# US 12,600,788 B2 · Compositions and methods for treatment of thyroid eye disease

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- Number: US 12,600,788 B2
- Document ID: US12600788B2
- Status: Granted
- Kind: B2
- Application number: 19/242,725
- Filed: 2025-06-18
- Published: 2025-12-18
- Granted: 2026-04-14
- Earliest claimed: 2020-10-14
- Assignees: Viridian Therapeutics, Inc.
- Applicants: Viridian Therapeutics, Inc.
- Inventors: Vahe Bedian; Peter Harwin; Tomas Kiselak; Angela She; Jonathan Violin; Yang Zhao
- Web page: https://patentgrep.com/patent/US12600788B2

## CPC

- C07K 16/2863: {against receptors for growth factors, growth regulators}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61P 27/02: Ophthalmic agents
- A61K 2039/505: {comprising antibodies}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/51: Complete heavy chain or Fd fragment, i.e. VH + CH1
- C07K 2317/515: Complete light chain, i.e. VL + CL
- C07K 2317/524: CH2 domain
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/77: Internalization into the cell
- 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)
- 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

## Abstract

Antibodies and compositions against Insulin-Like Growth Factor-1 Receptor (IGF-1R) with extended half-lives and uses thereof are provided herein. Antibodies and compositions described herein can be used in methods of treating or reducing the severity of thyroid eye disease (TED) in subjects in need thereof, by inhibiting the activity of IGF-1R with such antibodies and compositions.

## Claims

### Claim 1

A method of treating thyroid eye disease (TED) in a subject having TED and in need thereof, the method comprising administering an anti-IGF-1R antibody comprising a light chain and a heavy chain, wherein
a) the light chain comprises a light chain variable region comprising a LCDR1 having an amino acid sequence of SEQ ID NO: 53, a LCDR2 having an amino acid sequence of SEQ ID NO: 54, and a LCDR3 having an amino acid sequence of SEQ ID NO: 55, and
b) the heavy chain comprises a heavy chain variable region and a Fc region, wherein the heavy chain variable region comprises a HCDR1 having an amino acid sequence of SEQ ID NO: 56, a HCDR2 having an amino acid sequence of SEQ ID NO: 57, and a HCDR3 having an amino acid sequence of SEQ ID NO: 58, and the Fc region comprising M252Y, S254T, and T256E substitutions wherein numbering is according to the Kabat numbering system.

### Claim 2 (depends on 1)

The method of claim 1, wherein the anti-IGF-1R antibody is administered subcutaneously.

### Claim 3 (depends on 1)

The method of claim 1, wherein treating TED comprises reducing proptosis by at least 2 mm as measured by an exophthalmometer in one or both eyes of the subject.

### Claim 4 (depends on 1)

The method of claim 1, wherein treating TED comprises reducing a Clinical Activity Score (CAS) of the subject.

### Claim 5 (depends on 1)

The method of claim 1, wherein treating TED comprises reducing proptosis by at least 2 mm as measured by an exophthalmometer and reducing a clinical activity score (CAS) of the subject.

### Claim 6 (depends on 1)

The method of claim 1, wherein treating TED comprises reducing the severity of diplopia of the subject.

### Claim 7 (depends on 1)

The method of claim 1, wherein the light chain variable region comprises an amino acid sequence of SEQ ID NO: 13 and the heavy chain variable region comprises an amino acid sequence of SEQ ID NO: 14.

### Claim 8 (depends on 1)

The method of claim 1, wherein the light chain comprises an amino acid sequence of SEQ ID NO: 93 and the heavy chain comprises an amino acid sequence of SEQ ID NO: 94.

### Claim 9

A method of treating thyroid eye disease (TED) in a subject having TED and in need thereof, the method comprising administering to the subject an anti-IGF-1R antibody comprising a light chain and a heavy chain, wherein:
a) the light chain comprises a LCDR1 having an amino acid sequence of SEQ ID NO: 53, a LCDR2 having an amino acid sequence of SEQ ID NO: 54, and a LCDR3 having an amino acid sequence of SEQ ID NO: 55; and
b) the heavy chain comprises a heavy chain variable region and a Fc region,
wherein the heavy chain variable region comprises a HCDR1 having an amino acid sequence of SEQ ID NO: 56, a HCDR2 having an amino acid sequence of SEQ ID NO: 57, and a HCDR3 having an amino acid sequence of SEQ ID NO: 58, and
wherein the Fc region comprises an amino acid sequence of SEQ ID NO: 89.

### Claim 10 (depends on 9)

The method of claim 9, wherein the anti-IGF-1R antibody is administered subcutaneously.

### Claim 11 (depends on 9)

The method of claim 9, wherein treating TED comprises reducing proptosis in one or both eyes of the subject.

### Claim 12 (depends on 9)

The method of claim 9, wherein treating TED comprises reducing a Clinical Activity Score (CAS) of the subject.

### Claim 13 (depends on 9)

The method of claim 9, wherein treating TED comprises reducing proptosis by at least 2 mm as measured by an exophthalmometer and reducing clinical activity score (CAS) of the subject.

### Claim 14 (depends on 9)

The method of claim 9, wherein treating TED comprises reducing the severity of diplopia of the subject.

### Claim 15 (depends on 9)

The method of claim 9, wherein the light chain variable region comprises an amino acid sequence of SEQ ID NO: 13 and the heavy chain variable region comprises an amino acid sequence of SEQ ID NO: 14.

### Claim 16 (depends on 2)

The method of claim 2, wherein the light chain variable region comprises an amino acid sequence of SEQ ID NO: 13 and the heavy chain variable region comprises an amino acid sequence of SEQ ID NO: 14.

### Claim 17 (depends on 2)

The method of claim 2, wherein the light chain comprises an amino acid sequence of SEQ ID NO: 93 and the heavy chain comprises an amino acid sequence of SEQ ID NO: 94.

### Claim 18 (depends on 10)

The method of claim 10, wherein the light chain variable region comprises an amino acid sequence of SEQ ID NO: 13 and the heavy chain variable region comprises an amino acid sequence of SEQ ID NO: 14.