# US 2025/0367286 A1 · Cd38 modulating antibody agents

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- Number: US 2025/0367286 A1
- Document ID: US20250367286A1
- Status: Published application
- Kind: A1
- Application number: 19/213,464
- Filed: 2025-05-20
- Published: 2025-12-04
- Earliest claimed: 2017-06-08
- Inventors: Pascal Merchiers; Anne Goubier; Kevin Moulder; Nina Eissler; Josephin Salimu; Simone Filosto; Beatriz Goyenechea Corzo; Hemanta Baruah; Bianka Prinz
- Web page: https://patentgrep.com/patent/US20250367286A1

## CPC

- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61P 35/00: Antineoplastic agents
- C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere}
- 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 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- 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 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- C07K 2317/734: Complement-dependent cytotoxicity [CDC]
- C07K 2317/74: Inducing cell proliferation
- C07K 2317/75: Agonist effect on antigen
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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
- 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)

## Abstract

The present disclosure provides antibody sequences found in antibodies that bind to human CD38. In particular, the present disclosure provides sequences of anti-human CD38 antibodies. Antibodies and antigen-binding portions thereof including such sequences present features compatible with pharmaceutical manufacturing and development can be provided as fully human antibodies (e.g., fully human monoclonal antibodies or antigen-binding fragments) that can be useful for medical methods and compositions, in particular for treating cancer.

## Claims

### Claim 1

An anti-human CD38 antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof each comprises:
SEQ ID NO: 3 as variable heavy chain complementarity determining region 3, SEQ ID NO: 1 as variable heavy chain complementarity determining region 1, SEQ ID NO: 2 as variable heavy chain complementarity determining region 2, SEQ ID NO: 5 as variable light chain complementarity determining region 1, SEQ ID NO: 6 as variable light chain complementarity determining region 2; and
a sequence selected from SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, and SEQ ID NO: 13 as variable light chain complementarity determining region 3.

### Claim 2 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof comprises a variable heavy chain sequence having at least 95% sequence identity to SEQ ID NO: 4.

### Claim 3 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof comprises a variable heavy chain sequence having at least 95% sequence identity to a sequence selected from SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, and SEQ ID NO: 23.

### Claim 4 (depends on 1)

The antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof is mutated to remove the DG motif in the LCDR3 region.

### Claim at position 5

5-7. (canceled)

### Claim 8 (depends on 1)

The antibody or antigen-binding fragment thereof according to claim 1, wherein the antibody or an antigen-binding fragment thereof is selected from the group consisting of:
a) an antibody or antigen binding fragment thereof comprising an HCDR1 comprising the sequence of SEQ ID NO: 1, an HCDR2 comprising the sequence of SEQ ID NO: 2, an HCDR3 comprising the sequence of SEQ ID NO 3, an LCDR1 comprising the sequence of SEQ ID NO: 5, an LCDR2 comprising the sequence of SEQ ID NO: 6, and an LCDR3 comprising the sequence of SEQ ID NO: 10;
b) an antibody or antigen binding fragment thereof comprising an HCDR1 comprising the sequence of SEQ ID NO: 1, an HCDR2 comprising the sequence of SEQ ID NO: 2, an HCDR3 comprising the sequence of SEQ ID NO 3, an LCDR1 comprising the sequence of SEQ ID NO: 5, an LCDR2 comprising the sequence of SEQ ID NO: 6, and an LCDR3 comprising the sequence of SEQ ID NO: 11;
c) an antibody or antigen binding fragment thereof comprising an HCDR1 comprising the sequence of SEQ ID NO: 1, an HCDR2 comprising the sequence of SEQ ID NO: 2, an HCDR3 comprising the sequence of SEQ ID NO 3, an LCDR1 comprising the sequence of SEQ ID NO: 5, an LCDR2 comprising the sequence of SEQ ID NO: 6, and an LCDR3 comprising the sequence of SEQ ID NO: 12;
d) an antibody or antigen binding fragment thereof comprising an HCDR1 comprising the sequence of SEQ ID NO: 1, an HCDR2 comprising the sequence of SEQ ID NO: 2, an HCDR3 comprising the sequence of SEQ ID NO 3, an LCDR1 comprising the sequence of SEQ ID NO: 5, an LCDR2 comprising the sequence of SEQ ID NO: 6, and an LCDR3 comprising the sequence of SEQ ID NO: 13;
e) an antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising the sequence of SEQ ID NO: 4 and a light chain variable region comprising the sequence of SEQ ID NO: 20;
f) an antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising the sequence of SEQ ID NO: 4 and a light chain variable region comprising the sequence of SEQ ID NO: 21;
g) an antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising the sequence of SEQ ID NO: 4 and a light chain variable region comprising the sequence of SEQ ID NO: 22;
h) an antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising the sequence of SEQ ID NO: 4 and a light chain variable region comprising the sequence of SEQ ID NO: 23;
i) an antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising the sequence of SEQ ID NO: 14 and a light chain variable region comprising the sequence of SEQ ID NO: 15;
j) an antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising the sequence of SEQ ID NO: 14 and a light chain variable region comprising the sequence of SEQ ID NO: 16;
k) an antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising the sequence of SEQ ID NO: 14 and a light chain variable region comprising the sequence of SEQ ID NO: 17; and
l) an antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising the sequence of SEQ ID NO: 14 and a light chain variable region comprising the sequence of SEQ ID NO: 18.

