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TScan Therapeutics Granted FDA Clearance for Investigational New Drug Application for TSC-203-A0201, Targeting PRAME

Wednesday, August 30, 2023

TScan Therapeutics, Inc., a company listed on Nasdaq as TCRX and focused on advancing T cell receptor-engineered T cell therapies (TCR-T) for cancer, has declared that the U.S. Food and Drug Administration (FDA) has granted approval for its investigational new drug (IND) application for TSC-203-A0201. This TCR-T is designed to target PRAME, or PReferentially expressed Antigen in Melanoma, a protein found in approximately 90% of melanomas and commonly present in other solid tumors, such as around 90% of head and neck cancers and roughly 50% of non-small cell lung cancers. TSC-203-A0201 is intended for patients with the HLA type A*02:01, which includes over 40% of the U.S. population.

This IND approval marks the fourth TCR-T within TScan's solid tumor program to be granted clearance for clinical development. The earlier TCR-T candidates include TSC-200-A0201, TSC-204-A0201, and TSC-204-C0702. These target human papillomavirus 16 (HPV16) presented on HLA type A02:01, and MAGE-A1 presented on HLA types A02:01 and C*07:02, respectively.

All four TCR-T cell products are intended for combination therapy and are being developed under a unified master clinical trial protocol. Each product comprises the cancer antigen-specific TCR, CD8α/ß to engage helper T cells, and a dominant negative form of TGFß receptor II to enhance T-cell persistence. Patients will receive specific combinations of these TCR-T cell agents based on the expression of targets and HLAs in their tumors. The Phase 1 clinical trial will begin by evaluating each agent individually at two dose levels to establish safety. Following this, the agents can be combined with any other TCR-T cell product.

Dr. Debora Barton, Chief Medical Officer, expressed enthusiasm for the strategy, highlighting its potential to tailor treatments according to the patient's tumor biology. This strategy could be crucial in achieving lasting responses, overcoming tumor heterogeneity, and combating resistance, commonly observed in prevalent tumor types such as melanoma, lung, and head and neck cancers. A screening protocol to identify eligible patients is already in progress, and preparations are being made to initiate clinical development for all four TCR-Ts in the ImmunoBank. The aim is to treat the first patient with a TScan TCR-T and present preliminary data by the end of 2023.

Gavin MacBeath, Ph.D., CEO of TScan, emphasized the company's progress toward providing enhanced, multiplexed TCR-Ts to a broad patient base. The approval of TSC-203-A0201's IND clearance, as the fourth TCR-T cell product for their T-Plex solid tumor program, highlights the strength of their discovery platform and the potential of cell therapy in treating a wide range of solid tumors. PRAME is particularly significant due to its frequent presence in solid tumors and encouraging results in recent clinical trials. In parallel, TScan is intensifying discovery efforts to broaden the range of therapeutic TCRs suitable for clinical development, with more IND filings for their solid tumor program anticipated in the coming year.

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