US 8,617,545 B2Granted

Methods for use with BAFF antagonists

AssigneesBiogen Idec MA Inc., Genentech, Inc.

InventorsYen-Ming Hsu, Leonid Gorelik, Tatiana Novobrantseva, Joanne Quan, Flavius Martin, Susan L. Kalled

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Abstract

BAFF plays a central role in acquired immunity. The disclosure identifies BAFF-responsive genes that are substantially upregulated by administration of BAFF and substantially downregulated by treatment with a BAFF antagonist. Specific genes are: NF-κB2, CD23, H2-Mβ (the beta chain of H2-DM), Fig-1, and OBF-1. The disclosure provides methods and compositions for: monitoring the activity of a BAFF antagonist in a mammal; monitoring BAFF activity in a mammal; identifying a mammal to be treated with a BAFF antagonist; and related uses. Such methods include detecting one or more molecules selected from the group consisting of Fig-1 molecule, OBF-1 molecule, and H2-Mβ molecule in a biological sample of the mammal, and optionally further detecting NF-κB2 molecule and/or CD23 molecule in the biological sample.

Claims7

Dependent claims

A method for monitoring efficacy of an antagonist to BAFF (SEQ ID NO:30) in a human, comprising the steps of administering the BAFF antagonist to the human, obtaining from the human a biological sample comprising B cells, and detecting a level in the biological sample of one or more molecules selected from the group consisting of:

(a) a polypeptide comprising a sequence selected from SEQ ID NO:16, SEQ ID NO:17, and SEQ ID NO:18;
and
(b) an mRNA comprising a nucleotide sequence encoding an amino acid sequence selected from SEQ ID NO:16, SEQ ID NO:17, and SEQ ID NO:18,
wherein the level, relative to a control, of at least one of the detected molecules indicates efficacy of the BAFF antagonist in the human, and wherein the BAFF antagonist inhibits the interaction between BAFF and a BAFF receptor and is selected from the group consisting of an anti-BAFF antibody, an anti-BAFF-R antibody, and a BAFF-R-Fc polypeptide.

1 more element

Dependencies are inferred from the claim text.

Facts

Application: 12/083,614Filed 12 Oct 2006 · us provisional application
Priority: 13 Oct 2005
Published: US 2010/0330066 A130 Dec 2010
Granted: 31 Dec 2013
Term ends: Not estimatedThe source records don’t support an estimate.

Classification14 codes

C12Q 1/6886
For diseases caused by alterations of genetic material: for cancer
C12Q 1/6883
Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes: for diseases caused by alterations of genetic material
G01N 33/5041
For testing non-proliferative effects: involving analysis of members of signalling pathways
G01N 33/564
Immunoassay; Biospecific binding assay; Materials therefor: for pre-existing immune complex or autoimmune disease , i.e. systemic lupus…