TiGenix, an advanced biopharmaceutical company exploiting the anti-inflammatory properties of allogeneic or donor-derived stem cells to develop novel therapies for serious medical conditions, has obtained a license for the commercial production of expanded adipose-derived stem cells (eASCs) at its expanded manufacturing facility in Madrid.
The manufacturing license follows an inspection by the Spanish Medicines Agency (AEMPS) and provides production capacity for the potential initial European commercial roll out of Cx601, an investigational stem cell therapy, for the treatment of complex perianal fistulas in patients with Crohn's disease.
The expanded facility will also provide sufficient capacity for the manufacturing of other pipeline products under development by TiGenix, including Cx611, currently undergoing a Phase I/II trial in severe sepsis.
TiGenix has submitted a marketing authorisation (MA) application for Cx601 to the European Medicines Agency (EMA) on the basis of results from its Phase III ADMIRE-CD trial with a decision expected in 2017.
An MA would allow Cx601 to be marketed in all 28 member states of the EU plus Norway, Iceland and Lichtenstein. Cx601 has been licensed to Takeda for exclusive development and commercialisation outside of the US.
Wilfried Dalemans, Chief Technical Officer at TiGenix, said: “We are very pleased with this approval for our expanded facility, which confirms our state-of-the-art GMP manufacturing capabilities in the stem cell field.
We have now significantly increased our manufacturing capacity, a key step in the preparation for commercialisation of Cx601 in Europe and in the further development of our pipeline.
- Panés J, et al., “Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomized, double-blind controlled trial,” The Lancet. 388(10051), 1281-90 (2016).
- Panés J, et al., “OP009 Long-term efficacy and safety of Cx601, allogeneic expanded adipose-derived mesenchymal stem cells, for complex perianal fistulas in Crohn's disease: 52-week results of a phase III randomised controlled trial,” J Crohn's Colitis. 11, S5-S5 (2017).