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news.Swiss development and manufacturing firm Lonz has entered into an agreement for the supply of Belgian biopharmaceutical firm TiGenix's eASC product, Cx601, indicated to treat complex perianal fistulas in Crohn's disease patients.
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As part of the deal, Lonza will manufacture material for the Phase III trial of Cx601 in the US at Lonza’s cell therapy production facility in Walkersville, US.
TiGenix is focused on developing and commercializing new therapeutics from allogeneic expanded adipose-derived stem cells (eASCs) in inflammatory and autoimmune diseases.
Cx601 is a locally-injected suspension of allogeneic expanded adipose-derived stem cells (eASCs) and is currently in Phase III of clinical development in Europe.
TiGenix CEO Eduardo Bravo said: "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 III 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."
TiGenix is moving forward with the development of Cx601 for the US market, following the positive feedback received from the US Food and Drug Administration (FDA).
Lonza has been selected by TiGenix as its contract manufacturing organisation (CMO) 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 is expected to start the process of technology transfer to Lonza in the coming weeks.