# US 2026/0098084 A1 · Anti-tmprss6 antibodies and uses thereof

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- Number: US 2026/0098084 A1
- Document ID: US20260098084A1
- Status: Published application
- Kind: A1
- Application number: 19/323,318
- Filed: 2025-09-09
- Published: 2026-04-09
- Earliest claimed: 2021-05-11
- Assignees: Regeneron Pharmaceuticals, Inc.
- Applicants: Regeneron Pharmaceuticals, Inc.
- Inventors: Harvey CHIN; Sarah J. HATSELL; Heinrich Emil LOB; Andrew J. MURPHY; William OLSON; Kei SAOTOME; Bojie ZHANG
- Web page: https://patentgrep.com/patent/US20260098084A1

## CPC

- C07K 16/18: against material from animals or humans
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61K 2039/505: {comprising antibodies}
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- C07K 2317/31: multispecific
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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

Provided herein are monoclonal antibodies that bind to the transmembrane serine protease 6 (TMPRSS6) protein, and methods of use thereof. In various embodiments of the disclosure, the antibodies are fully human antibodies that bind to TMPRSS6. In some embodiments, the antibodies disclosed herein are useful in a method for treating or preventing a disease, disorder or condition associated with TMPRSS6 in humans.

## Claims

### Claim at position 1

1-61. (canceled)

### Claim 62

An isolated antibody or antigen-binding fragment thereof that binds to Transmembrane Protease Serine 6 (TMPRSS6) protein,
wherein the antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (HCDRs) and three light chain complementarity determining regions (LCDRs),
wherein the three HCDRs and the three LCDRs comprise one of the following sets of complementarity determining regions:
(a) SEQ ID NO: 4 (HCDR1), SEQ ID NO:6 (HCDR2), SEQ ID NO:8 (HCDR3), SEQ ID NO:12 (LCDR1), SEQ ID NO:14 (LCDR2), and SEQ ID NO:16 (LCDR3);
(b) SEQ ID NO: 24 (HCDR1), SEQ ID NO:26 (HCDR2), SEQ ID NO:28 (HCDR3), SEQ ID NO:12 (LCDR1), SEQ ID NO:14 (LCDR2), and SEQ ID NO:16 (LCDR3);
(c) SEQ ID NO: 34 (HCDR1), SEQ ID NO:36 (HCDR2), SEQ ID NO:38 (HCDR3), SEQ ID NO:12 (LCDR1), SEQ ID NO:14 (LCDR2), and SEQ ID NO:16 (LCDR3);
(d) SEQ ID NO: 44 (HCDR1), SEQ ID NO:46 (HCDR2), SEQ ID NO:48 (HCDR3), SEQ ID NO:52 (LCDR1), SEQ ID NO:54 (LCDR2), and SEQ ID NO:56 (LCDR3);
(e) SEQ ID NO: 64 (HCDR1), SEQ ID NO:66 (HCDR2), SEQ ID NO:68 (HCDR3), SEQ ID NO:72 (LCDR1), SEQ ID NO:74 (LCDR2), and SEQ ID NO:76 (LCDR3);
(f) SEQ ID NO: 84 (HCDR1), SEQ ID NO:86 (HCDR2), SEQ ID NO:88 (HCDR3), SEQ ID NO:92 (LCDR1), SEQ ID NO:14 (LCDR2), and SEQ ID NO:94 (LCDR3);
or
(g) SEQ ID NO: 102 (HCDR1), SEQ ID NO:104 (HCDR2), SEQ ID NO: 106 (HCDR3), SEQ ID NO:110 (LCDR1), SEQ ID NO:14 (LCDR2), and SEQ ID NO:112 (LCDR3).

### Claim 63 (depends on 62)

The antibody or antigen-binding fragment thereof of claim 62, wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable region (HCVR)/a light chain variable region (LCVR) comprising one of the following amino acid sequence pairs:
(a) SEQ ID NOs: 2/10;
(b) SEQ ID NOs: 22/10;
(c) SEQ ID NOs: 32/10;
(d) SEQ ID NOs: 42/50;
(e) SEQ ID NOs: 62/70;
(f) SEQ ID NOs: 82/90; or
(g) SEQ ID NOs: 100/108.

### Claim 64 (depends on 62)

The antibody or antigen-binding fragment thereof of claim 62, wherein the antibody or antigen-binding fragment thereof comprises a heavy chain (HC)/light chain (LC) comprising one of the following amino acid sequence pairs:
(a) SEQ ID NOs: 18/20;
(b) SEQ ID NOs: 30/20;
(c) SEQ ID NOs: 40/20;
(d) SEQ ID NOs: 58/60;
(e) SEQ ID NOs: 78/80;
(f) SEQ ID NOs: 96/98; or
(g) SEQ ID NOs: 114/116.

### Claim 65

An isolated antibody or antigen-binding fragment thereof that binds to Transmembrane Protease Serine 6 (TMPRSS6) protein,
wherein the antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (HCDRs) and three light chain complementarity determining regions (LCDRs),
wherein the three HCDRs comprise the amino acid sequences of SEQ ID NO: 102 (HCDR1), SEQ ID NO:104 (HCDR2), and SEQ ID NO:106 (HCDR3), and the three LCDRs comprise the amino acid sequences of SEQ ID NO:110 (LCDR1), SEQ ID NO:14 (LCDR2), and SEQ ID NO:112 (LCDR3).

### Claim 66 (depends on 65)

The antibody or antigen-binding fragment thereof of claim 65, wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:100 and a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 108.

### Claim 67 (depends on 66)

The antibody or antigen-binding fragment thereof of claim 66, wherein the antibody or antigen-binding fragment thereof comprises a heavy chain (HC) comprising the amino acid sequence of SEQ ID NO: 114 and a light chain (LC) comprising the amino acid sequence of SEQ ID NO: 116.

### Claim 68 (depends on 65)

A pharmaceutical composition comprising the isolated antibody or antigen-binding fragment thereof of claim 65 and a pharmaceutically acceptable carrier or diluent.

### Claim 69 (depends on 65)

A polynucleotide molecule comprising a polynucleotide sequence that encodes the antibody or antigen-binding fragment thereof of claim 65.

### Claim 70 (depends on 69)

A host cell comprising the polynucleotide molecule of claim 69.

### Claim 71 (depends on 70)

A method of producing an isolated antibody or antigen-binding fragment thereof that binds to Transmembrane Protease Serine 6 (TMPRSS6), comprising:
culturing the host cell of claim 70 under conditions permitting production of the antibody or antigen-binding fragment thereof, and
recovering the antibody or antigen-binding fragment thereof so produced.

### Claim 72 (depends on 71)

The method of claim 71, further comprising formulating the antibody or antigen-binding fragment thereof as a pharmaceutical composition comprising the antibody or antigen-binding fragment thereof and a pharmaceutically acceptable carrier.

### Claim 73 (depends on 65)

A method of ameliorating at least one symptom or indication of a disease or disorder associated with iron overload, the method comprising administering a pharmaceutical composition comprising a therapeutically effective amount of the antibody or antigen-binding fragment thereof of claim 65 to a subject in need thereof.

### Claim 74 (depends on 73)

The method of claim 73, wherein disease or disorder is a congenital dyserythropoietic anemia, Diamond-Blackfan anemia, alpha thalassemia, beta thalassemia, a transfusion-dependent hemolytic anemia, myelodysplastic syndrome, sickle cell disease, polycythemia vera, hereditary hemochromatosis, or chronic liver disease.

### Claim 75 (depends on 74)

The method of claim 74, wherein the disease or disorder is beta thalassemia.
