IP Library Granted Patent US 11,723,974
Granted Patent B2
US 11,723,974 · App. 17/115,618 · Granted Aug 15, 2023

Methods for treating digitally identified IL-4/IL-13-related disorders by administering an anti-IL4R-alpha antibody

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-Aventis Biotechnology
A61K39/3955A61K9/0019A61K31/137A61K31/522A61K31/56A61K31/573A61K45/06C07K16/2866G06N20/00A61K2039/545C07K2317/565
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,723,974
App. No.
17/115,618
Granted
Aug 15, 2023
Kind
B2
Abstract

Disclosed are methods of treating various disorders with anti-IL-4Rα antibodies and fragments thereof.

Claims (60)

1. A method of treating a subject with an anti-interleukin-4 receptor alpha (anti-IL-4Rα) antibody, comprising administering a therapeutically effective amount of an anti-IL-4Rα antibody to a subject exhibiting at least one symptom of a disorder selected from the group consisting of an esophageal-related disorder, a lung-related disorder, a blood-related disorder, a gastrointestinal-related disorder, a kidney-related disorder, a prostate-related disorder, Kawasaki's disease, a thyroid-related disorder, a blood-vessel-related disorder, a pregnancy-related disorder, and a cancer,

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-4Rα antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO:13 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO:14.

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

4. The method of claim 1 , wherein the administering is selected from:

(a) intradermal, intramuscular, intraperitoneal, intravenous, subcutaneous, intranasal, or epidural administration;

(b) via a pre-filled syringe;

(c) via a pre-filled pen; or

(d) via an autoinjector.

5. The method of claim 1 , wherein the anti-IL-4Rα antibody is administered over multiple doses.

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

7. 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,

wherein the anti-asthma medication is a corticosteroid, a non-steroidal agent, a beta agonist, a leukotriene antagonist, a xanthine, fluticasone, salmeterol, or albuterol.

8. The method of claim 1 , wherein the lung-related disorder is lung fibrosis.

9. The method of claim 1 , wherein the lung-related disorder is lung cirrhosis.

10. The method of claim 1 , wherein the lung-related disorder is chronic fibrotic lung disease.

11. The method of claim 1 , wherein the lung-related disorder is cystic fibrosis.

12. The method of claim 1 , wherein the lung-related disorder is bleomycin-induced pneumopathy and fibrosis.

13. The method of claim 1 , wherein the lung-related disorder is pulmonary alveolar proteinosis.

14. The method of claim 1 , wherein the lung-related disorder is adult respiratory distress syndrome.

15. The method of claim 1 , wherein the lung-related disorder is sarcoidosis.

16. The method of claim 1 , wherein the lung-related disorder is tuberculosis.

17. The method of claim 1 , wherein the lung-related disorder is aspirin-exacerbated respiratory disease.

18. The method of claim 1 , wherein the blood-related disorder is sickle cell disease.

19. The method of claim 1 , wherein the blood-related disorder is Churg-Strauss syndrome.

20. The method of claim 1 , wherein the blood-related disorder is autoimmune lymphoproliferative syndrome.

21. The method of claim 1 , wherein the blood-related disorder is systemic lupus erythematosus.

22. The method of claim 1 , wherein the blood-related disorder is antiphospholipid antibody syndrome (APS).

23. The method of claim 1 , wherein the blood-related disorder is autoimmune hemolytic anemia.

24. The method of claim 1 , wherein the esophageal-related disorder is Barrett's esophagus.

25. The method of claim 1 , wherein the esophageal-related disorder is eosinophilic gastritis.

26. The method of claim 1 , wherein the esophageal-related disorder is achalasia.

27. The method of claim 1 , wherein the esophageal-related disorder is gastroesophageal reflux disease (GERD).

28. The method of claim 1 , wherein the gastrointestinal-related disorder is ulcerative colitis.

29. The method of claim 1 , wherein the gastrointestinal-related disorder is Whipple's disease.

30. The method of claim 1 , wherein the gastrointestinal-related disorder is Behçet's disease.

31. The method of claim 1 , wherein the gastrointestinal-related disorder is Wegener granulomatosis.

32. The method of claim 1 , wherein the kidney-related disorder is nephrosis.

33. The method of claim 1 , wherein the kidney-related disorder is glomerulonephritis.

34. The method of claim 1 , wherein the kidney-related disorder is Goodpasture syndrome.

35. The method of claim 1 , wherein the prostate-related disorder is benign prostrate hyperplasia.

36. The method of claim 1 , wherein the prostate-related disorder is chronic prostatitis syndrome.

37. The method of claim 1 , wherein the disorder is Kawasaki's disease.

38. The method of claim 1 , wherein the pregnancy-related disorder is pre-eclampsia.

39. The method of claim 1 , wherein the pregnancy-related disorder is antiphospholipid syndrome.

40. The method of claim 1 , wherein the pregnancy-related disorder is immune thrombocytopenia.

41. The method of claim 1 , wherein the cancer is a cutaneous T-cell lymphoma.

42. The method of claim 1 , wherein the administering is via a pre-filled syringe.

43. The method of claim 1 , wherein the administering is via a pre-filled pen.

44. The method of claim 1 , wherein the administering is via an autoinjector.

45. The method of claim 1 , wherein the anti-IL-4Rα antibody is administered to the subject as an initial dose followed by one or more secondary doses.

46. The method of claim 45 , wherein the initial dose is about 600 mg and each secondary dose is about 300 mg.

47. The method of claim 45 , wherein the initial dose is about 400 mg and each secondary dose is about 200 mg.

48. The method of claim 45 , wherein each secondary dose is administered every 2 weeks.

Assignments (4)
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE'S NAME PREVIOUSLY RECORDED AT REEL: 57563 FRAME: 491. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT . Recorded Mar 21, 2025
From: MOLONY, CLIONA MARIE; JIMENEZ, FRANCISCO JAVIER JIMENEZ; DE RINALDIS, EMANUELE; BRYCE, PAUL
To: SANOFI BIOTECHNOLOGY
Reel/Frame 071752/0470 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 22, 2021
From: VECINO, RAMON ANTONIO HERNANDEZ
To: SANOFI-AVENTIS GROUPE
Reel/Frame 057563/0375 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 22, 2021
From: BRYCE, PAUL; RINALDIS, EMANUELE DE; JIMENEZ, FRANCISCO JAVIER JIMENEZ; MOLONY, CLIONA MARIE
To: SANOFI-AVENTIS BIOTECHNOLOGY
Reel/Frame 057563/0491 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 22, 2021
From: SANOFI-AVENTIS GROUPE
To: SANOFI BIOTECHNOLOGY
Reel/Frame 057563/0583 →
Priority Claims (2)
EP 20315281 · Nov 2, 2020 · regional
EP 20315450 · Nov 13, 2020 · regional
Continuity (3)
Provisional Application 63028919 · May 22, 2020
Provisional Application 62945807 · Dec 9, 2019
Related Publication 20210220470A1 · Jul 22, 2021
Cited By (1)
US 12,243,628