TiGenix

TiGenix was a Belgian biotechnology company specializing in cell therapies for inflammatory, autoimmune and cardiovascular diseases. Founded in 2000 as a university spin-off associated with Katholieke Universiteit Leuven and Ghent University, the company built its development strategy around living-cell medicines rather than conventional small-molecule or biologic drugs. Its principal technology platform used expanded allogeneic adipose-derived stem cells, while a separate cardiac stem-cell platform supported research into potential treatments for heart disease. The company's leading program was Cx601, an injectable allogeneic stem-cell therapy developed for complex perianal fistulas in adults with Crohn's disease. The treatment was evaluated in the pivotal ADMIRE-CD Phase III trial in Europe, whose results were published in The Lancet in July 2016. The program subsequently became the basis for Alofisel, which received European authorization for the treatment of complex perianal fistulas in Crohn's disease after inadequate response to conventional or biologic therapy. Alofisel was notable as a commercially developed advanced cell therapy and represented TiGenix's transition from a platform-oriented biotechnology business toward a company with a regulated product. TiGenix maintained its corporate headquarters in Leuven and operations in Madrid, Spain. Its activities included research, clinical development, regulatory work and commercialization planning for cell-based therapies. The company positioned itself around validated allogeneic stem-cell platforms, an approach intended to allow an off-the-shelf treatment model instead of requiring cells to be harvested and expanded separately for every patient. In January 2018, Takeda Pharmaceutical Company announced an agreement to acquire TiGenix for up to €520 million. The transaction brought TiGenix and Alofisel into Takeda's portfolio and ended TiGenix's existence as an independent biotechnology company. The acquisition also gave Takeda a commercial-stage cell-therapy asset and strengthened its presence in gastrointestinal disease. TiGenix is therefore best understood historically as an acquired European biotech brand whose principal legacy is the development of Cx601/Alofisel and the clinical validation of an allogeneic adipose-derived stem-cell approach for Crohn's-related fistulas.

TiGenix originated in Belgium in 2000 as a spin-off connected with Katholieke Universiteit Leuven and Ghent University. It was founded by Professor Frank P. Luyten and Gil Beyen and developed as a biotechnology company centered on regenerative medicine and therapeutic use of living cells. Rather than following a conventional pharmaceutical model based primarily on chemical compounds, TiGenix sought to develop cell-based products for diseases in which inflammation, tissue damage and immune dysregulation play a central role. The company's core scientific platform used expanded allogeneic adipose-derived stem cells, also described as expanded adipose-derived stem cells or eASCs. The allogeneic approach uses cells from a donor source and is designed to support the production of standardized, ready-to-administer treatments. TiGenix presented this platform as a potential means of overcoming some of the logistical limitations associated with patient-specific autologous cell therapies. Its research focus included autoimmune and inflammatory diseases, with additional work directed toward cardiovascular applications through a cardiac stem-cell platform. TiGenix's most advanced clinical program was Cx601. The product candidate was formulated as an injectable allogeneic stem-cell treatment for complex perianal fistulas in patients with Crohn's disease. These fistulas are a serious complication of Crohn's disease and can be difficult to manage when patients do not respond adequately to existing drug or surgical approaches. TiGenix advanced Cx601 through European clinical development and completed the ADMIRE-CD pivotal Phase III study. Results from the trial were published by The Lancet on 28 July 2016, providing the principal clinical evidence supporting the program's regulatory progress. Cx601 subsequently became known as Alofisel. The product was developed as a localized cell therapy for complex perianal fistulas in adult Crohn's disease patients after inadequate response to conventional or biologic treatment. Its progress represented an important milestone for TiGenix because it moved the company from experimental platform development toward a commercial-stage advanced therapy. Alofisel also gave the company a clearly defined product identity in the emerging European cell-therapy market. TiGenix's corporate headquarters were in Leuven, Belgium, and the company also operated in Madrid, Spain. Its business activities encompassed discovery research, clinical trials, regulatory development and preparation for commercialization. The company remained associated with the broader European regenerative-medicine and advanced-therapy sector, while its lead asset concentrated its commercial relevance on inflammatory bowel disease. In early January 2018, Takeda Pharmaceutical Company announced its intention to acquire TiGenix for up to €520 million. The transaction provided Takeda with access to TiGenix's cell-therapy platform and its leading product, Alofisel, at a time when Takeda was expanding its specialty-pharmaceutical and gastrointestinal portfolio. Following the acquisition, TiGenix ceased to operate as an independent company. Its historical importance rests primarily on the development of Cx601/Alofisel and on demonstrating that an allogeneic adipose-derived stem-cell therapy could progress through late-stage clinical development and into regulated commercial use.

• 2018

  Takeda announces acquisition

  [1]TiGenixen.wikipedia.org

  Takeda announced an agreement to acquire TiGenix for up to €520 million.

• 2016

  ADMIRE-CD results published

  [1]TiGenixen.wikipedia.org

  The Lancet published the results of the pivotal Phase III ADMIRE-CD trial of Cx601 for complex perianal fistulas in Crohn's disease.

• 2000

  TiGenix founded as a university spin-off

  [1]TiGenixen.wikipedia.org

  Frank P. Luyten and Gil Beyen founded TiGenix as a spin-off associated with Katholieke Universiteit Leuven and Ghent University.

A specialist European biotechnology company focused on allogeneic stem-cell medicines for inflammatory, autoimmune and cardiovascular conditions.

• Allogeneic cell therapy · 2018

  Alofisel

  Alofisel is the commercial name associated with TiGenix's Cx601 program. It is an injectable allogeneic expanded adipose-derived stem-cell therapy developed for complex perianal fistulas in adults with Crohn's disease after inadequate response to conventional or biologic treatment. The product was the company's leading clinical and commercial asset and was subsequently incorporated into Takeda's portfolio following the acquisition of TiGenix.

• Investigational cell therapy

  Cx601

  Cx601 was TiGenix's development code for an injectable allogeneic expanded adipose-derived stem-cell therapy targeting complex perianal fistulas associated with Crohn's disease. It was evaluated in the pivotal European ADMIRE-CD Phase III trial, with results published in 2016. The program later became associated with the Alofisel product name.

• 2018

  Accept acquisition by TakedaM&A

  Background

  After advancing Cx601 through pivotal European clinical development and establishing a commercial-stage cell-therapy asset, TiGenix became the subject of a proposed acquisition by Takeda.

  Action taken

  Takeda announced an agreement to acquire TiGenix for up to €520 million, bringing the company's lead cell-therapy program into Takeda's portfolio.

  Aftermath

  TiGenix ceased to operate as an independent biotechnology company, while Alofisel and the underlying cell-therapy capabilities became part of Takeda.

  Maximum announced transaction value. €520 million (Announced in January 2018)

  Source

1. 1TiGenixen.wikipedia.org