Talaris Therapeutics Announces Initiation of Phase 2 Clinical Trial of FCR001 in Delayed Tolerance Induction

BOSTON, Oct. 29, 2021 (GLOBE NEWSWIRE) — Talaris Therapeutics (Nasdaq: TALS), a late-clinical stage cell remedy firm growing therapies with the potential to remodel the usual of care in stable organ transplantation, sure extreme autoimmune ailments, and sure extreme non-malignant blood, immune and metabolic issues, at the moment introduced the initiation of the corporate’s Section 2 FREEDOM-2 research. Northwestern College is the primary FREEDOM-2 medical website to have been activated and has now begun screening for eligible sufferers. Further websites are anticipated to be activated in 2022. This trial will discover the security and efficacy of the corporate’s investigational allogeneic cell remedy, FCR001, to induce immune tolerance to a transplanted kidney in sufferers who acquired the transplant from a dwelling donor as much as a yr previous to administration of FCR001.

“This trial exploring the efficacy of FCR001 within the delayed tolerance setting is a vital step towards doubtlessly providing a substitute for long-term immunosuppression as the usual of look after organ transplant recipients at the moment,” stated Nancy Krieger, M.D., Chief Medical Officer at Talaris. “We imagine that this progressive strategy might permit us to broaden the chance to use this novel remedy in bigger affected person populations by increasing the choices for beforehand transplanted sufferers whose donor continues to be out there.”

FREEDOM-2 (NCT# NCT01649388) is a single-arm, open-label, multicenter research exploring the preliminary efficacy and evaluating the security of FCR001, the corporate’s investigational allogeneic cell remedy, in dwelling donor kidney transplant recipients 3-12 months following transplantation. The research consists of a one-time remedy administered with non-myeloablative conditioning, after which sufferers are adopted for 5 years, with a main evaluation carried out at 24 months.

“As a doctor, I imagine the opportunity of inducing immune tolerance to a previously-transplanted organ could be transformative,” stated Joseph R. Leventhal, M.D., Ph.D., Fowler McCormick Professor of Surgical procedure at Northwestern College Feinberg College of Drugs, and the principal investigator for the FREEDOM-2 trial. “I stay up for main this essential research and to the insights it can convey to enhance affected person care.”

About FCR001

FCR001 is an investigational, allogeneic cell remedy developed by Talaris Therapeutics to induce or restore sufferers’ immune tolerance. FCR001 builds on over 30 years of analysis by the corporate’s founder, Dr. Suzanne Ildstad, into the means by which sturdy immune tolerance may be induced in a affected person who receives a transplanted organ or may be restored in sufferers with sure immune-mediated or blood issues. FCR001 has acquired each Orphan Drug Designation and Regenerative Drugs Superior Remedy (RMAT) designation from the U.S. Meals and Drug Administration. A Section Three trial of FCR001 in dwelling donor kidney transplant recipients, FREEDOM-1, is now enrolling sufferers; extra info may be discovered at: http://freedom1study.com/

About Talaris Therapeutics

Talaris Therapeutics, Inc. is a late-clinical stage biopharmaceutical firm growing investigational, one-time, allogeneic cell therapies with the potential to remodel the usual of care in stable organ transplantation, sure extreme autoimmune ailments, and sure extreme non-malignant blood, immune and metabolic issues. Talaris maintains company places of work in Boston, MA, and its cell processing facility in Louisville, KY.

Cautionary Word Concerning Ahead-Trying Statements

This press launch comprises forward-looking statements throughout the that means of the Personal Securities Litigation Reform Act of 1995, as amended, together with, with out limitation, implied and categorical statements concerning Talaris Therapeutics, Inc.’s (“Talaris,” the “Firm,” “we,” or “our”) technique, enterprise plans and focus; the progress and timing of the preclinical and medical growth of Talaris’ applications, together with FCR001 and expectations concerning the timing and knowledge from the deliberate medical replace of FREEDOM-2. The phrases “could,” “may,” “will,” “might,” “would,” “ought to,” “anticipate,” “plan,” “anticipate,” “intend,” “imagine,” “anticipate,” “estimate,” “search,” “predict,” “future,” “venture,” “potential,” “proceed,” “goal” or the detrimental of those phrases and related phrases or expressions are supposed to establish forward-looking statements, though not all forward-looking statements include these figuring out phrases.

Any forward-looking statements on this press launch are based mostly on administration’s present expectations and beliefs and are topic to plenty of dangers, uncertainties and essential components which will trigger precise occasions or outcomes to vary materially from these expressed or implied by any forward-looking statements contained on this press launch, together with, with out limitation, dangers related to: the timing and anticipated timing and outcomes of its medical trials, technique and future operations, together with the anticipated timing and outcomes from FREEDOM-2,; the danger that the outcomes of Talaris’ medical trials is probably not predictive of future ends in reference to future medical trials; the Firm’s skill to efficiently reveal the security and efficacy of its drug candidates; the timing and end result of Talaris’ deliberate interactions with regulatory authorities; and acquiring, sustaining and defending its mental property. These and different dangers and uncertainties are described in better element within the part entitled “Threat Components” within the Firm’s Quarterly Report on Kind 10-Q for the quarter ended June 30, 2021, in addition to any subsequent filings with the Securities and Alternate Fee. As well as, any forward-looking statements symbolize Talaris’ views solely as of at the moment and shouldn’t be relied upon as representing our views as of any subsequent date. Talaris explicitly disclaims any obligation to replace any forward-looking statements. No representations or warranties (expressed or implied) are made in regards to the accuracy of any such forward-looking statements.

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