IP Library Granted Patent US 10,800,841
Granted Patent B2
US 10,800,841 · App. 15/703,414 · Granted Oct 13, 2020

Methods of treating autoimmunity using specific anti-IL-6 antibodies

Inventors: Leon Garcia-Martinez (Woodinville, WA); Anne Elisabeth Carvalho Jensen (Snohomish, WA); Katie Anderson (Kirkland, WA); Benjamin H. Dutzar (Seattle, WA); Ethan W. Ojala (Snohomish, WA); John Latham (Seattle, WA); Brian R. Kovacevich (Snohomish, WA); Jeffrey T. L. Smith (Bellevue, WA)
Assignee: VITAERIS, INC.
C07K16/248A61K39/3955A61K45/06A61K2039/505C07K2317/20C07K2317/24C07K2317/34C07K2317/41C07K2317/76C07K2317/94
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Quick Facts
Patent No.
US 10,800,841
App. No.
15/703,414
Granted
Oct 13, 2020
Kind
B2
Abstract

Methods of treating individuals with autoimmune conditions characterized by elevated IL-6 levels comprising the administration of anti-IL-6 antibodies or antibody fragments are provided.

Claims (17)

1. A method of inhibiting or treating an autoimmune disease characterized by elevated levels of interleukin-6 (IL-6) in a subject in need thereof comprising administering to said subject an effective amount of an anti-human IL-6 antibody or antigen-binding fragment comprising a variable light polypeptide comprising the complementarity regions (CDR's) of SEQ ID NO:4, 5 and 6 and a variable heavy polypeptide comprising the complementarity regions (CDR's) of SEQ ID NO:7, 8 or 120 and 9, wherein said administered amount of anti-IL-6 antibody or antigen-binding fragment effectively treats said autoimmune disease characterized by elevated levels of IL-6 which method further comprises (i) monitoring IL-6 and hemoglobin levels after antibody treatment, and/or (ii) administering another drug or therapy for treating anemia.

2. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment is a human, humanized or chimeric anti-human IL-6 antibody or fragment thereof.

3. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment contains a human Fc region.

4. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment is of the IgG1, IgG2, IgG3 or IgG4 isotype.

5. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment is of the IgG1 isotype.

6. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment is aglyclosylated.

7. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment contains an Fc region that has been modified to alter effector function, half-life, proteolysis, and/or glycosylation.

8. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment binds to IL-6 with a dissociation constant (K D ) of less than or equal to 5×10 −7 M −1 , 10 −7 M −1 , 5×10 −8 M −1 , 10 −8 M −1 , 5×10 −9 M −1 , 10 −9 M− 1 , 5×10 −10 M −1 , 10 −10 M −1 , 5×10 −11 M −1 , 10 −11 M −1 , 5×10 −12 M −1 , 10 −12 M −1 , 5×10 −13 M −1 , or 10 −13 M −1 .

9. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment binds to IL-6 with a dissociation constant (K D ) of less than or equal to 5×10 −11 M −1 .

10. The method of claim 1 wherein said administered anti-human IL-6 antibody or fragment binds to IL-6 with a dissociation constant (K D ) of less than or equal to 5×10 −12 M −1 .

11. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment is a humanized antibody or antibody fragment.

12. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment is a Fab, F(ab')2, Fv or scFv, camelbody, nanobody, or an IgNAR.

13. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment binds to IL-6 with a dissociation constant of less than or equal to 5×10 −10 M −1 .

14. The method of claim 1 , wherein said administered anti-human IL-6 antibody or fragment binds to IL-6 with an off-rate (K off ) of less than or equal to 10 −4 S −1 , 5×10 −5 S −1 , 10 −5 S −1 , 5×10 −6 S −1 , 10 −6 S −1 , 5×10 −7 S −1 , or 10 −7 S −1 .

15. The method of claim 1 , wherein the anti-IL-6 antibody or antibody fragment comprising said CDRs contains a variable heavy chain polypeptide identical to the polypeptide in SEQ ID NO:657 and a variable light chain identical to the polypeptide in SEQ ID NO:20.

16. The method of claim 1 , wherein said antibody or antibody fragment further comprises the heavy constant and light constant sequences in SEQ ID NO:588 and SEQ ID NO:586.

17. The method of claim 1 wherein the anti-IL-6 antibody comprising said CDRs contains a light chain polypeptide identical to the polypeptide in SEQ ID NO:586 and a heavy chain identical to the polypeptide in SEQ ID NO:588.

Assignments (6)
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED AT REEL: 054161 FRAME: 0877. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jun 2, 2021
From: LUNDBECK SEATTLE BIOPHARMACEUTICALS, INC
To: H. LUNDBECK A/S
Reel/Frame 056449/0543 →
CHANGE OF NAME Recorded Sep 3, 2020
From: ALDER BIOPHARMACEUTICALS, INC
To: LUNDBECK SEATTLE BIOPHARMACEUTICALS, INC
Reel/Frame 053681/0224 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 3, 2020
From: LUNDBECK SEATTLE BIOPHARMACEUTICALS, INC
To: H. LUNDBECK A/S.
Reel/Frame 054161/0877 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 14, 2020
From: H. LUNDBECK A/S
To: VITAERIS INC.
Reel/Frame 053496/0319 →
CHANGE OF NAME Recorded Jun 23, 2020
From: ALDER BIOPHARMACEUTICALS, INC.
To: LUNDBECK SEATTLE BIOPHARMACEUTICALS, INC.
Reel/Frame 053020/0143 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2020
From: LUNDBECK SEATTLE BIOPHARMACEUTICALS, INC
To: H. LUNDBECK A/S
Reel/Frame 053020/0205 →
Continuity (4)
Division 14604419 · Jan 23, 2015
Continuation 12601295
Provisional Application 60924550 · May 21, 2007
Related Publication 20180100013A1 · Apr 12, 2018