TScan Gets FDA Clearance for Three Investigational New Drug Apps

By Chris Wack

TScan Therapeutics Inc. said Monday that the Food and Drug Administration has cleared its investigational new drug applications for T-Plex, TSC-204-A0201 and TSC-204-C0702.

The Massachusetts-based clinical-stage biopharmaceutical company said T-Plex would now be the primary investigational new drug and TSC-204-A021 and TSC-204-C0702 the secondary investigational new drugs for its solid-tumor program.

The company said T-Plex allows patients to customize combinations of T-cell receptor-engineered T-cell therapies (TCR-T), chosen from its proprietary bank of TCRs, to treat cancers based on their specific markers. TSC-204-A0201 and TSC-204-C0702 target cancers associated with melanoma-associated antigen-1, a cancer-associated antigen overexpressed in head, neck, melanoma, cervical, and non-small cell lung cancers.

A Phase-1 clinical trial with a screening protocol expected to begin in the second quarter would assess repeat-dosing of TCR-Ts, and a secondary investigational new drug application would be filed for each unique TCR-T referencing the T-Plex application, TScan said.

The trial would evaluate each TCR-T as a singleplex therapy at two successive dose levels, the company said. Once single-agent safety is established, each TCR would become eligible for multiplexing, or combining it with any other TCR that has passed this threshold, the company said.

TScan shares were up 14% to $2.40 in premarket trading Monday.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 23, 2023 08:30 ET (13:30 GMT)

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