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Vedolizumab Overview

Introduction of Vedolizumab

Vedolizumab (EntyvioTM) is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte α4β7 integrin, a key mediator of gastrointestinal inflammation. It is used in the treatment of moderate to severe active ulcerative colitis and Crohn's disease for patients who have had an inadequate response with, lost response to, or were intolerant to inhibitors of tumor necrosis factor-alpha (TNF-alpha) or other conventional therapies. By blocking its primary target, α4β7 integrin, vedolizumab reduces inflammation in the gut. Vedolizumab is administered by IV infusion over a period of 30 minutes; after the first dose, it is given again at two and six weeks and then every 8 weeks thereafter.

Mechanism of Action of Vedolizumab

The inflammatory bowel diseases (IBDs) are chronic inflammatory disorders of the GI tract consisting primarily of two subtypes, ulcerative colitis (UC) and Crohn’s disease (CD). CD is characterized by transmural inflammation of any portion of the GI tract from mouth to anus, whereas UC is limited to the colon and rectum with inflammation typically restricted to the mucosa, although inflammatory involvement of the submucosa may occur in severe cases. Both CD and UC are characterized by an influx of inflammatory cells, especially leukocytes into gut mucosal tissue. An important leukocyte involved in the pathogenesis of both CD and UC is the α4β7-integrin-expressing T cell. Integrins, which consist of an α- and β-chain that together form a heterodimer, bind to ligands on endothelial cells, allowing leukocytes to firmly adhere to endothelial surfaces.

Extravasation of leukocytes from the blood into stromal tissues of gut mucosal tissue is a complex process involving a coordinated sequence of events between leukocytes and vascular endothelial cells. Several steps – tethering/rolling, activation, adhesion and extravasation/migration occur allowing immune cells to enter stromal tissues. Initially, leukocytes tether to the vascular endothelium through multiple transient interactions between selectins on leukocytes such as PSGL-1 and their ligands on the endothelial surface (P-selectin and E-selectin). This process decreases the speed of leukocytes to facilitate rolling along the endothelial surface. The slower speed of these leukocytes permits interactions to occur between integrins on the surface of the leukocyte and their ligands on the endothelium. Slowing leukocytes also allows chemokines from inflamed tissue to activate them resulting in leukocyte polarization, while also enhancing the binding affinity of integrins. When activated, these cells preferentially adhere to endothelial surfaces within the GI tract as well as the associated lymphoid tissues. Upon activation, α4β7-integrin-expressing T cells bind to their ligand MAdCAM-1 and leukocytes are primed for extravasation. Leukocytes subsequently cross the endothelium and enter the mucosa through a paracellular route.

Vedolizumab was designed specifcally targets α4β7, so that preventing the α4β7/MAdCAM-1 interaction, hence inhibiting leukocyte migration into gut mucosa. Commendably, based on studies performed by Millennium Pharmaceuticals (MA, USA), vedolizumab does not affect levels of T cells in the cerebrospinal fluid of healthy volunteers after a single dose nor does it inhibit immune surveillance of the CNS in nonhuman primates.

