According to industry sources on December 18, the number of domestic pharmaceutical and biotech companies that are seeking to develop cell therapy products has greatly increased. There are two primary concerns that domestic firms have. First of all, there is an outstanding boom in the development of a chimeric antigen receptor-T cell (CAR-T) therapeutic drugs. CAR-T is a genetically engineering reprogrammed technology that allows T cells which are a kind of common immune cells in blood to selectively attack cancer cells after pinpointing them.
Biotechnology venture firm ViroMed announced a plan in November to develop CAR-T drugs as the next pipeline of “VM202,” a diabetic neuropathy treatment which is currently on the global phase 3 clinical trial. The company aims to develop three CAR genes which are frequently found in solid cancer and blood cancer and start clinical trials on them by 2022. AbClon is also working together with Seoul National University College of Medicine to develop a treatment to minimize negative immunologic side effects of existing CAR-T drugs and begin experiments on animals soon.
Pharmaceutical companies that produce mainly chemical drugs are also joining competition to develop anti-cancer drugs using immunologically competent cells. JW CreaGene, a subsidiary of JW Shinyak, has started a phase 1/2 clinical trial for CreaVax-BC, a glioblastoma treatment that attack cancer stem cells by injecting glioblastoma-specific cancer antigen into dendritic cells. Boryung Pharmaceutical is developing blood cancer and lung cancer drugs using cytotoxic T cells through ViGenCell whose 52 percent stake was acquired by the company.
Stem cell companies, which seemed to have suffered from a long slump after the Hwang Woo-suk incident in 2005, have resumed aggressive research and development activities. Stem cell therapy, also known as regenerative medicine, is emerging as a new hope that can treat various intractable diseases such as dementia, acute stroke, atopy and hepatocirrhosis. Biotech firm Pharmicell received a go-ahead from the U.S Food and Drug Administration (FDA) to start a phase I clinical study with its Cellgram-LC stem cell drug that is designed to reduce fibrosis, a hardening of liver tissues damaged by alcohol, and restore functions of liver this month and will embark on the clinical study soon. The company already completed the phase II clinical trial of Cellgram-LC stem cell treatment in South Korea and filed for conditional approval of the new drug in the country. Nature Cell is also conducting a clinical study of its AstroStem that treats Alzheimer's dementia by injecting autologous adipose tissue derived stem cells in the U.S.
Industry officials say that the companies are making such move because the possibilities for success of stem cell treatments are greater than ever. With technologies related to cell culture and production as well as gene correction advancing a fast-growing rate, various technical problems that hamper drug development are solved. In addition, Novartis’ CAR-T therapy Kymriah received approval from the U.S. FDA for the first time in the world.
The government’s move to relax regulations also held domestic companies to make an investment in cell therapy development. An official from the industry said, “The U.S., which has had a strict standard on cell drugs, recently proposed its guidelines and the related global market is finding its place at a rapid pace. Since there is considerable support to ease regulations on stem cell and gene therapy under the new government, we have so much expectation.” However, there is also concerns that the industry can be mired in a deeper recession when the move to relieve regulations results in a failure.
Meanwhile, global research firm Frost & Sullivan said that the size of the global cell treatment market, including somatic cell, stem cell and immunocyte drugs, was estimated at US$4 billion (4.37 trillion won) as of 2015 and it will grow to US$10 billion (10.93 trillion won) in 2020 with an average annual growth of 20 percent.