HLB Subsidiary's CAR-T Therapy Designated for FDA Fast Track

HLB announced on the 6th that its U.S. subsidiary, Verismo Therapeutics, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its next-generation chimeric antigen receptor (CAR)-T therapy, ‘SynKIR-110,’ targeting mesothelioma.

Verismo Therapeutics logo
Photo by Verismo Therapeutics

The Fast Track designation is a system established by the FDA to actively support the development process by expediting the review process for drugs that are evaluated as new treatments or superior to existing therapies for diseases with high unmet medical needs.

Verismo’s NK cell immune globulin-like receptor (KIR)-CAR platform applies technology that expresses a multichain receptor similar to the receptor structure of NK immune cells on T cells, overcoming the limitations of existing CAR-T therapies that were limited to hematologic cancers and creating a concept effective against various solid tumors. SynKIR-110 received FDA approval for its Phase 1 clinical trial application (IND) in September last year and subsequently obtained orphan drug designation (ODD) for mesothelioma. Following the recent Fast Track designation, the clinical and review processes are expected to accelerate further.

SynKIR-110 is currently undergoing Phase 1 clinical trials as a treatment for mesothelioma, cholangiocarcinoma, and ovarian cancer, all of which overexpress mesothelin. Separately, clinical trials for hematologic cancers showing drug resistance after relapse are also being prepared. Since mesothelioma has an average 5-year survival rate of only 10%, making it a representative cancer urgently requiring innovative treatments, Verismo expects that the Fast Track designation will enable applications for Accelerated Approval or Priority Review in the future.

Brian Kim, CEO of Verismo, stated, “We are very pleased to receive the FDA’s Fast Track designation. This is a monumental milestone for our company, which is striving to provide innovative therapies to patients in desperate need of new treatment options. We will continue to demonstrate the outstanding efficacy of SynKIR across various indications through multifaceted clinical trials.”

HLB Group holds approximately 45% of the shares in Verismo, securing stable control. Additionally, the University of Pennsylvania, which holds the world’s largest number of patents in the CAR-T field, owns about 5% of the shares, indicating expectations for continuous collaboration during clinical and commercialization stages.

This content was produced with the assistance of AI translation services.