Cellusion and Minaris Regenerative Medicine, a member of Showa Denko Materials, Enter into Business Alliance for the Manufacturing of CLS001 for a Corneal Endothelial Cell Regenerative Therapy

TOKYO–()–Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D., “Cellusion”), a Japanese regenerative medicine startup aiming to solve the global corneal transplant waiting list problem with a unique differentiation induction method from iPS cells to Corneal Endothelial Cell Substitute from iPS Cells (CECSi Cells) for bullous keratopathy novel treatment (PJ code: CLS001), and Minaris Regenerative Medicine, LLC (CEO: Hiroto Bando, Ph.D. MBA, “Minaris”), a leading global contract and development manufacturing organization (“CDMO”) and a member of Showa Denko Materials Co., Ltd. (CEO: Hidehito Takahashi, “Showa Denko Materials”), today announced Letter of Intent (“LOI”) of the Manufacturing of CLS001 for a Corneal Endothelial Cell Regenerative therapy in the United States.

Under the LOI, Cellusion and Minaris will develop the manufacturing process of Cellusion’s leading program, CLS001, a novel regenerative medicine product for bullous keratopathy treatment. Minaris’ Allendale, New Jersey team will perform process optimization to meet requirements from the FDA.

“We are very enthusiastic to have the partnership with Minaris, a well-established regenerative medicine partner with over 20 years experiences including the predecessor companies, Progenitor Cell Therapy and Hitachi Chemical, and one of the leading CDMOs in the U.S. since the dawn of the field,” said Shin Hatou, M.D. Ph.D., CEO of Cellusion. “Together, we make our best efforts to develop the robust manufacturing process of CLS001 for patients suffering from bullous keratopathy due to the cornea donor shortage all over the world.”

Hiroto Bando, Ph.D. MBA, CEO of Minaris said “It is exciting for Minaris Regenerative Medicine to be part of advancing a potential solution to corneal blindness, a widespread need, and we look forward to leveraging our extensive development resources to support Cellusion. We hope to position Cellusion well for its next clinical trial and potentially further support them in their manufacturing needs.”

According to the World Health Organization (WHO) report, in 2021, at least 1 billion near or distant vision impairment cases could have been prevented or has yet to be addressed globally. Blindness of the cornea is the fourth leading cause of blindness, and is one of the major causes of visual deficiency after cataract, glaucoma, and age-related macular degeneration. Most of the patients with corneal blindness need corneal transplantation to restore their sight, but only 180,000 corneal transplants are conducted every year due to severe donor cornea shortage issues. Cellusion is striving to solve this problem, and by doing so support the UN’s Sustainable Development Goals 3 to ensure healthy lives and promote well-being for all ages.

Cellusion has announced that patient recruitment began for the Investigator-Initiated Study first-in-human study of CLS001 to initiate in 2022 at the Keio University Hospital. Cellusion has been preparing to start its clinical trial in Japan within a few years followed by global studies in the US and EU region.

[About CLS001]

In spite of the fact that more than 13 million waiting patients for potential blinding diseases such as Bullous Keratopathy, which can only be prevented by corneal transplantation, only about 180,000 corneal transplants are performed annually worldwide. The reason for such a large medical supply-demand gap generated is because current treatments require donor corneas, skilled corneal transplant ophthalmologists, and Eye Banks.

Cellusion is developing CLS001, CECSi cells for Corneal Endothelial regeneration to cure Bullous Keratopathy which is applied to more than half of all cases of corneal transplantation. CLS001 is expected to replace the current supply limitations by combining “CECSi Cells made from iPS cells with excellent proliferative properties” and “a simple injection cell delivery procedure without needs of human expertise.”

[About Minaris]

Minaris is a global CDMO for cell and gene therapies as a member of Showa Denko Materials group. Minaris offers their clients high value clinical and commercial manufacturing services, development solutions, and technologies. Minaris is a pioneer in the field with more than 20 years’ experience providing high quality and reliability. The facilities in the US, Europe, and Asia allow Minaris to supply patients worldwide with life-changing therapies.

For more information, please visit www.rm.minaris.com

Connect with Minaris: Twitter: https://twitter.com/MinarisRM

LinkedIn: https://www.linkedin.com/company/minaris-regenerative-medicine

[About Cellusion] 

Cellusion is a regenerative medicine startup born from the Department of Ophthalmology, Keio University School of Medicine in 2015. Cellusion aims to contribute to the improvement of health and well-being around the world by solving unmet medical needs in medicine with its cutting-edge cell therapy technologies, including a unique differentiation induction method from iPS cells to CECSi endothelial cells. Cellusion’s mission is to give the worldwide community a clear vision of the future with the cellular technology breakthrough.

Company: Cellusion Inc.

CEO: Shin Hatou, M.D., Ph.D.

Headquarters: 8-6 Nihonbashi-Kobuna, Chuo, Tokyo 103-0024, JAPAN

Founded: January 2015

URL: https://cellusion.jp/en/

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