|Public (euronext: TIG)|
|Eduardo Bravo, CEO|
Number of employees
TiGenix (Euronext : TIG) is a European cell therapy company with a proprietary validated allogeneic expanded adipose-derived stem cell (eASC) platform technology for the treatment of autoimmune and inflammatory diseases, and a commercialised product. Its corporate headquarters are in Leuven, Belgium, and it has operations in Madrid, Spain. TiGenix was founded in 2000 by Prof. Dr. Frank P. Luyten and Gil Beyen as a spin-off from the Katholieke Universiteit Leuven and the Universiteit Gent.
TiGenix's therapeutic approach is to focus on the use of living cells rather than conventional drugs for the treatment of inflammatory and autoimmune diseases, through its eASC-based platform, and heart disease, through its CSC-based platform. TiGenix's pipeline of stem cell programs is based on validated platforms of allogeneic stem cells.
As of March 31, 2016, TiGenix's pipeline portfoliowas the most advanced cell therapy platform in Europe, with positive pivotal Phase III data for its lead product candidate and three further product candidates in Phases II and I and pre-clinical development.
TiGenix has completed, and received positive data in, a single pivotal Phase III trial in Europe of its most advanced product candidate Cx601, a potential first-in-class injectable allogeneic stem cell therapy indicated for the treatment of complex perianal fistulas in patients suffering from Crohn's disease. On July 28, 2016 The Lancetpublished the 24-Week Results of the Phase 3 ADMIRE-CD Trial Investigating Cx601 in the Treatment of Complex Perianal Fistulas in Patients with Crohn’s Disease.
Cx601 has been granted orphan designation by the European Medicines Agency in recognition of its potential application for the treatment of anal fistulas, which affect approximately 120,000 adult patients in the United States and Europe and for which existing treatment options are inadequate.
TiGenix developed and commercialized ChondroCelect, the first cell-based medicinal product to receive marketing authorization from the EMA, which was indicated for cartilage repair in the knee. In July 2016, TiGenix requested the withdrawal of its marketing authorization for ChondroCelect.
In early January 2018, Takeda Pharmaceutical Company announced it would acquire TiGenix for up to €520 million ($632 million).
Immunosuppressive drugs, also known as immunosuppressive agents, immunosuppressants and antirejection medications are drugs that inhibit or prevent activity of the immune system.
Infliximab, a "chimeric monoclonal antibody", sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.
Hematopoietic stem cell transplantation (HSCT) is the transplantation of multipotent hematopoietic stem cells, usually derived from bone marrow, peripheral blood, or umbilical cord blood. It may be autologous, allogeneic or syngeneic.
Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the colon and small intestine. Crohn's disease and ulcerative colitis are the principal types of inflammatory bowel disease. Crohn's disease affects the small intestine and large intestine, as well as the mouth, esophagus, stomach and the anus, whereas ulcerative colitis primarily affects the colon and the rectum.
Evans syndrome is an autoimmune disease in which an individual's immune system attacks their own red blood cells and platelets, the syndrome can include immune neutropenia. These immune cytopenias may occur simultaneously or sequentially.
Leukapheresis is a laboratory procedure in which white blood cells are separated from a sample of blood. It is a specific type of apheresis, the more general term for separating out one particular constituent of blood and returning the remainder to the circulation.
Cell therapy is therapy in which cellular material is injected, grafted or implanted into a patient; this generally means intact, living cells. For example, T cells capable of fighting cancer cells via cell-mediated immunity may be injected in the course of immunotherapy.
Alemtuzumab is a medication used to treat chronic lymphocytic leukemia (CLL) and multiple sclerosis. In CLL has been used as both a first line and second line treatment. In MS it is generally only recommended if other treatments have not worked. It is given by injection into a vein.
Management of Crohn's disease involves first treating the acute symptoms of the disease, then maintaining remission. Since Crohn's disease is an immune system condition, it cannot be cured by medication or surgery. Treatment initially involves the use of medications to eliminate infections and reduce inflammation. Surgery may be required for complications such as obstructions or abscesses, or if the disease does not respond to drugs within a reasonable time. However, surgery cannot cure Crohn's disease. It involves removing the diseased part of the intestine and rejoining the healthy ends, but the disease tends to recur after surgery.
Certolizumab pegol is a biologic medication for the treatment of Crohn's disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It is a fragment of a monoclonal antibody specific to tumor necrosis factor alpha (TNF-α) and is manufactured by UCB.
Biological therapy, the use of medications called biopharmaceuticals or biologics that are tailored to specifically target an immune or genetic mediator of disease, plays a major role in the treatment of inflammatory bowel disease. Even for diseases of unknown cause, molecules that are involved in the disease process have been identified, and can be targeted for biological therapy. Many of these molecules, which are mainly cytokines, are directly involved in the immune system. Biological therapy has found a niche in the management of cancer, autoimmune diseases, and diseases of unknown cause that result in symptoms due to immune related mechanisms.
Ustekinumab, sold under the brand name Stelara, is a human monoclonal antibody used to treat psoriasis. It is also approved to treat Crohn's disease in the United States, Israel and Australia, and ulcerative colitis in the U.S., and in the European Union (EU) among people who have not responded to more traditional treatments. It was found not effective for multiple sclerosis.
Vedolizumab is a monoclonal antibody developed by Millennium Pharmaceuticals, Inc for the treatment of ulcerative colitis and Crohn's disease. It binds to integrin α4β7. Blocking the α4β7 integrin results in gut-selective anti-inflammatory activity. It is marketed under the trade name Entyvio.
Maribavir is an experimental oral antiviral drug candidate licensed by ViroPharma from GlaxoSmithKline in 2003 for the prevention and treatment of human cytomegalovirus (HCMV) disease in hematopoietic stem cell/bone marrow transplant patients. The mechanism by which maribavir inhibits HCMV replication is by inhibition of an HCMV encoded protein kinase enzyme called UL97 or pUL97. Maribavir showed promise in Phase II clinical trials and was granted fast track status, but failed to meet study goals in a Phase III trial. However, the dosage used in the Phase III trial may have been too low to be efficacious.
Lineage Cell Therapeutics ("Lineage") is a clinical-stage biotechnology company headquartered in Carlsbad, California, developing novel cell therapies for unmet medical needs. The company's current focus is on therapies for degenerative retinal diseases, neurological conditions associated with demyelination, and aiding the body in detecting and combating cancer. Lineage's programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform, Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer.
Mesoblast Limited is an Australian-based regenerative medicine company. It seeks to provide treatments for inflammatory ailments, cardiovascular disease and back pain. The company is led by Silviu Itescu, who founded the company in 2004.
Guo Mei is a hematologist and associate director of 307th Hospital of Chinese People’s Liberation Army and deputy director of Radiation Research Institute.
Ixazomib is a drug for the treatment of multiple myeloma, a type of white blood cell cancer, in combination with other drugs. It is taken by mouth in form of capsules.
Crohn’s disease (CD) of the vulva is a rare extra intestinal condition, with granulomatous cutaneous lesions affecting the female genitalia. Lesions connected to the affected gut via a healthy tissue are referred to as metastatic lesions.
Shimon Slavin, M.D., is an Israeli professor of medicine. Slavin pioneered the use of immunotherapy mediated by allogeneic donor lymphocytes and innovative methods for stem cell transplantation for the cure of hematological malignancies and solid tumors, and using hematopoietic stem cells for induction of transplantation tolerance to bone marrow and donor allografts.