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US 12,650,431 B2Granted
Human IgG autoantibodies against galactose-deficient IgA1, preparation method thereof, and use thereof
AssigneeNational Defense Medical University
InventorsShuk-Man Ka, Chia-Chao Wu, Ann Chen
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Abstract
The current invention provides high specificity monoclonal antibodies, which can specifically bind to Gd-IgA as a novel non-invasive method for rapid diagnosing of IgAN subjects, which can be applied to unravel the mechanisms of IgA nephropathy and establish therapeutical strategies.
Claims5
A reagent set for detecting the mechanism of IgA nephropathy and establishing a treatment strategy, which comprises a first IgG monoclonal antibody and a second IgG monoclonal antibody,
- wherein the first IgG monoclonal antibody comprises:
- an HCDR1 comprising the amino acid sequence SEQ ID NO:
- 1;
- an HCDR2 comprising the amino acid sequence SEQ ID NO:
- 2;
- an HCDR3 comprising the amino acid sequence SEQ ID NO:
- 3;
- an LCDR1 comprising the amino acid sequence SEQ ID NO:
- 7;
- an LCDR2 comprising the amino acid sequence SEQ ID NO:
- 8;
- and
- an LCDR3 comprising the amino acid sequence SEQ ID NO:
- 9;
- wherein the second IgG monoclonal antibody comprises:
- an HCDR1 comprising the amino acid sequence SEQ ID NO:
- 4;
- an HCDR2 comprising the amino acid sequence SEQ ID NO:
- 5;
- an HCDR3 comprising the amino acid sequence SEQ ID NO:
- 6;
- an LCDR1 comprising the amino acid sequence SEQ ID NO:
- 10;
- an LCDR2 comprising the amino acid sequence SEQ ID NO:
- 11;
- and
- an LCDR3 comprising the amino acid sequence SEQ ID NO:
- 12.
25 more elements
A method for detecting galactose-deficient O-glycosyl IgA1, comprising:
- (a) obtaining a biological sample from a subject;
- and
- (b) using a first IgG monoclonal antibody and a second IgG monoclonal antibody in an immunoassay to detect galactose deficient O-glycosyl IgA1 in the subject;
- wherein the first IgG monoclonal antibody comprises:
- an HCDR1 comprising the amino acid sequence SEQ ID NO:
- 1;
- an HCDR2 comprising the amino acid sequence SEQ ID NO:
- 2;
- an HCDR3 comprising the amino acid sequence SEQ ID NO:
- 3;
- an LCDR1 comprising the amino acid sequence SEQ ID NO:
- 7;
- an LCDR2 comprising the amino acid sequence SEQ ID NO:
- 8;
- and
- an LCDR3 comprising the amino acid sequence SEQ ID NO:
- 9;
- wherein the second IgG monoclonal antibody comprises:
- an HCDR1 comprising the amino acid sequence SEQ ID NO:
- 4;
- an HCDR2 comprising the amino acid sequence SEQ ID NO:
- 5;
- an HCDR3 comprising the amino acid sequence SEQ ID NO:
- 6;
- an LCDR1 comprising the amino acid sequence SEQ ID NO:
- 10;
- an LCDR2 comprising the amino acid sequence SEQ ID NO:
- 11;
- and
- an LCDR3 comprising the amino acid sequence SEQ ID NO:
- 12.
28 more elements
A method for diagnosing a subject with IgA nephropathy (IgAN), comprising:
- (a) using a first IgG monoclonal antibody or a second IgG monoclonal antibody, in an immunoassay;
- and
- (b) determining whether the first IgG monoclonal antibody or the second IgG monoclonal antibody binds to galactose-deficient O-glycosyl polypeptide, the binding of the first IgG monoclonal antibody or the second IgG monoclonal antibody to galactose-deficient O-glycosyl polypeptide indicating that the subject has or is at risk of developing IgA nephropathy;
- wherein the first IgG monoclonal antibody comprises:
- an HCDR1 comprising the amino acid sequence SEQ ID NO:
- 1;
- an HCDR2 comprising the amino acid sequence SEQ ID NO:
- 2;
- an HCDR3 comprising the amino acid sequence SEQ ID NO:
- 3;
- an LCDR1 comprising the amino acid sequence SEQ ID NO:
- 7;
- an LCDR2 comprising the amino acid sequence SEQ ID NO:
- 8;
- and
- an LCDR3 comprising the amino acid sequence SEQ ID NO:
- 9;
- wherein the second IgG monoclonal antibody comprises:
- an HCDR1 comprising the amino acid sequence SEQ ID NO:
- 4;
- an HCDR2 comprising the amino acid sequence SEQ ID NO:
- 5;
- an HCDR3 comprising the amino acid sequence SEQ ID NO:
- 6;
- an LCDR1 comprising the amino acid sequence SEQ ID NO:
- 10;
- an LCDR2 comprising the amino acid sequence SEQ ID NO:
- 11;
- and
- an LCDR3 comprising the amino acid sequence SEQ ID NO:
- 12, wherein the galactose-deficient O-glycosyl polypeptide for the binding of the first IgG monoclonal antibody is selected from SEQ ID NO:
- 17 and SEQ ID NO:
- 19, and wherein the galactose-deficient O-glycosyl polypeptide for the binding of the second IgG monoclonal antibody is selected from SEQ ID NO:
- 13, SEQ ID NO:
- 15, SEQ ID NO:
- 16 and SEQ ID NO:
- 19.
34 more elements
Dependencies are inferred from the claim text.