TiGenix is an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary and validated technology platform of donor-derived (allogeneic) expanded adipose-derived stem cells (known as eASC’s). TiGenix’s approach to cell therapy is to focus on the use of cells for medical treatment as an alternative to conventional drugs. Cells target a different pathway from conventional drugs which are currently used to treat autoimmune conditions, such as biological medicinal products or ‘biologics’, and may be effective in patients who fail to respond to conventional treatment.
Cx601, the company’s lead product candidate, is a first-in-class injectable allogeneic stem cell therapy that was granted orphan designation by the European Medicines Agency (EMA) for the treatment of anal fistulae. TiGenix is conducting a single pivotal Phase III trial for Cx601 in the treatment of complex perianal fistulae in patients suffering from Crohn’s disease, a painful and debilitating condition affecting approximately 100,000 patients in the United States and Europe. Data from this trial is expected to be available in the third quarter of 2015. With this, TiGenix plans to submit an application for marketing authorisation to the EMA in the first half of 2016.
Cx611, an intravenously administered allogeneic stem cell product, is in clinical development for two indications: in Phase II for early rheumatoid arthritis, and in Phase I for severe sepsis. If approved for early rheumatoid arthritis patients, Cx611 would have advantages over current treatments, such as ‘biologics’, due to its safety profile and induction of reduced disease activity. In 2013, TiGenix completed a successful Phase IIa trial of Cx611 in refractory rheumatoid arthritis patients, which demonstrated the safety of the therapy, and offered indications of efficacy in rheumatoid arthritis patients refractory to conventional treatment. If Cx611 is approved for severe sepsis, it would be as an add-on therapy to standard treatment with the potential to reduce mortality.
TiGenix’s third clinical stage pipeline asset is Cx621. This is an intra-lymphatic administration of allogeneic eASCs, and is currently on hold. Cx621’s use of a different mode of administration might open up applications in other autoimmune diseases.
TiGenix has also developed ChondroCelect, the first Advanced Therapy Medicinal Product (ATMP) to receive marketing authorisation from the EMA. ChondroCelect is indicated for cartilage repair in the knee. TiGenix has licensed the exclusive marketing and distribution rights of ChondroCelect to Swedish Orphan Biovitrium AB (’Sobi’) for the European Union (excluding Finland, where a pre-existing distribution agreement was already in place), Switzerland, Norway, Russia, Turkey and the Middle East, and the North Africa region.
The following chart summarises TiGenix’s current product and development pipeline portfolio as of 30 June 2014:
TiGenix is headquartered in Leuven, Belgium, and has operations in Madrid, Spain. It is listed on the NYSE Euronext exchange in Brussels, Belgium.