Lonza has announced an agreement for the supply of TiGenix’s eASC product, Cx601.Under the agreement, Lonza will manufacture material for the Phase III trial of Cx601 in the US at Lonza’s cell therapy production facility in Walkersville, Maryland.
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 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 (FDA), TiGenix is moving ahead with the development of Cx601 for the US market.
To supply Cx601 for a Phase III trial in the US, and potentially for the US market when the product has been fully approved, TiGenix chose to partner with Lonza as its contract manufacturing organisation (CMO).
TiGenix will begin the process of technology transfer to Lonza in the next few weeks.
In December 2014, TiGenix submitted to the FDA required documentation for a special protocol assessment (SPA) of its pivotal Phase III 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 trial design is aligned with the FDA’s requirements for the future approval of Cx601.
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.
Lonza Custom Manufacturing head of cell therapy David Smith said: “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.”