# US 2014/0193433 A1 · Bcma-based stratification and therapy for multiple myeloma patients

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- Number: US 2014/0193433 A1
- Document ID: US20140193433A1
- Status: Published application
- Kind: A1
- Application number: 14/150,127
- Filed: 2014-01-08
- Published: 2014-07-10
- Earliest claimed: 2011-04-21
- Assignees: Boehringer Ingelheim International GmbH
- Inventors: Eric BORGES; Jasmin Barbara HEBEIS
- Web page: https://patentgrep.com/patent/US20140193433A1

## CPC

- G01N 33/57505: of the blood, e.g. leukaemia
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 35/00: Antineoplastic agents
- C07K 16/2803: {against the immunoglobulin superfamily}
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- C07K 16/2887: {against CD20}
- C07K 16/3061: {Blood cells}
- G01N 33/6863: {Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors}
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- 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 invention relates to methods for the stratification of a multiple myeloma (MM) patient comprising determining whether or not B-cells, preferably malignant B-cells of said patient express BCMA protein on their surface. Also, methods for selecting an antibody-based multiple myeloma (MM) therapy is based on whether or not BCMA is expressed on the cell surface of B-cells, preferably malignant B-cells of a patient. Furthermore, antibody-based therapies for patients who have BCMA positive malignant B-cells are provided.

## Claims

### Claim 1

A method for the stratification of a multiple myeloma (MM) patient disposed to respond favorably to an anti-BCMA antibody therapy, comprising determining whether B-cells, preferably malignant B-cells of said patient express BCMA protein on the surface of said B-cells, wherein said patient is disposed to respond favorably to said anti-BCMA antibody therapy, if said B-cells express BCMA protein on their surface.

### Claim 2

A method for diagnosing a BCMA negative multiple myeloma (MM) patient, comprising determining whether B-cells, preferably malignant B-cells of said patient, express BCMA protein on their surface, wherein said patient suffers from BCMA negative MM, if no BCMA protein is detectable on the surface of said B-cells.

### Claim 3

A method for selecting an antibody-based multiple myeloma (MM) therapy, comprising determining whether B-cells, preferably malignant B-cells of a patient, express BCMA protein on the surface of said B-cells, wherein, if said B-cells are BCMA positive, the patient may be subject to an anti-CD20 antibody therapy and/or an anti-CD38 antibody therapy and/or an anti-BCMA antibody therapy and/or anti-CS1 antibody therapy, or, if said B-cells are BCMA-negative, the patient is subject to an anti-CD20 antibody therapy and/or an anti-CD38 antibody therapy and/or anti-CS1 antibody therapy.

### Claim 4 (depends on 1)

The method of claim 1, wherein said B-cells are malignant B-cells of said patient.

### Claim 5 (depends on 2)

The method of claim 2, wherein said B-cells are malignant B-cells of said patient.

### Claim 6 (depends on 3)

The method of claim 3, wherein said B-cells are malignant B-cells of said patient.

### Claim 7 (depends on 1)

The method of claim 1, wherein said B-cells are characterized to be CD38 positive, CD56 positive or negative, CD45 positive, and CD19 positive.

### Claim 8 (depends on 2)

The method of claim 2, wherein said B-cells are characterized to be CD38 positive, CD56 positive or negative, CD45 positive, and CD19 positive.

### Claim 9 (depends on 3)

The method of claim 3, wherein said B-cells are characterized to be CD38 positive, CD56 positive or negative, CD45 positive, and CD19 positive.

### Claim 10 (depends on 1)

The method of claim 1, wherein said patient is to be treated with an anti-BCMA antibody therapy.

### Claim 11 (depends on 2)

The method of claim 2, wherein said patient is to be treated with an anti-BCMA antibody therapy.

### Claim 12 (depends on 10)

The method of claim 10, wherein said anti-BCMA antibody is
a monoclonal antibody,
a chimeric antibody
a humanized antibody, or
a bispecific antibody.

### Claim 13 (depends on 11)

The method of claim 11, wherein said anti-BCMA antibody is
a monoclonal antibody,
a chimeric antibody
a humanized antibody, or
a bispecific antibody.

### Claim 14 (depends on 10)

The method of claim 10, wherein said anti-BCMA antibody is conjugated to a toxin.

### Claim 15 (depends on 11)

The method of claim 11, wherein said anti-BCMA antibody is conjugated to a toxin.

### Claim 16

A method for the treatment or amelioration of a multiple myeloma (MM) patient whose B-cells, preferably malignant B-cells are disposed to be BCMA positive, comprising administration of a therapeutically effective amount of an anti-BCMA antibody to said patient.

### Claim 17

A method for the treatment or amelioration of a multiple myeloma (MM) patient whose B-cells, preferably malignant B-cells are BCMA negative, comprising administration of a therapeutically effective amount of an anti-CD20 antibody and/or an anti-CD38 antibody and/or anti-CS1 antibody to said patient.

### Claim 18 (depends on 1)

The method of claim 1, wherein said BCMA protein is detectable with Vicky 1 or MAB 193.

### Claim 19 (depends on 2)

The method of claim 2, wherein said BCMA protein is detectable with Vicky 1 or MAB 193.

### Claim 20 (depends on 3)

The method of claim 3, wherein said BCMA protein is detectable with Vicky 1 or MAB 193.

### Claim 21 (depends on 1)

A kit comprising an anti-BCMA antibody and instructions for carrying out the method of claim 1.

### Claim 22 (depends on 2)

A kit comprising an anti-BCMA antibody and instructions for carrying out the method of claim 2.

### Claim 23 (depends on 3)

A kit comprising an anti-BCMA antibody and instructions for carrying out the method of claim 3.
