WALTHAM, Mass, May 29, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TSC-100 and TSC-101, the Company’s two lead TCR-T therapy candidates for the treatment of heme malignancies (NCT05473910).

马萨诸塞州沃尔瑟姆，2024年5月29日（环球通讯社）--TScan Therapeutics，Inc.（纳斯达克：TCRX），一家临床阶段生物制药公司，专注于开发用于治疗癌症患者的T细胞受体（TCR）工程化T细胞（TCR-T）疗法，今天宣布，美国食品和药物管理局（FDA）已授予TSC-100和TSC-101再生医学高级疗法（RMAT）称号，TSC-100和TSC-101是该公司治疗血红素恶性肿瘤的两个主要TCR-T候选疗法（NCT05473910）。

“We are delighted to receive FDA RMAT designation for both candidates in our heme program designed to treat patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning, based on encouraging initial data from the ALLOHA trial,” said Chrystal U.

Chrystal U。

Louis, M.D., Chief Medical Officer. “This is an important milestone that recognizes the transformative potential of our engineered TCR-T therapy candidates, TSC-100 and TSC-101, in multiple difficult-to-treat cancers. We look forward to working closely with the FDA in our ongoing commitment to deliver life-changing therapies to patients.” Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline products, including gene and cell therapies.

医学博士路易斯，首席医疗官。“这是一个重要的里程碑，它认识到我们的工程TCR-T治疗候选药物TSC-100和TSC-101在多种难治性癌症中的变革潜力。我们期待着与FDA密切合作，为患者提供改变生命的治疗。”根据《21世纪治愈法案》建立的RMAT指定是一个专门的计划，旨在加速药物开发和审查有前途的管道产品（包括基因和细胞疗法）的过程。

A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such a disease or conditio.

如果再生医学疗法旨在治疗，改变，逆转或治愈严重或危及生命的疾病或病症，并且初步临床证据表明该药物或疗法有可能解决此类疾病或病症未满足的医疗需求，则有资格获得RMAT指定。