TScan Therapeutics announces FDA clearance of three IND applications

TScan Therapeutics announced that the U.S. Food and Drug Administration, FDA, has cleared its investigational new drug, IND, applications for T-Plex, TSC-204-A0201, and TSC-204-C0702. T-Plex will now serve as the primary IND for TScan’s solid tumor program, enabling customized combinations of TCR-Ts to be administered to patients based on the targets and HLAs expressed in their tumors. The specific TCRs for each patient will be chosen from the Company’s ImmunoBank, consisting of high-affinity, naturally occurring TCRs that recognize a variety of prevalent cancer-specific targets and are associated with various common HLA types. Each unique TCR-T will be filed as a secondary IND and will reference the primary T-Plex IND. In addition to the T-Plex IND, TScan 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. TScan believes that TSC-204-C0702 is the first clinical program in MAGE-A1 for an HLA type other than A*02:01. With these INDs cleared, TScan is now working to open a multicenter Phase 1 clinical trial to establish the safety, preliminary efficacy, and feasibility of repeat dosing of multiplexed TCR-T. David P. Southwell, President and Chief Executive Officer continued: "Today marks the first three IND clearances for our solid tumor program and further validates the use of our proprietary platform to identify therapeutic TCRs suitable for clinical development. With the FDA clearance of T-Plex, along with two MAGE-targeting TCRs, we are now one step closer to bringing bespoke cell therapies to patients. We are continuing to build our ImmunoBank, with four more IND filings anticipated in 2023."