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TScan Therapeutics Announces FDA Clearance of Three Investigational New Drug Applications

Tuesday, January 24, 2023

TScan Therapeutics, Inc. 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 serves as the primary IND for TScan’s solid tumour programme, enabling customised combinations of TCR-Ts to be administered to patients based on the targets and HLAs expressed in the tumours. The specific TCRs for each patient will be chosen from the Company’s ImmunoBank, consisting of high-affinity, naturally occurring TCRs that recognise 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 (MAGE-A1) on HLA types A*02:01 and C*07:02. MAGE-A1 is a cancer-associated antigen overexpressed in 45% of head and neck cancers and 50% of melanoma, cervical, and non-small cell lung cancers. 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. The trial will include patients with non-small cell lung cancer, melanoma, head and neck cancer, ovarian cancer, and cervical cancer.

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