Orizuru Therapeutics, Inc. (Hereinafter referred to as “our company”) announced today that our company will provide an iPS cell-derived islet cell sheet, OZTx-410, as an investigational product for investigator-initiated phase 1/1b clinical trial in patients with severe type 1 diabetes at Kyoto University Hospital (Address: Sakyo-ku, Kyoto; Director: Akifumi Takaori) to evaluate the safety of OZTx-410 in patients with type 1 diabetes who are candidates for islet transplantation.

Ryo Ito, Head of iPS cell-derived Pancreatic Islet Cell (iPIC) Business Unit, said: “We have been engaged in research and development for over eight years with the goal of offering a new treatment for patients with type 1 diabetes. I am very pleased to announce today that we can provide our investigational product to medical institutions. This is a highly challenging treatment that requires the engraftment of over a billion cells over a lifetime, but we will continue to advance as a united team, collaborating with medical institutions and various companies.”

For details of the investigator-initiated clinical trial, please see the press release “Start of Investigator-Initiated Clinical Trial for iPS Cell-Derived Islet Cell Sheet Transplantation” posted on the website of Kyoto University Hospital. https://www.kuhp.kyoto-u.ac.jp/press/20241002.html

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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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