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

ALLENDALE, NJ, USA and YOKOHAMA, Japan, October 04, 2022 / B3C newswire / -- 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.