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The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave.
TxCell, a biotechnology company, announced that it has entered into an agreement for the production of clinical batches of Ovasave with Belgium-based CMO MaSTherCell. Ovasave, TxCell’s lead product candidate, is a personalized T cell immunotherapy product based on the properties of autologous ovalbumin-specific regulatory T lymphocytes. A Phase IIb placebo controlled study (CATS29) has been initiated for refractory Crohn's disease. EMA has classed Ovasave as an advanced therapy medicinal product (ATMP).
The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave. These Ovasave batches will be used by TxCell in Phase II evaluation of the product in refractory Crohn’s disease patients (CATS29 study). The transfer of technology will start immediately. The first clinical batches are expected to be manufactured in the second quarter of 2016.
TxCell is also taking measures to ensure full GMP compliance at its existing pilot Besançon manufacturing unit so that full manufacturing activities can begin following a partial temporary hold at the site. TxCell will file to re-obtain its GMP certificate and production will resume after approval of the GMP certificate by the French regulator ANSM.
Ovasave clinical batches for the CATS29 study will be manufactured in parallel by MaSTherCell and TxCell’s own facility. TxCell expects to announce top-line data from this study in 2017.
As part of the memorandum of understanding, TxCell and MaSTherCell will also discuss about the long-term clinical and commercial manufacturing by MaSTherCell of Ovasave and other TxCell products. The discussions are expected to take place in late 2015.