IP Library › Granted Patent US 12,625,149
Granted Patent B2
US 12,625,149 · App. 17/937,339 · Granted May 12, 2026

Pathologic TDP-43 as a biomarker for the diagnosis of TDP-43 proteinopathy

Inventor: Qinwen Mao (Salt Lake City, UT)
Assignee: UNIVERSITY OF UTAH RESEARCH FOUNDATION
G01N33/6896G01N2800/2814
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Quick Facts
Patent No.
US 12,625,149
App. No.
17/937,339
Granted
May 12, 2026
Kind
B2
Abstract

Disclosed herein are antibodies or antigen-binding fragments thereof and compositions comprising the same. Also disclosed are methods of detecting TAR DNA-binding protein 43 (TDP-43) in a biological sample, diagnosing a neurodegenerative disease in a subject, and selecting whether to enroll a subject in a clinical trial for frontotemporal lobar degeneration with TDP-43 inclusions (FTLD-TDP) using the antibodies or antigen-binding fragments thereof described herein. In addition, disclosed herein are immunoassay kits for selectively detecting TDP-43 in a biological sample.

Claims (42)

1 . An antibody or antigen-binding fragment thereof comprising an immunoglobulin heavy chain (HC) variable domain sequence and an immunoglobulin light chain (LC) variable domain sequence, wherein:

(a) the immunoglobulin HC variable domain sequence comprises

(i) an HC CDR1 comprising the amino acid sequence of SEQ ID NO: 4,

(ii) an HC CDR2 comprising the amino acid sequence of SEQ ID NO: 5, and

(iii) an HC CDR3 comprising the amino acid sequence of SEQ ID NO: 6; and

(b) the immunoglobulin LC variable domain sequence comprises

(i) an LC CDR1 comprising the amino acid sequence of SEQ ID NO: 8,

(ii) an LC CDR2 comprising the amino acid sequence of SEQ ID NO: 9, and

(iii) an LC CDR3 comprising the amino acid sequence of SEQ ID NO: 10.

2 . The antibody or antigen-binding fragment thereof of claim 1 , wherein the immunoglobulin HC variable domain sequence comprises the amino acid sequence of SEQ ID NO: 3; and

the immunoglobulin LC variable domain sequence comprises the amino acid sequence of SEQ ID NO: 7.

3 . An immunoassay kit comprising one or more of the antibodies or antigen-binding fragments thereof of claim 1 .

4 . An immunoassay kit for selectively detecting TAR DNA-binding protein 43 (TDP-43; SEQ ID NO: 1) in a biological sample, the kit comprising:

an antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment comprises an immunoglobulin heavy chain (HC) variable domain sequence and an immunoglobulin light chain (LC) variable domain sequence, wherein:

(a) the immunoglobulin HC variable domain sequence comprises

(i) an HC CDR1 comprising the amino acid sequence of SEQ ID NO: 4,

(ii) an HC CDR2 comprising the amino acid sequence of SEQ ID NO: 5, and

(iii) an HC CDR3 comprising the amino acid sequence of SEQ ID NO: 6; and

(b) the immunoglobulin LC variable domain sequence comprises

(i) an LC CDR1 comprising the amino acid sequence of SEQ ID NO: 8,

(ii) an LC CDR2 comprising the amino acid sequence of SEQ ID NO: 9, and

(iii) an LC CDR3 comprising the amino acid sequence of SEQ ID NO: 10; and, a detection reagent.

5 . The kit of claim 4 , further comprising a solid support for the antibody or antigen-binding fragment thereof.

6 . The kit of claim 4 , wherein the detection reagent is one or more of colorimetric substrates, chemiluminescent substrates, and fluorescent substrates.

7 . The kit of claim 4 , further comprising a second antibody or antigen-binding fragment thereof, wherein the second antibody or antigen-binding fragment comprises an immunoglobulin HC variable domain sequence and an immunoglobulin LC variable domain sequence, wherein:

(a) the immunoglobulin HC variable domain sequence comprises

(i) an HC CDR1 comprising the amino acid sequence of SEQ ID NO: 12,

(ii) an HC CDR2 comprising the amino acid sequence of SEQ ID NO: 13, and

(iii) an HC CDR3 comprising the amino acid sequence of SEQ ID NO: 14; and

(b) the immunoglobulin LC variable domain sequence comprises

(i) an LC CDR1 comprising the amino acid sequence of SEQ ID NO: 16,

(ii) an LC CDR2 comprising the amino acid sequence of SEQ ID NO: 17, and

(iii) an LC CDR3 comprising the amino acid sequence of SEQ ID NO: 18.

8 . The kit of claim 4 , further comprising a second antibody or antigen-binding fragment thereof, wherein the second antibody or antigen-binding fragment comprises an immunoglobulin HC variable domain sequence and an immunoglobulin LC variable domain sequence, wherein:

(a) the immunoglobulin HC variable domain sequence comprises

(i) an HC CDR1 comprising the amino acid sequence of SEQ ID NO: 20,

(ii) an HC CDR2 comprising the amino acid sequence of SEQ ID NO: 21, and

(iii) an HC CDR3 comprising the amino acid sequence of SEQ ID NO: 22; and

(b) the immunoglobulin LC variable domain sequence comprises

(i) an LC CDR1 comprising the amino acid sequence of SEQ ID NO: 24,

(ii) an LC CDR2 comprising the amino acid sequence of SEQ ID NO: 25, and

(iii) an LC CDR3 comprising the amino acid sequence of SEQ ID NO: 26.

Continuity (3)
Provisional Application 63252353 · Oct 5, 2021
Provisional Application 63251383 · Oct 1, 2021
Related Publication 20230107901A1 · Apr 6, 2023
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