TxCell SA, a biotechnology company developing innovative, personalised cell-based immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces that Col-Treg, its second therapeutic candidate from its ASTrIA platform, has been granted Advanced Therapy Medicinal Product (ATMP) classification by the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA).

“The grant of ATMP classification for Col-Treg, TxCell’s second full development programme, is a further step for TxCell to potentially create a novel, personalised cellular immunotherapy approach to reduce the terrible burden of uveitis,” said Damian Marron, chief executive officer of TxCell. “Col-Treg is a key programme within our pipeline of products focused on chronic inflammatory diseases where current treatments show limited efficacy, limited tolerability and for which many of the patients treated develop resistance.”

ATMP classified products are innovative, regenerative therapies that combine aspects of medicine, cell biology, science and engineering for the purpose of regenerating, repairing or replacing damaged tissues or cells. ATMPs comprise of gene- and cell-therapy and tissue-engineered medicinal products. The classification is defined by Regulation (EC) No. 1394/2007, which establishes the legal and regulatory framework for ATMP in the European Union.

Col-Treg is TxCell’s second therapeutic candidate from its ASTrIA platform after Ovasave, TxCell’s lead autologous Ag-Treg cell-based immunotherapy. TxCell initiated a full development programme in Q1 2014 with Col-Treg for the treatment of Autoimmune Uveitis. Autoimmune Uveitis is a serious inflammatory condition of the eye that often results in permanent vision damage. Uveitis is classified as a rare disease with a total incidence of around 35-50/100,0001. Col-Treg cells are purified autologous type 1 regulatory T lymphocytes specific for human type II collagen.

“Col-Treg is a novel potential personalised therapeutic option with a local, multi target inhibition of inflammation. Col-Treg has been developed for steroid refractory autoimmune uveitis patients that have very limited treatment alternatives,” said Miguel Forte, Sr. VP clinical development and regulatory affairs, TxCell. “TxCell will now complete the requirements for applying for orphan drug designations for Autoimmune Uveitis in the European Union and in the United States and prepare for a phase II proof of principle study to start in 2015.”