Curocell, which received full approval for Limcato, Korea's first chimeric antigen receptor T-cell (CAR-T) therapy, will speed up efforts to expand Limcato's treatment scope and enter global markets.
Curocell CEO Kim Geon-su said at a press briefing on May 14 at the Four Seasons Hotel in Gwanghwamun, Seoul, "Beyond treating relapsed or refractory hematologic cancers, we will widen indications to acute lymphoblastic leukemia (ALL) and lupus (SLE), and, given CAR-T therapies require cell collection as well as manufacturing and transport, we plan to accelerate global expansion starting with relatively accessible markets such as Türkiye and Southeast Asia."
Limcato, developed by Curocell, was approved on the 29th as a therapy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) by the Ministery of Food and Drug Safety.
CAR-T is a personalized gene therapy that genetically engineers a patient's immune cells to precisely find and attack cancer cells. A single infusion proliferates in the body and continually seeks out and attacks only cancer cells, earning it the name "living anticancer drug."
Limcato applies Curocell's proprietary "OVIS" technology. OVIS simultaneously inhibits the immune checkpoint protein PD-1, which allows cancer cells to masquerade as normal cells, and TIGIT, an immune receptor found on some T cells and natural killer (NK) cells. That leads to stronger treatment effects.
Since Novartis' Kymriah in 2017, seven CAR-T therapies, including Aucatzyl from Autolus Therapeutics in 2024, have received U.S. Food and Drug Administration (FDA) approval as treatments for blood cancers.
In Korea, Kymriah and Yescarta from Gilead Sciences are being prescribed, but both are manufactured in the United States, taking about two months for domestic patients to receive treatment. By contrast, Limcato is produced at a good manufacturing practice (GMP) facility in Daejeon, making it possible to go from T-cell collection to actual infusion in about 16 days.
Clinical results also proved competitive. In the final results of a phase 2 trial, Limcato posted a complete response (CR) rate of 67.1%, the share of patients in whom the cancer completely disappears. That is higher than Kymriah (40%), Breyanzi (53%), and Yescarta (54%).
The incidence of side effects was also relatively low. The rate of grade 3 or higher cytokine release syndrome (CRS), a representative side effect of cell therapies, was 9% for Limcato, lower than Kymriah's 17%, and neurotoxicity was also lower with Limcato (3.8%) than with Kymriah (11%).
Kim Won-seok, a professor of hematology-oncology at Samsung Medical Center who led Limcato's clinical trials, said, "Both the efficacy and safety of Limcato clearly came out better than existing CAR-T therapies, including Kymriah," adding, "In overall survival (OS) analysis, the risk of death was reduced by 53% compared with Kymriah."
Kim said, "Actual patient infusions are scheduled to begin in September," adding, "At Samsung Medical Center, CAR-T treatment for DLBCL patients will be shifted to focus on Limcato."
Global market entry is also moving into full swing. Given that CAR-T therapies require cell collection as well as manufacturing and transportation, the company is prioritizing entry into geographically closer Asian markets. It then plans to seek U.S. Food and Drug Administration (FDA) approval. With the National Comprehensive Cancer Network (NCCN) guidelines recommending CAR-T therapy as a preferred option in third-line treatment, the company sees strong potential for global expansion.
Curocell Executive Director Lee Seung-won said, "A total of 12 hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and the National Cancer Center, are preparing with the goal of a reimbursed launch in September," adding, "We are also pursuing entry into key Asian markets such as Türkiye, the Middle East, and Southeast Asia."
Curocell will also move into developing CAR-T therapies for solid tumors beyond blood cancers. All CAR-T therapies approved to date are for blood cancers, while research for solid tumors is still underway.
The company also plans to pursue technology transfer and partnerships with global big pharma based on its "HyperKine" platform and "in vivo CAR-T," a next-generation CAR-T technology that kills cancer cells directly in the body with a single injection.
It will also pursue a strategy to broaden target diseases. Clinical Development Center Director Cho Su-hee said, "We are conducting a trial to expand indications to adult acute lymphoblastic leukemia (ALL)," adding, "We are wrapping up phase 1, and from phase 2 we plan to proceed in Korea and Japan."
ALL is a rare blood cancer with about 300 new patients per year and is the most common among pediatric cancers. Currently, Kymriah is covered by health insurance only for pediatric and adult patients up to age 25, leaving limited treatment options for adults over 25.
Cho added, "We are also conducting expansion research targeting lupus (SLE), an autoimmune disease," explaining, "There are about 3.5 million patients worldwide, and about 30% progress to end-stage renal failure." A phase 1 clinical trial of CAR-T therapy for lupus is also underway.
Cho continued, "While it is currently used as a third-line treatment in DLBCL, through the ongoing phase 3 trial of Limcato we plan to expand the indication to second-line therapy," adding, "We expect approval for use in the disease areas currently under study by 2030."