Cellusion, a Japanese regenerative medicine startup, and Minaris Regenerative Medicine, a global CDMO, announced Letter of Intent (LOI) for the manufacturing of CLS001 for a Corneal Endothelial Cell Regenerative therapy in the U.S.
 
The companies will develop the manufacturing process of Cellusion’s leading program, CLS001, a novel regenerative medicine product for bullous keratopathy treatment. Minaris’ Allendale, NJ team will perform process optimization to meet FDA requirements.

“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.”