# US 10,308,722 B2 · Method for the treament of multiple myeloma or non-hodgkins lymphoma with anti-CD38 antibody in combination with thalidomine, lenalidomids, or pomalidomide

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- Number: US 10,308,722 B2
- Document ID: US10308722B2
- Status: Granted
- Kind: B2
- Application number: 15/670,811
- Filed: 2017-08-07
- Published: 2018-01-25
- Granted: 2019-06-04
- Earliest claimed: 2010-09-27
- Assignees: Morphosys AG
- Applicants: Morphosys AG
- Inventors: Lisa Rojkjaer; Rainer Boxhammer; Jan Endell; Mark Winderlich; Christofer Samuelsson
- Web page: https://patentgrep.com/patent/US10308722B2

## CPC

- C07K 16/40: against enzymes
- A61K 31/454: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
- A61K 31/69: Boron compounds
- A61K 38/05: Dipeptides
- A61K 38/07: Tetrapeptides
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 19/00: Drugs for skeletal disorders
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere}
- C07K 16/3061: {Blood cells}
- A61K 2039/505: {comprising antibodies}
- 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 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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

## Abstract

The present disclosure is directed to a method of treating multiple myeloma or non-hodgkins lymphoma with a pharmaceutical composition comprising an anti-CD38 antibody in combination with thalidomide, lenalidomide, or pomalidomide.

## Claims

### Claim 1

A method for treating multiple myeloma or non-hodgkins lymphoma in a subject in need thereof, wherein said method comprises administering to the subject a therapeutically effective amount of a combination of: (i) thalidomide, lenalidomide or pomalidomide, (ii) an antibody specific for CD38, comprising an HCDR1 region of sequence SYYMN (SEQ ID NO: 14) or GFTFSSYYMN (SEQ ID NO: 1), an HCDR2 region of sequence GISGDPSNTYYADSVKG (SEQ ID NO: 2), an HCDR3 region of sequence DLPLVYTGFAY (SEQ ID NO: 3), an LCDR1 region of sequence SGDNLRHYYVY (SEQ ID NO: 4), an LCDR2 region of sequence GDSKRPS (SEQ ID NO: 5), and an LCDR3 region of sequence QTYTGGASL (SEQ ID NO: 6).

### Claim 2 (depends on 1)

The method of claim 1, wherein said antibody comprises an HCDR1 region of sequence SYYMN (SEQ ID NO: 14).

### Claim 3 (depends on 1)

The method of claim 1, wherein said antibody comprises an HCDR1 region of sequence GFTFSSYYMN (SEQ ID NO: 1).

### Claim 4 (depends on 1)

The method of claim 1, wherein said antibody comprises a variable heavy chain of the sequence:
(SEQ ID NO: 10)
QVQLVESGGGLVQPGGSLRLSCAASGFTFSSYYMNWVRQAPGKGLEWVSG
ISGDP
SNTYYADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDLPLVYT
GF AYWGQGTLVTVSS;
and a variable light chain of the sequence:
(SEQ ID NO: 11)
DIELTQPPSVSVAPGQTARISCSGDNLRHYYVYWYQQKPGQAPVLVIYGD
SKRPS
GIPERFSGSNSGNTATLTISGTQAEDEADYYCQTYTGGASLVFGGGTKLT
VLGQ.

### Claim 5 (depends on 1)

The method of claim 1, wherein said antibody is an IgG antibody.

### Claim 6 (depends on 1)

The method of claim 1, wherein said antibody comprises an IgG1 Fc region.

### Claim 7 (depends on 1)

The method of claim 1, wherein said antibody comprises a modified Fc region, wherein said modification enhances ADCC activity.

### Claim 8 (depends on 1)

The method of claim 1, wherein said combination comprises said antibody and thalidomide.

### Claim 9 (depends on 8)

The method of claim 8, wherein said cancer is multiple myeloma.

### Claim 10 (depends on 1)

The method of claim 1, wherein said combination comprises said antibody and lenalidomide.

### Claim 11 (depends on 10)

The method of claim 10, wherein said cancer is multiple myeloma.

### Claim 12 (depends on 1)

The method of claim 1, wherein said combination comprises said antibody and pomalidomide.

### Claim 13 (depends on 12)

The method of claim 12, wherein said cancer is multiple myeloma.

### Claim 14 (depends on 1)

The method of claim 1, wherein said antibody and said thalidomide, lenalidomide or pomalidomide are administered separately.

### Claim 15 (depends on 12)

The method of claim 12, wherein said antibody and said thalidomide are administered separately.

### Claim 16 (depends on 12)

The method of claim 12, wherein said antibody and said lenalidomide are administered separately.

### Claim 17 (depends on 12)

The method of claim 12, wherein said antibody and said pomalidomide are administered separately.

### Claim 18

A method for treating multiple myeloma or non-hodgkins lymphoma in a subject in need thereof, wherein said method comprises administering to the subject a therapeutically effective amount of a combination of: thalidomide and an antibody specific for CD38, comprising an HCDR1 region of sequence SYYMN (SEQ ID NO: 14) or GFTFSSYYMN (SEQ ID NO: 1), an HCDR2 region of sequence GISGDPSNTYYADSVKG (SEQ ID NO: 2), an HCDR3 region of sequence DLPLVYTGFAY (SEQ ID NO: 3), an LCDR1 region of sequence SGDNLRHYYVY (SEQ ID NO: 4), an LCDR2 region of sequence GDSKRPS (SEQ ID NO: 5), and an LCDR3 region of sequence QTYTGGASL (SEQ ID NO: 6).

### Claim 19

A method for treating multiple myeloma or non-hodgkins lymphoma in a subject in need thereof, wherein said method comprises administering to the subject a therapeutically effective amount of a combination of: lenalidomide and an antibody specific for CD38, comprising an HCDR1 region of sequence SYYMN (SEQ ID NO: 14) or GFTFSSYYMN (SEQ ID NO: 1), an HCDR2 region of sequence GISGDPSNTYYADSVKG (SEQ ID NO: 2), an HCDR3 region of sequence DLPLVYTGFAY (SEQ ID NO: 3), an LCDR1 region of sequence SGDNLRHYYVY (SEQ ID NO: 4), an LCDR2 region of sequence GDSKRPS (SEQ ID NO: 5), and an LCDR3 region of sequence QTYTGGASL (SEQ ID NO: 6).

### Claim 20

A method for treating multiple myeloma or non-hodgkins lymphoma in a subject in need thereof, wherein said method comprises administering to the subject a therapeutically effective amount of a combination of: pomalidomide and an antibody specific for CD38, comprising an HCDR1 region of sequence SYYMN (SEQ ID NO: 14) or GFTFSSYYMN (SEQ ID NO: 1), an HCDR2 region of sequence GISGDPSNTYYADSVKG (SEQ ID NO: 2), an HCDR3 region of sequence DLPLVYTGFAY (SEQ ID NO: 3), an LCDR1 region of sequence SGDNLRHYYVY (SEQ ID NO: 4), an LCDR2 region of sequence GDSKRPS (SEQ ID NO: 5), and an LCDR3 region of sequence QTYTGGASL (SEQ ID NO: 6).