[{"orgOrder":0,"company":"Talaris Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Update on Talaris\u2019 Phase 2 Study of FCR001 in Living Donor Kidney Transplant Recipients to be Presented at ATC Virtual Congress","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Talaris Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Talaris Therapeutics\u2019 IND for Its Allogeneic Cell Therapy FCR001 to Be Evaluated in Patients With a Severe Form of Scleroderma","therapeuticArea":"Immunology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene 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2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Talaris Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Talaris Therapeutics Presents Data on Mechanisms of FCR001 Activity to Induce Immune Tolerance","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Talaris Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Talaris Therapeutics Announces Plans to Explore Strategic Alternatives and Implements Restructuring Plan","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene 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Find Clinical Drug Pipeline Developments & Deals by Talaris Therapeutics
The combined company will focus on advancing Tourmaline’s lead program, TOUR006, a potentially best-in-class anti-IL-6 antibody, for the treatment of thyroid eye disease (TED) and atherosclerotic cardiovascular disease (ASCVD).
The combined company will focus on advancing Tourmaline’s lead program, TOUR006, a potentially best-in-class anti-IL-6 antibody, for the treatment of thyroid eye disease (TED) and atherosclerotic cardiovascular disease (ASCVD).
FCR001 has the potential to restore self-tolerance in patients suffering from scleroderma and other severe autoimmune diseases by eradicating diseased autoreactive cells and regenerating a new and healthy supply of immune cells.
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.
Lead Product(s):
Cryopreserved Allogeneic Stem Cell Therapy
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.
All FREEDOM-1 patients who received FCR001 (cryopreserved allogeneic stem cell therapy) at least three months prior to the data cutoff date have achieved and maintained >50% T-cell chimerism, a potential biomarker predictive of achieving tolerance.
Lead Product(s):
Cryopreserved Allogeneic Stem Cell Therapy
Real-world, retrospective analysis of Phase 2 patients versus matched controls finds FCR001-treated patients have improved kidney function and fewer cardiometabolic complications than patients on immunosuppression after 5 years.
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose in kidney transplant recipients who received a non-myeloablative conditioning regimen.
Lead Product(s):
Cryopreserved Allogeneic Stem Cell Therapy
Result demonstrated, 26 of 37 LDKT recipients of FCR001 from Company’s Phase 2 study achieved durable chimerism and were able to discontinue and remain off all IS for the duration of follow-up, with a median follow-up of over six years.
Lead Product(s):
Cryopreserved Allogeneic Stem Cell Therapy
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