Berismo, with only a 10% 5-year survival rate, receives US FDA Fast Track designation for mesothelioma treatment

HLB Group's New Drug Pipeline Development Speed to Accelerate

HLB's U.S. subsidiary Eleva is preparing a New Drug Application (NDA) for a first-line treatment for liver cancer, and another U.S. affiliate, Verismo, is also showing rapid progress in drug development.

HLB announced on the 6th that its U.S. affiliate Verismo Therapeutics is developing a next-generation CAR-T therapy (SynKIR-110) which has been granted Fast Track designation by the U.S. FDA for mesothelioma.

The Fast Track designation is a procedure established by the FDA to expedite the review process and support development for drugs that address diseases with high unmet medical needs, offering new treatment methods or drugs evaluated to be superior to existing therapies.

Verismo’s KIR-CAR platform applies technology that expresses a multichain receptor similar to the NK immune cell receptor structure on T cells. This overcomes the limitations of existing CAR-T therapies, which are confined to treating hematologic cancers, and is characterized by its therapeutic effects on various solid tumors.

In an unusual move, Verismo received FDA approval for its Phase 1 clinical trial application (IND) within just one month last September. It was designated as an orphan drug for mesothelioma. With the Fast Track designation, the clinical and review processes are expected to accelerate going forward.

Mesothelioma refers to tumors occurring in the pleura, peritoneum, pericardium, and other areas surrounded by mesothelial cells. The average 5-year survival rate for patients is only 10%, making it one of the cancers urgently requiring innovative treatments. With the Fast Track designation, Verismo can also apply for Accelerated Approval or Priority Review in the future.

SynKIR-110 is currently undergoing Phase 1 clinical trials as a treatment for mesothelioma, cholangiocarcinoma, and ovarian cancer, all of which overexpress mesothelin. Verismo is also preparing clinical trials for hematologic cancers that show drug resistance after relapse.

Brian Kim, CEO of Verismo, said, "We are pleased to receive the Fast Track designation from the FDA. This designation is a monumental milestone for Verismo, which is striving to provide innovative therapies to patients urgently in need of new treatment options." He added, "We will demonstrate SynKIR’s outstanding efficacy across various indications through multifaceted clinical trials."

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

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