TiGenix, an advanced biotechnological company committed to developing and marketing new therapeutics from allogeneic expanded adipose-derived stem cells (eASCs) for autoimmune and inflammatory diseases, together with Lonza, a leading and global company of biological and cell therapy manufacturing, have recently announced an agreement for Cx601, TiGenix’s eASC product, to address Crohn’s disease. The new agreement stipulates that Lonza will manufacture material for the Cx601 Phase 3 trial in the US, to be conducted at Lonza’s cell therapy production facility in Walkersville, Maryland (US).

Cx601 is a locally-injected suspension of allogeneic expanded adipose-derived stem cells (eASCs) appropriated to treat complex perianal fistulas in patients suffering with Crohn’s disease; the drug is currently in ongoing Phase 3 studies in Europe.

Since TiGenix received positive feedback from the US Food and Drug Administration (FDA) at a recent meeting, the company is advancing Cx601’s development for the US market. In order to be prepared to start a Phase 3 trial of Cx601 in the US and to supply the American market once the product is fully approved, TiGenix decided to partner with Lonza. In the following weeks, the technology transfer process between the two companies will begin.

In late December 2014, TiGenix submitted a Special Protocol Assessment (SPA) requirement to the FDA. The understanding between the company and the FDA about the SPA assures that the trial is designed in tune with the FDA’s requirements to have the drug approved. If this Phase 3 program in the US shows positive results, together with the European trial, TiGenix will be able to file a Biologics License Application (BLA) with the FDA.

Eduardo Bravo, TiGenix’s CEO, said in a press release: “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 3 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.”

David Smith, Lonza’s representative, concluded: “We are pleased to partner with TiGenix for the production of Cx601.  Lonza will utilise our manufacturing knowledge and world class quality systems to manufacture this potentially life- changing product for Crohn’s disease patients with complex perianal fistulas. Lonza is looking forward to a long and productive partnership with TiGenix.”