# US 2025/0084162 A1 · Anti-hemojuvelin (hjv) antibodies for treating myelofibrosis

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- Number: US 2025/0084162 A1
- Document ID: US20250084162A1
- Status: Published application
- Kind: A1
- Application number: 18/896,718
- Filed: 2024-09-25
- Published: 2025-03-13
- Earliest claimed: 2020-05-13
- Assignees: Disc Medicine, Inc.; AbbVie Inc.; AbbVie Deutschland GmbH & Co. KG
- Applicants: Disc Medicine, Inc.; AbbVie Inc.; AbbVie Deutschland GmbH & Co. KG
- Inventors: Maria Beconi; John Quisel; Brian MacDonald; Steven Robinette; Bernhard Mueller; Andreas Popp; Jennifer M. Perez
- Web page: https://patentgrep.com/patent/US20250084162A1

## CPC

- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- A61P 7/06: Antianaemics
- A61P 35/00: Antineoplastic agents
- A61K 2039/505: {comprising antibodies}
- 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 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/524: CH2 domain
- C07K 2317/526: CH3 domain
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/71: Decreased effector function due to an Fc-modification
- C07K 2317/72: Increased effector function due to an Fc-modification
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/90: characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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
- 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)

## Abstract

Aspects of the application provide anti-hemojuvelin antibodies and methods of using the same in treating myelofibrosis and/or conditions associated with myelofibrosis.

## Claims

### Claim at position 1

1-52. (canceled)

### Claim 53

A method of treating a subject having myelofibrosis, the method comprising:
administering to the subject an effective amount of an isolated antibody that binds to human hemojuvelin (HJV), wherein the antibody comprises:
a heavy chain comprising the amino acid sequence of SEQ ID NO: 61 or 117, and a light chain comprising the amino acid sequence of SEQ ID NO: 62.

### Claim 54 (depends on 53)

The method of claim 53, wherein the subject antibody is administered to the subject via subcutaneous injection.

### Claim 55 (depends on 53)

The method of claim 53, wherein the subject has anemia resulting from hepcidin expression that is induced by at least one pro-inflammatory cytokine.

### Claim 56 (depends on 55)

The method of claim 55, wherein the administration of the antibody reduces the anemia.

### Claim 57 (depends on 55)

The method of claim 55, wherein the at least one pro-inflammatory cytokine comprises Interleukin-6 (IL-6).

### Claim 58 (depends on 53)

The method of claim 53, wherein the administration reduces hepcidin-25 in the subject within 24 hours of the administration.

### Claim 59 (depends on 58)

The method of claim 58, wherein the administration reduces a hepcidin-25 level by at least 50% compared to the hepcidin-25 level in the subject prior to the administration.

### Claim 60 (depends on 53)

The method of claim 53, wherein the subject has one or more myelofibrosis-initiating mutations in JAK2, MPL, ASXL1, TET2, NFE2, SH2B3, SF3B1, and/or CALR.

### Claim 61 (depends on 53)

The method of claim 53, wherein the subject has primary myelofibrosis, post-essential thrombocythemia (ET) MF, or post-polycythemia vera (PV) MF.

### Claim 62 (depends on 61)

The method of claim 61, wherein the subject has a Dynamic International Prognostic Scoring System (DIPSS) score of more than 1.

### Claim 63 (depends on 61)

The method of claim 61, wherein the subject has a DIPSS score of 3-4.

### Claim 64 (depends on 61)

The method of claim 61, wherein the subject has a DIPSS score of at least 5.

### Claim 65 (depends on 53)

The method of claim 53, wherein the subject has a serum hemoglobin level of less than 10 g/dL.

### Claim 66 (depends on 53)

The method of claim 53, wherein the subject has a serum hemoglobin level of less than 8 g/dL.

### Claim 67 (depends on 53)

The method of claim 53, wherein the subject is erythrocyte transfusion-dependent.

### Claim 68 (depends on 53)

The method of claim 53, wherein the subject has previously received a selective JAK-STAT inhibitor.

### Claim 69 (depends on 68)

The method of claim 68, the selective JAK-STAT inhibitor is ruxolitinib, fedratinib, pacritinib, INCB039110, AG490, or PpYLKTK.

### Claim 70 (depends on 53)

The method of claim 53, wherein the subject is receiving a selective JAK-STAT inhibitor while being administered the antibody.

### Claim 71 (depends on 70)

The method of claim 70, the selective JAK-STAT inhibitor is ruxolitinib, fedratinib, pacritinib, INCB039110, AG490, or PpYLKTK.

### Claim 72 (depends on 53)

The method of claim 53, wherein the antibody is administered to the subject once monthly.

### Claim 73

A method of treating anemia in a subject having myelofibrosis, the method comprising administering to the subject a composition comprising:
(i) an effective amount of an anti-human hemojuvelin (HJV) comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 61, and a light chain comprising the amino acid sequence of SEQ ID NO: 62; and
(ii) an effective amount of an anti-human hemojuvelin (HJV) comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 117, and a light chain comprising the amino acid sequence of SEQ ID NO: 62.

### Claim 74

An isolated antibody that binds to human hemojuvelin (HJV), wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 63 or 118, and a light chain comprising the amino acid sequence of SEQ ID NO: 62.

### Claim 75 (depends on 74)

An isolated nucleic acid encoding the HC and/or LC of the isolated antibody of claim 74.

### Claim 76

A composition comprising:
(i) an anti-human hemojuvelin (HJV) comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 63, and a light chain comprising the amino acid sequence of SEQ ID NO: 62; and
(ii) an anti-human hemojuvelin (HJV) comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 118, and a light chain comprising the amino acid sequence of SEQ ID NO: 62.
