Cx601 product is currently in Phase III trials in Europe
Lonza has agreed a contract to supply Belgian biopharmaceutical developer TiGenix with material for a Phase III trial of a stem cell-based treatment for Crohn's Disease.
Cx601 will be manufactured in the US at Lonza’s cell therapy production facility in Walkersville, Maryland in preparation for a Phase III trial in the US.
The product 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. A Phase III trial is currently taking place in Europe.
Following positive feedback received at a meeting with the Centre for Biologics Evaluation and Research within the US Food and Drug Administration (FDA), TiGenix is moving ahead with the development of Cx601 for the US market. The company will begin the process of technology transfer to Lonza in the coming weeks.
The Phase III trial in the US, if successful, together with positive data from the European Phase III trial, would enable TiGenix to file a Biologics License Application (BLA) with the FDA.
'It was critical for us to have secured an agreement with a leading CMO, like Lonza, for Cell Therapy Manufacturing,' said Eduardo Bravo, CEO of TiGenix.
'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.'