Shimon Sakaguchi (CTO)
We founded Regcell Co., Ltd. in January, 2016. RegCell aims to generate novel therapeutic technologies through augmenting or controlling the immune system and our goal is to save patients who suffer from autoimmune diseases and cancer .
I have been continuing the research about immunology in particular studying the character and the function of Regulatory T cells (Tregs) for more than 30 years and I have been able to understand it’s roles with regard to the symptom or mechanism of autoimmune diseases, allergy and immune-reactions related to organ transplantation. Currently, many researchers are focusing on the development and function of Tregs for the purpose of applying it to actual clinical use.
Treg is a lymphocyte specialized in suppressing immune function, and it will be possible to cure autoimmune disease like rheumatoid arthritis, relieve allergic symptoms, and inhibit immune reactions related to the organ transplantation through expansion or functional enhancement of antigen-specific Treg. On the other hand, it will also be possible to enhance the immune response to cancer and the pathogenic microbe through the decrease or functional suppression of Treg. Clinical trials of Treg have been conducted abroad for practical medical use of Treg.
Regcell aims to generate novel medical technologies using Tregs and provide innovative medical solutions for patients as commercially available therapy.
Furthermore, Regcell aims to develop new cancer immunotherapy using cytotoxic T lymphocyte (CTL) attacking cancer. We are developing a new concept that is highly effective cancer immunotherapy using CTL derived from iPSC. Dr. Hiroshi Kawamoto, professor of Institute for Frontier Life and Medical Sciences, Kyoto University leads this project.
Regcell will contribute to improving the health of people worldwide in terms of both immune-suppression and immune-enhancement.
Kyoto University Medical School Doctor of Philosophy (Ph.D.) (1983 )
Professor: Institute for Frontier Medical Sciences, Kyoto University (1998-2011)
Director: Institute for Frontier Medical Sciences, Kyoto University (2007-2011)
Professor: Immunology Frontier Research Center, Osaka University (2011- present)
Vice-director, Immunology Frontier Research Center, Osaka University (2012 -present)
Distinguished Professor, Osaka University (2013- present)
Chief Technical Officer: RegCell Co., Ltd. (2016- present)Awards
Japan Academy Award (2012)
Canada Gairdner International Award (2015)
Thomson Reuters Citation Laureates (2015)
Person of Cultural Merits (2017)
Chief Scientific Adviser
Kyoto University, Faculty of Medicine (M. D.) (1980-1986 )
Kyoto University, Graduate School of Medicine (Ph. D.) (1989-1993)
Resident, Kyoto University Hospital (1986)
Assistant Professor, Faculty of Medicine, Kyoto University (2001)
Team Leader, Riken Research Center for Allergy and Immunology, Yokohama, RIKEN (2002)
Professor, Institute for Frontier Medical Sciences, Kyoto University (2012)
Professor/Deputy Director, Institute for Frontier Life and Medical Sciences (2016) (reorganization), Kyoto University
President and CEO
Resident: Nagoya City University, Kyoto University, Ootsu Red Cross Hospital (1980-1983)
Postdoctoral Fellow: The Johns Hopkins University, Stanford University, Scripps Institute (1983-1989)
Research Associate,: Tokyo Metropolitan Institute of Gerontology, Institute for Frontier Medical Sciences, Kyoto University (1998-2008)
Specially appointed Assistant Professor (full time):Immunology Frontier Research Center, Osaka University (2008-2016)
Executive Director, Vice President, Research Division: RegCell Co., Ltd. (2016-2018)
Fujifilm Corporation (previously named Fuji Photo film Corporation), Tokyo(1989-2013)
Secretary general of Forum for Innovative Regenerative Medicine association, Tokyo(2010-2013)
iPS Portal, Inc, Kyoto(2015-2016)
RegCell Co., Ltd., Kyoto(2016)
Ph.D. (1979, Kyoto University Graduate School of Medicine)
Professor in Pharmacology (1992-2013) and Dean (2004-2007), Kyoto University Graduate School of Medicine
Presently Project Professor and Director, Medical Innovation Center, Kyoto University Graduate School of MedicineAwards
The Japan Academy Award
Lorenzini Gold Medal
