Orizuru Therapeutics, Inc. (Hereinafter referred to as “our company”) announces today that OZTx-410, an iPS cell-derived islet cell sheet, provided from our company was implanted in the first type 1 diabetes patient with recurrent severe hypoglycemia in the investigator-initiated phase 1/1b clinical trial at Kyoto University Hospital (Address: Sakyo-ku, Kyoto; Director: Akifumi Takaori).

For details of the implantation of OZTx-410, please see the press release “The first case of implantation in the Investigator-Initiated Clinical Trial for iPS Cell-Derived Islet Cell Sheet implantation” posted on the website of Kyoto University Hospital.
https://www.kuhp.kyoto-u.ac.jp/press/20250415.html
(Japanese release only)

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[About OZTx-410]
iPS cell-derived islet cells (iPICs) are composed of safe, homogenous and high-purity pancreatic endocrine cell aggregates, which are manufactured using our company’s proprietary purification method with small molecular compounds. Therefore, iPICs are expected to exhibit physiological insulin secretion in response to glucose load and hypoglycemia. OZTx-410 is a sheet-like product containing iPICs, which aims to normalize blood glucose levels and improve the quality of life of patients with severe type 1 diabetes by enabling long-term engraftment of iPICs subcutaneously and reproduction of the islet structures.
The investigational product uses iPS cell stock established by the CiRA Foundation as a raw material. The manufacturing process utilizes a high-efficiency continuous single-use culture system for stably culturing islet cells in large quantities, jointly developed with SATAKE MultiMix Corporation (Headquarters: Toda, Saitama; President: Mitsutoshi Nishioka), and a well bag for large-scale production of homogeneous islet-like cell aggregates, developed with Toyo Seikan Group Holdings, Ltd. (Headquarters: Shinagawa, Tokyo; President: Ichio Otsuka). The investigational product will be manufactured by S-RACMO Co., Ltd. (Headquarters: Suita, Osaka; President: Atsushi Tsuchida).

[Support for this clinical trial]
This clinical trial is supported by the Translational Research grant, Japan Agency for Medical Research and Development (AMED)
“Development of Cell Therapy for Type 1 Diabetes Using iPS Cell-Derived Islet Cells” (Research Support Agency: Kyoto University)

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For further information, please contact:
Public Relations, Orizuru Therapeutics, Inc.
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