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September 01, 2021

Joint research on personalized cancer immunotherapy using regenerated T cells derived from iPS cells

Suita and Kyoto --- The Center for iPS Cell Research and Application, Kyoto University ("CiRA"; Headquarters: Sakyo-ku, Kyoto, Japan; Director: Shinya Yamanaka), KOTAI Biotechnologies, Inc. ("KOTAI"; Headquarters: Suita, Osaka, Japan; CEO, Kazuo Yamashita) and Thyas Co. Ltd. ("Thyas"; Headquarters: Sakyo-ku, Kyoto, Japan; CEO, Yasumichi Hitoshi) jointly announced today that
Thyas has joined joint research initiated by CiRA and KOTAI on personalized cancer immunotherapy using regenerated T cells1 derived from induced pluripotent stem (iPS) cells2.

The laboratory of Professor Shin Kaneko, CiRA, Department of Cell Growth and Differentiation, is conducting research on therapeutic regenerative T cells using iPS cells for cancer immune cell therapies. In these therapies, cytotoxic T cells3 that can attack cancer cells are isolated from cancer patients and reprogrammed into iPS cells. These patients-derived iPS cells (or allogeneic iPS cells transduced with these patients-derived TCR genes) are then used to produce large numbers of rejuvenated T cells with high anti-cancer function (see figure below). CiRA and KOTAI started the joint research in October, 2020 to establish more efficacious personalized cancer immune cell therapies using a surface antigens4 specifically expressed on anti-cancer cytotoxic T cells and immuno-informatics technologies possessed by KOTAI.

Thyas is developing robust and standardized manufacturing methods to produce regenerated T cells for industrial use using the research achievements by Professor Kaneko. It has also been manufacturing the clinical-grade batches of regenerated T cell products for clinical studies. The inclusion of Thyas, well-experienced in the production of regenerated T cells, is expected to accelerate the clinical application of the joint research outcomes.

In this joint research, CiRA will isolate T cells from cancer tissue and conduct iPS cell induction, T cell redifferentiation, and functional evaluation, while KOTAI will provides information on the surface antigen for the T cell isolation and performs genetic analysis of the cells. Thyas will optimize the production of regenerated T cells for clinical trials. The first trials are scheduled to begin by 2025 and will be the world's first iPSC-derived therapeutic cells equipped with personalized TCRs5.

By conducting this joint research, CiRA, KOTAI, and Thyas aim to establish personalized cancer immunotherapy using regenerated T cells and contribute to the further development and popularization of cancer immune cell therapy through the efforts toward clinical trials.

(Note 1) T cells:
A type of lymphocyte that acts in immunity by recognizing and eliminating infected cells and cancer cells. Each T cell responds to a specific antigen. There are various types of T cells, such as cytotoxic T cells, helper T cells and others.

(Note 2) iPS cells:
Somatic cells, such as skin or blood cells are reprogrammed into the pluripotent state by introducing a few genes. iPS cells are a type of stem cell with almost indefinite capacity to multiply and can differentiate into almost any kind of cell in the body.

(Note 3) Cytotoxic T cells:
A type of T cell. When antigen information is received from other immune cells, cytotoxic T cells attack the cells corresponding to the antigen.

(Note 4) Surface antigen:
A substance on a cell surface recognized by an antibody.

(Note 5) Thyas' Regenerated T Cell Products:
Thyas aims to start clinical trials of allogeneic iPS cell-derived regenerated T cell therapy targeting common antigens in 2023 as its first pipeline. Development of this personalized T cell therapy will be its second pipeline.

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