EN Cell said Thursday that it has signed a contract manufacturing organization (CMO) agreement with Hanmi Pharmaceutical to manufacture HM21001, anti-cancer gene stem cell therapy, and started producing the substance for clinical trials.
EN Cell, founded by Professor Jang Jong-wook of Samsung Medical Center, focuses on the development of stem cell treatment for rare diseases and the contract development and manufacturing organization (CDMO) project for stem cell therapy.
HM21001 is a glioblastoma (GMB) gene cell therapy using bone marrow-derived mesenchymal stem cells, which Hanmi Pharm co-developed with Professor Seo Hae-young at Ajou University in 2016 as part of its open innovation strategy.
To sign the contract, EN Cell passed all audits of the strict good manufacturing practice (GMP) plant as well as manufacturing and quality systems supervised by Hanmi. The company also completed preparations for technology transfer and clinical trial drug production after signing the contract.
“Through the CMO contract with Hanmi, the company has received recognition for its know-how in the fields of GMP technology and stem cell therapy products,” Jang said. “We hope that pharmaceutical companies, ventures, and universities that have no cell therapy GMP facilities will be able to develop stem cell treatments without investing in early GMP facilities and human resources.”