HLB "Subsidiary's CAR-T Therapy Designated Fast Track by US FDA"
HLB announced on the 6th that its U.S. affiliate Verismo Therapeutics' CAR-T therapy candidate 'SynKIR-110' has been designated as a Fast Track product by the U.S. Food and Drug Administration (FDA).
Fast Track is a system that allows clinical development and preparation for approval applications to proceed simultaneously, thereby shortening the time to commercialization.
This candidate drug was also designated as an orphan drug for mesothelioma in the United States last year.
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SynKIR-110 is a CAR-T therapy that extracts and edits T cells, which are immune cells in the body, to attack cancer cells. Phase 1 clinical trials are currently underway for the treatment of mesothelioma, cholangiocarcinoma, and ovarian cancer.
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