Analysis confirms that FCR001 induces durable tolerance in highly mismatched related and unrelated recipients
Boston and Louisville, Kentucky, December 14, 2021 (Global News Agency) - Talaris Therapeutics, Inc. (NASDAQ: TALS), a clinical advanced cell therapy company, today New analysis of HLA mismatch between donors. Recipients participating in the company's Phase 2 trial of living donor kidney transplantation (LDKT). High-resolution allelic typing of six loci found that FCR001 induces durable immune tolerance in highly mismatched related and unrelated receptors. The American Society of Hematology (ASH) Fowler McCormick, Professor of Surgery at Northwestern University Feinberg School of Medicine, and Joseph R. Leventhal, MD, Ph.D., lead investigator of the American Society of Hematology (ASH) Phase 2 study, shared these findings in an oral report) annual meeting.
The new analysis is based on DNA samples collected in the FCR001 Phase 2 trial conducted by Talaris in living kidney transplant recipients. The focus of the analysis is to use the high-resolution allelic typing of HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 to assess the degree of donor/recipient HLA mismatches, and understand their and capabilities The correlation between the two establishes a long-lasting mosaic in this patient sample.
All 12 relevant HLA alleles were evaluated for 29 samples out of 37 donor/recipient pairs; because the samples did not have enough DNA to detect locus DPB1, the other three donor/recipient pairs were evaluated An evaluation of 10 alleles was performed. In the former group, 21 of the 29 donor/acceptor pairs had 6/12 or more mismatches; in the latter group, two of the three pairs had 5/10 or more mismatches. match. Despite this high degree of mismatch, the persistent chimerism induced by FCR001 allowed the complete discontinuation of immunosuppression (IS) in 25 of these 32 subjects, with a period of 3.5 to 11 years for discontinuation of IS. Twelve of these 25 pairs were not associated with ≥8 HLA mismatches, and most of the patients receiving treatment showed >95% donor whole blood/T cell mosaicism. As previously reported, the incidence of GvHD is limited, and there are two cases, both of which occurred in the context of female donors and unrelated male recipients. The exclusion criteria for this donor-acceptor pairing have been added to the Phase 2 trial.
"We are pleased to share this new, more detailed examination of patients with HLA mismatches in our phase 2 trial, which shows that FCR001 induces durable immune tolerance at very high levels of mismatches," said Nancy, MD. Krieger said, Talaris. "As we conduct the ongoing Phase 3 registration study in LDKT, FREEDOM-1, and as we continue to promote the application of allogeneic hematopoietic stem cell transplantation therapies to other areas where patient demand is high, these insights are very valuable ."
About Talaris Therapeutics Talaris Therapeutics, Inc. is a late-stage clinical biopharmaceutical company that develops research and disposable allogeneic cell therapies that may change solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood , Immunity and metabolic disorders. Talaris has a corporate office in Boston, Massachusetts, a cell processing facility in Louisville, Kentucky, and other research facilities in Houston, Texas.
Note on 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 but not limited to Talaris Therapeutics, Inc. ("Talaris", "Company", " Our" or "our") strategy, business plan and focus; the progress and timing of the preclinical and clinical development of the Talaris project, including FCR001, and the promotion of the continued application of allogeneic hematopoietic stem cell transplantation therapy in other areas of high patient demand Extension. "May", "may", "will", "may", "should", "should", "expect", "plan", "anticipate", "intend", "believe", "expect" and other words " "Estimate", "seek", "forecast", "future", "project", "potential", "continue", "target" or the negative words and similar words or expressions of these terms are intended to identify forward-looking statements, although they are 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 many risks, uncertainties and important factors, which may cause actual events or results to be expressed or implied in any forward-looking statements. The content is quite different. The statement contained in this press release includes, but is not limited to, the risks associated with: the timing and expected time and results of its clinical trials; Talaris' clinical trial results may not be able to predict the risks of future results related to future clinical trials; the company's success The ability to prove the safety and effectiveness of its drug candidates. These and other risks and uncertainties have been updated in the section entitled “Risk Factors” in the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2021, and any subsequent filings with the U.S. Securities and Exchange Commission. Detailed description. In addition, any forward-looking statements only represent the views of Talaris as of today and should not be considered as representing our views on any subsequent date. Talaris expressly disclaims any obligation to update any forward-looking statements. No representations or guarantees (express or implied) are made as to the accuracy of any such forward-looking statements.
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