On December 20, 2022 Thyas Co. Ltd. ("Thyas"; Kyoto, Japan; Representative Directors, Yasumichi Hitoshi and Ryosuke Gonotsubo) has reported 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) (Press release, Thyas , DEC 20, 2022, View Source [SID1234629216]).

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The details of the agreements are as shown below:
Contracts Contents Contract Parties Joint
Research
Agreements Thyas to support clinical manufacturing of iCARNK CiRA, CiRA_F, Thyas Patent
License Agreement CiRA and Kirin Holdings to license Thyas an
Exclusive use of patents and data related to the clinical manufacturing methods of iCAR-NK CiRA, Thyas Research
Data
License Agreement CiRA, Kirin Holdings, Thyas
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 iCARNK 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 iCARNK. The first patient is dosed in Fall 2021.

About iCAR-NK
Professor Kaneko’s group at CiRA developed iCAR-NK by introducing a chimeric antigen receptor (CAR) gene that recognizes GPC3 into iPS cells and differentiated them into natural killer cells. In recent years, clinical development of cancer immune-cell therapy is growing rapidly all over the world. However, at present, only a few clinical trials have been

conducted with iPSC-derived immune cells. The iCAR-NK, developed by Professor Kaneko’s group, is the world’s first iPSC-derived immune cell product for a clinical trial involving patients with a solid tumor.