RIKEN Immune Regenerative Medicine Inc.

RIKEN Immune Regenerative Medicine Inc. (President and CEO: Jie Tokuoka, Headquarters: 10-2 Ichiban-cho, Chiyoda-ku, Tokyo) is a company developing a cancer immunotherapy, NKT cell-targeted therapy (RIKEN-NKT™ *1).Currently, as of the end of March 2022, NKT cell-targeted therapy is being implemented at 17 medical institutions nationwide, and 275 cases have been treated.

At this time, doctors from these medical institutions will play a central role in verifying the effectiveness of NKT cell-targeted cancer treatment from a variety of basic and clinical angles, aiming for a more effective treatment technology, and disseminating it widely to society. With the aim of contributing to this, the Japan Society for NKT Cell Targeted Therapy was established on April 1, 2022, and RIKEN Immune Regenerative Medicine Inc. has decided to support its activities.

＜Outline of the society＞

Name：Japan Society for NKT Cell Targeted Therapy
英文名称：Japan Society for NKT Cell Targeted Therapy
Purpose of establishment：In order for the cancer immunotherapy, “NKT cell-targeted therapy (RIKEN-NKT™),” to be widely recognized as a part of cancer treatment, it is necessary to demonstrate the medical validity of the treatment.In order to realize this, doctors of affiliated medical institutions will cooperate to launch a society, based on the construction of a case database, standardization of treatment protocols, standardization of efficacy evaluation methods, etc., to scientifically and medically clarify its effectiveness as a cancer treatment.On the other hand, the reality is that many cancer patients seek not only standard treatments but also new treatments.Our society will provide scientific evidence for the efficacy of NKT cell-targeted therapy and provide immunotherapy that can serve as a vessel for such reality.
Purpose of establishment：Collaborating with affiliated medical institutions to verify the effectiveness of NKT cell-targeted therapy as cancer immunotherapy from a basic and clinical perspective and developing treatment techniques with the aim of contributing to the further enhancement of the effectiveness of cancer treatment.
Founder：Dr. Junichi Masuyama, Physician of New City Osaki Clinic
Nobuhisa Ito Chairman of Shinaikai
Keiichi Nakagawa irector of Tokyo Seaside Clinic
Jie Tokuoka Representative Director, RIKEN Immune Regenerative Medicine Inc.

RIKEN Immune Regenerative Medicine Inc.

RIKEN Immune Regenerative Medicine Inc. is a Japanese medical science company headquartered in Chiyoda-ku, Tokyo.The company name “RIKEN” is used because it is a company that originated from RIKEN.Established in 2014, we develop RIKEN-NKT™, a cancer treatment technology using NKT cells, which are special immune cells, and provide regenerative medicine products for cancer treatment to medical institutions.

RIKEN-NKT（TM）

This is a cancer treatment technology that uses autologous immune cells developed independently by RIKEN Immune Regenerative Medicine based on “NKT cell-targeted therapy” medical technology for the treatment of cancer, which has been researched and developed over a long period of time by RIKEN and has been clinically tested with national universities.
Focusing on the properties of special immune cells, NKT cells, which are contained in the blood in extremely small amounts, it activates the NKT cells in the body.Activated NKT cells attack cancer cells while restoring the body’s immune environment, and cytokines produced by activated NKT cells simultaneously activate immune cells of the innate and adaptive immune systems. Together they attack cancer cells.It has also been shown that activated NKT cells acquire long-term immunological memory.
Due to its unique mechanism, RIKEN-NKT™ is characterized by being applicable to all people, almost all cancer types and sites, and all stages from stage I to IV.In addition, it is a treatment method that uses autologous immune cells, and side effects are minimal.It can be used in combination with standard anticancer drugs and radiotherapy (some caution may be required).The essential ligand (α-galactosylceramide) used in RIKEN-NKT™, which activates NKT cells in the body, was independently synthesized by RIKEN Immunology and Regenerative Medicine, and it is manufactured in compliance with GMP through a contract with a domestic pharmaceutical manufacturer*2, and RIKEN Immune Regenerative Medicine holds exclusive rights to its manufacture and supply.
Since June 2016, RIKEN-NKT™ has been used in more than 275 cases in Japan under the Regenerative Medicine Acts*3.
Currently, we are providing RIKEN-NKT™ regenerative medicine products to 17 carefully selected affiliated medical institutions nationwide. The treatment is not covered by insurance, and the treatment fee is about 3.52 million yen (including tax)*4.

※１　“RIKNKT®” was renamed to “RIKEN-NKT™ ” from April 1, 2022.

※２　A unique synthesis method was invented by RIKEN Immune Regenerative Medicine Inc., and it is manufactured in compliance with GMP through a contract with a domestic pharmaceutical manufacturer.GMP (Good Manufacturing Practice) refers to “good manufacturing practices” (manufacturing control and quality control standards) required of manufacturers (including foreign manufacturers) and marketing authorization holders.Quality control refers to work related to the receipt of raw materials such as pharmaceuticals, inspection, manufacturing, product packaging, shipping management, product storage, collection processing, etc.Pharmaceutical manufacturing is stipulated to comply with the GMP ministerial ordinance based on the Pharmaceutical Affairs Law, which also applies to medical institutions that conduct clinical trials.

※３　Refers to the “Act on the Safety of Regenerative Medicine” and “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices”.In 2013, with the aim of comprehensively promoting measures from research and development to practical application of regenerative medicine, the “Law for the Promotion of Comprehensive Measures to Facilitate Swift Distribution and Safe Use of Regenerative Medicines Available to the Public (Regenerative Medicine Promotion Act)” was promulgated.As a result of deliberations on specific measures related to regenerative medicine based on this legislative bill, two regenerative medicine bills, the Act on the Safety of Regenerative Medicine (ASRM) and the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMDA) was enacted and came into force on November 25, 2014.

※４　The treatment cost of about 3.52 million yen (tax included) includes all costs such as the initial examination fee, pre-examination fee, re-examination fee, blood collection fee, administration fee, immune function test, etc.However, there are some differences in treatment costs depending on the medical institution.

For inquiries regarding this release, please contact RIKEN Immune Regenerative Medicine Inc. (representative number 03-5226-5880).