TiGenix said today it has acquired the cell therapy company Coretherapix from its owner Genetrix for up to €291.7 million ($318.5 million), in a deal that expands the buyer’s pipeline into cardiology treatments.
TiGenix will add to its offerings Coretherapix’s lead candidate AlloCSC-01, an allogeneic cardiac stem cell product now in the ongoing Phase II CAREMI clinical trial in heart attack or acute myocardial infarction (AMI). A six-month interim analysis from that trial is expected in the second half of 2016, with final results in the first half of 2017.
Also in AMI, Coretherapix is in preclinical phases of co-developing a polymer-based microsphere vehicle designed to deliver an effective and safe dose of proven reparative growth factors—insuli-like growth factor (IGF-1) and human growth factor (HGF)—in a time-controlled way via capillary entrapment.
Coretherapix is also in preclinical development of AlloCSC-01 for chronic ventricular tachycardia, with plans to initiate clinical evaluation in 2017, the company states on its website. Coretherapix bases its cell therapy candidates on adult allogeneic cardiac progenitor/stem cells isolated from the right atrial appendages of donors, and expanded in vitro.
“This acquisition is an important step towards our ambition to become one of the world leaders in the cell therapy space,” TiGenix CEO Eduardo Bravo said in a statement. “Tactically, it broadens our current pipeline with another Phase II program which targets a very significant commercial opportunity. Strategically, it allows us to enter completely new markets with a platform of cardiac stem cells which could be developed in several attractive cardiology indications.
TiGenix’s lead product is Cx601, an adipose-derived allogeneic stem cell suspension indicated for complex perianal fistulas in Crohn’s disease patients. Later this quarter, TiGenix expects to have results from one Phase III trial, with a second Phase III study now in preparation in the U.S. By year’s end, TiGenix expects to advance another intravenously-administered product of allogeneic expanded adipose-derived stem cells, Cx611, into Phase II development in severe sepsis and early rheumatoid arthritis
TiGenix’s platform uses expanded stem cells extracted from adipose tissue (eASCs) derived from and applied to consenting patients, avoiding the use of embryonic stem cells. According to TiGenix, eASCs offer advantages in cell obtention, expansion, efficacy abd safety over bone marrow- derived stem cells.
As for AlloCSC-01, the Phase II study is being conducted in nine hospitals in Belgium and Spain. Following a successful open-label dose escalation phase of six patients, the trial aims to recruit 49 additional patients who will be randomized 2:1 to receive either AlloCSC-01 or placebo by intracoronary injection 5 to 8 days after AMI. More than 60% of patients have already been recruited, TiGenix said.
The study’s primary endpoint is all-cause mortality and major adverse cardiac events (MACE) at 30 days. Secondary endpoints include efficacy MRI parameters that include evolution of infarct size and evolution of biomechanical parameters; clinical parameters that include the 6 minute walking test and the New York Heart Association scale; all-cause mortality and MACE, all measured at 6 and 12 months.
Leading the trial are Francisco Fernandez-Aviles Diaz, M.D., Ph.D., of Gregorio Marañon University Hospital in Madrid; and Stefan Janssens, M.D., Ph.D., of Gasthuisberg Leuven University Hospital in Leuven, Belgium.
“Our preclinical data has shown evidence of the strong cardio-protective and immunoregulatory activity of AlloCSC-01. In vivo studies suggest that AlloCSC-01 has a cardio-reparative potential activating endogenous regenerative pathways and promoting the formation of new contractile tissue,” Coretherapix states on its website.
AlloCSC-01 has also displayed a superior tropism for the heart enabling a high retention of cells in the myocardium after intracoronary administration, the acquired company added.
To acquire Coretherapix, TiGenix agreed to pay Genetrix approximately €1.2 million ($1.3 million) in cash upfront, and approximately €5.5 million ($6 million) in new TiGenix shares. Genetrix may also receive up to €15 million ($16.4 million) in new TiGenix shares depending on the results of the ongoing clinical trial of Coretherapix.
Subject to future sales milestones, Genetrix may receive in addition up to €245 million ($267.5 million) plus certain percentages of the direct net sales of the first product, or certain percentages of any third party royalties and sales milestones for the first product. Sales milestones start when annual net sales reach €150 million (about $163.8 million) and the last one will be payable once annual net sales are above €750 million ($818.8 million). Genetrix will also receive a €25 million ($27.3 million) milestone payment per additional product reaching the market.