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TScan Therapeutics (NASDAQ:TCRX) said the US Food and Drug Administration (FDA) has approved its investigational new drug (IND) applications that seek to begin trials of the 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, which enables personalized combinations of T-cell receptor (TCR)-engineered T-cell therapies (TCR-T) to be delivered to patients based on the targets and HLA 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 IND T-Plex, according to the company.
In addition to the T-Plex IND, TScan reported secondary INDs for two early TCR-T products TSC-204-A0201 and TSC-204-C0702 that target melanoma-associated antigen 1 (MAGE-A1) in A*02 types of HLA: 01 and C*07:02.
TScan said it is now working to open a multicenter phase 1 repeat-dose trial 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 authorization of these three INDs, we believe that we are the only company in the field of cell therapy that has a clear clinical and regulatory path to develop multiplexed TCR-T cell therapy, which we consider critical to achieving durable responses in patients.” with solid tumors by overcoming resistance due to loss of target or HLA,” said Gavin MacBeat, chief science 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.
TCRX +14.76% to $2.40 before marketing on January 23
