Kangstem Biotech today announces the selection of MaSTherCell as its contract manufacturing partner for its European clinical trial of FURESTEM-AD(R).
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(R). 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 MaSTherCell
MaSTherCell S.A. is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. MaSTherCell is a subsidiary of MaSTherCell Global Inc.– a gathering of MaSTherCell in Belgium, Atvio Biotech Ltd., an Israel-based CDMO, and Curecell Co. Ltd., a Korea-based CDMO partner. Masthercell Global is majority-owned by Orgenesis Inc. (Nasdaq:ORGS), a cell therapy and regenerative medicine company that is committed to developing a cure for Type 1 diabetes. At the heart of MaSTherCell is a team of highly dedicated experts combining strong experience in cGMP cell therapy manufacturing with a technology-focused approach and a substantial knowledge of the industry. From technology selection to business modeling, GMP manufacturing, process development, quality management and assay development, MaSTherCell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients. The company operates in a validated and flexible facility located in the strategic center of Europe within the Walloon healthcare cluster, Biowin. For more information, please visit www.masthercell.com.
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(R)), rheumatoid arthritis (Furestem-RA®), and Crohn’s disease (Furestem-CD(R)). Therapeutic product targeting osteoarthritis (Furestem-OA(R)) 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.
