regulatory
confidence high
sentiment positive
materiality 0.70
TScan receives FDA clearance for three INDs in solid tumor program, including T-Plex and two MAGE-A1-targeting TCRs
TScan Therapeutics, Inc.
- FDA cleared primary IND T-Plex enabling customized multiplexed TCR-T combinations based on tumor target/HLA expression.
- Secondary INDs for TSC-204-A0201 and TSC-204-C0702 targeting MAGE-A1 on HLA A*02:01 and C*07:02 respectively.
- MAGE-A1 overexpressed in 45% of head and neck cancers and 50% of melanoma, cervical, and non-small cell lung cancers.
- TScan plans multicenter Phase 1 trial; screening protocol expected in Q2 2023, initial clinical data by end of 2023.