# US 12,215,152 B2 · Humanized anti-human CD19 antibodies and methods of use

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- Number: US 12,215,152 B2
- Document ID: US12215152B2
- Status: Granted
- Kind: B2
- Application number: 17/578,655
- Filed: 2022-01-19
- Published: 2022-06-30
- Granted: 2025-02-04
- Earliest claimed: 2015-10-01
- Assignees: Hoffmann-La Roche Inc.
- Applicants: Hoffmann-La Roche inc.
- Inventors: Claudia Ferrara Koller; Guy Georges; Alexander Haas; Hubert Kettenberger; Ekkehard Moessner; Tilman Schlothauer; Michael Molhoj; Laurent Lariviere
- Web page: https://patentgrep.com/patent/US12215152B2

## CPC

- C07K 16/2803: {against the immunoglobulin superfamily}
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- C07K 2317/734: Complement-dependent cytotoxicity [CDC]
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Herein is reported an antibody that specifically hinds to human CD 19, wherein the antibody comprises (a) HVR-H1 comprising the amino acid sequence of SEQ ID NO: 03, (b) HVR-H2 comprising the amino acid sequence of SEQ ID NO: 11, (c) HVR-H3 comprising the amino acid sequence of SEQ ID NO: 05, (d) HVR-L1 comprising the amino acid sequence of SEQ ID NO: 20 or 28, (e) HVR-L2 comprising the amino acid sequence of SEQ ID NO: 07, and (f) HVR-L3 comprising the amino acid sequence of SEQ ID NO: 08, as well as methods of using the same.

## Claims

### Claim 1

An antibody that specifically binds to human CD19, wherein the antibody comprises:
(a) HVR-H1 comprising the amino acid sequence of SEQ ID NO: 03,
(b) HVR-H2 comprising the amino acid sequence of SEQ ID NO: 11,
(c) HVR-H3 comprising the amino acid sequence of SEQ ID NO: 05,
(d) HVR-L1 comprising the amino acid sequence of SEQ ID NO: 40,
(e) HVR-L2 comprising the amino acid sequence of SEQ ID NO: 07, and
(f) HVR-L3 comprising the amino acid sequence of SEQ ID NO: 08.

### Claim 2 (depends on 1)

The antibody according to claim 1, wherein the antibody is a monoclonal antibody.

### Claim 3 (depends on 1)

The antibody according to claim 1, wherein the antibody is a human, humanized or chimeric antibody.

### Claim 4 (depends on 1)

The antibody according to claim 1, wherein the antibody is an antibody fragment that specifically binds to human CD19.

### Claim 5 (depends on 1)

The antibody according to claim 1, wherein the antibody comprises:
a VH sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 09 and a VL sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 27.

### Claim 6 (depends on 1)

A pharmaceutical formulation, comprising the antibody according to claim 1 and a pharmaceutically acceptable carrier.

### Claim 7 (depends on 1)

A method of treating an individual having a B-cell cancer, comprising the step of administering to the individual an effective amount of the antibody according to claim 1.

### Claim 8 (depends on 1)

A method of depleting B-cells in an individual in need thereof, comprising the step of administering to the individual an effective amount of the antibody according to claim 1 to deplete B-cells.