Talaris Therapeutics Presents Data on Mechanisms of FCR001 Activity to Induce Immune Tolerance
November 07 2022 - 7:00AM
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 new data
characterizing the mechanisms of FCR001-induced immune tolerance in
two oral presentations at the 2022 American Society of Nephrology
(ASN) Annual Meeting.
The first presentation reported on transcriptional changes
following successful tolerization with FCR001. Urinary cell mRNA
profiling was conducted on 19 patients tolerized with FCR001 in the
Company’s Phase 2 clinical trial and 159 control patients who
received a living donor kidney transplant (LDKT) but were not
treated with FCR001. The analysis identified a unique urinary cell
mRNA signature that is consistent with immune quiescence as defined
by the ratio of CTLA-4 to granzyme B mRNA, which is significantly
higher in the FCR001 cohorts compared to the control cohorts. This
signature may help identify FCR001 patients who could safely
discontinue chronic immunosuppression.
In a second oral presentation, the Company reported data on the
specific composition of patients’ peripheral blood mononuclear
cells (PBMCs) following treatment with FCR001 in a small cohort of
patients enrolled in the Company’s Phase 3 FREEDOM-1 trial.
Longitudinal single-cell RNA sequencing was conducted on PBMCs from
three patients treated with FCR001 and one patient in the standard
of care control arm treated with immunosuppressants. The analysis
found that immune reconstitution following FCR001 treatment was
characterized by important changes in natural killer (NK) cell and
B cell sub-populations, and that this immune activation preceded
observation of clinical manifestations.
“We are pleased to present these new analyses that shed light on
how FCR001 treatment may modulate the immune landscape to induce
durable immune tolerance,” said Nancy Krieger, M.D., Chief Medical
Officer of Talaris. “These important insights into the
transcriptional response and immune cell behavior will inform our
ongoing development of Facilitated Allo-HSCT Therapy across
multiple therapeutic areas.”
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 timing and anticipated timing and results of its clinical
trials; the risk that the results of Talaris’ clinical trials may
not be predictive of future results in connection with future
clinical trials; 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 June 30, 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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