TxCell has announced that it has successfully concluded the most important milestone in the transfer of its manufacturing technology to MaSTherCell, its contract manufacturing organization (“CMO”) for the European manufacturing of TxCell’s product portfolio, including its lead product Ovasave(R).
MaSTherCell successfully completed the manufacturing of a series of contractually defined validation runs of Ovasave. Validation runs are conducted as a test to demonstrate the capacity of a new manufacturing unit to manufacture products according to specifications. Validation runs are an industry-defined marker of the successful transfer of technology to a CMO.
TxCell announced the signing of a strategic agreement with MaSTherCell in December 2015 for European manufacturing of all products from TxCell’s first product platform ASTrIA. This was an extension to the agreement in July 2015 for the manufacturing of TxCell’s lead product Ovasave for the ongoing CATS29 study. This trial is a phase IIb clinical study with TxCell’s Ovasave in refractory Crohn’s disease.
Following the successful validation runs at MaSTherCell, TxCell has submitted an amendment of its CATS29 clinical protocol. Specifically, the amendment refers to site change approval for the European national competent authority agencies that initially approved the CATS29 study through the Voluntary Harmonized Procedure (VHP). This should enable TxCell to resume CATS29 in Q2 2016, as per the planning previously announced. Should the trial restarts effectively in Q2 2016, TxCell expects to complete recruitment in CATS29 at the end of 2017 and announce topline data by Q4 2017 or Q1 2018.
The amendment will also be submitted to the FDA, where CATS29’s Investigational New Drug (IND) dossier has been active since August 2015.
“The achievement of critical transfer technology milestones with successful validation runs in only a few months, especially regarding stringent specifications that go with cellular therapy products is a major achievement for both TxCell’s team and its strategic production partner MaSTherCell. TxCell is now on target for the resumption of the CATS29 trial of our lead product Ovasave in Q2 2016 as planned,” said Stephane Boissel, CEO, TxCell. “This new strategy and the technology transfer will allow TxCell to fully concentrate on our key strengths of research, clinical development and new partnerships. This has given us the confidence to set ambitious product development schedules from our two discovery platforms based on Ag-Tregs (ASTrIA) and CAR-Tregs (ENTrIA). To accelerate further, TxCell expects to also rapidly secure a CMO agreement for production of its products in the USA, where Ovasave has both an open IND as well as a Fast Track Designation by the FDA and where Col-Treg, TxCell’s second most advanced product, has obtained the orphan drug designation status in 2015.”