Having completed a Phase I/Iia study of Ovasave, a drug candidate from its first generation non-modified antigen-specific regulatory T cells (Tregs), TxCell expects to start a first in man study of a candidate from its next generation Treg platform in 2018. The company switched emphasis from its ASTrIA platform to the ENTrIA platform two years ago after coming up against some manufacturing issues. ENTrIA is a platform that uses Tregs engineered with a chimeric antigen receptor (CAR). The company has more than 10 CAR-Treg development programs focusing on diseases such as lupus nephritis, bullous pemphigoid, multiple sclerosis and Crohn’s disease. “We are working mainly in autoimmunity and inflammatory disorders because we believe it is in these indications that regulatory T cells have the most potential,“ explained TxCell CEO Stephane Boissel. Indeed, with Ovasave, TxCell successfully completed a Phase I/IIa study in refractory Crohn’s disease patients with positive clinical efficacy and good tolerability. Now with the new ENTrIA CAR-Treg platform, Boissel anticipates first in man studies in 2018. “We know we can technically insert a lentivirus in CAR cells and have some preclinical concept in a clinically-relevent inflammatory disease mouse model,“ he added. Since its inception in 2001, the company has raised €70 million – including going public on the Euronext exchange in Paris in 2014 – and consequently should have enough funds to finance a first IND. Beyond that milestone it is likely the company will need to raise additional funds either from the capital market or potential partners. Initial discussions with partners have started.