Cardiac troponin I specific antibody, kit and uses thereof

Patent metadata

Field	Value
Publication number	US-12590144-B2
Application number	US-202318479371-A
Country	US
Kind code	B2
Filing date	Oct 2, 2023
Priority date	Sep 30, 2022
Publication date	Mar 31, 2026
Grant date	Mar 31, 2026

Abstract

The present disclosure provides an antibody specifically targeting cardiac troponin I. The present disclosure further provides antibody pairs and kits comprising the antibodies. The present disclosure further provides the use of these antibodies to detect levels of cardiac troponin I, and to diagnose myocardial injury.

First claim

What is claimed is:

1 . An isolated antibody or antigen-binding fragment(s) thereof that specifically binds to cardiac troponin I, having a heavy chain and a light chain, wherein the heavy chain comprises a heavy chain variable region, and the light chain comprises a light chain variable region,
wherein the heavy chain variable region comprises:
a. CDR-H1, having the amino acid sequence of SEQ ID NO.1;
b. CDR-H2, having the amino acid sequence of SEQ ID NO.2; and
c. CDR-H3, having the amino acid sequence of SEQ ID NO.3,
wherein the light chain variable region comprises:
a. CDR-L1, having the amino acid sequence of SEQ ID NO.4;
b. CDR-L2, having the amino acid sequence of SEQ ID NO.5; and
c. CDR-L3, having the amino acid sequence of SEQ ID NO.6.

2 . The isolated antibody or antigen-binding fragment(s) thereof according to claim 1 , wherein, the antibody or antigen-binding fragment(s) thereof has a KD value of less than 20 nM.

3 . The isolated antibody or antigen-binding fragment(s) thereof according to claim 2 , wherein, the antibody or antigen-binding fragment(s) thereof has a KD value of less than 5 nM.

4 . The isolated antibody or antigen-binding fragment(s) thereof according to claim 3 , wherein, the antibody or antigen-binding fragment(s) thereof has a KD value of less than 2 nM.

5 . A conjugate, comprising the antibody or antigen-binding fragment(s) thereof according to claim 1 and a coupling moiety, wherein the coupling moiety is a detectable marker.

6 . An antibody pair, comprising a capture antibody and a detection antibody, wherein the capture antibody and the detection antibody target different epitopes of cardiac troponin I, wherein one of the capture antibody and the detection antibody is selected from an antibody or antigen-binding fragment(s) thereof according to claim 1 , and the other is selected from a group consisting of Known Antibody 1, Known Antibody 2, Known Antibody 3, or Known Antibody 4 antibody, wherein,
the Known Antibody 1 is an antibody which comprises CDR-H1-3 having respective amino acid sequence of SEQ ID NO: 7-9; and CDR-L1-3 having respective amino acid sequence of SEQ ID NO: 10-12; the Known Antibody 2 is an antibody which comprises CDR-H1-3 having respective amino acid sequence of SEQ ID NO: 13-15; and CDR-L1-3 having respective amino acid sequence of SEQ ID NO: 16-18; the Known Antibody 3 is an antibody which comprises CDR-H1-3 having respective amino acid sequence of SEQ ID NO: 19-21; and CDR-L1-3 having respective amino acid sequence of SEQ ID NO: 22-24; the Known Antibody 4 is an antibody which comprises CDR-H1-3 having respective amino acid sequence of SEQ ID NO: 25-27; and CDR-L1-3 having respective amino acid sequence of SEQ ID NO: 28-30.

7 . The antibody pair according to claim 6 , wherein, the capture antibody is an antibody which comprises CDR-H1 having the amino acid sequence of SEQ ID NO.1 and CDR-H2 having the amino acid sequence of SEQ ID NO.2, and CDR-H3 having the amino acid sequence of SEQ ID NO.3; and CDR-L1 having the amino acid sequence of SEQ ID NO.4, CDR-L2 having the amino acid sequence of SEQ ID NO.5, and CDR-L3 having the amino acid sequence of SEQ ID NO.6; the detection antibody is the Known Antibody 4.

8 . A kit, comprising the antibody or antigen-binding fragment(s) thereof according to claim 1 .

9 . The kit according to claim 8 , wherein the kit further comprises a second antibody, which specifically recognizes the antibody or antigen-binding fragment(s) thereof.

10 . A kit, comprising the antibody pair of claim 6 .

11 . A method of
detecting the presence or a level of cardiac troponin I in a sample from a subject comprising contacting the sample with the antibody or antigen-binding fragment(s) thereof according to claim 1 .

12 . A method
for assisting diagnosis of myocardial injury comprising detecting the presence or a level of cardiac troponin I in a sample from a subject by contacting the sample with the antibody or antigen-binding fragment(s) thereof according to claim 1 .

13 . An isolated antibody or antigen-binding fragment(s) thereof, wherein, the isolated antibody or antigen-binding fragment(s) thereof specifically binds to cardiac troponin I secreted by a hybridoma cell strain deposited with the Russian National Collection of Industrial Microorganisms (VKPM) with an accession/deposit number of H-202.

Assignees

• Shenzhen Mindray Biomedical Electronics Co Ltd

Inventors

• Ageeva Ludmila V
• Bereznikova Anastasia V
• Bogomolova Agnessa P
• Katrukha Alexey G
• Kozlovsky Stanislav V
• Popova Anfisa S
• Postnikov Alexander B
• Rozov Fedor N
• Tamm Natalia N
• Zhang Yi
• Luo Sheng
• Chen Puguang

Classifications

• G01N33/6887

  from muscle, cartilage or connective tissue · CPC title

• C07K2317/92

  Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value · CPC title

• A61K47/6897

  Pre-targeting systems with two or three steps using antibody conjugates; Ligand-antiligand therapies · CPC title

• G01N2800/325

  Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure · CPC title

• G01N2333/91205

  Phosphotransferases in general · CPC title