# US 12,595,308 B2 · Anti-B7H3 antibody and use thereof

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- Number: US 12,595,308 B2
- Document ID: US12595308B2
- Status: Granted
- Kind: B2
- Application number: 18/003,996
- Filed: 2020-12-15
- Published: 2025-01-09
- Granted: 2026-04-07
- Earliest claimed: 2020-06-30
- Assignees: Guangzhou Bio-Gene Technology Co., Ltd
- Applicants: Guangzhou Bio-Gene Technology Co., Ltd
- Inventors: Min Luo; Guangchao Li; Zhao Zhou; Xuejun Wang
- Web page: https://patentgrep.com/patent/US12595308B2

## CPC

- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/41: Glycosylation, sialylation, or fucosylation
- C07K 2317/52: Constant or Fc region; Isotype
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/64: comprising a combination of variable region and constant region components
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Provided are an anti-B7H3 antibody and the use thereof. A variable region of the antibody comprises amino acid sequences as shown in SEQ ID NOs: 25-39. The anti-B7H3 antibodies 26B6, 6F7, 2B8, and 23H1 have a significant binding capability to B7H3, can not only bind to purified or free B7H3 protein, but also can bind to B7H3 protein on a cell surface; and after humanized modification, the affinity between the antibody and B7H3 is further improved, and the antibody has important application prospects in clinical diagnosis and/or treatment of B7H3-positive tumors.

## Claims

### Claim 1

An anti-B7H3 antibody or antigen-binding fragment thereof, comprising heavy chain variable domain CDRs: CDRH1, CDRH2, and CDRH3; and light chain variable domain CDRs: CDRL1, CDRL2, and CDRL3;
wherein CDRH1 is selected from SEQ ID NOs: 17, 18, 19, or 20;
wherein CDRH2 is selected from SEQ ID NOs: 9, 10, 11, or 12;
wherein CDRH3 is selected from SEQ ID NOs: 1, 2, 3, or 4;
wherein CDRL1 is selected from SEQ ID NOs: 21, 22, 23, or 24;
wherein CDRL2 is selected from SEQ ID NOs: 13, 14, 15, or 16; and
wherein CDRL3 is selected from SEQ ID NOs: 5, 6, 7, or 8.

### Claim 2 (depends on 1)

The anti-B7H3 antibody or antigen-binding fragment thereof according to claim 1, wherein the CDRH1 is SEQ ID NO:17, the CDRH2 is SEQ ID NO:9, and the CDRH3 is SEQ ID NO:1; and
the CDRL1 is SEQ ID NO:21, the CDRL2 is SEQ ID NO:13, and the CDRL3 is SEQ ID NO:5; or,
the CDRH1 is SEQ ID NO:18, the CDRH2 is SEQ ID NO:10, and the CDRH3 is SEQ ID NO:2; and
the CDRL1 is SEQ ID NO:22, the CDRL2 is SEQ ID NO:14, and the CDRL3 is SEQ ID NO:6; or,
the CDRH1 is SEQ ID NO:19, the CDRH2 is SEQ ID NO:11, and the CDRH3 is SEQ ID NO:3; and
the CDRL1 is SEQ ID NO:23, the CDRL2 is SEQ ID NO:15, and the CDRL3 is SEQ ID NO:7; or,
the CDRH1 is SEQ ID NO:20, the CDRH2 is SEQ ID NO:12, and the CDRH3 is SEQ ID NO:4; and
the CDRL1 is SEQ ID NO:24, the CDRL2 is SEQ ID NO:16, and the CDRL3 is SEQ ID NO:8.

### Claim 3 (depends on 1)

The anti-B7H3 antibody or antigen-binding fragment thereof according to claim 1, comprising a heavy chain variable domain and a light chain variable domain;
wherein the heavy chain variable domain is SEQ ID NO: 25, and the light chain variable domain is SEQ ID NO: 26;
wherein the heavy chain variable domain is SEQ ID NO: 27, and the light chain variable domain is SEQ ID NO: 28;
wherein the heavy chain variable domain is SEQ ID NO: 29, and the light chain variable domain is SEQ ID NO: 30;
wherein the heavy chain variable domain is SEQ ID NO: 31, and the light chain variable domain is SEQ ID NO: 32 or SEQ ID NO: 33;
wherein the heavy chain variable domain is SEQ ID NO: 34, and the light chain variable domain is SEQ ID NO: 35;
wherein the heavy chain variable domain is SEQ ID NO: 36, and the light chain variable domain is SEQ ID NO: 37; or
wherein the heavy chain variable domain is SEQ ID NO: 38, and the light chain variable domain is SEQ ID NO: 39.

### Claim 4 (depends on 1)

A nucleic acid molecule, comprising a DNA fragment for encoding the antigen-binding fragment according to claim 1.

### Claim 5 (depends on 4)

An expression vector, comprising the nucleic acid molecule according to claim 4.

### Claim 6 (depends on 5)

A host cell, comprising the expression vector according to claim 5.

### Claim 7 (depends on 1)

A method for preparing an antibody, comprising the following steps:
(1) ligating an encoding nucleic acid of the antigen-binding fragment according to claim 1 to a plasmid, transferring the plasmid into competent cells and culturing the competent cells, then selecting a positive clone by screening;
(2) extracting expression vectors from the positive clone, transferring the vectors into host cells, culturing the host cells and collecting a supernatant, then obtaining the antibody by separation and purification.

### Claim 8 (depends on 3)

A pharmaceutical composition, comprising the antibody according to claim 3;
wherein the pharmaceutical composition further comprises any one or a combination of at least two of a pharmaceutically acceptable carrier, a diluent or an excipient.

### Claim 9 (depends on 1)

A method comprising preparing a tumor detection reagent and/or a tumor treatment drug using the antigen-binding fragment according to claim 1;
wherein the tumor comprises a tumor that is positive for B7H3 expression; and
wherein the tumor comprises any one or a combination of at least two of nervous system tumor, melanoma, lung cancer, head and neck cancer, colorectal cancer, pancreatic cancer, gastric cancer, kidney cancer, bladder cancer, prostate cancer, breast cancer, ovarian cancer or hepatocellular carcinoma.

### Claim 10 (depends on 1)

The anti-B7H3 antibody according to claim 1, further comprising a constant region.

### Claim 11 (depends on 1)

The anti-B7H3 antibody according to claim 1, wherein the antibody is modified with a glycosylation group.