US2004121370A1PendingUtilityA1

Novel composition and methods for the treatment of immune related diseases

56
Assignee: GENENTECH INCPriority: Sep 11, 2002Filed: Sep 9, 2003Published: Jun 24, 2004
Est. expirySep 11, 2022(expired)· nominal 20-yr term from priority
A61P 37/06A61P 37/04A61P 3/10A61P 37/00A61P 37/02A61P 37/08A61P 9/00A61P 7/06A61P 27/16A61P 25/00A61P 29/00A61K 2039/505G01N 2800/24A61P 11/00G01N 2800/065A61P 11/06A61P 1/16A61P 17/02G01N 2800/205C07K 16/18C12Q 1/6883C12N 2799/026A61P 13/12A61P 17/06C07K 14/47C12Q 2600/158G01N 2500/10A61P 17/00A61P 19/02
56
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Claims

Abstract

The present invention relates to compositions containing a novel protein and methods of using those compositions for the diagnosis and treatment of immune related diseases.

Claims

exact text as granted — not AI-modified
What is claimed:  
     
         1 . Isolated nucleic acid having at least 80% nucleic acid sequence identity to a nucleotide sequence comprising the nucleotide sequence shown in FIG. 1 (SEQ ID NO: 1).  
     
     
         2 . Isolated nucleic acid having at least 80% nucleic acid sequence identity to a nucleotide sequence encoding the polypeptide shown in FIG. 2 (SEQ ID NO:2).  
     
     
         3 . Isolated nucleic acid consisting of the full-length coding sequence of the nucleotide sequence shown in FIG. 1 (SEQ ID NO: 1).  
     
     
         4 . A vector comprising the nucleic acid of  claim 1 .  
     
     
         5 . The vector of  claim 4  operably linked to control sequences recognized by a host cell transformed with the vector.  
     
     
         6 . A host cell comprising the vector of  claim 4 .  
     
     
         7 . The host cell of  claim 6 , wherein said cell is a CHO cell, an  E.coli  cell or a yeast cell.  
     
     
         8 . A process for producing a PRO52254 polypeptide comprising culturing the host cell of  claim 6  under conditions suitable for expression of said PRO52254 polypepfide and recovering said PRO52254 polypeptide from the cell culture.  
     
     
         9 . An isolated polypeptide having at least 80% amino acid sequence identity to an amino acid sequence of the polypeptide shown in FIG. 2 (SEQ ID NO:2).  
     
     
         10 . A chimeric molecule comprising a polypeptide according to  claim 9  fused to a heterologous amino acid sequence.  
     
     
         11 . The chimeric molecule of  claim 10 , wherein said heterologous amino acid sequence is an epitope tag sequence or an Fc region of an immunoglobulin.  
     
     
         12 . An antibody which specifically binds to a polypeptide according to  claim 9 .  
     
     
         13 . The antibody of  claim 12 , wherein said antibody is a monoclonal antibody, a humanized antibody or a single-chain antibody.  
     
     
         14 . A composition of matter comprising (a) a polypeptide of  claim 9 , (b) an agonist of said polypeptide, (c) an antagonist of said polypeptide, or (d) an antibody that binds to said polypeptide, in combination with a carrier.  
     
     
         15 . The composition of matter of  claim 14 , wherein said carrier is a pharmaceutically acceptable carrier.  
     
     
         16 . The composition of matter of  claim 14  comprising a therapeutically effective amount of (a), (b), (c) or (d).  
     
     
         17 . An article of manufacture, comprising: 
 a container;    a label on said container; and    a composition of matter comprising (a) a polypeptide of  claim 9 , (b) an agonist of said polypeptide, (c) an antagonist of said polypeptide, or (d) an antibody that binds to said polypeptide, contained within said container, wherein label on said container indicates that said composition of matter can be used for treating an immune related disease.    
     
     
         18 . A method of treating an immune related disorder in a mammal in need thereof comprising administering to said mammal a therapeutically effective amount of (a) a polypeptide of  claim 9 , (b) an agonist of said polypeptide, (c) an antagonist of said polypeptide, or (d) an antibody that binds to said polypeptide.  
     
