# US 2021/0079110 A1 · Monoclonal antibody and use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0079110 A1 - Document ID: US20210079110A1 - Status: Published application - Kind: A1 - Application number: 16/763,386 - Filed: 2018-11-09 - Published: 2021-03-18 - Earliest claimed: 2017-11-14 - Assignees: School Juridical Person Kitasato Institute - Applicants: School Juridical Person the Kitasato Institute - Inventors: Takashi FUKUYAMA; Hitoshi YAMAZAKI; Mariko OGI; Noritada KOBAYASHI; Yoshinobu ICHIKI; Masahiko HATAKEYAMA - Web page: https://patentgrep.com/patent/US20210079110A1 ## CPC - C07K 16/30: from tumour cells - C07K 16/3069: {Reproductive system, e.g. ovaria, uterus, testes, prostate} - C07K 16/32: against translation products of oncogenes - C12N 5/12: Fused cells, e.g. hybridomas - G01N 33/575: for cancer - G01N 33/5753: of the stomach or small intestine - G01N 33/5759: {involving compounds localised on the membrane of tumour or cancer cells} - C07K 2317/565: Complementarity determining region [CDR] - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Provided is a monoclonal antibody or a fragment thereof in which heavy-chain complementarity-determining regions (CDRs) 1 to 3 respectively consist of amino acid sequences of SEQ ID NOs: 2 to 4 and light-chain CDRs 1 to 3 respectively consist of amino acid sequences of SEQ ID NOs: 5 to 7; a monoclonal antibody or a fragment thereof in which heavy-chain CDRs 1 to 3 respectively consist of amino acid sequences obtained by deleting, substituting, or adding one or several amino acids in the amino acid sequences of SEQ ID NOs: 2 to 4 and light-chain CDRs 1 to 3 respectively consist of amino acid sequences obtained by deleting, substituting, or adding one or several amino acids in the amino acid sequences of SEQ ID NOs: 5 to 7, and which has binding properties to a KK-LC-1 protein; or a monoclonal antibody or a fragment thereof which competes with the monoclonal antibody or a fragment thereof in which the heavy-chain CDRs 1 to 3 respectively consist of the amino acid sequences of SEQ ID NOs: 2 to 4 and the light-chain CDRs 1 to 3 respectively consist of the amino acid sequences of SEQ ID NOs: 5 to 7, and has binding properties to the KK-LC-1 protein. ## Claims ### Claim 1 A monoclonal antibody or a fragment thereof, which is one of the following (i) to (iii): (i) a monoclonal antibody or a fragment thereof in which heavy-chain complementarity-determining regions (CDRs) 1 to 3 respectively consist of amino acid sequences of SEQ ID NOs: 2 to 4 and light-chain CDRs 1 to 3 respectively consist of amino acid sequences of SEQ ID NOs: 5 to 7; (ii) a monoclonal antibody or a fragment thereof in which heavy-chain CDRs 1 to 3 respectively consist of amino acid sequences obtained by deleting, substituting, or adding one or several amino acids in the amino acid sequences of SEQ ID NOs: 2 to 4 and light-chain CDRs 1 to 3 respectively consist of amino acid sequences obtained by deleting, substituting, or adding one or several amino acids in the amino acid sequences of SEQ ID NOs: 5 to 7, and which has binding properties to a Kitakyushu lung cancer antigen-1 (KK-LC-1) protein; and (iii) a monoclonal antibody or a fragment thereof which competes with the monoclonal antibody or a fragment thereof in which the heavy-chain CDRs 1 to 3 respectively consist of the amino acid sequences of SEQ ID NOs: 2 to 4 and the light-chain CDRs 1 to 3 respectively consist of the amino acid sequences of SEQ ID NOs: 5 to 7, and has binding properties to the KK-LC-1 protein. ### Claim 2 (depends on 1) The monoclonal antibody or a fragment thereof according to claim 1, wherein the monoclonal antibody or a fragment thereof has binding properties to a KK-LC-1 protein in a fixed biological sample. ### Claim 3 (depends on 2) The monoclonal antibody or a fragment thereof according to claim 2, wherein the biological sample is fixed with a crosslinking fixative. ### Claim 4 (depends on 3) The monoclonal antibody or a fragment thereof according to claim 3, wherein the crosslinking fixative is formaldehyde, paraformaldehyde, or glutaraldehyde. ### Claim 5 (depends on 1) The monoclonal antibody or a fragment thereof according to claim 1, wherein the monoclonal antibody or a fragment thereof has binding properties to a peptide consisting of an amino acid sequence set forth in SEQ ID NO: 1. ### Claim 6 (depends on 1) The monoclonal antibody or a fragment thereof according to claim 1, wherein the monoclonal antibody or a fragment thereof has binding properties to a peptide consisting of an amino acid sequence set forth in SEQ ID NO: 12. ### Claim 7 (depends on 1) The monoclonal antibody or a fragment thereof according to claim 1, wherein the monoclonal antibody or a fragment thereof is produced by a hybridoma cell line having an accession number of NITE BP-02527. ### Claim 8 (depends on 1) A cancer detection kit comprising the monoclonal antibody or a fragment thereof according to claim 1. ### Claim 9 (depends on 1) A nucleic acid encoding the monoclonal antibody or a fragment thereof according to claim 1. ### Claim 10 (depends on 1) A cancer detection method comprising reacting a fixed biological sample with the monoclonal antibody or a fragment thereof according to claim 1. ### Claim 11 A hybridoma cell line having an accession number of NITE BP-02527. ### Claim 12 A method for detecting a KK-LC-1 protein in a biological sample, comprising detecting a peptide consisting of an amino acid sequence set forth in SEQ ID NO: 1 or a partial peptide thereof. ### Claim 13 (depends on 12) The method according to claim 12, wherein the partial peptide is a peptide consisting of an amino acid sequence set forth in SEQ ID NO: 12.