Amgen Inc.

Medimmune Limited

William Rees

Meina Liang

Jing Li

Brandon Higgs

Raffaella Faggioni

Koustubh Ranade

Yen-Wah Lee

Katie Streicher

Robert W Georgantas, Iii

Chris Morehouse

Robert A Gasser, Jr

Jingjing Chen

Inna Vainshtein

Hailing Hsu

Barbara Sullivan

Dominique Christian Borie

Wei-Jian Pan

Barbara Anne Sullivan

Dominique Borie

The present invention relates to the use of the Chemokine (C&#x2014;C motif) ligand 20 (CCL20) as a biomarker to stratify or identify populations of patients suffering from interleukin-23 (IL23)-mediated diseases (e.g., Crohn's disease) responsive to treatment with an, anti-IL23 antagonist (including, e.g., anti-IL23 antibodies). Levels of CCL20 above or below a predetermined threshold can be used, for example, (i) to determine whether a patient with an IL23-mediated disease or disorder such a Crohn's disease is eligible or non-eligible for treatment with a therapeutic agent, (ii) to determine whether treatment with a certain agent should be commenced, suspended, or modified, (iii) to diagnose whether the IL23-mediated disease is treatable or not treatable with a specific therapeutic agent, or (iv) to predict the outcome of treating the IL23-mediated disease with a specific therapeutic agent. CCL20 can be used in combination with other IL23 pathway biomarkers such as IL22 and/or lipocalin-2 (LCN2).

CCL20 as a predictor of clinical response to IL23-antagonists

The present invention relates to the use of components of the IL23 pathway as biomarkers, e.g., IL22, LCN2 and combinations thereof, to stratify or identify populations of patients suffering from IL23-mediated diseases (e.g., Crohn's disease) responsive to treatment with an anti-IL23 antagonist (including, e.g., anti-IL23 antibodies or antigen-binding fragments thereof). Levels of IL23 pathway biomarkers above or below a predetermined threshold can be used, for example, (i) to determine whether a patient with an IL23-mediated disease or disorder such a Crohn's disease is eligible or non-eligible for treatment with a therapeutic agent (e.g., an ant-IL23 antibody), (ii) to determine whether treatment with a certain agent should be commenced, suspended, or modified, (iii) to diagnose whether the IL23-mediated disease is treatable or not treatable with a specific therapeutic agent, or (iv) to predict the outcome of treating the IL23-mediated disease with a specific therapeutic agent.

Prediction of clinical response to IL23-antagonists using IL23 pathway biomarkers

There is provided a method of treating a subject afflicted with a condition that is associated with inappropriate trafficking of cells expressing alpha4beta7 to the gastrointestinal tract, comprising administering to the subject an alpha4beta7 heterodimer specific antibody in an amount and at an interval sufficient to ameliorate the condition.

Administration of alpha4beta7 hetero-dimer-specific antibody

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Thousand Oaks, CA, United States of America

William Rees