Granted Patent B2

US 12,440,562 · App. 18/365,505 · Granted Oct 14, 2025

Inventors: Paul Bryce (Bridgewater, NJ); Emanuele De Rinaldis (Bridgewater, NJ); Ramon Antonio Hernandez Vecino (Paris, FR); Francisco Javier Jimenez Jimenez (Brookline, MA); Cliona Marie Molony (Bridgewater, NJ)

Assignee: Sanofi Biotechnology

A61K39/3955A61K9/0019A61K31/137A61K31/522A61K31/56A61K31/573A61K45/06C07K16/2866G06N20/00A61K2039/545C07K2317/565

Abstract

Claims (24)

1. A method of treating an eye-related disorder in a subject in need thereof with an anti-interleukin-4 receptor alpha (anti-IL-4Rα) antibody, wherein the eye-related disorder is selected from dry eye, blepharitis, cicatricial pemphigoid, Mooren's corneal ulcer, Vogt-Koyanagi-Harada syndrome, sympathetic opthalmia, phacoanaphylaxis endophthalmitis, or a combination thereof, the method comprising administering a therapeutically effective amount of an anti-IL-4Rα antibody to a subject, wherein the anti-IL-4Rα antibody comprises:

a variable heavy chain CDR1 of SEQ ID NO:1 (GFTFRDYA);

a variable heavy chain CDR2 of SEQ ID NO:2 (ISGSGGNT);

a variable heavy chain CDR3 of SEQ ID NO:3 (AKDRLSITIRPRYYGLDV);

a variable light chain CDR1 of SEQ ID NO:4 (QSLLYSIGYNY);

a variable light chain CDR2 of SEQ ID NO:5 (LGS); and

a variable light chain CDR3 of SEQ ID NO:6 (MQALQTPYT).

2. The method of claim 1 , wherein the anti-IL-4Ra antibody comprises a heavy chain variable region (VH) comprising SEQ ID NO: 13 and a light chain variable region (VL) comprising SEQ ID NO: 14.

3. The method of claim 1 , wherein the anti-IL-4Rα antibody comprises a heavy chain comprising SEQ ID NO: 17 and a light chain comprising SEQ ID NO: 18.

4. The method of claim 1 , wherein the anti-IL-4Rα antibody is formulated as a pharmaceutical composition comprising an acceptable carrier.

5. The method of claim 1 , wherein the subject is human.

6. The method of claim 1 , wherein the administering is subcutaneous, intradermal, intramuscular, intraperitoneal, intravenous, intranasal, or epidural administration.

7. The method of claim 1 , wherein the anti-IL- 4 Rα antibody is diluted in a 2 mL solution in a single-dose pre-filled syringe.

8. The method of claim 1 , wherein the administering is via a pre-filled syringe, a pre-filled pen, or an autoinjector.

9. The method of claim 8 , wherein the administering is subcutaneous.

10. The method of claim 1 , wherein the anti-IL- 4 Rα antibody is administered to the subject as an initial dose followed by a secondary dose.

11. The method of claim 10 , wherein the initial dose is about 600 mg and the secondary dose is about 300 mg.

12. The method of claim 10 , wherein the initial dose is about 400 mg and the secondary dose is about 200 mg.

13. The method of claim 10 , wherein the secondary dose is administered every 1 to 14 weeks after the initial dose.

14. The method of claim 13 , wherein the secondary dose is administered every 2 weeks.

15. The method of claim 1 , wherein the anti-IL-4Rα antibody is administered at a dose of about 0.0001 mg/kg to about 10 mg/kg of patient body weight.

16. The method of claim 1 , further comprising administering a second therapeutic agent selected from a second antibody or antigen binding fragment thereof, a soluble cytokine receptor, an IgE antagonist, or an anti-asthma medication.

17. The method of claim 16 , wherein the anti-asthma medication is a corticosteroid, a non-steroidal agent, a beta agonist, a leukotriene antagonist, a xanthine, fluticasone, salmeterol, or albuterol.

18. The method of claim 1 , further comprising, prior to administering the therapeutically effective amount of the anti-IL-4Rα antibody, selecting the subject exhibiting one or more symptoms of the eye-related disorder IL 4Rα related disorder.

Assignments (3)

Priority Claims (2)

Continuity (4)

References Cited (88)