Talaris Therapeutics Presents Additional Phase 2 Data and Analyses at American Transplant Congress 2022
June 07 2022 - 4:01PM
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, presented additional data and
analyses from its Phase 2 trial of FCR001 and other studies of its
Facilitated Allo-HSCT Therapy platform at the 2022 American
Transplant Congress (ATC).
“We are pleased to be sharing a number of new clinical and
preclinical analyses at ATC, including a real-world, retrospective
analysis reflecting key health outcomes of our Phase 2 patients
treated with FCR001 compared to a matched group of patients treated
with standard of care,” said Scott Requadt, Chief Executive Officer
of Talaris. “This study underscores the potential benefits to
kidney function and cardiometabolic health experienced by patients
who are able to avoid long-term immunosuppression.”
A conference call to provide an interim update on the FREEDOM-1
study, originally planned for June 8, 2022, has been rescheduled
pending receipt of data from all participating sites and will now
be held on June 30, 2022.
ATC Data Presentation Highlights
- Real-world data comparison of matched controls to Phase
2 treated patients. In a poster presented at the 2022 ATC
meeting, Talaris reported findings of a retrospective, real-world
assessment of the safety and efficacy of FCR001 as compared with
standard of care (SOC) immunosuppression. Medical records were used
to identify 144 patients who received transplants contemporaneously
and at the same institution as 36 of the 37 Phase 2 clinical trial
participants, and who met the study’s inclusion and exclusion
criteria, including age, HLA mismatch and BMI.The analysis
indicated that patients treated with FCR001 had no higher incidence
of death, graft loss or biopsy-proven acute rejection than did
patients on IS in the five years post-transplant. Kidney function,
defined as estimated glomerular filtration rate (eGFR), was
significantly higher in patients treated with FCR001 at five years
(p=0.02), and key immunosuppression-related cardiometabolic
complications were observed less frequently in patients treated
with FCR001 compared to those on IS.
- Phase 2 long-term follow-up shows consistent durability
off IS. In an oral presentation at the 2022 ATC meeting,
Talaris provided an update on the continued long-term follow-up of
patients in its Phase 2 LDKT study. Talaris previously reported
that 26 of 37 (70%) patients in its Phase 2 study achieved stable
T-cell chimerism and were weaned off all chronic IS by
approximately 12 months after their transplant. To date, all
surviving patients weaned off IS remain IS- and rejection-free.
Talaris has followed these patients from five to 12.8 years
post-transplant. Six subjects have remained off IS > 10 years.
- In the Phase 2 study, Talaris did not observe any correlation
between the degree of HLA mismatch and the safety or efficacy
measures in the study. Patients at all levels of HLA matching were
able to discontinue chronic immunosuppression, with 19 out of 26
recipients (73%) who durably discontinued their chronic IS having
an HLA match of three or less to their donor.
- As of May 31, 2022, Talaris has accumulated over 250
patient-years of exposure to FCR001 in LDKT, and the safety profile
observed in the Phase 2 patients remains generally consistent with
that expected with kidney and allogeneic stem cell transplantation
involving non-myeloablative conditioning.
- COVID-19 outcomes among Phase 2 patients.
In a poster presented at the 2022 ATC meeting, investigators at
Northwestern University shared updated data on COVID-19 rates,
effects of COVID-19 infection and antibody response to vaccination
among evaluable patients in the Company’s Phase 2 study. Of the 23
durably chimeric patients off chronic IS, 18 were vaccinated, of
whom 5 (28%) tested positive for COVID-19. None of these 18
patients lost chimerism as a result of their COVID-19 vaccination.
Among the remaining 5 patients who were off all chronic IS but were
unvaccinated, 3 (60%) tested positive for COVID-19. Among the 5
patients who remained on chronic IS, 4 of whom were vaccinated, 3
(60%) tested positive for COVID-19. COVID-19 infection did not lead
to reduction in renal function for patients, and none of the
COVID-19-infected patients were hospitalized or experienced acute
kidney injury as a result of their infection. As previously
reported, post-vaccination antibody testing had been performed on 4
patients (3 durably chimeric, 1 not). These data showed that all 4
patients produced strong antibody responses to COVID-19
vaccination.
- Identification of immune cells involved in
sensitization. In a poster presented at the 2022 ATC
meeting, Talaris reported findings from a study in animal models to
discern the mechanisms of immune sensitization,
which increases the risk of graft rejection for bone marrow
and solid organ transplants. An examination of immune response to
foreign cells in mice engineered to lack either T cell receptors or
Fcγ receptors found that Fcγ-bearing macrophages and NK cells, and
not T cells, mediate this type of immune rejection.
- Potential urinary biomarker of immune
quiescence. In an oral presentation at the 2022 ATC
meeting, Talaris reported findings of urinary mRNA profiling that
it performed in a subgroup of Phase 2 LDKT patients who were
tolerized to their donated kidney, as well as in a biopsy-matched
cohort of standard of care LDKT recipients on chronic IS. The
analysis identified potential signals of greater immune quiescence
in the kidneys of tolerized patients as compared to the standard of
care cohort. These findings may provide further support that these
patients have been tolerized to their donated kidney.
Conference Call & Webcast
InformationTalaris will host an investor webcast and
conference call on Thursday, June 30, 2022 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, pending
receipt of data from all participating sites. 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 "News & Events" 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.
Cautionary Note Regarding Forward-Looking
StatementsThis 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 COVID-19 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’ 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 the
Company’s product candidates, including FCR001 and the Company’s
ability to successfully demonstrate the safety and efficacy of its
drug candidates. 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 our 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
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