# US 10,865,246 B2 · Anti-PD-L1 antibody for detecting PD-L1

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- Number: US 10,865,246 B2
- Document ID: US10865246B2
- Status: Granted
- Kind: B2
- Application number: 16/491,145
- Filed: 2018-03-23
- Published: 2020-01-30
- Granted: 2020-12-15
- Earliest claimed: 2017-03-27
- Assignees: Fuso Pharmaceutical Industries, Ltd.; National University Corporation Hokkaido University
- Applicants: Fuso Pharmaceutical Industries, Ltd.; National University Corporation Hokkaido University
- Inventors: Satoru Konnai; Kazuhiko Ohashi; Shiro Murata; Tomohiro Okagawa; Asami Nishimori; Naoya Maekawa; Satoshi Takagi; Yumiko Kagawa; Yasuhiko Suzuki; Chie Nakajima
- Web page: https://patentgrep.com/patent/US10865246B2

## CPC

- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- C12N 5/10: Cells modified by introduction of foreign genetic material
- C12N 15/85: for animal cells
- C12Q 1/04: Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor {(C12Q1/6897 takes precedence)}
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 33/5695: {Mycobacteria}
- G01N 33/5759: {involving compounds localised on the membrane of tumour or cancer cells}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/565: Complementarity determining region [CDR]
- G01N 2800/26: Infectious diseases, e.g. generalised sepsis
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention provides an anti-PD-L1 antibody capable of staining tumor cells such as melanoma cells. An anti-PD-L1 antibody comprising (a) a light chain comprising CDR1 having the amino acid sequence of KSISKY (SEQ ID NO: 1), CDR2 having the amino acid sequence of SGS and CDR3 having the amino acid sequence of QQHNEYPLT (SEQ ID NO: 2) and (b) a heavy chain comprising CDR1 having the amino acid sequence of GYTFTDYI (SEQ ID NO: 3), CDR2 having the amino acid sequence of INPDSGGN (SEQ ID NO: 4) and CDR3 having the amino acid sequence of ARGITMMVVISHWKFDF (SEQ ID NO: 5). A composition for detecting PD-L1, comprising the above antibody as an active ingredient. A method for preparing the above antibody is also provided.

## Claims

### Claim 1

An anti-PD-L1 antibody comprising (a) a light chain comprising CDR1 having the amino acid sequence of KSISKY (SEQ ID NO: 1), CDR2 having the amino acid sequence of SGS and CDR3 having the amino acid sequence of QQHNEYPLT (SEQ ID NO: 2) and (b) a heavy chain comprising CDR1 having the amino acid sequence of GYTFTDYI (SEQ ID NO: 3), CDR2 having the amino acid sequence of INPDSGGN (SEQ ID NO: 4) and CDR3 having the amino acid sequence of ARGITMMVVISHWKFDF (SEQ ID NO: 5).

### Claim 2 (depends on 1)

The antibody of claim 1, which is from rat.

### Claim 3 (depends on 2)

The antibody of claim 2, which is a rat anti-bovine PD-L1 antibody.

### Claim 4 (depends on 3)

The antibody of claim 3, wherein the light chain variable region has the amino acid sequence as shown in SEQ ID NO. 6 and the heavy chain variable region has the amino acid sequence as shown in SEQ ID NO: 7.

### Claim 5 (depends on 1)

The antibody of claim 1, wherein the light chain constant region has the amino acid sequence of the constant region of kappa chain.

### Claim 6 (depends on 1)

The antibody of claim 1, wherein the heavy chain constant region has the amino acid sequence of the constant region of IgG2a.

### Claim 7 (depends on 5)

The antibody of claim 5, wherein the light chain constant region has the amino acid sequence as shown in any one of SEQ ID NOS: 8, 10 to 12 and the heavy chain constant region has the amino acid sequence as shown in SEQ ID NO: 9 or 13.

### Claim 8 (depends on 1)

The antibody of claim 1 which has a four-chain structure comprising two light chains and two heavy chains.

### Claim 9 (depends on 1)

A composition comprising the antibody of claim 1 as an active ingredient and a carrier.

### Claim 10 (depends on 9)

A method to diagnose malignant melanoma cancer comprising contacting in vitro one or more cells from a subject with the composition of claim 9; determining if said antibodies in said composition binds to said one or more cells, wherein increased binding to cancer cell as compared to a control is indicative of malignant melanoma cancer.