Mechanism of action of Vedolizumab Figure 1 Mechanism of Action of Vedolizumab

Clinical Projects of Vedolizumab *

NCT ID Status Conditions Lead Sponsor Update Time
NCT03329209 Recruiting Colitis, Ulcerative, Crohn Disease Takeda March 19, 2018
NCT02559713 Recruiting Colitis, Ulcerative,Crohn Disease Takeda April 13, 2018
NCT03309865 Not yet recruiting Ulcerative Colitis, Dietary Modification Mayo Clinic November 22, 2017
NCT03029143 Recruiting Colitis, Ulcerative Takeda July 2, 2018
NCT03196427 Not yet recruiting Ulcerative Colitis, Crohn's Disease Takeda June 7, 2018
NCT03138655 Recruiting Ulcerative Colitis,Crohn's Disease Takeda June 11, 2018
NCT02743806 Recruiting Colitis, Ulcerative, Crohn Disease Takeda May 12, 2017
NCT03142321 Recruiting Crohn Disease of Small Intestine Washington University School of Medicine June 12, 2018
NCT02878083 Recruiting ULCERATIVE COLITIS May 21, 2018
NCT02728895 Active, not recruiting Allogeneic Hematopoietic Stem Cell Transplantation Takeda March 14, 2018
NCT03147859 Recruiting HIV-infection/AIDS Ottawa Hospital Research Institute November 21, 2017
NCT02768532 Recruiting Crohn Disease Centre Hospitalier Universitaire de Saint Etienne January 23, 2018
NCT02929316 Recruiting Celiac Disease AGA Clinical Research Associates, LLC June 27, 2018
NCT02630966 Active, not recruiting Crohn Disease Takeda June 19, 2018
NCT02862132 Recruiting Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease Shaare Zedek Medical Center April 17, 2018
NCT02834754 Not yet recruiting Crohn's Disease Marc Schwartz May 31, 2018
NCT02425111 Active, not recruiting Crohn's Disease Takeda August 1, 2017
NCT02790138 Recruiting Colitis, Ulcerative Takeda June 19, 2018
NCT02620046 Recruiting Colitis, Ulcerative,Crohn Disease Takeda May 28, 2018
NCT02678052 Recruiting Colitis, Ulcerative, Crohn's Disease Takeda June 7, 2017
NCT02674308 Recruiting Ulcerative Colitis and Crohn's Disease Takeda June 2, 2017
NCT02038920 Active, not recruiting Crohn's Disease Takeda July 2, 2018
NCT02953275 Recruiting Crohn Disease University of Miami December 15, 2017
NCT02954159 Recruiting Ulcerative Colitis Medical College of Wisconsin July 11, 2017
NCT03375424 Recruiting Inflammatory Bowel Diseases, Treatment Ced Service GmbH December 18, 2017
NCT03234907 Recruiting Crohn's Disease Takeda January 16, 2018
NCT03221036 Recruiting Moderately to Severely Active Ulcerative Colitis Takeda January 12, 2018
NCT02611817 Active, not recruiting Crohn's Disease Takeda June 25, 2018
NCT02646683 Recruiting Crohn Disease Geert D'Haens July 6, 2017
NCT02646657 Recruiting Colitis, Ulcerative Geert D'Haens July 6, 2017
NCT02611830 Active, not recruiting Colitis, Ulcerative Takeda June 26, 2018
NCT02788175 Recruiting HIV National Institute of Allergy and Infectious Diseases (NIAID) April 25, 2018
NCT03237260 Recruiting Ulcerative Colitis University of Pennsylvania August 2, 2017
NCT02986724 Recruiting Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases Takeda February 13, 2018
NCT03535649 Not yet recruiting Colitis, Ulcerative Takeda May 24, 2018
NCT02497469 Active, not recruiting Colitis, Ulcerative Takeda May 14, 2018
NCT03378388 Recruiting Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases Takeda April 30, 2018
NCT02324699 Recruiting Crohn's Disease Icahn School of Medicine at Mount Sinai June 14, 2017
NCT02764762 Recruiting Crohn Disease Takeda June 25, 2018
NCT03558152 Recruiting Ulcerative Colitis Genentech, Inc. June 26, 2018
NCT02721719 Recruiting Ulcerative Colitis University of British Columbia June 8, 2018
NCT02760615 Recruiting Colitis, Ulcerative, Crohn Disease Takeda November 22, 2017
NCT02617927 Recruiting Pregnancy Complications Ariella Shitrit October 14, 2016
NCT03500653 Not yet recruiting Inflammatory Bowel Diseases Henit Yanai April 17, 2018
NCT03056924 Recruiting Inflammatory Bowel Diseases Boston Medical Center July 12, 2017
NCT03257345 Recruiting Ulcerative Colitis, Crohn's Disease University Hospital Southampton NHS Foundation Trust April 9, 2018
NCT03043677 Not yet recruiting Inflammatory Bowel Disease Fundación de Investigación Biomédica - Hospital Universitario de La Princesa August 14, 2017
NCT03219359 Recruiting Crohn Disease Icahn School of Medicine at Mount Sinai February 28, 2018
NCT03093259 Active, not recruiting Ulcerative Colitis Abivax S.A. May 23, 2018
NCT02461758 Recruiting Inflammatory Bowel Disease (IBD) University of Wisconsin, Madison November 21, 2017
NCT02972450 Not yet recruiting HIV-1-infection French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) April 30, 2018
NCT03266471 Enrolling by invitation Inflammatory Bowel Diseases Vanderbilt University Medical Center April 12, 2018
NCT03108326 Recruiting Crohn Disease Ced Service GmbH January 25, 2018
NCT03504930 Not yet recruiting Ulcerative Colitis Hospices Civils de Lyon April 20, 2018
NCT03351647 Recruiting Crohn Disease Hospices Civils de Lyon February 23, 2018
NCT02610569 Recruiting Ulcerative Colitis Dr. Arnaud Bourreille October 13, 2016
NCT03063957 Recruiting Colitis, Microscopic Massachusetts General Hospital February 24, 2017
NCT02910245 Recruiting Colitis, Ulcerative Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) February 21, 2018
NCT02377258 Recruiting IBD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives April 12, 2016
NCT03006809 Recruiting Ulcerative Colitis Najwa Elnachef October 26, 2017

Approved Drugs of Vedolizumab **

INN (trade name) Therapeutic area Dose Strength Route Company Marketing start Market
Entyvio Ulcerative Colitis, Crohn’s Disease Injection, powder, for solution 300 mg/5mL Intravenous Takeda May 20,2014 Vedolizumab Overview
Entyvio Ulcerative Colitis, Crohn’s Disease Injection, powder, for solution 300 mg/5mL Intravenous Takeda Pharma A/S May 22,2014 Vedolizumab Overview
Entyvio Ulcerative Colitis, Crohn’s Disease Powder, for solution 300 mg Intravenous Takeda April 21,2015 Vedolizumab Overview
Entyvio/
Kynteles
Ulcerative Colitis, Crohn’s Disease Powder for injection 300 mg Intravenous Takeda Pharmaceuticals Australia Pty Ltd June 26, 2014 Vedolizumab Overview

What We Provide

Therapeutic Antibody
Vedolizumab

We provide high-quality Vedolizumab for use in WB, FC, IP, ELISA, Neut, FuncS, IF and most other immunological methods. For lab research use only, not for diagnostic, therapeutic or any in vivo human use.

Resources
* The table was excerpted from the following website
https://clinicaltrials.gov/ct2/results?cond=&term=Vedolizumab&cntry=&state=&city=&dist=

** Information presented in the table was collected from the following websites:
https://www.drugbank.ca/drugs/DB09033
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002782/WC500168528.pdf
https://www.tga.gov.au/sites/default/files/auspar-vedolizumab-141117.pdf
https://www.fda.gov/downloads/drugs/drugsafety/ucm491477.pdf


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