ALL STEM CELLS

Development of CAR-T treatment in Korea

In 2021, domestic companies jumped into the development of CAR-T treatment one after another. The arrival of Novartis' CAR-T treatment, Kymria (ingredient name: Tisagen Lexel) in Korea, was a kind of signal.

CAR-T therapy is a cell therapy product that is genetically modified to attack cancer cells by injecting CAR (chimeric antigen receptor) into immune T cells. Because of its high response rate, it is also called the so-called “miracle anticancer drug”. However, the manufacturing process is complicated, such as collecting the patient's T cells at a medical institution and then culturing them in a GMP facility. In addition, in the case of CAR-T treatments from existing global pharmaceutical companies, it is difficult for domestic patients to access them because they are expensive.

Accordingly, domestic companies are expected to solve these problems through the development and domestic production of native CAR-T therapeutics. Until now, a number of companies, including Curocell, Abclone, GC Cell (formerly GC Green Cross Cell), Ticaros, Helixsmith, Toolgen, Selenzine, Eutilex, and Baxelbio, are developing or will develop CAR-T treatments.

In February, Curocell received approval from the Ministry of Food and Drug Safety for a phase 1 clinical trial of ‘CRC01’, a candidate CAR-T treatment, and won the title of entering Korea’s first CAR-T treatment clinical trial. CRC01 is a CD19 CAR-T treatment that suppresses the expression of immune checkpoint receptors, PD-1 and TIGIT. Curocell's proprietary technology called OVIS (Overcome Immune Suppression) was applied.

The clinical trial institution was Samsung Seoul Hospital, which recruited patients with diffuse large B-cell lymphoma who were relapsed and refractory after two or more times of systemic chemotherapy. Curocell, which started treatment for patients in April, has raised expectations by disclosing the interim results of the phase 1 lowest dose cohort (2 out of 3 complete remissions).

Unlike previous companies, GC Cell plans to develop a CAR-T treatment in the United States. The plan is to conduct a clinical trial for a mesothelin-targeted CAR-T treatment through Novacell, a local corporation in the United States. Indications are also aimed at treating solid cancer.

Companies are not the only ones showing interest in CAR-T treatments. Major university hospitals have also started researching CAR-T treatments and preparing treatment infrastructure.

Samsung Seoul Hospital opened the country's first CAR-T cell treatment center in April, and in September, the Catholic University of Korea Seoul St. Mary's Hospital Blood Hospital signed a memorandum of understanding (MOU) with Eutilex to develop a CAR-T treatment.

Earlier this month, Seoul National University Hospital received approval from the Ministry of Health and Welfare and the Ministry of Food and Drug Safety for a CAR-T treatment clinical study in children and adolescents with relapsed and refractory acute lymphoblastic leukemia.