Orgenesis Subsidiary MaSTherCell to Manufacture TxCell's Lead Product Ovasave for Multi-National Phase 2b Trial
GERMANTOWN, MD -- (Marketwired) -- 07/29/15 -- Orgenesis Inc. (OTCQB: ORGS), a cell therapy and regenerative medicine company with a novel therapeutic technology dedicated to converting a patient's own cells into functioning insulin-producing cells as a treatment for diabetes, today announced that its wholly owned subsidiary, MaSTherCell, a Contract Development and Manufacturing Organization (CDMO) has entered into a Memorandum of Understanding with France-based TxCell (Paris: TXCL) (Euronext Paris: FR0010127662 - TXCL), to manufacture clinical batches of Ovasave®, TxCell's lead product. Ovasave is an antigen specific autologous T regulatory somatic cell therapy in development for the treatment of Inflammatory Bowel Disease. As part of the Memorandum of Understanding, MaSTherCell and TxCell also agreed to enter into discussions for the long-term clinical and commercial manufacturing by MaSTherCell of TxCell products.
Ovasave batches manufactured by MaSTherCell will be used by TxCell in its ongoing Phase 2b trial, CATS29, for the treatment of Crohn's disease. The first clinical batches could be manufactured by MaSTherCell as soon as Q2 2016. CATS29 is a multi-center, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection 4-parallel groups study. The trial has been designed to include 160 severe refractory Crohn's disease patients. It is currently on-going in 30 study sites in 6 countries including Austria, Belgium, France, Germany, Italy, the United Kingdom, and may be extended into the U.S. The United States Food and Drug Administration recently granted Fast Track Designation to Ovasave for the treatment of moderate to severe Crohn's disease.
"MaSTherCell is a European leader in cellular therapy products manufacturing with a significant track record in production of clinical materials. This strategic relationship with MaSTherCell is very important to TxCell," said Stéphane Boissel, Chief Executive Officer of TxCell.
Vered Caplan, Chairperson and CEO of Orgenesis, commented, "We are pleased that MaSTherCell has entered into a substantial cell manufacturing agreement with TxCell for Ovasave, in an indication that has a clear unmet need which may best be treated through a cutting edge cell therapy like Ovasave. We look forward to working very closely with TxCell to deliver unparalleled manufacturing services for its trial."
About TxCell S.A.
TxCell develops innovative, personalized T cell immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need. TxCell has created ASTrIA, a unique and proprietary product platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has initiated a phase IIb study of its lead product candidate, Ovasave®, in refractory Crohn's disease patients.
MaSTherCell SA (Manufacturing Synergies for Therapeutic Cells), a spin-off from ULB (Université Libre de Bruxelles) launched in 2011, is a CDMO specialized in cell therapy development for advanced medicinal products. The company is located in Gosselies, Belgium and provides GMP manufacturing for cell therapy companies. Its mission is to combine expertise, quality systems and infrastructure to help its customers bring highly potent cell therapy products faster to the market. MaSTherCell believes that the best way to serve customers is to combine scientific and business expertise as well as operational acumen to provide an unequalled manufacturing service in the cell therapy field. Its technology-driven, quality-minded and customer-oriented team of committed experts is dedicated to achieving that mission. For more information, visit www.masthercell.com.
About Orgenesis Inc.
Orgenesis is a cell therapy and regenerative medicine company that is committed to developing a cure for Type 1 Diabetes. In pursuit of this goal, the company has developed and patented a novel technology called "cellular trans-differentiation" that turns an insulin-dependent patient's own liver cells into functional insulin producing cells. Orgenesis has proven that, when exposed ex-vivo to certain pancreatic transcription factors and in specific sequence, human adult liver cells can be transformed into fully functional, beta cell-like insulin producing cells (IPCs). After ex-vivo expansion, the IPCs are re-infused via the portal vein of the diabetic patient. In pre-clinical models of Type 1 Diabetes (Non-Obese Diabetic mice), the re-introduced IPCs remain in the liver, effectively respond to glucose challenge and successfully maintain glycemic homeostasis. In the same NOD model, the implanted IPCs were not subject to auto-immune attack or cellular ablation. Orgenesis plans to initiate P1/2 trials in the next 12-18 months. Orgenesis believes that converting the diabetic patient's own tissue into insulin-producing cells has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation. For more information, visit www.orgenesis.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" which are not purely historical. Such forward-looking statements include, among other things, the expectations of management that our regeneration technology can be developed as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; and that we will initiate Phase I and Phase II clinical trials in the near-term. No assurance can be given that any of the events anticipated by the forward-looking statements will occur or, if they do occur, what benefits Orgenesis will obtain from them. Actual results could differ from those projected in any forward-looking statements due to numerous factors, including, among others, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing; the ability to pass clinical trials so as to move on to the next phase; our ability to retain key employees; our ability to finance development and operations; our ability to satisfy the rigorous regulatory requirements for new medical procedures; and competitors may develop better or cheaper alternatives to our products. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should refer to the risk factors disclosure outlined in our periodic reports filed from time-to-time with the Securities and Exchange Commission.
Source: Orgenesis Inc.
Released July 29, 2015