Lonza, a global leader in biological and cell therapy manufacturing and TiGenix, an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from allogeneic expanded adipose-derived stem cells (eASCs) in inflammatory and autoimmune diseases, announced today an agreement for the supply of TiGenix’s eASC product, Cx601. Under the agreement, Lonza will manufacture material for the Phase 3 trial of Cx601 in the US 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) for the treatment of complex perianal fistulas in Crohn’s disease patients, currently in Phase 3 of clinical development in Europe. Following the positive feedback received at a meeting with the Center 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. To supply Cx601 for a Phase 3 trial in the US, 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.
In December 2014, TiGenix submitted to the FDA the required documentation for a Special Protocol Assessment (SPA) of its pivotal Phase 3 trial design for Cx601 in the treatment of complex perianal fistulas in patients with Crohn’s disease in the US. Agreement with the FDA on the SPA will ensure that the trial design is aligned with the FDA’s requirements for the future approval of Cx601. The Phase 3 trial in the US, if successful, together with positive data from the European Phase 3 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 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.”
“We are pleased to partner with TiGenix for the production of Cx601. Lonza will utilize our manufacturing knowledge and world class quality systems to manufacture this potentially life- changing product for Crohn’s disease patients with complex perianal fistulas”, said David Smith, Head of Cell Therapy, Lonza Custom Manufacturing. “Lonza is looking forward to a long and productive partnership with TiGenix.”