On February 1, 2021 The CiRA Foundation (CiRA_F) reported that it has signed the following two agreements with Thyas Co. Ltd. ("Thyas"; located in Sakyo-ku, Kyoto) (Press release, Thyas , FEB 1, 2021, View Source [SID1234629212]).

(1) Basic agreement on the manufacturing of autologous regenerated T cells by Thyas
(2) Joint research on the my iPS Project for the production of autologous regenerated T cells

(1) Basic agreement on the manufacturing of autologous regenerated T cells by Thyas
CiRA_F has conducted a basic agreement with Thyas to manufacture intravenous autologous iPS cellderived cytotoxic T cells (hereinafter referred to as "autologous regenerative T cells") for use in clinical trials. The term of the consignment is planned to be from March 2022 to February 2024, with aim for a clinical trial scheduled to start in the second half of 2022. Currently, Thyas and CiRA_F are negotiating the conclusion of a formal outsourcing contract.

It is said that thousands of cancer cells are generated every day in the body of a healthy person, but these cells are regularly eradicated by the immune system. If the immune function does not work properly, however, cancer cells persist and proliferate, eventually leading to cancer. In recent years, immunotherapies have been developed to treat cancer patients by strengthening their immune systems.

T cells are a type of white blood cell that attacks foreign substances in the body. However, T cells in cancer patients are chronically stimulated and exhausted by cancer cells. Professor Shin KANEKO and his colleagues at the Center for iPS Cell Research and Application (CiRA), Kyoto University, are using iPS cell technology to develop a new form of immunotherapy, in which T cells are reprogrammed into iPS cells, which are then expanded and differentiated into T cells that can effectively suppress cancer. As part of this research, they have developed a technology to manufacture such T cells in large quantities. Thyas is working with Professor Kaneko to put this technology into practical use by preparing autologous regenerated T cells.

(2) Joint research on the my iPS Project to produce autologous regenerated T cells
Currently, CiRA_F is working on the "my iPS Project", with the goal of delivering patient iPS cells and cells derived from them by 2025. Although it is possible to produce patient iPS cells, the current cost is about 40 million yen (about US$400,000) per production. In the my iPS Project, the CiRA_F aims to provide safe patient iPS cells at 1 million yen (around US$10,000) per case by automating the cell manufacturing and improving the efficiency of quality control.

In this joint research, Thyas and CiRA_F will study the manufacturing method so that patient iPS cells can be used as the raw material for autologous regenerated T cells. Specifically, biomarkers and other properties will be analyzed to evaluate the best iPS cell lines for T cell differentiation. Accordingly, the differentiation method of my iPS to T cells will also be intensively investigated.

The CiRA Foundation collaborates with academia and industry to provide iPS cell-derived regenerative medicines to clinical practice as soon as possible.

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