Oslo, Norway and Gosselies, Belgium, March 8, 2018 - Zelluna Immunotherapy, a biotechnology company specializing in T-cell receptor (TCR) based immunotherapies for solid tumors with a high unmet medical need, today announces the appointment of MaSTherCell as its contract development and manufacturing (CDMO) partner for the Zelluna TCR adoptive cell therapy platform.
The partnership provides Zelluna access to MaSTherCell’s cell therapy manufacturing expertise and capabilities. The selection of the CDMO is an important milestone for Zelluna on its path to clinical trial readiness and commercialization of Zelluna’s TCR-T multiple targets program. The partnership also enables MaSTherCell to strengthen its presence into the solid tumors TCR manufacturing field.
MaSTherCell will perform process development, optimization and industrialization of the current Zelluna manufacturing process. The result will be the delivery of a GMP manufacturing platform for Zelluna’s TCR product pipeline. The manufacturing platform will ensure clinical manufacturing capabilities with increased efficiency and geographical spread. As a result, Zelluna will have industrialized manufacturing capabilities to support clinical development and commercialization.
Zelluna’s partnership with MaSTherCell at an early developmental phase enables the integration of GMP industrialization concepts into the clinical development of Zelluna TCR therapies, supporting the progress towards clinical trials. Zelluna expects to commence trials in 2019.
“Following the recent successes of CAR-Ts, TCRs could present a significant therapeutic solution to the high unmet medical need of solid tumors. The differentiated Zelluna TCR targeting approach has the potential to reach both a market and industry leading position. In order to achieve that, it is essential to expand our existing manufacturing capabilities and strategy to take us through the clinical stage to commercialization,” said Miguel Forte, CEO, Zelluna Immunotherapy. “As a result, we have appointed MaSTherCell as an internationally leading cell therapy CDMO to enhance the Zelluna TCR manufacturing capabilities. The expertise and success of MaSTherCell in the cell therapy field will translate directly to TCRs and will be invaluable for Zelluna.”
“MaSTherCell now has gained considerable and varied expertise in adoptive T-cell therapy manufacturing. This will be significant when invested in the differentiated and innovative TCR approach developed by Zelluna,” said Denis Bedoret, Managing Director, MaSTherCell. “This know-how will specifically enable MaSTherCell to drastically accelerate the industrialization of Zelluna’s process and fast track the clinical trial start. TCR technologies have a promising potential to address solid tumors and this is why we are looking forward to our collaboration with Zelluna.”
MaSTherCell 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. The company is the subsidiary of Orgenesis Inc. (OTCQB:ORGS), a cell therapy and regenerative medicine company that is committed to developing a cure for Type 1 diabetes. The heart of MaSTherCell is a team of more than 80 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 http://www.masthercell.com.
About Zelluna Immunotherapy
Zelluna Immunotherapy specializes in immunotherapies targeting a broad range of solid cancers with a high unmet medical need. The company is developing a unique portfolio of non-engineered tumor specific T-cell receptors (TCRs) isolated from long term surviving patients from cancer vaccine trials. The TCRs combine specificity and affinity to have the potential for a safe and efficient therapy to target a variety of common cancer types. Zelluna has a long term CRADA with the Department for Cell Therapy at Oslo University Hospital (OUH), providing comprehensive capabilities of TCR development, ranging from lead discovery to clinical translation. For more information, please visit www.zelluna.com.