French T-cell Expert restarts trial for Crohn’s after Manufacturing Hiccup

26/05/2016 - 2 minutes

TxCell is restarting its trial for Ovasave, an autologous T-cell therapy, with a new manufacturing partner. This therapy is targeting Crohn’s disease which does not respond to current treatments.

TxCell is based in Sophia-Antipolis (France) and is developing immunotherapies based on a type of T-cells that have anti-inflammatory properties – regulatory T-lymphocytes (Tregs).

Its most advanced programme is in refractory Crohn’s disease with Osave, a personalised T-cell therapy that was already in a Phase IIb trial (CATS29). The trial had been suspended, following some problems with the manufacturing of the therapy.

TxCell can now restart this trial with an altered protocol and using a new manufacturer, after authorisation from European regulatory authorities.

It is looking forward to resuming the trial as soon as possible. After that, topline data is expected within 18 to 21 months. The primary endpoint is the same, with the objective being a response rate of 70% in the treated patients (vs. 30% in those with placebo).

The new manufacturer is MaSTherCell,

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