     
         19 . The method of  claim 18 , wherein the immune related disorder is systemic lupus erythematosis, rheumatoid arthritis, osteoarthritis, juvenile chronic arthritis, a spondyloarthropathy, systemic sclerosis, an idiopathic inflammatory myopathy, Sjögren's syndrome, systemic vasculitis, sarcoidosis, autoimmune hemolytic anemia, autoimmune thrombocytopenia, thyroidifis, diabetes mellitus, immune-mediated renal disease, a demyelinating disease of the central or peripheral nervous system, idiopathic demyelinating polyneuropathy, Guillain-Barré syndrome, a chronic inflammatory demyelinating polyneuropathy, a hepatobiliary disease, infectious or autoimmune chronic active hepatitis, primary biliary cirrhosis, granulomatous hepatitis, sclerosing cholangitis, inflammatory bowel disease, gluten-sensitive enteropathy, Whipple's disease, an autoimmune or immune-mediated skin disease, a bullous skin disease, erythema multiforme, contact dermatitis, psoriasis, an allergic disease, asthma, allergic rhinitis, atopic dermatitis, food hypersensitivity, urticaria, an immunologic disease of the lung, eosinophilic pneumonias, idiopathic pulmonary fibrosis, hypersensitivity pneumonitis, a transplantation associated disease, graft rejection or graft-versus-host-disease.  
     
     
         20 . A method for determining the presence of a PRO52254 polypeptide in a sample suspected of containing said polypeptide, said method comprising exposing said sample to an anti-PRO52254 antibody and determining binding of said antibody to a component of said sample.  
     
     
         21 . A method of diagnosing an immune related disease in a mammal, said method comprising detecting the level of expression of a gene encoding PRO52254 polypeptide (a) in a test sample of tissue cells obtained from the mammal, and (b) in a control sample of known normal tissue cells of the same cell type, wherein a higher or lower level of expression of said gene in the test sample as compared to the control sample is indicative of the presence of an immune related disease in the mammal from which the test tissue cells were obtained.  
     
     
         22 . A method of diagnosing an immune related disease in a mammal, said method comprising (a) contacting an anti-PRO52254 antibody with a test sample of tissue cells obtained from said mammal and (b) detecting the formation of a complex between the antibody and the polypeptide in the test sample, wherein formation of said complex is indicative of the presence of an immune related disease in the mammal from which the test tissue cells were obtained.  
     
     
         23 . A method of identifying a compound that inhibits the activity of a PRO52254 polypeptide, said method comprising contacting cells which normally respond to said polypeptide with (a) said polypeptide and (b) a candidate compound, and determining the lack responsiveness by said cell to (a).  
     
     
         24 . A method of identifying a compound that inhibits the expression of a gene encoding a PRO52254 polypeptide, said method comprising contacting cells which normally express said polypeptide with a candidate compound, and determining the lack of expression said gene.  
     
     
         25 . The method of  claim 24 , wherein said candidate compound is an antisense nucleic acid.  
     
     
         26 . A method of identifying a compound that mimics the activity of a PRO52254 polypeptide, said method comprising contacting cells which normally respond to said polypeptide with a candidate compound, and determining the responsiveness by said cell to said candidate compound.  
     
     
         27 . A method of stimulating the immune response in a mammal, said method comprising administering to said mammal an effective amount of a PRO52254 polypeptide antagonist, wherein said immune response is stimulated.  
     
     
         28 . A method of diagnosing an inflammatory immune response in a mammal, said method comprising detecting the level of expression of a gene encoding PRO52254 polypeptide (a) in a test sample of tissue cells obtained from the mammal, and (b) in a control sample of known normal tissue cells of the same cell type, wherein a higher or lower level of expression of said gene in the test sample as compared to the control sample is indicative of the presence of an inflammatory immune response in the mammal from which the test tissue cells were obtained.  
     
     
         29 . A method of diagnosing psoriasis in a mammal, said method comprising detecting the level of expression of a gene encoding PRO52254 polypeptide (a) in a test sample of tissue cells obtained from the mammal, and (b) in a control sample of known normal tissue cells of the same cell type, wherein a higher or lower level of expression of said gene in the test sample as compared to the control sample is indicative of the presence of psoriasis in the mammal from which the test tissue cells were obtained.  
     
     
         30 . A method of diagnosing inflammatory bowel disease in a mammal, said method comprising detecting the level of expression of a gene encoding PRO52254 polypeptide (a) in a test sample of tissue cells obtained from the mammal, and (b) in a control sample of known normal tissue cells of the same cell type, wherein a higher or lower level of expression of said gene in the test sample as compared to the control sample is indicative of the presence of inflammatory bowel disease in the mammal from which the test tissue cells were obtained.

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