Korea's first next-generation chimeric antigen receptor T-cell (CAR-T, "kati") therapy has been born.
The Ministery of Food and Drug Safety said on the 29th it approved Korea's first kati therapy, "Limcato" (development name Anbalcel), developed by Curocell. It targets patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Kati is a personalized gene therapy that genetically engineers a patient's immune cells to precisely find and attack cancer cells. With a single infusion, it proliferates in the body and continuously seeks out and attacks only cancer cells, earning the name "living anticancer drug."
Since Novartis' Kymriah in 2017, seven kati therapies, including Aucatyl from Autolus Therapeutics in 2024, have won U.S. Food and Drug Administration (FDA) approval for blood cancers. The decision is expected to spur broader prescribing of kati therapies.
Limcato features application of Curocell's proprietary "OVIS" technology. OVIS simultaneously suppresses the immune checkpoint protein PD-1, which cancers use to disguise themselves as normal cells, and the immune receptor TIGIT found on some T cells and natural killer (NK) cells. That yields stronger treatment effects.
Clinical results also appeared superior to existing therapies. In its phase 2 trial's final readout, Limcato was shown to be more effective than six FDA-approved therapies. Its complete response (CR) rate—the share of patients whose cancer disappeared completely—was 67.1%, higher than Kymriah (40%), Breyanzi (53%), and Yescarta (54%).
Side effects were also lower. The incidence of grade 3 or higher cytokine release syndrome (CRS), a representative adverse reaction of cell therapies, was about 9% with Limcato, lower than Kymriah (17%). Neurotoxicity was also lower with Limcato (3.8%) than with Kymriah (11%).
Access to treatment is expected to improve. Existing kati therapies took about two months from manufacturing at a U.S. plant to infusion in Korea, but Limcato is manufactured in Daejeon and can be infused in about 14 days.
Prices could also come down. In Korea, Kymriah and "Yescarta" from U.S.-based Gilead Sciences have been introduced, and only Kymriah is covered by health insurance, lowering the patient out-of-pocket cost from 360 million won to 5.98 million won per infusion. Limcato is expected to receive reimbursement at a similar or slightly lower level.
Limcato was designated last August as eligible for the advanced biopharmaceutical expedited processing system and won approval based only on phase 2 results. Curocell plans to seek approval from the U.S. Food and Drug Administration (FDA) next.