MaSTherCell Appointed as Process Development and Manufacturing Partner for Zelluna Immunotherapy’s TCR Adoptive Cell Therapy Platform
GERMANTOWN, Md., March 19, 2018 (GLOBE NEWSWIRE) -- Orgenesis Inc. (Nasdaq:ORGS), a manufacturer, service provider and developer of advanced cell therapies, today announced that its manufacturing subsidiary, MaSTherCell S.A. (“MaSTherCell”) was appointed by Zelluna Immunotherapy AS (“Zelluna”), a biotechnology company specializing in T-cell receptor (TCR)-based immunotherapies for solid tumors with a high unmet medical need, as its contract development and manufacturing (CDMO) partner for Zelluna’s TCR adoptive cell therapy platform.
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.
Vered Caplan, Chief Executive Officer of Orgenesis, stated, “I’m proud to build out MaSTherCell’s development activities further with the addition of Zelluna’s platform TCR technology. Manufacturing and providing process industrialization from the preclinical ground-level offers significant upside potential for us as the TCR products advance into further stages of clinical development, which Zelluna plans to commence in the 2019. Our world-class facilities are continually being optimized to improve the quality and throughput of CDMO services for Zelluna and all our other customers.”
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. The company is the subsidiary of Orgenesis Inc. (Nasdaq: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 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 Zelluna Immunotherapy
Zelluna Immunotherapy AS 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.
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, our ability to raise additional capital when needed, the sufficiency of working capital, our ability to achieve profitability, the development of our regeneration technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1 of our Annual Report on Form 10-K for the fiscal year ended November 30, 2017, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.
Edison Advisors (investors)
Released March 19, 2018