunity to advance FCR001 to a Phase 3
registration study, bringing it one step closer to helping organ
transplant recipients and other patients live better lives, free from
immunosuppression.”

About Living Donor Kidney Transplants (LDKTs)

Kidney transplants are the most frequent organ transplant procedure in
the world. Over 6,400 LDKTs were performed in the U.S. alone in 2018.
Currently, organ transplant recipients require lifelong
immunosuppression to prevent rejection of their transplanted organ.
Chronic immunosuppression brings significant side effects, an increased
risk of infection and malignancy, and reduced quality of life.
Additionally, the toxicity of these drugs to the kidney leads to
declining kidney function, typically resulting in kidney failure and the
need for a new transplant within 15 years.

About FCR001

FCR001 is an investigational, allogeneic cell therapy developed by
Talaris to induce or restore patients’ immune tolerance. FCR001 builds
on over 30 years of research by the company’s founder, Dr. Suzanne
Ildstad, into the means by which durable immune tolerance can be induced
in a patient who receives a transplanted organ or can be restored in
patients with certain immune-mediated or blood disorders. It was
patented and incubated at the University of Louisville. The lead
indication for FCR001 is to induce durable immune tolerance in living
donor kidney transplant recipients. FCR001 has received Orphan Drug
Designation and a 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
[email protected]
(617)
903-8783

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