Cellusion and Minaris Regenerative Medicine Enter into Business Alliance for the Manufacturing of CLS001 for a Corneal Endothelial Cell Regenerative Therapy
Cellusion, a Japanese regenerative medicine startup aiming to solve the global corneal transplant waiting list problem, and Minaris Regenerative Medicine, a global contract and development manufacturing organization, announced a 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,” Shin Hatou, MD, PhD, CEO of Cellusion, said in a company news release. “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, PhD, 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.”
Cellusion has announced that patient recruitment began for the investigator-initiated 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.