TScan Therapeutics (NASDAQ:TCRX) said that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) applications seeking to start trials of cancer drugs T-Plex, TSC-204-A0201, and TSC-204-C0702.
T-Plex will serve as the primary IND for TScan’s solid tumor program, enabling customized combinations of T cell receptor (TCR)-engineered T cell therapies (TCR-T) to be administered to patients based on the targets and HLAs expressed in their tumors, the company added.
The specific TCRs for each patient will be chosen from the company’s ImmunoBank. Each unique TCR-T will be filed as a secondary IND and will reference the primary T-Plex IND, according to the company.
In addition to the T-Plex IND, TScan filed secondary INDs for two initial TCR-T products TSC-204-A0201 and TSC-204-C0702 which target melanoma-associated antigen 1 (MAGE-A1) on HLA types A*02:01 and C*07:02.
TScan said it is now working to open a multicenter phase 1 trial 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 patients with solid tumors by overcoming resistance due to target or HLA loss,” said Gavin MacBeat, chief scientific and operations officer.
MacBeath added that the company plans to share initial clinical data for the most advanced TCRs in this program by the end of 2023.
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