# US 11,028,175 B2 · Depletion of plasmacytoid dendritic cells

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- Number: US 11,028,175 B2
- Document ID: US11028175B2
- Status: Granted
- Kind: B2
- Application number: 16/260,490
- Filed: 2019-01-29
- Published: 2019-05-16
- Granted: 2021-06-08
- Earliest claimed: 2013-12-16
- Assignees: The University of North Carolina at Chapel Hill
- Applicants: The University of North Carolina at Chapel Hill
- Inventors: Lishan Su
- Web page: https://patentgrep.com/patent/US11028175B2

## CPC

- C07K 16/2851: {against the lectin superfamily, e.g. CD23, CD72}
- A61K 39/39541: {against normal tissues, cells}
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/12: Antivirals
- A61P 31/18: for HIV
- 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
- C12N 5/0081: {Purging biological preparations of unwanted cells}
- A61K 2039/505: {comprising antibodies}
- 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 2317/56: variable (Fv) region, i.e. VH and/or VL
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention relates to antibodies targeted to BDCA2 that deplete plasmacytoid dendritic cells (pDC) and methods of using the antibodies to treat disorders associated with pDC.

## Claims

### Claim 1

A method of depleting plasmacytoid dendritic cells (pDC) in a subject, comprising delivering to the subject an effective amount of an antibody or a fragment thereof that specifically binds to blood dendritic cell antigen-2 (BDCA2) and depletes pDC, thereby depleting pDC;
wherein the antibody or a fragment thereof comprises a heavy chain variable region comprising the three complementarity determining regions of the amino acid sequence of SEQ ID NO:2 or SEQ ID NO:6; and
the antibody or a fragment thereof comprises a light chain variable region comprising the three complementarity determining regions of the amino acid sequence of SEQ ID NO:4 or SEQ ID NO:8,
wherein the subject has cancer.

### Claim 2

A method of treating cancer in a subject in need thereof, comprising delivering to the subject a therapeutically effective amount an antibody or a fragment thereof that specifically binds to BDCA2 and depletes pDC, thereby treating the cancer;
wherein the antibody or a fragment thereof comprises a heavy chain variable region comprising the three complementarity determining regions of the amino acid sequence of SEQ ID NO:2 or SEQ ID NO:6; and
the antibody or a fragment thereof comprises a light chain variable region comprising the three complementarity determining regions of the amino acid sequence of SEQ ID NO:4 or SEQ ID NO:8.

### Claim 3 (depends on 2)

The method of claim 2, wherein the cancer is a tumor-forming cancer.

### Claim 4 (depends on 3)

The method of claim 3, wherein the antibody or a fragment thereof is delivered into a tumor or the tissue surrounding a tumor.

### Claim 5 (depends on 2)

The method of claim 2, wherein the cancer is breast cancer, prostate cancer, lymphoma., skin cancer, pancreatic cancer, colon cancer, melanoma, malignant melanoma, ovarian cancer, brain cancer, primary brain carcinoma, head-neck cancer, glioma, glioblastoma, liver cancer, bladder cancer, non-small cell lung cancer, head or neck carcinoma, breast carcinoma, ovarian carcinoma, lung carcinoma, small-cell lung carcinoma, Wilms' tumor, cervical carcinoma, testicular carcinoma, bladder carcinoma, pancreatic carcinoma, stomach carcinoma, colon carcinoma, prostatic carcinoma, genitourinary carcinoma, thyroid carcinoma, esophageal carcinoma, myeloma, multiple myeloma, adrenal carcinoma, renal cell carcinoma, endometrial carcinoma, adrenal cortex carcinoma, malignant pancreatic insulinoma, malignant carcinoid carcinoma, choriocarcinoma, mycosis fungoides, malignant hypercalcemia, cervical hyperplasia. leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, chronic granulocytic leukemia, acute granulocytic leukemia, hairy cell leukemia, neuroblastoma, rhabdomyosarcoma, Kaposi's sarcoma, polycythemia vera, essential thrombocytosis, Hodgkin's disease, non-Hodgkin's lymphoma, soft-tissue sarcoma, osteogenic sarcoma, primary macroglobulinemia, or retinoblastoma.

### Claim 6 (depends on 2)

The method of claim 2, wherein the cancer is breast cancer, ovarian cancer, melanoma, head-neck cancer, or multiple myeloma.

### Claim 7 (depends on 2)

The method of claim 2, wherein the cancer is pDC-derived leukemia.

### Claim 8 (depends on 2)

The method of claim 2, wherein the BDCA2 is human BDCA2.

### Claim 9 (depends on 2)

The method of claim 2, wherein the antibody or a fragment thereof is a monoclonal antibody or a fragment or derivative thereof.

### Claim 10 (depends on 9)

The method of claim 9. wherein the monoclonal antibody or a fragment thereof specifically binds the epitope IQNLKRNSSYFLGLSDPGGR, (SEQ ID NO:9) or a fragment thereof of at least 5 contiguous amino acids.

### Claim 11 (depends on 9)

The method of claim 9, wherein the monoclonal antibody or a fragment thereof comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:2 or a sequence at least 90% identical thereto.

### Claim 12 (depends on 9)

The method of claim 9, wherein the monoclonal antibody or a fragment thereof comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:4 or a sequence at least 90% identical thereto.

### Claim 13 (depends on 9)

The method of claim 9, wherein the monoclonal antibody or a fragment thereof comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:6 or a sequence at least 90% identical thereto.

### Claim 14 (depends on 9)

The method of claim 9, wherein the monoclonal antibody or a fragment thereof comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO:8 or a sequence at least 90% identical thereto.

### Claim 15 (depends on 9)

The method of claim 9, wherein the monoclonal antibody or a fragment thereof is a chimeric antibody or a fragment thereof.

### Claim 16 (depends on 9)

The method of claim 9. wherein the monoclonal antibody or a fragment thereof is a humanized antibody or a fragment thereof.