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Biomarkers related to interleukin-33 (il-33)-mediated diseases and uses thereof

A technology of interleukin and its use, applied in the field of biomarkers and its uses related to interleukin-33 (IL-33)-mediated diseases, which can solve the problems of unidentified biomarkers

Pending Publication Date: 2018-06-08
REGENERON PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] To date, no biomarkers have been identified for identifying patients with or predisposed to an IL-33-mediated disease or disorder, or for determining the likelihood of a patient responding to therapy with an IL-33 antagonist

Method used

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  • Biomarkers related to interleukin-33 (il-33)-mediated diseases and uses thereof
  • Biomarkers related to interleukin-33 (il-33)-mediated diseases and uses thereof
  • Biomarkers related to interleukin-33 (il-33)-mediated diseases and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0103] Production of Human Antibodies

[0104] Methods for producing human antibodies in transgenic mice are known in the art. Any such known method may be used in the context of the present invention to prepare human antibodies that specifically bind human IL-33.

[0105] Use VELOCIMMUNE TM technology (see, eg, US 6,596,541, Regeneron Pharmaceuticals) or any other known method for producing monoclonal antibodies, initially high affinity chimeric antibodies to IL-33 are isolated having human variable regions and mouse constant regions. The technique involves making transgenic mice that have a genome comprising human heavy and light chain variable regions operably linked to endogenous mouse constant region loci such that the mice respond to antigenic stimulation to produce human Antibodies to the variable and mouse constant regions. DNA encoding the variable regions of the heavy and light chains of the antibody is isolated and operably linked to DNA encoding the constant re...

Embodiment 1

[0144] Example 1. Preparation of human antibodies against human IL-33

[0145] Immunogens comprising human IL-33 were administered directly to cells comprising DNA encoding human immunoglobulin heavy chain and kappa light chain variable regions together with an adjuvant (to stimulate an immune response). mice. Antibody immune responses were monitored by IL-33-specific immunoassay. When the desired immune response is achieved, spleen cells are harvested and fused with mouse myeloma cells to maintain their viability and form hybridoma cell lines. Hybridoma cell lines were screened and selected to identify IL-33-specific antibody producing cell lines. Using this technique, several anti-IL-33 chimeric antibodies (i.e., antibodies with human variable domains and mouse constant domains) were obtained; exemplary antibodies generated in this manner were named as follows: H1M9559N, H1M9566N, H1M9568N and H1M9565N. The human variable domains from the chimeric antibodies were then c...

Embodiment 2

[0148] Example 2. Heavy and Light Chain Variable Region Amino Acid Sequences

[0149] Table 1 sets forth the heavy and light chain variable region amino acid sequence pairs and CDR sequences of selected anti-IL-33 antibodies, and their corresponding antibody identifiers.

[0150] Table 1

[0151]

[0152]

[0153] Antibodies are generally referred to herein according to the following nomenclature: an Fc prefix (e.g. "H1M" or "H4H") followed by a numerical identifier (e.g. "9559", "9566" or "9629", as in Table 1 shown in ), followed by a "P" or "N" suffix. Thus, according to this nomenclature, antibodies may be referred to herein, eg, "H1M9559N", "H1M9566N", "H4H9629P", etc. The H1M and H4H prefixes on antibody nomenclature as used herein indicate the particular Fc region isotype of said antibody. For example, an "H1M" antibody has a mouse IgG1 Fc, while an "H4H" antibody has a human IgG4 Fc. As one of ordinary skill in the art will appreciate, an antibody with a part...

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Abstract

The present invention relates to the identification of certain biomarkers for use in identifying patients who have, or are likely to develop an IL-33 mediated disease or disorder and who are more likely to respond to therapy with an IL-33 antagonist. The invention also relates to methods of treatment of an IL-33-mediated disease or disorder in a patient by administering an IL-33 antagonist to thepatient in need thereof and monitoring the effectiveness of therapy using the biomarkers described herein. Also provided are methods for decreasing the level of at least one biomarker in a subject suffering from an IL-33-mediated disease or disorder, and methods for treating such diseases or disorders according to the expression levels of one or more biomarkers. The methods of the present invention comprise administering to a subject in need thereof a pharmaceutical composition comprising an interleukin-33 antagonist.

Description

[0001] References to Sequence Listings [0002] This application incorporates by reference the Sequence Listing submitted in computer readable form as file 10187WO01-Sequence.txt (created October 4, 2016 and containing 159,920 bytes). technical field [0003] The present invention relates to the identification of specific biomarkers in mammals associated with the expression of IL-33 and the use of these biomarkers for identifying patients who have or are at risk of developing an IL-33 mediated disease or disorder and They are more likely to respond to therapy with IL-33 antagonists. The invention also relates to methods of treating IL-33 mediated diseases or disorders in a patient by administering an IL-33 antagonist to a patient in need thereof and monitoring the effectiveness of the therapy using the biomarkers described herein. Background technique [0004] Interleukin-33 (IL-33) is a member of the IL-1 superfamily of cytokines expressed primarily by mesenchymal cells, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/24C07K14/715G01N33/50
CPCA61K2039/505C07K2317/24C07K2317/76C07K14/57527A61K38/1793C07K16/244C07K2317/21C07K2319/30G01N33/6893G01N2333/54G01N2333/585A61P1/00A61P11/00A61P11/02A61P11/06A61P17/00A61P17/06A61P19/02A61P25/00A61P25/04A61P29/00A61P37/06A61P37/08A61P43/00A61P7/00A61P9/00A61K45/06C07K14/7155A61K38/00C07K2317/56A61K39/3955
Inventor J·M·奥兰格J·阿林内W·菲里Y·白
Owner REGENERON PHARM INC
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