# US 12,600,790 B2 · Variant antibody that binds CD38

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- Number: US 12,600,790 B2
- Document ID: US12600790B2
- Status: Granted
- Kind: B2
- Application number: 17/127,766
- Filed: 2020-12-18
- Published: 2021-05-06
- Granted: 2026-04-14
- Earliest claimed: 2018-06-20
- Assignees: Vivasor, Inc.
- Applicants: Sorrento Therapeutics, Inc.
- Inventors: Barbara A. Swanson; Heyue Zhou; Jian Cao
- Web page: https://patentgrep.com/patent/US12600790B2

## CPC

- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 2039/505: {comprising antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/55: Fab or Fab'
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C12N 5/00: Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor; (plant reproduction by tissue culture techniques A01H4/00)
- C12N 15/00: Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor (mutants or genetically engineered microorganisms, per se C12N1/00, C12N5/00, C12N7/00; new plants per se A01H; plant reproduction by tissue culture techniques A01H4/00; new animals per se A01K67/00; use of medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases, gene therapy A61K48/00)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present disclosure provides anti-CD38 IgG class antibody having improved ability to be manufactured at higher yields compared to the parent antibody having the original wild type sequence. The present disclosure provides a mutated antibody light chain that reduces cleavage heterogeneity for improved production of a homogeneous population of antibody light chains.

## Claims

### Claim 1

An antigen binding protein that binds CD38, comprising a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region comprises the sequence of SEQ ID NO: 1 and the light chain variable region comprises the sequence of SEQ ID NO: 3.

### Claim 2 (depends on 1)

The antigen binding protein of claim 1, which is a fully human single chain antibody, comprising a heavy chain comprising a heavy chain variable region having the amino acid sequence of SEQ ID NO:1, and a light chain comprising a light chain variable region having the amino acid sequence of SEQ ID NO:3.

### Claim 3 (depends on 1)

A pharmaceutical composition comprising a pharmaceutically-acceptable excipient and the antigen binding protein of claim 1.

### Claim 4

A fully human antibody of an IgG class or antibody Fab fragment thereof, comprising a heavy chain comprising a heavy chain variable region having the amino acid sequence of SEQ ID NO:1, and a light chain comprising a light chain variable region having the amino acid sequence of SEQ ID NO:3.

### Claim 5 (depends on 4)

The fully human antibody or antibody Fab fragment thereof of claim 4, which is a fully human antibody.

### Claim 6 (depends on 4)

The fully human antibody or antibody Fab fragment thereof of claim 4, which is a Fab fragment.

### Claim 7 (depends on 4)

A nucleic acid encoding the fully human antibody of claim 4.

### Claim 8

A nucleic acid encoding an antibody light chain comprising a light chain variable region having the amino acid sequence of SEQ ID NO:3.

### Claim 9 (depends on 8)

The nucleic acid of claim 8, further comprising a nucleic acid encoding an antibody heavy chain which comprises the amino acid sequence of SEQ ID NO:1.

### Claim 10 (depends on 8)

An expression vector comprising a promoter operably linked to the nucleic acid of claim 8.

### Claim 11 (depends on 10)

The expression vector of claim 10 further comprising a nucleic acid encoding an antibody heavy chain which comprises the amino acid sequence of SEQ ID NO: 1.

### Claim 12 (depends on 11)

An isolated host cell comprising the expression vector of claim 11.

### Claim 13 (depends on 12)

A method for preparing a fully human antibody light chain, comprising: culturing a population of the host cell of claim 12 under conditions suitable for expressing the antibody light chain.

### Claim 14 (depends on 13)

The method of claim 13, further comprising recovering from the host cells the expressed antibody light and heavy chains.

### Claim 15 (depends on 14)

The method of claim 14, wherein the percentage of the recovered expressed antibody light chains having the correct length, the correct N-terminal amino acid, and having 100% sequence identity to the light chain variable domain of SEQ ID NO: 3 is 90-100%.

### Claim 16 (depends on 10)

An isolated host cell comprising the expression vector of claim 10.

### Claim 17 (depends on 16)

A method for preparing a fully human antibody light chain, comprising: culturing a population of the host cell of claim 16 under conditions suitable for expressing the antibody light chain.

### Claim 18 (depends on 17)

The method of claim 17, further comprising recovering from the host cells the expressed antibody light chain.

### Claim 19 (depends on 18)

The method of claim 18, wherein the percentage of the recovered expressed antibody light chains having the correct length, the correct N-terminal amino acid, and having 100% sequence identity to the light chain variable domain of SEQ ID NO: 3 is 90-100% and/or wherein the homogeneity of the recovered expressed antibody light chains is 90-100%.