Verismo's CAR-T therapy designated fast-track status by FDA

Verismo Therapeutics, a US affiliate of South Korean pharmaceutical firm HLB Co., has received fast-track designation from the US Food and Drug Administration (FDA) for its CAR-T therapy, SynKIR-110, according to an announcement by HLB on Thursday.

The therapy aims to treat lymphoma, cholangiocarcinoma and ovarian cancer by extracting and editing T-cells to attack cancer cells.

The fast-track system will allow for simultaneous progress in clinical development and application for approval, reducing the time required for commercialization.

SynKIR-110 was also designated as an orphan drug for lymphoma in the US last year. Phase 1 clinical trials for these therapies are currently underway.

Write to Ji-Hyun Lee at bluesky@hankyung.com