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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).
Lead Product(s): TOUR006
Therapeutic Area: Immunology Product Name: TOUR006
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Tourmaline Bio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger October 19, 2023
Details:
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).
Lead Product(s): TOUR006
Therapeutic Area: Immunology Product Name: TOUR006
Highest Development Status: Phase IIProduct Type: Large molecule
Recipient: Tourmaline Bio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger June 22, 2023
Details:
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.
Lead Product(s): FCR001
Therapeutic Area: Immunology Product Name: FCR001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2023
Details:
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
Therapeutic Area: Immunology Product Name: FCR001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 07, 2022
Details:
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.
Lead Product(s): FCR001
Therapeutic Area: Immunology Product Name: FCR001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2022
Details:
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
Therapeutic Area: Immunology Product Name: FCR001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2022
Details:
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.
Lead Product(s): FCR001
Therapeutic Area: Immunology Product Name: FCR001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2022
Details:
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
Therapeutic Area: Immunology Product Name: FCR001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
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
Therapeutic Area: Immunology Product Name: FCR001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
Analysis confirms FCR001 (Cryopreserved Allogeneic Stem Cell Therapy) induced durable tolerance in highly mismatched related and unrelated living donor kidney transplant recipients.
Lead Product(s): Cryopreserved Allogeneic Stem Cell Therapy
Therapeutic Area: Immunology Product Name: FCR001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2021
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