and Ulysses Medal
Person of Cultural Merit 2017
Fujifilm Corporation, Tokyo(2010-2014)
Clarivate Analytics (Japan) Co., Ltd. (previously named Thomson Reuters Professional Co., Ltd), Tokyo(2014-2015)
NISSAY CAPITAL Co., Ltd., Tokyo(2015-present)
Audit & Supervisory Board Member
57th Legal apprentices(2003)
Osaka Bar Association(2004-present)
Lawyer: Yodoyabashi & Yamagami Legal Professional Corparation(2004-present)
Audit & Supervisory Board Member: RegCell Co., Ltd. (2017-present)
Executive Vice President, Kyoto University
Team leader, RIKEN
Team Director, Laboratory for Autoimmune Diseases, RIKEN Center for Integrative Medical Sciences
|Company Name||RegCell Co., Ltd|
|Address||Creation Core Kyoto Mikuruma, 448-5, Kajii-cho, Kamigyo-ku, Kyoto 602-0841, Japan|
|Number of employees||12 (as of the end of February 2018)|
Induction and amplification culture of Treg
In the immune system of the humans, basically, the immune cells attacking “the self” are removed in the process of the development in thymus. However, some immune cells happen to survive and may attack “the self” recklessly. Although Treg acts as a brake (suppressor), the imbalance between the accelerator and the brake may result in the development of an autoimmune disease. In this case, it would be possible to cure autoimmune disease by increasing Treg or decreasing CTL in patients.Regcell has built the technologies, as mentioned below, which enable such medical cure.
-Technology to separate and expand nTreg (natural Treg) from a patient’s blood and return it to the same patients.
-Technology to induce iTreg (induced Treg) from all kinds of T cell and exclude Treg after expanding all types of T cell by cultivation.
-Technology to induce antigen-specific nTreg/iTreg that suppresses immunoreaction specific for certain antigen.
It is thought to be possible to cure allergic disease or GVHD on transplantation and not only autoimmune disease by using these technologies.
Reproduction of antigen-specific CTL from pluripotent stem cells
The efficacy of cancer immunotherapy becomes clear through the clinical use of immune checkpoint inhibitors. The most important effector in cancer immunotherapy is CTL, which attacks a cancer cell by recognizing cancer specific-antigen. As one method of CTL immunotherapy, it may be considered to use CTL derived from a patient after expansion of CTL in vitro. But it might be difficult to obtain enough cells from a patient, and the long time required to expand CTL for getting adequate cell number by cultivation might be a problem. Thus, Regcell has built the technologies, as mentioned below, for providing “Off-the-Shelf” cell therapy through reproducing CTL from pluripotent stem cells like iPS cell.
-Technology to introduce a gene of TCR (T cell receptor) to a stem cell effectively and express it on the cell.
-Technology to reproduce CTL by stimulation of specific antigen which is recognized by the TCR following the differentiation step to CD8+(αβtype) T cell which is known to have strong antigen-specific cytotoxicity from the TCR-introduced stem cell.
It would be possible to stock the antigen-specific CTLs and provide them to patients timely.
In the immune suppression field, we are planning a clinical trial of autologous-Treg therapy for a refractory autoimmune disease as a first indication by using Treg manufactured by the induce/expansion technology of Regcell. At this moment, we are working on the evaluation using a disease model-animal and the establishment of cell processing method for clinical use, and plan to start the first-in-human trial in 2020. In addition, we also plan to start clinical trial early for transplantation after the completion of evaluation on animal experiments.Regarding the cancer immunotherapy by using a CTL derived from HLA haplotype-homo iPS, we have established the reproduction method of antigen-specific CTL and are proceeding with the construction of the manufacturing process for clinical use. We plan to start a clinical trial of the CTL for multiple myeloma as the first indication. We are also seeking a partner who has a promising TCR for developing novel CTL by using our technology platform and the co-development of cancer immunotherapy by the CTL.