TxCell receives €1m payment for Ovasave clinical trial

2 February 2015

T-cell immunotherapy developer TxCell SA has announced the receipt of the latest milestone payment of €1 million from the Ovasave agreement with 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 being conducted in six 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 €76m, subject to achievement of development, commercial and manufacturing milestones, plus royalties on future sales of Ovasave.

Ferring secured the option for €3m 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 €3m, Ferring has paid TxCell a €1m milestone upon signature, announced on March 14th, 2014. The second €1m 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 €73m, 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 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.”

Further information

About Ovasave

Ovasave (Ova-Treg cells), TxCell’s lead product, is a personalized T cell immunotherapy product, based on the properties of autologous ovalbumin-specific regulatory T lymphocytes. A first clinical study (CATS1) has been completed with Ovasave in refractory Crohn’s disease patients and has reported positive clinical efficacy and good tolerability. A phase IIb (CATS29) multicenter, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection, 4 parallel group study is ongoing to evaluate the efficacy and the safety of Ovasave. Top line results of this study are expected end 2016/early 2017.

After administration, Ova-Treg cells home in to the site of inflammation where they are activated by the specific antigen. The Ova-Tregs then act by locally releasing immune suppressive factors, cell-cell contacts and cytotoxic activity to treat the inflammation. Ovasave is classified an Advanced Therapy Medicinal Product (ATMP), by the European Medicines Agency (EMA). Ovasave is developed in partnership with the Swiss company Trizell Holding SA and Ferring International Center remains the intended final commercializing party.

About CATS29

The CATS29 (Crohn’s and Treg Study) study is a multicenter (six countries: Austria, Belgium, France, Germany, Italy and United Kingdom), randomized, double-blinded, placebo-controlled, multi-dose and multi-injection, 4 parallel group study. It will evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn’s disease.

The primary objective of the CATS29 study is the evaluation of the response rate for a single intravenous injection of 106 cells dose of Ovasave compared to placebo 6 weeks post administration. The study has been designed to include 160 severe refractory Crohn’s disease patients.

Source: TxCell

	TxCell receives €1m payment for Ovasave clinical trial 2 February 2015 T-cell immunotherapy developer TxCell SA has announced the receipt of the latest milestone payment of €1 million from the Ovasave agreement with 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 being conducted in six 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 €76m, subject to achievement of development, commercial and manufacturing milestones, plus royalties on future sales of Ovasave. Ferring secured the option for €3m 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 €3m, Ferring has paid TxCell a €1m milestone upon signature, announced on March 14th, 2014. The second €1m 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 €73m, 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 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.” Further information *About Ovasave* Ovasave (Ova-Treg cells), TxCell’s lead product, is a personalized T cell immunotherapy product, based on the properties of autologous ovalbumin-specific regulatory T lymphocytes. A first clinical study (CATS1) has been completed with Ovasave in refractory Crohn’s disease patients and has reported positive clinical efficacy and good tolerability. A phase IIb (CATS29) multicenter, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection, 4 parallel group study is ongoing to evaluate the efficacy and the safety of Ovasave. Top line results of this study are expected end 2016/early 2017. After administration, Ova-Treg cells home in to the site of inflammation where they are activated by the specific antigen. The Ova-Tregs then act by locally releasing immune suppressive factors, cell-cell contacts and cytotoxic activity to treat the inflammation. Ovasave is classified an Advanced Therapy Medicinal Product (ATMP), by the European Medicines Agency (EMA). Ovasave is developed in partnership with the Swiss company Trizell Holding SA and Ferring International Center remains the intended final commercializing party. *About CATS29* The CATS29 (Crohn’s and Treg Study) study is a multicenter (six countries: Austria, Belgium, France, Germany, Italy and United Kingdom), randomized, double-blinded, placebo-controlled, multi-dose and multi-injection, 4 parallel group study. It will evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn’s disease. The primary objective of the CATS29 study is the evaluation of the response rate for a single intravenous injection of 106 cells dose of Ovasave compared to placebo 6 weeks post administration. The study has been designed to include 160 severe refractory Crohn’s disease patients. Source: TxCell To top