Date: 2015-02-12
Type of information: Production agreement
Compound: Cx601 (adipose derived allogeneic stem cell therapy)
Company: Tigenix (Belgium) Lonza (Switzerland)
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Type agreement: manufacturing production
Action mechanism: Cell therapy. Cx601 is a suspension of expanded allogeneic adult stem cell product derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or eASCs) that is delivered locally in the fistula through intra-lesional injection.)
Disease: complex perianal fistulas in patients with Crohn\'s disease
Details: * On February 12, 2015, Lonza, a global leader in biological and cell therapy manufacturing and TiGenix, an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from allogeneic expanded adipose-derived stem cells (eASCs) in inflammatory and autoimmune diseases, announced an agreement for the supply of TiGenix\'s expanded adipose-derived stem cells (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 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 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 organisation (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.
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