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. 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, Kimria 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 Kimria 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.
On the 10th, the Ministry of Health and Welfare selected Limkato as a subject for the 'Approval Application - Coverage Evaluation - Price Negotiation Pilot Project.' Consequently, the approval from the Ministry of Food and Drug Safety and the price negotiation will proceed simultaneously. Kimria received insurance coverage just 13 months after its release, and Limkato may achieve coverage even faster.
◇ Efficacy and safety superior to FDA-approved therapies
Currently, the only approved CAR-T therapy in South Korea is Novartis's Kimria. To date, the U.S. FDA has approved six CAR-T therapies, including Kimria, 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 Kimria (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 Kimria. Neurotoxicity (NE) was also lower at 3.8% for Limkato compared to 11% for Kimria.
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, Kimria, 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 recently acquired the U.S. biotech company Veris Molecular Therapeutics to enter the CAR-T therapy market. Veris was founded in 2020 by researchers from the University of Pennsylvania who led the development of Kimria. Currently, clinical trials are underway for solid tumor patients with conditions such as malignant mesothelioma, ovarian cancer, and bile duct cancer.