Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage
cell therapy company developing therapies with the potential to
transform the standard of care in solid organ transplantation and
severe immune and blood disorders, today provided a clinical update
on its ongoing Phase 3 FREEDOM-1 study in living donor kidney
transplant (LDKT) recipients.
To date, Talaris has enrolled 22 donor-recipient pairs in the
Phase 3 FREEDOM-1 study (NCT# 03995901) of FCR001. Seven patients
have been successfully dosed at five different trial sites. All
three patients who were dosed more than 12 months prior to the data
cutoff date have been successfully weaned off all chronic
anti-rejection drugs without evidence of rejection and with stable
kidney function. All of these patients, including the first patient
who is now 24 months post-transplant, continue to remain off all
anti-rejection drugs. Furthermore, all patients treated with FCR001
at least three months prior to the data cutoff date have achieved
and maintained T-cell chimerism levels >50% at each of the 3-,
6- and 12-month timepoints post-transplant. The safety profile
observed was generally consistent with that expected in patients
receiving a kidney transplant and an allo-HSCT. Three cases of
low-grade acute graft-versus-host disease (aGvHD) were reported,
all of which were treatment-responsive and have since resolved. One
of these patients is more than 12 months post-transplant and has
been successfully weaned off all anti-rejection drugs. As a result
of an internal review triggered by the GvHD cases, Talaris has
modified its mobilization protocol and added a second
post-transplant dose of cyclophosphamide for GvHD prophylaxis.
Trial enrollment continues.
Phase 3 FREEDOM-1 Highlights¹
- Enrollment, demographics and degree of HLA
mismatching. A total of 22 LDKT donor-recipient pairs
have been enrolled to date in the FREEDOM-1 study at 10 different
clinical sites. Of these, 13 were randomized to receive FCR001, 8
were randomized to the control arm and 1 failed final screening
criteria. Currently, 7 of those randomized to FCR001 have received
their kidney transplant and have been dosed with FCR001. The
clinical trial continues to enroll donor/recipient pairs across all
degrees of HLA mismatch. Figure 1 shows the distribution of
all FCR001 recipients dosed to date, by the number of HLA
mismatches between the donor and the recipient.
- Efficacy data in FCR001-dosed patients. As
shown in Figure 2, a total of 7 patients have been dosed and
all patients dosed at least three months prior to the cutoff date
have achieved and maintained T-cell chimerism levels >50% at
each of the 3-, 6- and 12-month timepoints post-transplant. All 3
of the patients dosed more than 12 months prior to the data cutoff
date have been successfully weaned off all chronic anti-rejection
drugs. The longest of these has been followed for 24 months
post-transplant.
In the context of transplantation, chimerism refers to a state
wherein both the donor’s and the recipient’s hematopoietic stem
cells (HSCs) coexist in the recipient’s bone marrow. Talaris
believes chimerism to be an important potential study biomarker,
predictive of inducing a state of allogeneic tolerance in the
recipient, whereby the recipient tolerates the donated organ
without the need for chronic anti-rejection drugs. Achieving high
levels of durable donor T-cell chimerism in the LDKT recipient is
one of the goals of the Company’s Facilitated Allo-HSCT Therapy. In
the Company’s Phase 2 study, establishment and maintenance of
>50% donor T-cell chimerism in an LDKT recipient at 3, 6 and 12
months after administration of FCR001 all correlated strongly with
the patient’s ability to durably discontinue chronic anti-rejection
drugs approximately one year after transplant, without subsequent
graft rejection.
- Safety profile in FCR001-dosed patients.
Adverse events (AEs) and serious adverse events (SAEs) observed in
FCR001-dosed patients are consistent with those generally expected
in someone receiving both a kidney transplant and an allogeneic
stem cell transplant involving non-myeloablative conditioning.
Three cases of low-grade (grade II) aGvHD were reported, all of
which responded to treatment and resolved. One of these patients is
more than 12 months post-transplant and, notwithstanding their
treatment-responsive aGvHD, has been weaned off all anti-rejection
drugs. One of the three aGvHD patients was subsequently diagnosed
with moderate chronic GvHD and is also responding to treatment. No
trial stopping rules were triggered by the GvHD cases, and trial
screening and enrollment continued. However, to investigate these
aGvHD cases, Talaris conducted an internal review of all GvHD cases
in Phase 2 and 3. Through this review, a correlation was identified
between these cases and the use of plerixafor as a donor mobilizing
agent, the use of which has been higher to date under the Phase 3
mobilization protocol compared with the Phase 2.
