Medimmune Limited

Amgen Inc.

The Brigham and Women's Hospital, Inc.

Chris Morehouse

Meina Liang

Jing Li

Brandon Higgs

Raffaella Faggioni

Koustubh Ranade

Yen-Wah Lee

Steven A Greenberg

Katie Streicher

Robert W Georgantas, Iii

William Rees

Robert A Gasser, Jr

Jingjing Chen

Inna Vainshtein

Yihong Yao

Bahija Jallal

Jiaqi Huang

Theresa Lavalle

Wei Zhu

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

Without limitation, this disclosure relates to compositions and methods for detecting and quantifying the expression of insulin receptor isoform A (IR-A) and/or insulin receptor isoform B (IR-B) in a tissue sample. The disclosure also relates to methods of diagnosis and classification based at least in part upon detecting and quantifying the expression of insulin receptor isoform A (IR-A) and/or insulin B (IR-B) in a tissue sample. Methods of treating a subject based upon such a classification are among additional aspects of the disclosure presented herein.

Quantification of IR-A and IR-B for tumor classification

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Gaithersburg, MD, United States of America

Chris Morehouse