Thyas Co. Ltd. ("Thyas"; Kyoto, Japan; Representative Directors, Yasumichi Hitoshi and Ryosuke Gonotsubo) has announced it concluded a joint research agreement and a license agreement for an exclusive use of data and patents of clinical manufacturing methods of iPSC-derived CAR-transduced natural killer cells ("iCAR-NK") with the Center for iPS Cell Research and Application, Kyoto University ("CiRA"; Kyoto, Japan; Director: Jun Takahashi), The CiRA Foundation ("CiRA_F"; Kyoto, Japan; Representative Director: Shinya Yamanaka), Kirin Holdings Company, Limited ("Kirin Holdings"; Tokyo, Japan; President and CEO: Yoshinori Isozaki).

The details of the agreements are as shown below:

Under the agreements, Thyas participates in the manufacturing of iCAR-NK for the Phase I clinical trial (the "Clinical Trial"; investigator-initiated clinical trial) of the product. Thyas obtains an exclusive license of the patents related to the manufacturing methods of iCAR-NK from Kyoto University and the manufacturing data and documents from Kyoto University and Kirin Holdings.


About The Clinical Trial and AMED's "Innovative Cancer Research Project
Funded by the Japan Agency for Medical Research and Development ("AMED") (The project is called "Innovative Cancer Therapy Research Project for Practical Use"), the Clinical Trial is being conducted by Professor Shin Kaneko's group at CiRA and the National Cancer Center Hospital East. In the Clinical Trial, patients with inoperable advanced recurrent ovarian clear cell carcinoma that expresses glypican-3 (GPC3; a protein only certain tumors specifically express) are treated with GPC3-specific iCAR-NK. The endpoints of the Clinical Trial is to evaluate the safety, tolerability, and preliminary efficacy of the iCAR-NK. The first patient is dosed in Fall 2021.


About Thyas
Founded in 2015, Thyas is a Kyoto University spinoff committing to R&D for the clinical application of iPSC-derived immune cell differentiation methods established by Dr. Shin Kaneko at CiRA. Dr. Kaneko is the world's first scientist to establish T cells from hiPSC and demonstrated in vitro and in vivo efficacy in 2013. CiRA is the institute where the world's most advanced iPSC researchers are developing cutting-edge iPSC-derived cell therapies; Dr. Shinya Yamanaka, the director emeritus, won the Nobel Prize in 2012 for establishing iPSC for the first time in the world. Thyas is specialized in producing various immune cells from iPSC, i.e., NK cells, killer T cells, CD4-expressing lymphocytes and others. Combined with Chimeric Antigen Receptors (CARs) or T Cell Receptors (TCRs) of interests, this platform can generate therapeutic immune cells for many types of cancers. Thyas' goal is to become a leader in iPSC-derived cancer immune cell therapeutics, and turn cancers into curable diseases.


About CiRA Foundation
The CiRA_F is a public interest incorporated foundation that was spun off from CiRA, and started its activities with the philosophy of delivering top iPS cell technologies at affordable prices. The CiRA_F is promoting the iPS cell stock project for regenerative medicine; that project was initiated by CiRA in 2013 and transferred to CiRA_F. In this project, iPS cells are generated from healthy donors who are homozygous for HLA (human leukocyte antigen) -A,-B, and-DR to minimize immune rejection. After various quality evaluations, iPS cell lines qualified for regenerative medicine are provided to academia, companies, etc. In addition, we contribute to the practical application of regenerative medicine by providing services including the manufacturing of iPS cell-derived products, quality assessment, and storage, and publication of SOPs (standard operating procedures) for manufacturing.


About Kirin Holdings
Kirin Holdings had supported CiRA for the production of iPSC-derived immune cells for clinical trials of cancer cell therapy. With its cell processing technology, Kirin Holdings continues to build new business foundation for the Kirin Group, and contribute to the industry to deliver quality-assured iPSC-derived cells to patients suffering from intractable diseases.