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TScan Therapeutics Announces FDA Clearance of Three Investigational New Drug Applications for the Treatment of Solid Tumors
Primary IND for solid tumor program, T-Plex, supports simultaneous use of multiple TCRs to create customized, multiplexed TCR-T cell therapies based on target
About this update from Tscan Therapeutics, Inc.
[{"type":"text","content":"Primary IND for solid tumor program, T-Plex, supports simultaneous use of multiple TCRs to create customized, multiplexed TCR-T cell therapies based on target and HLA expression INDs for TSC-204-A0201 and TSC-204-C0702 introduce the first two TCRs into TScan’s ImmunoBank, targeting MAGE-A1 on HLA types A*02:01 and C*07:02, respectively WALTHAM, Mass., Jan. 23, 2023 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today 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 (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. “With the clearance of these three INDs, we believe we are the only company in the cell therapy field to have a clear clinical and regulatory path to develop multiplexed TCR-T cell therapy, which we see as critical for achieving durable responses in pati...