TiGenix and Lonza sign agreement for the manufacture of Crohn’s disease treatment

Swiss CMO Lonza and Belgian cell therapy firm TiGenix (NYSE Euronext: TIG) have agreed that Lonza will manufacture material for the Phase III trial of TiGenix’s eASC product Cx601 in the USA at Lonza’s cell therapy production facility in Maryland, USA.

Cx601 is a locally-injected suspension of allogeneic expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas in Crohn’s disease patients in Phase III of clinical development in Europe. Following positive feedback at a meeting with the Center for Biologics Evaluation and Research within the US Food and Drug Administration TiGenix is moving ahead with the development of Cx601 for the US market.  To supply Cx601 for a Phase III trial in the USA, and potentially for the US market when the product has been fully approved, TiGenix has chosen to partner with Lonza as its contract manufacturing organization (CMO).  TiGenix will begin the process of technology transfer to Lonza in the coming weeks.

Eduardo Bravo, TiGenix' chief executive, said: “It was critical for us to have secured an agreement with a leading CMO, like Lonza, for Cell Therapy Manufacturing. With our appointment of a US advisory board in gastroenterology and inflammatory bowel disease, our submission to the FDA for an SPA for our US Phase III trial design, and now the agreement with Lonza for our US-based manufacturing, we have completed the early steps to prepare Cx601 for approval and entry in the American market.”