TScan Announces FDA Clearance Of 3 INDs For Solid Tumors

(RTTNews) - Clinical-stage biopharmaceutical company TScan Therapeutics, Inc. (TCRX) announced Monday that the FDA has cleared its investigational new drug or IND applications for T-Plex, TSC-204-A0201, and TSC-204-C0702.

The company said T-Plex will serve as the primary IND for its solid tumor program, enabling customized combinations of TCR-Ts to be administered to patients. Each unique TCR-T will be filed as a secondary IND and will reference the primary T-Plex IND.

TScan also filed secondary INDs for two initial TCR-T products, TSC-204-A0201 and TSC-204-C0702, that target melanoma-associated antigen 1 on HLA types A*02:01 and C*07:02.

Further, the company said it is now working to open a multicenter Phase 1 clinical trial to establish the safety, efficacy, and feasibility of repeat dosing of multiplexed TCR-T.