Lonza and Tigenix Sign Toll Manufacture Agreement
Swiss fine and specialty chemicals producer Lonza has signed a toll manufacturing agreement with 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.
Under the agreement, Lonza, which has gained a reputation as a global leader in biological and cell therapy manufacturing, will produce material for the Phase 3 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 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 will begin transferring the process of technology to Lonza in the coming weeks.
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.
