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TiGenix Begins Recruiting for New U.S. HQ in Massachusetts

6/29/2017 8:38:44 AM

TiGenix Begins Recruiting for New U.S. HQ in Massachusetts June 29, 2017
By Mark Terry, Breaking News Staff

TiGenix NV (TIG), headquartered in Leuven, Belgium, announced that it is opening an office in Cambridge, Mass.

The company focuses on the anti-inflammatory aspects of donor-derived stem cells to develop new drugs. Its lead product is Cx601 to treat complex perianal fistulas in Crohn’s disease patients.

The company’s U.S. operations will be based at the Cambridge Innovation Center in Kendall Square. It is still in the process of appointing a senior support team for the U.S. and Canadian launch of its worldwide Phase III clinical trial for Cx601. The trial started in Europe and Israel in June 2017.

“It is very exciting to be establishing TiGenix at the heart of one of the world’s leading biotechnology hubs,” said Eduardo BravoTiGenix’ chief executive officer, in a statement. “We are working hard to progress the development of Cx601 in the U.S. and having a team based in Cambridge will add further momentum to these efforts to bring a new treatment option to U.S. patients suffering from this severe and debilitating complication of Crohn’s disease.”

TiGenix launched an initial public offering (IPO) in December 2016, and has rocketed by 40 percent since. And the company inked a licensing deal with Japanese company Takeda (TKPYY) over rights to Cx601 outside the U.S. for $400 million-plus. TiGenix kept all U.S. rights.

Logribel Biostocks, writing for Seeking Alpha, says, “If approved, Cx601 would be the first major medical innovation for over a decade in the treatment of what is an extremely debilitating side-effect of Crohn’s disease. Today, patients suffering from refractory, complex perianal fistulas are typically treated with antiTNFalpha drugs (Remicade being the only approved treatment after patients have failed conventional drugs) and an estimated 80 percent of those patients end up being refractory to the drug at one point, leaving them with surgery as a last resort—a painful procedure with high risks of relapse and anal incontinence.”
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Christophe Weber, the chief executive officer of Takeda, during the company’s first-quarter 2017 earnings call, discussed Cx601, saying, “It’s a very innovative way of intervening, the number of patients is much—is very limited, but the medical need is very, very significant because there is very little alternative except surgery. So I think for the moment, we are very much working on preparing the launch, working out the supply chain because it’s a new field with stem cell therapy. That’s also what is very attractive in our mind is that this is potentially helping us to learn how to manage this type of product which will—there will be more and more of this product in the future. So I think that’s very exciting. And we’ll continue to see whether we want to expand the partnership beyond Europe.”

Logribel Biostocks projects potential peak worldwide sales of Cx601 to range from $475 million to almost $1 billion.

Logribel Biostocks cites several potential catalysts for TiGenix, with the earliest being the European approval of Cx601 by the end of this year, with news of potential RMAT designation in early 2018 or an Orphan Drug Designation in the third quarter of this year.

RMAT is a new designation that came out of the 21st Century Cures Act, signed into law on December 13, 2016. It stands for Regenerative Medicine Advanced Therapy Designation. Companies of certain cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combo products, may obtain the RMAT designation if it has potential to meet unmet medical needs. This can make them eligible for priority review and accelerated approval.

“However,” Logribel Biostocks writes, “the biggest potential catalyst in the coming months would certainly be the partnering of Cx601’s U.S. rights, which are currently wholly-owned by TiGenix. As a market opportunity considered as nearly twice as big as Europe, this would represent a significant upside potential especially considering that Takeda agreed to a $400+ million deal, excluding double-digit royalties, for the EU market alone.”

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