Nestec S.a.

Prometheus Laboratories Inc.

Societe Des Produits Nestle S.a.

Prometheus Biosciences, Inc.

Linda Ohrmund

Sharat Singh

Shui Long Wang

Scott Hauenstein

Nicholas Hoe

Steve Lockton

Shui-Long Wang

The present invention provides methods for personalized therapeutic management of a disease in order to optimize therapy and/or monitor therapeutic efficacy. In particular, the present invention comprises measuring an array of one or a plurality of biomarkers at a plurality of time points over the course of therapy with a therapeutic agent to determine a mucosal healing index for selecting therapy, optimizing therapy, reducing toxicity, and/or monitoring the efficacy of therapeutic treatment. In certain instances, the therapeutic agent is a TNFα inhibitor for the treatment of a TNFα-mediated disease or disorder.

Methods of disease activity profiling for personalized therapy management

The present invention provides methods for personalized therapeutic management of a disease in order to optimize therapy and/or monitor therapeutic efficacy. In particular, the present invention comprises measuring an array of one or a plurality of biomarkers at a plurality of time points over the course of therapy with a therapeutic agent to determine a mucosal healing index for selecting therapy, optimizing therapy, reducing toxicity, and/or monitoring the efficacy of therapeutic treatment. In certain instances, the therapeutic agent is a TNF&#x3b1; inhibitor for the treatment of a TNF&#x3b1;-mediated disease or disorder.

The present invention provides assays for detecting and measuring the presence or level of neutralizing and non-neutralizing autoantibodies to biologics such as anti-TNF&#x3b1; drug therapeutics in a sample. The present invention is useful for monitoring the formation of neutralizing and/or non-neutralizing anti-drug antibodies over time while a subject is on biologic therapy. The present invention is also useful for predicting and/or determining the cross-reactivity of neutralizing anti-drug antibodies in a subject's sample with alternative biologic therapies. As such, the present invention provides information for guiding treatment decisions for those subjects receiving therapy with a biologic agent and improves the accuracy of optimizing therapy, reducing toxicity, and/or monitoring the efficacy of therapeutic treatment to biologic therapy.

Assays for detecting neutralizing autoantibodies to biologic therapy

The present invention provides assays for detecting and measuring the presence or level of anti-TNF&#x3b1; drug therapeutics and autoantibodies in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNF&#x3b1; drug therapeutics to detect the presence or level of autoantibodies (e.g., HACA and/or HAHA) against the drug.

Assays for the detection of anti-TNF drugs and autoantibodies

The present invention provides assay methods for the determination of one or more anti-drug antibody (ADA) isotypes in a sample. As a non-limiting example, the assays of the present invention are particularly useful for determining different ADA isotypes in samples from ADA-positive patients receiving an anti-TNF&#x3b1; drug such as REMICADE&#x2122; (infliximab) or HUMIRA&#x2122; (adalimumab). The present invention also provides methods for optimizing therapy and/or reducing toxicity in subjects receiving TNF&#x3b1; inhibitors for the treatment of TNF&#x3b1;-mediated disease or disorders.

Growing community of inventors

San Diego, CA, United States of America

Linda Ohrmund