IP Library › Granted Patent US 12,686,713
Granted Patent B2
US 12,686,713 · App. 18/340,797 · Granted Jul 21, 2026

Methods for treating complement-mediated diseases

Inventors: Miguel Alonso Alonso (Somerville, MA); Nazem Atassi (Newton, MA); Rene Belder (Hopewell, NJ); Timothy Wing Yau Chow (Boston, MA); Pirouz Shamszad (Basking Ridge, NJ); Michael John Storek (Cambridge, MA); Christopher Lawrence Vinnard (Pennington, NJ); Erik Holger Wallstroem (Boston, MA); Yu Jyu Nancy Wong (North Andover, MA)
Assignee: Bioverativ USA Inc.
C07K16/18A61P7/06A61K2039/505A61K2039/54A61K2039/545C07K2317/24
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Quick Facts
Patent No.
US 12,686,713
App. No.
18/340,797
Filed
Jun 23, 2023
Granted
Jul 21, 2026
Kind
B2
Art Unit
1641
USPC
424/135.1
Abstract

Provided herein are methods of treating cold agglutinin disease (CAD) or chronic inflammatory demyelinating polyneuropathy (CIDP) in a subject in need thereof. The methods comprise administering to a subject a humanized antibody that specifically binds complement component C1s (anti-C1s antibody). Methods of treating CAD comprise administering the anti-C1s antibody to a subject in a fixed dose. Methods of treating CIDP comprise administering to a subject a weight-based loading dose of the anti-C1s antibody followed by one or more fixed maintenance doses. The methods comprise administering an effective dose of anti-C1s antibody to achieve a minimum level of CP inhibition for therapeutic effect.

Claims (20)

1 . A method for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in a subject in need thereof, the method comprising:

administering to the subject a loading dose of about 50 mg/kg of the subject's body weight of a humanized antibody that specifically binds complement component C1s, and one or more maintenance doses of about 300 mg, about 600 mg, about 1,200 mg, about 2,400 mg, about 3,600 mg, or about 7,200 mg of the antibody,

wherein the antibody comprises: a light chain (LC) complementarity determining region (CDR) 1 comprising the amino acid sequence of SEQ ID NO: 1, a LC CDR2 comprising the amino acid sequence of SEQ ID NO: 2, and a LC CDR3 comprising the amino acid sequence of SEQ ID NO: 3; and a heavy chain (HC) CDR1 comprising the amino acid sequence of SEQ ID NO: 4, an HC CDR2 comprising the amino acid sequence of SEQ ID NO: 5, and an HC CDR3 comprising the amino acid sequence of SEQ ID NO: 6.

2 . The method of claim 1 , wherein the one or more maintenance doses are administered about every 1, 2, 4, or 12 weeks thereafter.

3 . The method of claim 1 , wherein the loading dose is administered intravenously on Day 1, followed by subcutaneous administration of the maintenance dose about every week starting on Day 8.

4 . The method of claim 1 , wherein the subject has received another CIDP treatment prior to the loading dose or is concomitantly receiving another CIDP treatment.

5 . The method of claim 1 , wherein the subject has not received another treatment for CIDP within about 6 months prior to the loading dose.

6 . The method of claim 1 , wherein the antibody comprises a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 7 and a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 8.

7 . The method of claim 1 , wherein the antibody comprises a heavy chain constant region of the isotype IgG4.

8 . The method of claim 7 , wherein the IgG4 constant region comprises a proline substitution, a glutamic acid substitution, a leucine substitution, and a serine substitution at amino acid residues 108, 115, 308, and 314, respectively, relative to the IgG4 constant region sequence of SEQ ID NO: 11.

9 . The method of claim 1 , wherein the antibody comprises a light chain comprising the amino acid sequence of SEQ ID NO: 9 and a heavy chain comprising the amino acid sequence of SEQ ID NO: 10.

10 . The method of claim 1 , wherein the antibody is a Fab fragment, a F(ab′)2 fragment, a scFv, or a Fv.

11 . The method of claim 1 , wherein the antibody is administered intravenously or subcutaneously.

12 . The method of claim 1 , wherein administration of the antibody results in a one point or greater decrease in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score relative to the INCAT score prior to treatment with the antibody.

13 . The method of claim 1 , wherein following administration of the antibody, the subject has a plasma concentration of the antibody of at least about 100 μg/mL.

14 . The method of claim 1 , wherein the subject is refractory to another CIDP treatment.

15 . The method of claim 1 , wherein the antibody is administered using a syringe, a pre-filled syringe, or a large-volume drug delivery system.

16 . The method of claim 1 , wherein the antibody is administered using an autoinjector.

17 . The method of claim 4 , wherein the subject has received another CIDP treatment within about one week of the loading dose.

18 . The method of claim 4 , wherein the other CIDP treatment is intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg), or corticosteroids.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2024
From: ALONSO, MIGUEL ALONSO; ATASSI, NAZEM; WALLSTROEM, ERIK HOLGER; BELDER, RENE; CHOW, TIMOTHY WING YAU; SHAMSZAD, PIROUZ; STOREK, MICHAEL JOHN; VINNARD, CHRISTOPHER LAWRENCE; WONG, YU JYU NANCY
To: BIOVERATIV USA INC.
Reel/Frame 066338/0717 →
Continuity (5)
Provisional Application 63379626 · Oct 14, 2022
Provisional Application 63375041 · Sep 8, 2022
Provisional Application 63370484 · Aug 4, 2022
Provisional Application 63355296 · Jun 24, 2022
Related Publication 20240025978A1 · Jan 25, 2024
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