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The TRUST project will focus on the process development of Col-Treg, which is TxCell’s autologous collagen type II specific Treg immunotherapy product for the treatment of autoimmune uveitis.
Biotechnology company TxCell announced that the TRUST project (TRegs in Uveitis STudy) has been granted EUR 1.28 million by the French government’s Unique Interministerial Fund (FUI). The TRUST project will focus on the process development of Col-Treg, which is TxCell’s autologous collagen type II specific Treg immunotherapy product for the treatment of autoimmune uveitis.
TxCell has selected CMO Provepep to help optimize the production process of Col-Treg. With expertise in the manufacturing and formulation of peptides and proteins under GMP standards, Provepep will bring solutions based on the use of synthetic immuno-peptides specific to type II collagen to improve the quality of Col-Treg. The TRUST project will also focus on a first-in-man study (sponsored by TxCell) for severe and refractory autoimmune uveitis patients, expected to start in 2016.
According to TxCell, the FUI panel awarded the TRUST funding application the highest score. 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 has also appointed to the consortium two European leading ophthalmology centers in Paris, 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.
The collaborative project, which has been accredited by European competitive clusters Eurobiomed and Medicen, will be financially supported by the French Government, the Provence-Alpes-Côte-D’Azur region, and the Pays D’Aix agglomeration community. The grant for this project is EUR 1,281,850 in total. Consortium leader, TxCell 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.
TxCell’s Col-Treg, classified as an advanced therapy medicinal product by EMA, has shown promising preclinical efficacy and tolerability data in models of autoimmune uveitis. Col-Treg has also received orphan drug designation for the treatment of non-infectious (autoimmune) uveitis from the EMA in December 2014.