CAR T Cell therapy in Korea
CAR T cell therapy is an advanced cancer treatment that has gained significant momentum in South Korea. It involves genetically modifying a patient’s T cells to recognize and attack cancer cells, particularly in hematologic malignancies like leukemia and lymphoma. South Korea, known for its cutting-edge medical research and robust biotechnology sector, has actively invested in developing CAR T cell therapy in Korea to provide innovative treatment options.
Several Korean biopharmaceutical companies and research institutes are engaged in CAR T cell therapy development, focusing on improving efficacy, safety, and accessibility. The government has also supported this field through regulatory reforms and funding initiatives. In 2023, South Korea approved its first domestically developed CAR T therapy, aiming to reduce dependence on foreign-developed treatments and lower costs.
Major hospitals in Korea, such as Samsung Medical Center and Seoul National University Hospital, are conducting clinical trials and offering CAR T therapy to eligible patients. The country is also exploring next-generation CAR T therapies to address solid tumors and minimize side effects. With strong governmental support, rapid advancements in biotechnology, and increasing patient access, South Korea is emerging as a key player in the global CAR T cell therapy landscape.
Curocell develops Limkato
The localization of the chimeric antigen receptor T cell (CAR-T) therapy, referred to as a ‘dream cancer treatment,’ is approaching. If the approval process proceeds as planned, domestic patients will be able to receive a domestic cancer treatment that is more effective and cheaper than the only CAR-T therapy currently available, Novartis’s Kimria, in the second half of next year.
Curocell applied for the product license for its domestic CAR-T therapy, ‘Limkato (ingredient name: Anbasel),’ to the Ministry of Food and Drug Safety on the 30th Dec 2024. Curocell is the first pharmaceutical and biotech corporation in South Korea to develop a CAR-T therapy and submit a final approval application.
CAR-T is a therapy that extracts T cells, a type of immune cell from the patient, adds genes, and modifies them to specifically target cancer cells. This approach increases treatment efficacy while minimizing side effects by preserving normal cells.
Limkato, approval decision expected in the second half of next year
Limkato is a treatment for relapsed or refractory large B-cell lymphoma (LBCL), a type of blood cancer. The core of this therapy is Curocell’s proprietary OVIS technology. OVIS simultaneously inhibits immune checkpoint receptors, including PD-1, which thwart cancer treatment, as well as the immune receptor TIGIT found in some T cells and natural killer cells, resulting in significant treatment efficacy.
Curocell’s Limkato was designated as a subject for rapid processing of advanced biopharmaceuticals by the Ministry of Food and Drug Safety in August. Being selected as a rapid processing candidate allows it to receive approval based solely on the results of phase 2 clinical trials under the ‘Advanced Biopharmaceutical Product License Review’ regulations. The company plans to challenge for U.S. Food and Drug Administration (FDA) approval after obtaining domestic approval.
The decision on Limkato’s domestic approval is expected to be made in the second half of next year. If Limkato is approved, domestic blood cancer patients will be able to receive CAR-T therapies more quickly than before. Currently, Kymriah takes about two months to reach patients after being manufactured in a U.S. facility, while Limkato can be delivered to patients in just 14 days after being produced in Daejeon.
The price may also decrease. The cost for a single administration of Kymriah is 360 million won, but the out-of-pocket expense for patients after insurance coverage is 5.98 million won. Limkato is expected to have a similar or slightly lower cost under insurance coverage.
The Ministry of Health and Welfare chose Limkato as a target for the ‘Approval Application – Coverage Evaluation – Price Negotiation Pilot Project’ on the 10th. As a result, the Ministry of Food and Drug Safety’s approval and price negotiation will move simultaneously. Kymriah gained insurance coverage 13 months after its launch, and Limkato could gain coverage even sooner.
Efficacy and safety of Limkato
Currently, the only approved CAR-T therapy in South Korea is Novartis’s Kymriah. To date, the U.S. FDA has approved six CAR-T therapies, including Kymriah, Bristol-Myers Squibb’s Abecma and Breyanzi, Johnson & Johnson’s Carvykti, and Gilead’s Tecartus and Yescarta.
Earlier, Limkato was proven to be more effective than the six therapies approved by the FDA based on the final results of its phase 2 clinical trial. The complete response rate (CR), which indicates the percentage of patients with complete cancer remission, was 67.1%, significantly higher than that of Kymriah (40%), Breyanzi (53%), and Yescarta (54%).
The safety results are also better. The incidence of cytokine release syndrome (CRS), a representative side effect of cell therapies, was 9% for Limkato and 17% for Kymriah. Neurotoxicity (NE) was also lower at 3.8% for Limkato compared to 11% for Kymriah.
With the high efficacy and safety of Limkato proven, predictions are emerging that the global CAR-T therapy market will undergo a significant change. According to a report by the Korea Health Industry Development Institute, the CAR-T therapy with the highest market share last year was Gilead’s Yescarta, which generated approximately $1.5 billion (2 trillion won) in revenue. In comparison, Kymriah, Carvykti, and Abecma recorded revenues between $360 million (500 billion won) and $510 million (700 billion won).
Several corporations in South Korea, following Curocell, have embarked on developing CAR-T therapies. AbClon is currently registering patients for phase 2 clinical trials, with interim results expected by the end of the year. Ticaro is administering phase 1 clinical trial treatments, while GC Cell, HK InnoEN, and VaxCell-Bio have started developing CAR-T therapies for solid tumors.
HLB Group’s HLB Innovation has just acquired the United States biotech firm Veris Molecular Therapeutics to enter the CAR-T therapy space. Veris was established in 2020 by scientists from the University of Pennsylvania who spearheaded the creation of Kymriah. Clinical trials are now in progress for patients suffering from solid tumors of diseases like malignant mesothelioma, ovarian cancer, and bile duct cancer.
Conclusion
South Korea is rapidly advancing in CAR T cell therapy, driven by strong government support, world-class research institutions, and innovative biotech companies. A major milestone in this journey was the approval of Limkato, the first domestically developed CAR T cell therapy by Curocell, in 2023. This breakthrough marked a significant step toward reducing reliance on foreign treatments and making CAR T therapy more accessible to Korean patients.
Limkato’s approval underscores Korea’s growing capability in cell and gene therapy, demonstrating its potential to become a global leader in this field. As hospitals and research institutes continue to refine CAR T technology, future advancements will likely focus on enhancing efficacy, expanding applications to solid tumors, and reducing treatment costs. With its commitment to innovation, Korea is well-positioned to play a crucial role in shaping the future of CAR T cell therapy worldwide.
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.
Research Highlights
Dr. Mittal's research has focused on several key areas:
1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.
2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.
4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.
Publications and Presentations
Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.
In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.
