# US 10,118,963 B2 · Antigen binding proteins that bind PD-L1

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- Number: US 10,118,963 B2
- Document ID: US10118963B2
- Status: Granted
- Kind: B2
- Application number: 15/418,514
- Filed: 2017-01-27
- Published: 2017-08-03
- Granted: 2018-11-06
- Earliest claimed: 2016-01-29
- Assignees: Sorrento Therapeutics, Inc.
- Applicants: Sorrento Therapeutics, Inc.
- Inventors: Heyue Zhou
- Web page: https://patentgrep.com/patent/US10118963B2

## CPC

- C07K 16/2803: {against the immunoglobulin superfamily}
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 37/02: Immunomodulators
- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- C07K 16/30: from tumour cells
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- C07K 2317/21: from primates, e.g. man
- C07K 2317/51: Complete heavy chain or Fd fragment, i.e. VH + CH1
- C07K 2317/55: Fab or Fab'
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/622: Single chain antibody (scFv)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

There is disclosed anti-PD-L1 IgG class antibodies that have an improved ability to be manufactured at higher yields. More specifically, there is disclosed human antibodies that bind PD-L1, PD-L1-binding fragments that can be manufactured at higher yields.

## Claims

### Claim 1

A fully human antibody of an IgG class that binds to a PD-L1 epitope, wherein the antibody comprises a heavy chain variable domain comprising a CDR1 domain, a CDR2 domain, and a CDR3 domain as set forth in the amino acid sequences of SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 7, respectively, and comprises a light chain variable domain comprising an amino acid sequence as set forth in SEQ ID NO. 2 or SEQ ID NO. 3.

### Claim 2 (depends on 1)

The fully human antibody of claim 1, wherein the antibody has a heavy chain/light chain variable domain amino acid sequence combination of either SEQ ID NO. 1/SEQ ID NO. 2 or SEQ ID NO. 1/SEQ ID NO. 3.

### Claim 3 (depends on 1)

The fully human antibody of claim 1, which is an IgG1 or an IgG4.

### Claim 4

An anti-PD-L1 Fab fully human antibody fragment having a variable domain from a heavy chain and a variable domain from a light chain, wherein the heavy chain variable domain comprises a CDR1 domain, a CDR2 domain, and a CDR3 domain as set forth in the amino acid sequences of SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 7, respectively, and wherein the light chain variable domain comprises an amino acid sequence as set forth in SEQ ID NO. 2 or SEQ ID NO. 3.

### Claim 5 (depends on 4)

The fully human antibody Fab fragment of claim 4, wherein the antibody has a heavy chain/light chain variable domain amino acid sequence combination of either SEQ ID NO. 1/SEQ ID NO. 2 or SEQ ID NO. 1/SEQ ID NO. 3.

### Claim 6

An anti-PD-L1 single chain human antibody having a heavy chain variable domain and a light chain variable domain connected via a peptide linker, wherein the heavy chain variable domain comprises a CDR1 domain, a CDR2 domain, and a CDR3 domain as set forth in the amino acid sequences of SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 7, respectively, and wherein the light chain variable domain comprises an amino acid sequence as set forth in either SEQ ID NO. 2 or SEQ ID NO. 3.

### Claim 7 (depends on 6)

The fully human single chain antibody of claim 6, wherein the single chain fully human antibody has a heavy chain/light chain variable domain amino acid sequence combination of either SEQ ID NO. 1/SEQ ID NO. 2 or SEQ ID NO. 1/SEQ ID NO. 3.

### Claim 8 (depends on 1)

A method for treating a human subject having cancer or an autoimmune or inflammatory disease, said method comprising administering an effective amount of the fully human antibody of claim 1 to the human subject.

### Claim 9 (depends on 4)

A method for treating a human subject having cancer or an autoimmune or inflammatory disease, said method comprising administering an effective amount of the fully human antibody Fab fragment of claim 4 to the human subject.

### Claim 10 (depends on 6)

A method for treating a human subject having cancer or an autoimmune or inflammatory disease, said method comprising administering an effective amount of the fully human single chain antibody of claim 6 to the human subject.

### Claim 11 (depends on 8)

The method of claim 8, wherein the cancer is selected from the group consisting of ovarian cancer, colon cancer, breast cancer, lung cancer, myeloma, a neuroblastic-derived CNS tumor, monocytic leukemia, B-cell derived leukemia, T-cell derived leukemia, B-cell derived lymphoma, T-cell derived lymphoma, and a mast cell derived tumor.

### Claim 12 (depends on 8)

The method of claim 8, wherein the autoimmune or inflammatory disease is selected from the group consisting of intestinal mucosal inflammation, wasting disease associated with colitis, multiple sclerosis, systemic lupus erythematosus, a viral infection, rheumatoid arthritis, osteoarthritis, psoriasis, Crohn's disease, and inflammatory bowel disease.

### Claim 13 (depends on 1)

The antibody of claim 1, which is produced in a mammalian host cell.

### Claim 14 (depends on 13)

The antibody of claim 13, wherein the mammalian host cell is a Chinese hamster ovary (CHO) cell.

### Claim 15 (depends on 1)

A pharmaceutical composition comprising the fully human antibody of claim 1, and a pharmaceutically acceptable excipient.

### Claim 16 (depends on 4)

A pharmaceutical composition comprising the fully human antibody Fab fragment of claim 4, and a pharmaceutically acceptable excipient.

### Claim 17 (depends on 6)

A pharmaceutical composition comprising the fully human single chain antibody of claim 6, and a pharmaceutically acceptable excipient.
