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US 12,760,115 B2Granted
Antibodies against claudin 18.2 useful in cancer diagnosis
AssigneesAstellas Pharma Inc., TRON—Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg-Universität Mainz gemeinnützige GmbH
InventorsUgur Sahin, Ozlem Tureci, Rita Mitnacht-Kraus, Stefan Woll
Life of this patent
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Abstract
The invention relates to antibodies directed against an epitope located within the C-terminal portion of CLDN18.2 which are useful, for example, in diagnosing cancer and/or in determining whether cancer cells express CLDN18.2.
Claims15
A method for detecting CLDN18.2 or determining the quantity of CLDN18.2 in a sample comprising the steps of:
- (A) contacting a sample with an antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is selected from the group consisting of:
- (i) an antibody produced by or obtainable from a clone deposited under the accession no. DSM ACC3144 (muAB 43-14A) or DSM ACC3143 (muAB 35-22A),
- (ii) an antibody which is a chimerized or humanized form of the antibody under (i),
- (iii) an antibody comprising the antigen binding site of the antibody under (i), and
- (iv) an antigen-binding fragment of the antibody under any one of (i) to (iii);
- and wherein the antibody or antigen-binding fragment thereof
- (a) binds to a peptide having the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO:
- 5) or EVQSYPSKHDYV (SEQ ID NO:
- 6) and/or
- (b) binds to claudin 18.2 (CLDN18.2), wherein said antibody or antigen-binding fragment thereof binds to CLDN18.2 by binding at least to an epitope within CLDN18.2 having the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO:
- 5) or EVQSYPSKHDYV (SEQ ID NO:
- 6);
- and
- (B) detecting the formation of a complex or determining the quantity of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2.
11 more elements
A method for determining whether cells express CLDN18.2 comprising the steps of:
- (A) contacting a cellular sample with an antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is selected from the group consisting of:
- (i) an antibody produced by or obtainable from a clone deposited under the accession no. DSM ACC3144 (muAB 43-14A) or DSM ACC3143 (muAB 35-22A),
- (ii) an antibody which is a chimerized or humanized form of the antibody under (i),
- (iii) an antibody comprising the antigen binding site of the antibody under (i), and
- (iv) an antigen-binding fragment of the antibody under any one of (i) to (iii);
- and wherein the antibody or antigen-binding fragment thereof
- (a) binds to a peptide having the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO:
- 5) or EVQSYPSKHDYV (SEQ ID NO:
- 6) and/or
- (b) binds to claudin 18.2 (CLDN18.2), wherein said antibody or antigen-binding fragment thereof binds to CLDN18.2 by binding at least to an epitope within CLDN18.2 having the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO:
- 5) or EVQSYPSKHDYV (SEQ ID NO:
- 6);
- and
- (B) detecting the formation of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2 expressed by cells in said sample.
11 more elements
A method for diagnosis, detection or monitoring of cancer comprising the steps of:
- (A) contacting a biological sample with an antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is selected from the group consisting of:
- (i) an antibody produced by or obtainable from a clone deposited under the accession no. DSM ACC3144 (muAB 43-14A) or DSM ACC3143 (muAB 35-22A),
- (ii) an antibody which is a chimerized or humanized form of the antibody under (i),
- (iii) an antibody comprising the antigen binding site of the antibody under (i), and
- (iv) an antigen-binding fragment of the antibody under any one of (i) to (iii);
- and wherein the antibody or antigen-binding fragment thereof
- (a) binds to a peptide having the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO:
- 5) or EVQSYPSKHDYV (SEQ ID NO:
- 6) and/or
- (b) binds to claudin 18.2 (CLDN18.2), wherein said antibody or antigen-binding fragment thereof binds to CLDN18.2 by binding at least to an epitope within CLDN18.2 having the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO:
- 5) or EVQSYPSKHDYV (SEQ ID NO:
- 6);
- and
- (B) detecting the formation of a complex and/or determining the quantity of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2;
- wherein the presence of CLDN18.2 or a quantity of CLDN18.2 in the sample which is increased compared to a reference level is indicative of the presence and/or stage of cancer.
12 more elements
A method for determining whether a cancer is treatable by a cancer therapy targeting CLDN18.2 comprising the steps of:
- (A) contacting a sample comprising cancer cells with an antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is selected from the group consisting of:
- (i) an antibody produced by or obtainable from a clone deposited under the accession no. DSM ACC3144 (muAB 43-14A) or DSM ACC3143 (muAB 35-22A),
- (ii) an antibody which is a chimerized or humanized form of the antibody under (i),
- (iii) an antibody comprising the antigen binding site of the antibody under (i), and
- (iv) an antigen-binding fragment of the antibody under any one of (i) to (iii);
- and wherein the antibody or antigen-binding fragment thereof
- (a) binds to a peptide having the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO:
- 5) or EVQSYPSKHDYV (SEQ ID NO:
- 6) and/or
- (b) binds to claudin 18.2 (CLDN18.2), wherein said antibody or antigen-binding fragment thereof binds to CLDN18.2 by binding at least to an epitope within CLDN18.2 having the amino acid sequence TEDEVQSYPSKHDYV (SEQ ID NO:
- 5) or EVQSYPSKHDYV (SEQ ID NO:
- 6);
- and
- (B) detecting the formation of a complex between the antibody or the antigen-binding fragment thereof and CLDN18.2;
- wherein formation of the complex indicates the presence of CLDN18.2or CLDN18.2-expressing cells in the sample and allows for determination of a quantity of CLDN18.2 or CLDN18.2-expressing cells in the sample;
- and wherein the presence or the quantity of CLDN18.2 or CLDN18.2-expressing cells in the sample indicates that the cancer is treatable by a cancer therapy targeting CLDN18.2.
13 more elements
Dependencies are inferred from the claim text.