Pharma Focus America

TScan Therapeutics Announces FDA Approvals for Solid Tumor Treatment in the United States

Friday, February 10, 2023

The U.S. Food and Drug Administration (FDA) has approved TScan Therapeutics' investigational new drug (IND) applications for T-Plex, TSC-204-A0201, and TSC-204-C0702.

T-Plex will allow patients to get individualized combinations of T cell receptor (TCR)-engineered T cell therapies (TCR-T) based on the HLAs and targets expressed in their tumours. It will serve as the principal IND for TScan's solid tumour programme.

Each patient's individual TCRs will be chosen from the ImmunoBank of TScan. Each distinct TCR-T will be submitted as a secondary IND with a reference to the T-Plex primary IND.

In addition to the T-Plex IND, TScan also submitted secondary INDs for the original TCR-T products, TSC-204-A0201 and TSC-204-C0702.

With the approval of these INDs, TScan is now working to begin a multicenter Phase I clinical trial in order to determine the preliminary efficacy, safety, and viability of repeating multiplexed TCR-T doses.

Patients with melanoma, non-small cell lung cancer, head and neck cancer, ovarian cancer, and cervical cancer will participate in this experiment.

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