HLB’s US affiliate gets FDA’s fast-track nod for anticancer therapy

HLB said Thursday that its U.S. subsidiary Verismo Therapeutics has won the fast-track designation from the Food and Drug Administration for its CAR-T drug, SynKIR-110, as a mesothelioma treatment.

The fast-track designation is a process of the FDA to support the development of new drugs or those with superior efficacy to existing ones to treat diseases with high unmet needs by, for instance, speeding up their reviewing process more swiftly.

Verismo’s KIR-CAR platform applies technology to express multichain receptors similar to the receptor structure of NK immune cells to T cells, overcoming the limitations of existing CAR-T treatments limited to the treatment of blood cancer and is expected to be effective in various solid cancers.

Verismo won FDA’s nod for a phase 1 IND (investigational new drug) clinical trial in September last year and the fast-track designation for mesothelioma.

The company expected the two approvals would facilitate the following clinical and reviewing processes.

Verismo is developing SynKIR-110 to treat mesothelioma with overexpressed mesothelioma, bile duct, and ovarian cancer. It is also preparing a clinical trial for blood cancer that shows drug non-responsiveness after recurrence.

Mesothelioma is representative cancer in urgent need of the development of innovative treatments because the patient's five-year average survival rate is only 10 percent. Verismo expects the designation of the fast track to lead to a request for accelerated approval or priority review.

“We are very pleased to receive fast-track designation from FDA,” Verismo Therapeutics CEO Brian Kim said. “The designation comes as a milestone for the efforts of this company to provide innovative treatments for patients who desperately need new options. We will continue to prove the excellent efficacy of SynKIR in various indications through multifaceted clinical trials.”