TxCell receives milestone payment of EUR 1 million concerning Ovasave collaboration, license agreement from Trizell

Milestone payment triggered by first patient enrolment in the phase IIb clinical trial for refractory Crohn’s disease

TxCell SA (FR0010127662 – TXCL), a biotechnology company developing innovative, cost-effective, personalized T-cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today the receipt of the latest milestone payment of EUR 1 million from the Ovasave collaboration option, development and license agreement from Trizell (Trizell Holding SA). This milestone payment is a result of the first patient enrolment in the phase IIb clinical trial of TxCell’s lead product Ovasave for refractory Crohn’s disease. Top line results of this study are expected at the end of 2016 / early 2017.

The Ovasave phase IIb study, named CATS29 (Crohn’s And Treg Study), is a multicenter, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection, 4 parallel group study. The trial is conducted in 6 countries (Austria, Belgium, France, Germany, Italy and United Kingdom) and has been designed to include 160 severe refractory Crohn’s disease patients.

The exclusive worldwide license option agreement was signed by Ferring International Center (Ferring) and TxCell in December 2013 and its assignment to Trizell was announced on the 2nd January 2015. Ferring and Trizell are both affiliates of the Dr Frederik Paulsen Foundation. The agreement is worth up to EUR 76 million, subject to achievement of development, commercial and manufacturing milestones, plus royalties on future sales of Ovasave. Ferring secured the option for EUR 3 million and is the intended final commercializing party for Ovasave for the treatment of Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis. Of that EUR 3 million, Ferring has paid TxCell a EUR 1 million milestone upon signature, announced on March 14th, 2014. The second EUR 1 million has just been received for the first patient enrolment of the CATS29 Ovasave phase IIb study. The final balance will be paid depending on the progress of the CATS29 clinical study. The agreement also includes supplementary development, commercial and manufacturing milestone payments up to EUR 73 million, plus royalties on future sales of Ovasave.

Trizell Holding SA is a company dedicated to advanced therapies, i.e. cellular and gene therapies. Ovasave will benefit from the additional focus and expertise that Trizell will supply. Ferring remains the intended final commercializing party.

“Receiving this latest milestone payment provides additional support to TxCell for Ovasave’s development. This new step marks further progress in our collaboration with Ferring/Trizell,” said Damian’s Marron, CEO, TxCell. “Ovasave offers the chance of new therapeutic innovation for refractory Crohn’s disease patients who have no treatment option. There are currently over 100,000 such patients per year in Europe and in the US alone.”