### Claim 9 (depends on 1)

The antibody or an antigen-binding fragment thereof of claim 1, wherein the antibody or antigen-binding fragment thereof is a-fucosylated.

### Claim at position 8

10-11. (canceled)

### Claim 12 (depends on 1)

An affinity matured variant of an antibody or antigen binding fragment thereof of claim 1.

### Claim 13 (depends on 1)

The antibody or antigen-binding fragment thereof according to claim 1, wherein the antibody or antigen-binding fragment thereof is a monoclonal antibody, a domain antibody, a single chain antibody, a Fab fragment, a F(ab′)2 fragment, a single chain variable fragment (scFv), a scFv-Fc fragment, or a single chain antibody (scAb).

### Claim 14 (depends on 1)

The antibody or antigen-binding fragment thereof according to claim 1, wherein the antibody or antigen-binding fragment thereof is a rabbit, mouse, chimeric, humanized or fully human antigen-binding antibody.

### Claim 15 (depends on 1)

The antibody or antigen-binding fragment thereof according to claim 1, wherein the antibody is selected from the group consisting of IgG1, IgG2, IgG3, and IgG4 isotype antibodies.

### Claim 16 (depends on 1)

The antibody or antigen-binding fragment thereof according to claim 1, wherein the antibody or antigen-binding fragment thereof is comprised in a bispecific antibody, a multispecific antibody, or an immunoconjugate further comprising a therapeutic or diagnostic agent.

### Claim 17 (depends on 1)

The antibody or antigen-binding fragment thereof according to claim 1, wherein the antibody or antigen-binding fragment thereof binds the extracellular domain of human CD38.

### Claim 18 (depends on 1)

The antibody or antigen-binding fragment thereof according to claim 1, wherein the antibody or antigen-binding fragment thereof binds cells expressing human CD38 on their surface and is a CD38 Modulating Antibody Agent.

### Claim 19 (depends on 1)

A nucleic acid molecule encoding the antibody or antigen-binding fragment thereof of claim 1.

### Claim 20 (depends on 19)

A nucleic acid vector comprising the nucleic acid molecule of claim 19.

### Claim 21 (depends on 20)

A host cell comprising the nucleic acid vector of claim 20.

### Claim 22 (depends on 21)

A method for producing an antibody or antigen-binding fragment thereof comprising:
SEQ ID NO: 3 as variable heavy chain complementarity determining region 3, SEQ ID NO: 1 as variable heavy chain complementarity determining region 1, SEQ ID NO: 2 as variable heavy chain complementarity determining region 2, SEQ ID NO: 5 as variable light chain complementarity determining region 1, SEQ ID NO: 6 as variable light chain complementarity determining region 2; and
a sequence selected from SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, and SEQ ID NO: 13 as variable light chain complementarity determining region 3,
the method comprising culturing a host cell of claim 21.

### Claim 23 (depends on 1)

A composition comprising an antibody or antigen-binding fragment thereof according to claim 1 and a pharmaceutically acceptable carrier or excipient.

### Claim at position 21

24-27. (canceled)

### Claim 28 (depends on 23)

A method of treating cancer in a subject, comprising administering to the subject an effective amount of the composition of claim 23.

### Claim 29

(canceled)

### Claim 30 (depends on 28)

The method of claim 28, further comprising administering, simultaneously or sequentially in any order, a second agent to the subject.

### Claim 31 (depends on 28)

The method according to claim 28 wherein the subject has a solid tumor.

### Claim 32 (depends on 28)

The method according to claim 28 wherein the subject has a haematological cancer.

### Claim 33 (depends on 1)

A method of preparing an anti-CD38 antibody comprising providing an antibody according to claim 1, and subjecting the antibody to affinity maturation, wherein the anti-CD38 antibody produced has a greater affinity to CD38 than the parental antibody.

### Claim 34 (depends on 33)

A method of preparing a pharmaceutical composition comprising providing an antibody prepared according to a method of claim 33 and co-formulating the antibody with at least one or more pharmaceutically acceptable excipients.

### Claim 35 (depends on 23)

A kit comprising the composition of claim 23 in a container.