Anaplastic lymphoma kinase (ALK) is a receptor tyrosine kinase (RTK) belonging to the insulin receptor (IR) superfamily. ALK also known CD246 is encoded by the ALK gene in humans. Immunohistochemical analysis of adult human tissues reveals that ALK expression is sparsely scattered in neural cells, endothelial cells and pericytes in the brain. ALK mRNA is also expressed in the small intestine, testis, prostate, and colon. ALK was initially identified as the product of a gene rearrangement in anaplastic large cell lymphoma (ALCL). ALK was subsequently found to be rearranged, mutated, or amplified in a series of tumors including lymphoma, neuroblastoma, and non-small cell lung cancer (NSCLC). There is strong clinical evidence that ALK is one a key driving factor of oncogenesis, thus making it a key drug target.
Currently marketed ALK inhibitors include Zykadia (ceritinib) and Alecensa (alectinib). These drugs are indicated for the treatment of gastrointestinal cancer and non small cell lung cancer. The ALK inhibitors pipeline has more than 15 molecules and is expected to achieve regulatory approval in foreseeable future, few of which are ensartinib (X-396), X-376, X-390, CEP-28122, EBI-215, EBI-600215, and ASP3026. In pipeline analysis, these are analyzed on the basis of route of administration (ROA) and type of molecule. The pipeline is also assessed based on monotherapy and combination therapy, and different clinical phases including Phase III, Phase II, Phase I and pre-clinical stage. Few key companies which are involved in the development of ALK inhibitors include AstraZeneca, Teva, Delenex Therapeutics, Astellas, Amgen and Tesaro.
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