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FDA approval
TScan Therapeutics receives FDA RMAT designation for two TCR-T therapies
Cell & Gene Therapy
Jun 30, 2024
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Cell & Gene Therapy

Cell & Gene Therapy

Jun 30, 2024

TScan Therapeutics receives FDA RMAT designation for two TCR-T therapies

FDA approval

  • TScan Therapeutics has been granted the Regenerative Medicine Advanced Therapeutics (RMAT) designation from the FDA for its two TCR-T therapies, TSC-100 and TSC-101, for the treatment of various forms of leukemia and myelodysplastic syndrome for those undergoing specific hematopoietic stem cell transplants (HSCT).

  • The TSC-100 and TSC-101 therapies, currently in the trial phase, work by targeting HA-1 and HA-2 antigens, respectively. The major function of the therapies is to eradicate all remaining host hematopoietic cells after a transplant without harming donor-originated cells, which could potentially improve the cure rate for patients undergoing HSCT. The company claimed that all eight patients treated in early trials remained relapse-free during the 10-month follow-up period. 

  • TScan Therapeutics is a clinical-stage biopharmaceutical company focused on developing T cell receptor (TCR)-engineered T-cell therapies (TCR-T) to treat patients with cancer. The company's primary candidates, TSC-100 and TSC-101, aim to eliminate residual disease and prevent relapse in patients with hematologic malignancies such as acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndromes (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT). Additionally, TScan is advancing multiplexed TCR-T therapies for solid tumors, leveraging its ImmunoBank repository of therapeutic TCRs tailored to diverse targets and HLA types​.

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