TxCell re-acquires full rights to its lead product Ovasave

French biotech firm TxCell (Euronext Paris: TXCL), which is developing innovative, personalized cell immunotherapies using regulatory T-cells to treat severe chronic inflammatory and autoimmune diseases, has agreed with Trizell Holding, an affiliate of the Dr Frederik Paulsen Foundation, to terminate the collaboration, option, development and license agreement concerning TxCell’s lead product Ovasave.

The agreement granted Trizell an exclusive option to in-license development and commercialization rights to Ovasave, an antigen-specific Treg cell-based immunotherapy, in inflammatory bowel disease, including Crohn’s disease. The collaboration on Ovasave that TxCell previously had with privately-held Switzerland-headquartered Ferring International was assigned to Trizell early this year (The Pharma Letter January 4). TxCell has now regained full rights to Ovasave.

Following this reacquisition, TxCell now proposes to amend the CATS29 Phase IIb trial for Ovasave, currently underway in refractory Crohn’s disease patients. The primary endpoint of the trial (1 million cell dose versus placebo) is intended to be maintained. The dose exploring arms are however expected to be omitted.

Following the amendments to the CATS29 trial, TxCell intends to recommence the trial in the second quarter of 2016, with the drug product manufactured by MaSTherCell, a contract manufacturing organization. TxCell expects to complete recruitment in CATS29 at the end of 2017 and announce top-line data by fourth-quarter 2017 or first-quarter 2018.