Based on this analysis, the Company has modified the FREEDOM-1
trial protocol to eliminate plerixafor from the donor mobilization
regimen in all but exceptional cases, and has also added a second
dose of post-transplant cyclophosphamide (PTCy) for the FCR001
recipient. The revised mobilization protocol better aligns with
current customary donor mobilization practices and the additional
dose of PTCy reflects the current standard of care for GvHD
prophylaxis in HLA-mismatched allogeneic stem cell transplants. All
findings and recommendations were reviewed and endorsed by a panel
of external scientific advisors as well as the FREEDOM-1 data
monitoring committee (DMC), which supported continuation of the
trial with these modifications.
“Today, organ transplant recipients must take lifelong
immunosuppression to avoid rejecting their transplanted organ.
These immunosuppressive regimens have significant morbidities,
risks and quality of life challenges,” said Scott Requadt, Chief
Executive Officer of Talaris. “A treatment alternative for these
patients is greatly needed. The interim update presented today from
our FREEDOM-1 study continues to support our prior data and belief
that patients who achieve >50% T cell chimerism at 3, 6 and 12
months after the administration of FCR001 may be durably weaned
from chronic immunosuppression without rejecting their transplanted
organ. Overall, we are pleased with the continued progress of our
FREEDOM-1 trial, with seven study patients now successfully dosed
and 100% engraftment across all dosed patients, at multiple trial
sites. These interim results continue to give us confidence that
FCR001 has the potential to transform the standard of care in solid
organ transplantation.”
Figure 1:
Figure 2:
Conference Call & Webcast
InformationTalaris will host an investor webcast and
conference call today at 8:00 a.m. ET to discuss its presentations
at the American Transplant Congress (ATC) and provide a data update
from its ongoing Phase 3 FREEDOM-1 study in living donor kidney
transplant (LDKT) recipients. To access the conference call, the
dial-in numbers are 1-855-605-1739 for domestic callers and
1-914-987-7955 for international callers. The conference ID number
for the live call will be 6249115. A live webcast and replay of the
conference call will also be available under "Events &
Presentations" in the Investors section of the Company's website
at www.talaristx.com.
About Talaris TherapeuticsTalaris Therapeutics,
Inc. is a late-clinical stage cell therapy company developing
therapies with the potential to transform the standard of care in
solid organ transplantation and severe immune and blood disorders.
Talaris maintains corporate offices in Boston, MA, its cell
processing facility in Louisville, KY, and additional research
operations in Houston, TX.
About the FREEDOM-1 StudyFREEDOM-1 is a
randomized, controlled, open-label Phase 3 registrational study of
FCR001 in 120 adult LDKT recipients in the United States. The
primary endpoint of FREEDOM-1 is the proportion of kidney
transplant recipients treated with FCR001 who are free from chronic
IS, without biopsy-proven acute rejection (BPAR), at month 24
post-transplant.
Cautionary Note Regarding Forward-Looking
Statements This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including, without limitation,
implied and express statements regarding Talaris Therapeutics,
Inc.’s (“Talaris,” the “Company,” “we,” or “our”) strategy,
business plans and focus; the progress and timing of the
preclinical and clinical development of Talaris’ programs,
including FCR001. The words “may,” “might,” “will,” “could,”
“would,” “should,” “expect,” “plan,” “anticipate,” “intend,”
“believe,” “expect,” “estimate,” “seek,” “predict,” “future,”
“project,” “potential,” “continue,” “target” or the negative of
these terms and similar words or expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, risks associated
with: the impact of the ongoing COVID-19 pandemic on countries or
regions in which the Company has operations or does business, as
well as on the timing and anticipated timing and results of its
clinical trials, strategy and future operations, including the
expected timing and results from FREEDOM-1, the risk that the
results of Talaris’ prior clinical trials may not be predictive of
or consistent with future and/or final results in connection with
the Company’s ongoing or future clinical trials; the therapeutic
benefits expected from FCR001 and the Company’s ability to
successfully demonstrate its safety and efficacy. These and other
risks and uncertainties are described in greater detail in the
section entitled “Risk Factors” in the Company’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2022, as well as any
subsequent filings with the Securities and Exchange Commission. In
addition, any forward-looking statements represent Talaris’ views
only as of today and should not be relied upon as representing its
views as of any subsequent date. Talaris explicitly disclaims any
obligation to update any forward-looking statements. No
representations or warranties (expressed or implied) are made about
the accuracy of any such forward-looking statements.
Media ContactLisa RaffenspergerTen Bridge
Communicationslisa@tenbridgecommunications.com(617)
903-8783
Investor ContactChris BrinzeyICR
Westwickechris.brinzey@westwicke.com(339)
970-2843
________________________
¹ All data reported is as of the June 15, 2022 data cutoff
date
Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/40bcc976-1444-4ce3-8e83-82756ba1242a
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