公开(公告)号：US20160209426A1

公开(公告)日：2016-07-21

申请号：US14858226

申请日：2015-09-18

Applicant: GENENTECH, INC.

Inventor： Lauri Diehl ,  Mary Keir ,  Meina Tao Tang ,  Xiaohui Wei ,  Marna B. Williams

IPC: G01N33/68 ,  C12Q1/68

CPC classification number: G01N33/6893 ,  C07K16/2839 ,  C12Q1/6883 ,  C12Q2600/106 ,  C12Q2600/158 ,  G01N2333/70546 ,  G01N2800/065 ,  G01N2800/52

Abstract: Methods of assessing or monitoring the effect, efficacy, responsiveness to treatment, and/or determining a dose or dosing regimen of therapeutic agents, such as integrin beta7 antagonists, for the treatment of gastrointestinal inflammatory disorders are provided. In certain aspects, methods of using integrin beta7 subunit-containing receptor occupancy by the integrin beta7 antagonist on colonic lymphocytes as an indicator (“biomarker”) of the effect, efficacy, or responsiveness to treatment, and/or as a means to determine dosing or dosing regimens of therapeutic agents such as beta7 integrin antagonists for the treatment of gastrointestinal inflammatory disorders are provided. In certain aspects, methods of assessing the effect, efficacy, or responsiveness to beta7 integrin antagonist treatment by measuring gene expression levels of one or more integrin receptor ligands, lymphocyte genes, cytokine genes, or the number of alphaE-positive cells in intestinal crypt epithelium are provided.

Abstract translation: 提供了评估或监测效果，疗效，对治疗反应性和/或确定治疗剂（例如整联蛋白β7拮抗剂）的剂量或给药方案用于治疗胃肠道炎症性疾病的方法。 在某些方面，使用整联蛋白β7拮抗剂在结肠淋巴细胞上的整合素β7亚基受体占据作为指示剂（“生物标志物”）对治疗的作用，功效或反应性的方法和/或作为测定剂量的方法 或治疗剂如β7整联蛋白拮抗剂的给药方案用于治疗胃肠道炎症性疾病。 在某些方面，通过测量一种或多种整联蛋白受体配体，淋巴细胞基因，细胞因子基因或肠隐窝上皮中αE阳性细胞的数量来评估对β7整联蛋白拮抗剂治疗的作用，功效或反应性的方法 被提供。

公开(公告)号：US20220357343A1

公开(公告)日：2022-11-10

申请号：US17552211

申请日：2021-12-15

Applicant: GENENTECH, INC.

Inventor： Lauri Diehl ,  Mary Keir ,  Meina Tao Tang ,  Xiaohui Wei ,  Marna B. Williams

IPC: G01N33/68 ,  C12Q1/6883 ,  C07K16/28

Abstract: Methods of assessing or monitoring the effect, efficacy, responsiveness to treatment, and/or determining a dose or dosing regimen of therapeutic agents, such as integrin beta7 antagonists, for the treatment of gastrointestinal inflammatory disorders are provided. In certain aspects, methods of using integrin beta7 subunit-containing receptor occupancy by the integrin beta7 antagonist on colonic lymphocytes as an indicator (“biomarker”) of the effect, efficacy, or responsiveness to treatment, and/or as a means to determine dosing or dosing regimens of therapeutic agents such as beta7 integrin antagonists for the treatment of gastrointestinal inflammatory disorders are provided. In certain aspects, methods of assessing the effect, efficacy, or responsiveness to beta7 integrin antagonist treatment by measuring gene expression levels of one or more integrin receptor ligands, lymphocyte genes, cytokine genes, or the number of alphaE-positive cells in intestinal crypt epithelium are provided.

公开(公告)号：US11091551B2

公开(公告)日：2021-08-17

申请号：US15844952

申请日：2017-12-18

Applicant: Genentech, Inc.

Inventor： Mary Keir ,  Gaik Wei Tew

IPC: A61K39/395 ,  A61K39/00 ,  C07K16/28 ,  G01N33/68 ,  C12Q1/6883

Abstract: Biomarkers predictive of responsiveness to integrin beta7 antagonists, including anti-beta7 integrin subunit antibodies, and methods of using such biomarkers are provided. In addition, methods of treating gastrointestinal inflammatory disorders such as inflammatory bowel diseases including ulcerative colitis and Crohn's disease are provided. Also provided are methods of using such predictive biomarkers for the treatment of inflammatory bowel diseases including ulcerative colitis and Crohn's disease.

公开(公告)号：US20200025775A1

公开(公告)日：2020-01-23

申请号：US16288893

申请日：2019-02-28

Applicant: GENENTECH, INC.

Inventor： Lauri Diehl ,  Mary Keir ,  Meina Tao Tang ,  Xiaohui Wei ,  Marna B. Williams

IPC: G01N33/68 ,  C12Q1/6883 ,  C07K16/28

Abstract: Methods of assessing or monitoring the effect, efficacy, responsiveness to treatment, and/or determining a dose or dosing regimen of therapeutic agents, such as integrin beta7 antagonists, for the treatment of gastrointestinal inflammatory disorders are provided. In certain aspects, methods of using integrin beta7 subunit-containing receptor occupancy by the integrin beta7 antagonist on colonic lymphocytes as an indicator (“biomarker”) of the effect, efficacy, or responsiveness to treatment, and/or as a means to determine dosing or dosing regimens of therapeutic agents such as beta7 integrin antagonists for the treatment of gastrointestinal inflammatory disorders are provided. In certain aspects, methods of assessing the effect, efficacy, or responsiveness to beta7 integrin antagonist treatment by measuring gene expression levels of one or more integrin receptor ligands, lymphocyte genes, cytokine genes, or the number of alphaE-positive cells in intestinal crypt epithelium are provided.

公开(公告)号：US20180346576A1

公开(公告)日：2018-12-06

申请号：US15844952

申请日：2017-12-18

Applicant: Genentech, Inc.

Inventor： Mary Keir ,  Gaik Wei Tew

IPC: C07K16/28 ,  G01N33/68 ,  C12Q1/6883

CPC classification number: C07K16/2839 ,  C07K2317/24 ,  C12Q1/6883 ,  C12Q2600/106 ,  C12Q2600/158 ,  G01N33/6872 ,  G01N33/6893 ,  G01N2333/7051 ,  G01N2333/70546 ,  G01N2800/06 ,  G01N2800/065 ,  G01N2800/52

Abstract: Biomarkers predictive of responsiveness to integrin beta7 antagonists, including anti-beta7 integrin subunit antibodies, and methods of using such biomarkers are provided. In addition, methods of treating gastrointestinal inflammatory disorders such as inflammatory bowel diseases including ulcerative colitis and Crohn's disease are provided. Also provided are methods of using such predictive biomarkers for the treatment of inflammatory bowel diseases including ulcerative colitis and Crohn's disease.