TIGENIX IN A NUTSHELL
We are an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of stem cells to develop novel therapies for serious medical conditions. Our current therapeutic focus is inflammatory, autoimmune and cardiac diseases, which we target through products developed from our two proprietary platforms of adipose-derived (eASC) and cardiac stem cells (CSC). Both platforms use allogeneic (donor derived) stem cells, which allow the development of off-the-shelf products.
We have three product candidates under development:
A local injectable stem cell therapy (eASC) for the treatment of complex perianal fistulas. In December 2017, Cx601 received a positive CHMP opinion in Europe 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. A global Phase III trial intended to support a future U.S. Biologic License Application (BLA) started in 2017. Takeda holds ex-US development and commercialization rights to Cx601.
Systemic (intravenous) suspension of eASCs for the treatment of autoimmune diseases. Cx611 is currently being evaluated in a Phase I/II trial in severe sepsis – a major cause of mortality in the developed world.
Intracoronary administration of a suspension of allogeneic CSCs for the treatment of acute ischemic heart disease. Top-line one year results of our CAREMI Phase I/II study in acute myocardial infarction demonstrated safety and pointed towards a reduction in infarct size in a subset of patients with a large myocardial infarction and poor prognosis.
We retain full rights to both platforms and aim to build on the experience acquired in the development of these first products to bring additional product candidates to the market to meet the needs of patients where no effective therapies are currently available.
TiGenix is listed on both Euronext Brussels and NASDAQ under the stock symbol TIG.
TiGenix NV was incorporated in the year 2000. In 2011, TiGenix acquired Cellerix SL in Spain, shifting its focus to the development of allogeneic stem cell therapies and creating the basis for what the company is today.
- Clinical development of Cx611 in Sepsis initiated.
- Patient recruitment for the European Phase III trial of Cx601 completed ahead of schedule.
- Acquisition of Coretherapix, thereby extending the therapeutic focus to cardiac disease
- Cx601 meets primary endpoint in pivotal Phase III trial
- Safety and tolerability of Cx611 confirmed in Phase I sepsis challenge trial
- Licensing Agreement with Takeda for Ex-U.S. rights to Cx601 for the treatment of complex perianal fistulas in patients with Crohn’s disease
- Positive 52-week data announced for Cx601
- Submission of the marketing authorization application (MAA) to EMA for Cx601
- IPO on NASDAQ
- Positive Feedback from the FDA on Cx601 Global Phase III Trial Protocol received.
- First patient in Phase Ib/IIa clinical trial of Cx611 in Severe Sepsis enrolled.
- Start of Global Phase III trial for Cx601.
- Cx601 receives Orphan Drug Designation by FDA in the US.
- Positive opinion by the Committee for Medicinal Products for Human Use recommending a marketing authorization.