Kangstem Biotech selects MaSTherCell for GMP manufacturing of FURESTEM-AD© in Europe

Seoul, Korea and Gosselies, Belgium, October 1, 2018 – Kangstem Biotech, a biotechnology company specializing in developing cell therapies using mesenchymal stem cells derived from human umbilical cord blood, today announces the selection of MaSTherCell as its contract manufacturing partner for its European clinical trial of FURESTEM-AD. MaSTherCell, a subsidiary of Orgenesis Inc. (NASDAQ:ORGS) through Masthercell Global Inc. is a cell therapy dedicated Contract Development and Manufacturing Organization (CDMO). MaSTherCell will perform a technology transfer of FURESTEM-AD’s process and manufacture FURESTEM-AD for Kangstem’s European clinical trial.

Kangstem is moving into late phase clinical trials in Korea and strengthened by this expertise, now takes the opportunity to enter into Europe with its innovative cell therapy products. “The European clinical trial of Furestem-AD will be a milestone for our company. We believe that MaSTherCell’s expertise and experience will be the key to enable it”, said Mr. Tae Wha Lee, CEO of Kangstem.

“Kangstem’s allogeneic human umbilical cord blood-derived stem cell based project fits perfectly in MaSTherCell’s long term strategy to provide services across all segments of the cell therapy field” said Romain de Rauville, Business Development Manager and Head of Europe at MaSTherCell “Being selected by a Korean cell therapy company really portrays MaSTherCell’s expertise and agility in assisting our partners with their globalization. Kangstem’s efficient manufacturing process will further increase MaSTherCell’s expertise and skills to broaden the impact of both companies on the cell therapy field.”

The partnership provides Kangstem access to MaSTherCell’s cell therapy manufacturing expertise, capabilities and commercial state of the art new facility. The Agility by Design facility will provide Kangstem with the most efficient clean room set-up for its unique and high-value large-scale manufacturing process.  If desired, MaSTherCell’s global facilities further allow Kangstem to easily expand to other continents. This puts Kangstem in a fast-track position to provide its innovative cell therapy products to more patients.

About KangStem Biotech

Kangstem Biotech Co., LTD. (KSB) is developing stem cell therapeutic products which target autoimmune diseases. KSB has developed methods to isolate and to mass culture high purity human umbilical cord blood-derived stem cells (hUCB-SCs). Based on these platform technologies, KSB was able to establish immune-modulating mechanism of hUCB-SCs, and currently conducting clinical trials for the development of stem cell therapeutic products targeting atopic dermatitis (Furestem-AD®), rheumatoid arthritis (Furestem-RA®), and Crohn’s disease (Furestem-CD®). Therapeutic product targeting osteoarthritis (Furestem-OA®) is currently on the pre-clinical trial stage. KSB is also conducting research on directly converted neural stem cell (dcNSC) to provide patient specific regenerative medicine for neurological disorder.

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