Following its acceptance for review by the European Medicines Agency (EMA), Takeda and TiGenix announced this week Swissmedic has accepted for review the file for compound Cx601, an allogeneic expanded adipose-derived stem cell (eASC) therapy for the treatment of complex perianal fistulas in patients with Crohn’s disease.
The therapy is being made from TiGenix’ site in Madrid, Spain but CEO Eduardo Bravo told Biopharma-Reporter its partner Takeda – which holds the rights for Cx601 in non-US markets following a licensing agreement inked last year – will take responsibility for its manufacture from 2021 from a purpose built manufacturing facility in Europe.
Takeda spokesman Luke Willats told this publication: “After a transition period for technology transfer during which TiGenix will manufacture Cx601, Takeda will assume responsibility for manufacturing the compound.”
But while Willats added the firm is exploring how it “can best meet manufacturing responsibilities for Cx601 following a potential European Commission (EC) approval decision for the compound in 2017,” he could not comment further on specific plans or CAPEX investments.
The Japanese pharma firm has its European headquarters in Switzerland, with production sites in Austria, Belgium, Denmark, Estonia, Germany, Ireland, Italy, Norway, Poland and Russia.
Cx601 is produced by TiGenix in plastic flasks in incubators at a one-litre scale, using stem cells taken from healthy volunteers who have undergone liposuction for cosmetic reasons, Bravo told us.
“The fat gets sent to our facility in Madrid and is processed to extract the stem cells, which account for about 2% of the material. These are placed in plastic flasks with serum to multiply the number. This is repeated until there is a large population and then the cells are frozen, creating the master cell bank (MCB).”
According to Bravo, one liposuction when expanded produces upwards of 360 billion cells, enough to treat 2,400 patients.
While TiGenix is considering using bioreactors for its future pipeline, it will continue making the product as it does now due to not needing to increase volume and the challenges of making production changes in the middle or end of development.
“For cell therapies, the process defines the product. Anything you change could change the cells themselves, effectively changing the product.”
US deal with Lonza
TiGenix holds the US rights to Cx601 and is discussing with the US Food and Drug Administration (FDA) whether it can file using EMA data, something Bravo said would be decided in the next six-to-eight months.
US trial material will be produced by TiGenix’s contract manufacturing organisation (CMO) Lonza, which is undergoing tech transfer at its site in Maryland.
But looking ahead to commercialisation, Bravo said “it is not yet decided whether we continue using a CMO or build our own [US] facility.”