Biomarkers for assessing subjects with multiple sclerosis
Inventors
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Assignees
Leland Stanford Junior University
Member
Oklahoma Medical Research FoundationFounded in 1946, this independent nonprofit biomedical research institute conducts basic, translational, and clinical research in critical areas such as heart disease, cancer, autoimmune, and neurodegenerative diseases. Its mission focuses on understanding biological mechanisms and advancing diagnostics and therapeutics. Activities include conducting clinical trials, managing a patent portfolio, commercializing biotechnologies, and supporting the biotech community. Research efforts are funded by grants and philanthropy, and the institute hosts advanced facilities, interdisciplinary research teams, and collaborations with academia and industry.
Founded in 1946, this independent nonprofit biomedical research institute conducts basic, translational, and clinical research in critical areas such as heart disease, cancer, autoimmune, and neurodegenerative diseases. Its mission focuses on understanding biological mechanisms and advancing diagnostics and therapeutics. Activities include conducting clinical trials, managing a patent portfolio, commercializing biotechnologies, and supporting the biotech community. Research efforts are funded by grants and philanthropy, and the institute hosts advanced facilities, interdisciplinary research teams, and collaborations with academia and industry.
Publication Number
US-11740248-B2
Publication Date
2023-08-29
Expiration Date
Abstract
Disclosed herein are methods in which an individual with multiple sclerosis (MS) can be classified into one of six subject groups, each subject group predictive for the patient's responsiveness to an interferon-β (IFN-β) therapy. The individual with MS can be classified according to the individual's serum marker levels, e.g., at baseline or following treatment with therapy. Depending on the classification, the individual with MS can be treated with standard therapies (e.g. IFN-β) or one or more alternative therapies with or without IFN-β.
Core Innovation
The invention provides methods, data, and systems that classify multiple sclerosis subjects into six biomarker-defined groups using a serum cytokine/protein panel and hierarchical clustering to predict responsiveness to interferon-β. The invention defines group-specific biomarker signatures in the panel comprising IL-1β, IL-8, CCL2/MCP1, IL-1RA, CXCL1/Groα, IL-6, G-CSF, CD40L, IL-17F, IFN-β, and CXCL10/IP10, and associates groups with clinical correlation to IFN-β response.
The background problem addressed is variability in patient responsiveness to interferon-β and the need for biomarker-guided treatment selection. The invention provides treatment selection guidance tied to group assignment and specifies assay modalities and sample types/timing [procedural detail omitted for safety]. It discloses computer/system/kit embodiments and statistical validation from a clinical cohort.
Claims Coverage
This coverage identifies four main inventive features extracted from the two independent claims.
Biomarker panel comprising specified proteins
A panel of biomarkers comprising IL-1β, IL-8, CCL2/MCP1, IL-1RA, CXCL1/Groα, IL-6, G-CSF, CD40L, IL-17F, IFN-β, and CXCL10/IP10 is determined in a sample from the subject.
Classification into six biomarker-defined groups
Classifying the subject into at least one of group 1, group 2, group 3, group 4, group 5, and group 6 based on expression levels of the panel as compared to a control profile, where group 1: only CD40L elevated; group 2: lower or not significantly different levels of all biomarkers; group 3: IL-8, CXCL1/Groα, IL-1β, IL-1RA, and CCL2/MCP1 elevated; group 4: G-CSF and CD40L elevated; group 5: CXCL10/IP10 and IL-6 elevated; group 6: IFN-β and IL-17F elevated.
Comparison to a control profile
Classification is performed by comparing the subject's biomarker expression levels to a control profile of biomarker levels in patients with multiple sclerosis.
Group-specific treatment selection
Treating the subject based on group assignment, wherein groups 1 or 5 are treated with IFN-β alone or in combination with listed therapies; groups 3 or 6 are treated with glatiramer acetate, anti-VLA4, dimethyl fumarate, or teriflunomide alone or with listed adjuncts; and groups 2 or 4 are treated with combinations including IFN-β and specified therapies or adjuncts.
The independent claims cover measuring a specified eleven-protein biomarker panel, comparing expression to a control profile, classifying subjects into six defined biomarker groups, and selecting group-specific treatments.
Stated Advantages
Predict responsiveness to interferon-β (IFN-β).
Provide treatment selection guidance based on biomarker-defined group assignment.
Documented Applications
Classifying multiple sclerosis subjects into six biomarker-defined groups to predict IFN-β responsiveness and guide selection of IFN-β or alternative therapies.
Measuring the biomarker panel [procedural detail omitted for safety].
Implementing computer, system, and kit embodiments for classification and treatment guidance and validating the approach using statistical analysis of a clinical cohort.
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