TxCell SA, a biotechnology company, announced that the French government’s Unique Interministerial Fund (FUI) has granted EUR 1.28 million to the TRUST project (TRegs in Uveitis STudy). The FUI panel awarded the TRUST funding application the highest score, and as a result, the project qualified for the maximum percentage of funding from the French government.

The TRUST project will be run by a consortium headed by TxCell and will be dedicated to process and clinical development of Col-Treg, TxCell’s second lead product, for the treatment of autoimmune uveitis.

The TRUST project will first focus on the process development of Col-Treg, TxCell’s autologous collagen type II specific Treg immunotherapy product for the treatment of autoimmune uveitis. To optimize the production process of Col-Treg, TxCell has selected Provepep, a company specialized in the manufacturing and formulation of synthetic peptides under good manufacturing practices (GMP). Provepep will bring innovative solutions based on the use of synthetic immuno-peptides specific to type II collagen to improve the quality of Col-Treg.

The second focus of the TRUST project will be a first-in-man clinical study for severe and refractory autoimmune uveitis patients, scheduled to start in 2016 as previously disclosed. TxCell will be the sponsor of the study. TxCell has also appointed to the consortium two European leading ophthalmology centres in Paris. These centres will be represented by Pr. Barham Bodaghi at the hospital La Pitié Salpêtrière (APHP) and by Dr. Marie-Hélène Errera at the Quinze-Vingts hospital center of ophthalmology.

This collaborative project has been accredited by two leading European competitive clusters Eurobiomed and Medicen. The project will be financially supported by the French government, the Provence-Alpes-Côte-D’Azur region and the Pays D’Aix agglomeration community.

The grant totals EUR 1,281,850. TxCell, as leader of the consortium will receive EUR 842,736. Provepep will receive EUR 290,852, the hospital La Pitié Salpêtrière (APHP) will receive EUR 48,686 and the Quinze-Vingt hospital center will receive EUR 99,576.

“The combination of the funding and the selection of the highly specialized consortium members by TxCell, represents additional important steps to accelerate the development of the orphan drug Col-Treg, as a new therapeutic option for refractory autoimmune uveitis patients,” said Arnaud Foussat, chief scientific officer of TxCell.

“This funding for the TRUST project will also allow TxCell to bring a second product from ASTrIA, TxCell’s first product platform, to the clinic. Critically, this will benefit sufferers of autoimmune uveitis, a leading cause of blindness in the developed world, with approximately 30,000 patients in the US and EU alone that are refractory to other treatments. This will also further strengthen TxCell’s product pipeline of personalised T cell immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need.”

TxCell’s Col-Treg has been classified as an advanced therapy medicinal product by the European Medicine Agency (EMA). Col-Treg has shown very promising preclinical efficacy and tolerability data in models of autoimmune uveitis. Col-Treg has also received an Orphan Drug designation for the treatment of non-infectious (autoimmune) uveitis from the EMA in December 2014.

The University Hospital La Pitié Salpérière is a public health establishment and part of the Assistance Publique - Hôpitaux of Paris (AP-HP). As a proximity, speciality, teaching and research hospital, the University Hospital La Pitié Salpêtrière is the largest French hospital group.

The Quinze-Vingts Hospital Center of Ophthalmology, the cradle of French ophthalmology and located in the 12th arrondissement of Paris, ensures, in addition to home and emergency care, a mission of teaching, research and prevention.