Under the agreement, Catalent will manufacture an anti-CORIN monoclonal antibody using its proprietary GPEx cell line expression technology for a planned clinical trial to develop an iPS cell-based transplant therapy for Parkinson’s disease at CiRA, which is directed by Shinya Yamanaka, the joint winner of the Nobel Prize in Physiology or Medicine in 2012.
“Kyoto will take care of the whole therapy, and Catalent will make the monoclonal antibody as a tool to research the therapy,” a Catalent spokesman from Japan told us. “The monoclonal antibody Catalent will manufacture will be used at the cell sorting step to mark up the dopaminergic cells. Kyoto University will manage the whole process from basic research to clinical trials, including challenging Japanese regulatory authorities.”
The anti-CORIN monoclonal antibody was discovered and developed through collaborative research between CiRA and KAN Research Institute, which is a subsidiary of Eisai.
Catalent has already engineered cell lines producing the anti-CORIN monoclonal antibody for CiRA using their GPEx technology, and the antibody has been shown to be useful for sorting CORIN-expressing cells in in vitro studies at CiRA.
“This agreement is not aimed at bringing a monoclonal antibody to market, but rather employing the monoclonal antibody manufactured by Catalent for Kyoto University to conduct their research,” the spokesman said.
Under the agreement, Catalent will conduct further clonal selection and manufacturing of the monoclonal antibody under a properly conditioned environment for CiRA, which will use the antibody to select dopaminergic neurons derived from iPS cells and plans to transplant the selected cells into patients in a possible clinical research program upon receipt of regulatory approval.
Catalent will also support CiRA, with formulation, production, and sterile fill/finish of the monoclonal antibody, aspects of the project that could not be handled within academia.
“It is a great honor to work with a team led by world renowned Professor Doctor Jun Takahashi,” said Shingo Nakamura, Catalent’s Director of Biologics, Japan. “We are very excited to help accelerate the development of a unique regenerative therapy using our GPEx technology and look forward to working with CiRA to bring better treatments to market faster.”
Jonathan Arnold, VP and general manager of Catalent Biologics, added, “We are witnessing an increased demand for biologics in the Asia Pacific market. Our GPEx technology, our expertise, and access to antibody drug conjugates, combined with our investment in state-of-the art manufacturing facilities, mean that we are ideally placed to act as a partner to CiRA in this exciting project.”