# US 2019/0169294 A1 · Anti-lag-3 antibody

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- Number: US 2019/0169294 A1
- Document ID: US20190169294A1
- Status: Published application
- Kind: A1
- Application number: 16/325,150
- Filed: 2017-08-10
- Published: 2019-06-06
- Earliest claimed: 2016-08-15
- Assignees: National University Corporation Hokkaido University; Fuso Pharmaceutical Industries, Ltd.
- Applicants: National University Corporation Hokkaido University; Fuso Pharmaceutical Industries, Ltd.
- Inventors: Satoru Konnai; Kazuhiko Ohashi; Shiro Murata; Tomohiro Okagawa; Asami Nishimori; Naoya Maekawa; Yasuhiko Suzuki; Chie Nakajima
- Web page: https://patentgrep.com/patent/US20190169294A1

## CPC

- C07K 16/2803: {against the immunoglobulin superfamily}
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61P 15/14: for lactation disorders, e.g. galactorrhoea
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/06: for tuberculosis
- A61P 31/10: Antimycotics
- A61P 33/02: Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- C07K 16/46: Hybrid immunoglobulins (hybrids of an immunoglobulin with a peptide not being an immunoglobulin C07K19/00)
- C12N 5/10: Cells modified by introduction of foreign genetic material
- C12N 15/09: Recombinant DNA-technology
- C12N 15/85: for animal cells
- 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
- C12N 2015/8518: {expressing industrially exogenous proteins, e.g. for pharmaceutical use, human insulin, blood factors, immunoglobulins, pseudoparticles}
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention provides an anti-LAG-3 antibody capable of repeated administration even to animals other than rat. An anti-LAG-3 antibody comprising (a) a light chain comprising a light chain variable region containing CDR1 having the amino acid sequence of QSLLDSDGNTY (SEQ ID NO: 16), CDR2 having the amino acid sequence of SVS and CDR3 having the amino acid sequence of MQATHVPFT (SEQ ID NO: 17) and the light chain constant region of an antibody of an animal other than rat; and (h) a heavy chain comprising a heavy chain variable region containing CDR1 having the amino acid sequence of GFDFDTYP (SEQ ID NO: 18), CDR2 having the amino acid sequence of ITIKTHNYAT (SEQ ID NO: 19) and CDR3 having the amino acid sequence of NREDFDY (SEQ ID NO: 20) and the heavy chain constant region of an antibody of an animal other than rat. A pharmaceutical composition comprising the above anti-LAG-3 antibody as an active ingredient. A method for preparing the above anti-LAG-3 antibody is also provided.

## Claims

### Claim 1

An anti-LAG-3 antibody comprising (a) a light chain comprising a light chain variable region containing CDR1 having the amino acid sequence of QSLLDSDGNTY (SEQ ID NO: 16), CDR2 having the amino acid sequence of SVS and CDR3 having the amino acid sequence of MQATHVITT (SEQ ID NO: 17) and the light chain constant region of an antibody of an animal other than rat; and (b) a heavy chain comprising a heavy chain variable region containing CDR1 having the amino acid sequence of GFDFDTYP (SEQ ID NO: 18), CDR2 having the amino acid sequence of ITIKITINYA717 (SDI) ID NO: 19) and CDR3 having the amino add sequence of NREDFDY (SEQ II) NO: 20) and the heavy chain constant region of an antibody of an animal other than rat.

### Claim 2 (depends on 1)

The antibody of claim 1, wherein the light chain variable region and the heavy chain variable region are derived from rat.

### Claim 3 (depends on 2)

The antibody of claim 2, wherein the light chain variable region is the light chain variable region of a rat anti-bovine LAG-3 antibody and the heavy chain variable region is the heavy chain variable region of a rat anti-bovine LAG-3 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. 1 and the heavy chain variable region has the amino acid sequence as shown in SEQ ID NO: 2.

### Claim 5 (depends on 1)

The antibody of claim 1, wherein the light chain constant region of an antibody of an animal other than rat has the amino acid sequence of the constant region of lambda chain or kappa chain.

### Claim 6 (depends on 1)

The antibody of claim 1, wherein the heavy chain constant region of an antibody of an animal other than rat has the amino acid sequence of the constant region of an immunoglobulin equivalent to human IgG4 or said amino acid sequence having mutations introduced thereinto that reduce ADCC activity and/or CDC activity.

### Claim 7 (depends on 6)

The antibody of claim 6, wherein the animal other than rat is bovine; the light chain constant region of the bovine antibody has the amino acid sequence of the constant region of lambda chain; and the heavy chain constant region of the bovine antibody has mutations introduced thereinto that reduce ADCC activity and/or CDC activity.

### Claim 8 (depends on 7)

The antibody of claim 7, wherein the light chain constant region of the bovine antibody has the amino acid sequence as shown in SEQ ID NO: 3 and the heavy chain constant region of the bovine antibody has the amino acid sequence as shown in SEQ ID NO: 4.

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

A pharmaceutical composition comprising the antibody of claim 1 as an active ingredient.

### Claim 11 (depends on 10)

The pharmaceutical composition of claim 10 for prevention and/or treatment of cancers and/or inflammations.

### Claim 12 (depends on 11)

The pharmaceutical composition of claim 11, wherein the cancers and/or inflammations are selected from the group consisting of neoplastic diseases, leukemia, Johne's disease, anaplasmosis, bacterial mastitis, mycotic mastitis, mycoplasma infections (such as mycoplasma mastitis, mycoplasma pneumonia or the like), tuberculosis, Theileria orientalis infection, cryptosporidiosis, coccidiosis, trypanosomiasis and leishmaniasis.

### Claim 13

An artificial genetic DNA comprising (a′) a DNA encoding a light chain comprising a light chain variable region containing CDR1 having the amino acid sequence of QSLLDSDGNTY (SEQ ID NO: 16), CDR2 having the amino acid sequence of SVS and CDR3 having the amino acid sequence of MQATHVPFT (SEQ ID NO: 17) and the light chain constant region of an antibody of an animal other than rat; and (b′) a DNA encoding a heavy chain comprising a heavy chain variable region containing CDR1 having the amino acid sequence of GFDFDTYP (SEQ ID NO: 18), CDR2 having the amino acid sequence of rincniNyAT (SEQ ID NO: 19) and CDR3 having the amino acid sequence of NREDFDY (SEQ ID NO: 20) and the heavy chain constant region of an antibody of an animal other than rat.

### Claim 14 (depends on 13)

A vector comprising the artificial genetic DNA of claim 13.

### Claim 15 (depends on 14)

A hostcell transformed with the vector of claim 14.

### Claim 16 (depends on 15)

A method of preparing an antibody, comprising culturing the host cell of claim 15 and collecting an anti-LAG-3 antibody from the resultant culture.

### Claim 17

A DNA encoding a light chain comprising a light chain variable region containing CDR1 having the amino acid sequence of QSLLDSDGNTY (SEQ ID NO: 16), CDR2 having the amino acid sequence of SVS and CDR3 having the amino acid sequence of MQATHVPFT (SEQ ID NO: 17) and the light chain constant region of an antibody of an animal other than rat.

### Claim 18

A DNA encoding a heavy chain comprising a heavy chain variable region containing CDR1 having the amino acid sequence of GFDFDTYP (SEQ ID NO: 18), CDR2 having the amino acid sequence of ITIKTENY AT (SEQ ID NO: 19) and CDR3 having the amino acid sequence of NREDFDY (SEQ ID NO: 20) and the heavy chain constant region of an antibody of an animal other than rat.