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TiGenix NV (Euronext Brussels and Nasdaq: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. TiGenix' lead product, Cx601 (darvadstrocel) is a local injectable stem cell therapy (eASC) for the treatment of complex perianal fistulas. In Europe, Cx601 will be launched under the trade name Alofisel® following the EC approval in March 2018 for the treatment of complex perianal fistulas in adult Crohn’s disease patients that have previously shown an inadequate response to at least one conventional therapy or biologic therapy. Alofisel® was the first allogeneic stem cell therapy to be approved in Europe. A global Phase III trial with Cx601 started in 2017 to support a future U.S. Biologic License Application (BLA). TiGenix has an exclusive licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda maintains the exclusive right to commercialize Cx601/ Alofisel for complex perianal fistulas outside the United States. TiGenix' second product, Cx611, is a systemic (intravenous) suspension of eASCs for the treatment of autoimmune diseases. Cx611 is currently being evaluated in a Phase Ib/IIa trial in severe sepsis secondary to community-acquired pneumonia (sCAP) in patients who require mechanical ventilation and/or vasopressors – a major cause of mortality in the developed world. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain) and Cambridge, MA (USA). For more information, please visit www.tigenix.com.
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