The number of clinical trials on CAR-T (chimeric antigen receptor T-cell) therapies surged to more than 100 this year from two in 2015, drawing the attention of the industry watchers.
CAR-T cell therapies are new treatments to genetically modify receptor genes in T-cells, one of the immunocytes, to recognize cancer cells as antigen and kill them. CAR-T technology injects modified genes in T-cells in the blood to have them attack cancer cells only. CAR-T cell therapies are considered the next-generation immunotherapy.
After Novartis received in August the first U.S. FDA approval for its CAR-T cell therapy Kymriah (ingredient: tisagenlecleucel) to treat acute lymphoblastic leukemia, Gilead got the second approval for Yescarta (axicabtagene ciloleucel) in October, another CAR-T cell therapy to treat relapsing large B-cell lymphoma, untreatable with other medicines.
The price of Kymriah is about 420 million won ($387,000) per person, and Yescarta, 535 million won.
Currently, more than 100 clinical trials are testing CAR-T cell therapies around the world, a drastic increase from two between 2012 and 2015.
No local drugmaker is conducting a clinical trial on CAR-T cell therapy for now. However, many Korean firms, including ViroMed, Green Cross Cell, and AbClon, have begun researches with an aim to enter a clinical trial.
ViroMed said in a recent investor relations event that it would start CAR-T cell therapy business in earnest. The company aims to prepare three optimized genes to kill solid cancer or blood cancer cells and get them tested in a phase-1 clinical trial by 2020-2022.
AbClon is developing a CAR-T cell therapy to treat leukemia, jointly with a research team led by Professor Chung Jun-ho at the Seoul National University’s College of Medicine.
Green Cross Cell, a cell-therapy specializing unit under Green Cross, has recently issued 60 billion-won convertible bonds with zero interest rate to finance R&D costs for a CAR-T cell therapy. The company recently said it would use the money to invest in production facility and research for cell therapies including CAR-T cell therapy.
Clinical trials on CAR-T cell therapies will get more aggressive around the world, experts say, predicting that various products will come out on the market by 2020.
Coherent Market Insights, a global research firm, forecast that the global CAR-T cell therapy market would quickly grow from 612 billion won in 2020 to 4.24 trillion won in 2025, and to 8.97 trillion won in 2028.