# US 2020/0399395 A1 · Antibody Therapeutics that Bind CD38

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- Number: US 2020/0399395 A1
- Document ID: US20200399395A1
- Status: Published application
- Kind: A1
- Application number: 17/016,104
- Filed: 2020-09-09
- Published: 2020-12-24
- Earliest claimed: 2015-04-08
- Assignees: Sorrento Therapeutics, Inc.
- Applicants: Sorrento Therapeutics, Inc.
- Inventors: Heyue Zhou; John Dixon Gray
- Web page: https://patentgrep.com/patent/US20200399395A1

## CPC

- 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 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- C07K 16/40: against enzymes
- A61K 2039/505: {comprising antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/72: Increased effector function due to an Fc-modification
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- C12N 2510/00: Genetically modified cells
- C12N 2800/00: Nucleic acids vectors
- 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)

## Abstract

There is disclosed compositions and methods relating to or derived from anti-CD38 antibodies. More specifically, there is disclosed fully human antibodies that bind CD38, CD38-antibody binding fragments and derivatives of such antibodies, and CD38-binding polypeptides comprising such fragments. Further still, there is disclosed nucleic acids encoding such antibodies, antibody fragments and derivatives and polypeptides, cells comprising such polynucleotides, methods of making such antibodies, antibody fragments and derivatives and polypeptides, and methods of using such antibodies, antibody fragments and derivatives and polypeptides, including methods of treating a disease.

## Claims

### Claim at position 1

1-18. (canceled)

### Claim 19

One or more nucleic acids encoding an antibody of an IgG class that binds to a CD38 epitope, wherein said antibody comprises
(i) a heavy chain variable domain sequence comprising the amino acid sequence of SEQ ID NO: 3; and
a light chain variable domain sequence comprising the amino acid sequence of SEQ ID NO: 4; or
(ii) a heavy chain variable domain comprising CDR1, CDR2, and CDR3 of the amino acid sequence of SEQ ID NO: 3 and a light chain variable domain comprising CDR1, CDR2, and CDR3 of the amino acid sequence of SEQ ID NO: 4.

### Claim 20 (depends on 19)

The one or more nucleic acids of claim 19, wherein said antibody comprises the heavy chain variable domain sequence comprising the amino acid sequence of SEQ ID NO: 3 and the light chain variable domain sequence comprising the amino acid sequence of SEQ ID NO: 4.

### Claim 21 (depends on 19)

The one or more nucleic acids of claim 19, wherein the antibody is an IgG1 antibody.

### Claim 22 (depends on 19)

The one or more nucleic acids of claim 19, wherein the antibody is an IgG4 antibody.

### Claim 23 (depends on 19)

The one or more nucleic acids of claim 19, wherein the antibody is a full-length antibody.

### Claim 24 (depends on 19)

The one or more nucleic acids of claim 19, wherein the antibody is an antibody fragment or single chain antibody comprising the heavy chain variable domain sequence and the light chain variable domain sequence.

### Claim 25 (depends on 24)

The one or more nucleic acids of claim 24, wherein the antibody fragment or single chain antibody is a Fab or F(ab′)2 fragment or an scFv.

### Claim 26 (depends on 19)

The pharmaceutical composition of claim 19, wherein the antibody binds CD38 with a binding affinity of at least 10−6 M.

### Claim 27 (depends on 19)

The pharmaceutical composition of claim 19, wherein the antibody binds CD38 with a binding affinity of at least 10−8M.

### Claim 28 (depends on 20)

The pharmaceutical composition of claim 20, wherein the antibody is an IgG1 antibody.

### Claim 29 (depends on 20)

The pharmaceutical composition of claim 20, wherein the antibody is an antibody fragment or single chain antibody comprising the heavy chain variable domain sequence and the light chain variable domain sequence.

### Claim 30 (depends on 20)

The one or more nucleic acids of claim 20, wherein the antibody is an IgG4 antibody.

### Claim 31 (depends on 20)

The one or more nucleic acids of claim 20, wherein the antibody binds CD38 with a binding affinity of at least 10−6 M.

### Claim 32 (depends on 20)

The one or more nucleic acids of claim 20, wherein the antibody binds CD38 with a binding affinity of at least 10−8 M.

### Claim 33 (depends on 19)

The one or more nucleic acids of claim 19, wherein the antibody comprises a heavy chain variable domain comprising the amino acid sequence that is at least 95% identical to SEQ ID NO: 3, a light chain variable domain comprising the amino acid sequence that is at least 95% identical to SEQ ID NO: 4, three heavy chain complementarity determining regions (CDRs) as set forth in the heavy chain variable region amino acid sequence of SEQ ID NO: 3, and three light chain CDRs as set forth in the light chain variable region amino acid sequence of SEQ ID NO: 4.

### Claim 34 (depends on 19)

One or more vectors comprising the one or more nucleic acids of claim 19.

### Claim 35 (depends on 19)

A host cell comprising the one or more nucleic acids of claim 19.

### Claim 36 (depends on 34)

A host cell comprising the one or more vectors of claim 34.

### Claim 37 (depends on 35)

A method of producing an antibody, comprising culturing the cell of claim 35 under conditions wherein the antibody is produced.

### Claim 38 (depends on 36)

A method of producing an antibody, comprising culturing the cell of claim 36 under conditions wherein the antibody is produced.