VALBONNE, France--(BUSINESS WIRE)--Regulatory News:
TxCell SA (Paris:TXCL) (FR0010127662 – TXCL), a biotechnology company developing innovative, personalized cell immunotherapies using regulatory T-cells to treat severe chronic inflammatory and autoimmune diseases, today announces it has signed a 5-year agreement with MaSTherCell, a Contract Manufacturing Organization (CMO), based in Belgium.
The agreement means MaSTherCell will be the exclusive manufacturer in Europe of all products from TxCell’s ASTrIA platform.
TxCell already appointed MaSTherCell in July 2015 for the manufacturing of TxCell’s lead product Ovasave® for the ongoing CATS29 study. CATS29 is a phase 2b trial of Ovasave conducted in refractory Crohn’s diseases patients.
With the new agreement, the transfer of manufacturing will be extended to Col-Treg, TxCell’s second lead product. Col-Treg is expected to enter a clinical trial by the end of 2016 targeting non-infectious uveitis.
“Following the review of our strategy at the start of Q4, 2015, TxCell is now exclusively concentrating on its key strengths of research, clinical development and new partnerships. This means we are able to commit to an ambitious product development schedule from our two discovery platforms” said Miguel Forte, COO, TxCell. “As a result, it is critical for TxCell to have the security of a strategic relationship with MaSTherCell as a long term manufacturing partner that will be able to deliver TxCell’s innovative cell therapy products throughout their clinical development.”
Exclusivity will not apply to TxCell (as a potential manufacturer) nor to its future licensees. Other contractual terms and conditions were not disclosed.
About MaSTherCell: www.masthercell.com
MaSTherCell SA (Manufacturing Synergies for Therapeutic Cells), a spin-off from ULB (Université Libre de Bruxelles) launched in 2011, is a technology-driven, quality-minded and customer-oriented Contract Development and Manufacturing Organization (CDMO) specialized in cell therapy development for advanced medicinal products. The company is an affiliate of Orgenesis Inc. (ORGS) 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.
About TxCell: www.txcell.com
TxCell is a publicly listed biotechnology company that develops platforms for innovative, personalized T cell immunotherapies for the treatment of severe chronic inflammatory and autoimmune diseases with high unmet medical need. TxCell is the only clinical stage cellular therapy company dedicated to the science of regulatory T lymphocytes (Tregs). Tregs are a recently discovered T cell population for which anti-inflammatory properties have been demonstrated. Ovasave®, TxCell’s lead product candidate, is currently in a phase IIb clinical trial in refractory Crohn’s disease patients. Col-Treg, its second product candidate, for the treatment of autoimmune uveitis, should enter clinical trials in 2016. Based in Sophia-Antipolis, France, TxCell is listed on Euronext Paris and currently has 62 employees.
This press release contains certain forward-looking statements concerning TxCell and its business. Such forward-looking statements are based on assumptions that TxCell considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward-looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of TxCell registered by the French Financial Markets Authority (Autorité des marchés financiers) on June 11, 2015 under number R. 15-049 and in the half year financial report of TxCell as of June 30, 2015 (a copy of which is available on www.txcell.com) and to the development of economic conditions, financial markets and the markets in which TxCell operates. The forward-looking statements contained in this press release are also subject to risks not yet known to TxCell or not currently considered material by TxCell. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of TxCell to be materially different from such forward-looking statements.
This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, TxCell shares in any country.