Prometheus Laboratories Inc.

Nestec S.a.

Prometheus Biosciences, Inc.

Precision Ibd, Inc.

Pierian Holdings, Inc.

Anjali Jain

Sharat Singh

Venkateswarlu Kondragunta

Michael Hale

Nicholas Chi-Kwan Ling

Jared Salbato

Phillip Kim

Stefan Westin

The present disclosure provides methods for assessing mucosal healing in a patient with Crohn's Disease. The methods include detecting expression levels of analytes in a serum sample from a patient, and applying a mathematical algorithm to the expression levels, thereby producing a Mucosal Healing Index score for the patient. The present disclosure also provides kits that include two or more binding partners, each or which is capable of binding a different analyte measured in the disclosed mucosal healing assessment methods.

Methods for assessing mucosal healing in inflammatory bowel disease patients

The present invention provides a sensitive and specific indirect homogeneous mobility shift assay using size exclusion chromatography to measure biologics such as vedolizumab and ustekinumab in a patient sample. The assays of the present invention are particularly advantageous for detecting the presence or level of biologics that target complex or large antigens including cell surface proteins, transmembrane proteins, heavily glycosylated proteins, and multimeric proteins, as well as antigens that cannot be purified, impure antigens, and partially or substantially purified antigens. The present invention also provides isolated soluble α4β7 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.

Indirect homogeneous mobility shift assays for the detection of biologics in patient samples

Methods for assessing mucosal healing in ulcerative colitis disease patients

The present disclosure provides methods for assessing mucosal healing in a patient with Chron's Disease. The methods include detecting expression levels of analytes in a serum sample from a patient, and applying a mathematical algorithm to the expression levels, thereby producing a Mucosal Healing Index score for the patient. The present disclosure also provides kits that include two or more binding partners, each or which is capable of binding a different analyte measured in the disclosed mucosal healing assessment methods.

Methods for assessing mucosal healing in Crohn's disease patients

The present invention provides a sensitive and specific indirect homogeneous mobility shift assay using size exclusion chromatography to measure biologics such as vedolizumab and ustekinumab in a patient sample. The assays of the present invention are particularly advantageous for detecting the presence or level of biologics that target complex or large antigens including cell surface proteins, transmembrane proteins, heavily glycosylated proteins, and multimeric proteins, as well as antigens that cannot be purified, impure antigens, and partially or substantially purified antigens. The present invention also provides isolated soluble &#x3b1;4&#x3b2;7 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.

The present invention provides methods for predicting whether an individual having inflammatory bowel disease (IBD) is likely to respond to vedolizumab treatment. Also provided are methods for predicting whether an individual with IBD such as Crohn's disease or ulcerative colitis will develop autoantibodies against vedolizumab. The present invention also provides a treatment regimen for an IBD patient which includes measuring the level of one or more predictive markers of response to vedolizumab prior to administering the anti-&#x3b1;4&#x3b2;7 integrin drug.

Methods for establishing a vedolizumab dosing regimen to treat patients with irritable bowel disease

The present invention provides assays and methods for predicting the survival of a subject having colorectal cancer (CRC), thereby determining whether the subject will have a good prognosis or poor prognosis. The present invention also provides assays and methods for predicting therapeutic efficacy and/or response to anti-cancer therapeutics in a subject having CRC, thereby selecting a therapeutic regimen to which the subject is likely to be responsive.

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San Diego, CA, United States of America

Anjali Jain