IP Library › Granted Patent US 12,297,264
Granted Patent B2
US 12,297,264 · App. 18/358,833 · Granted May 13, 2025

Methods, compositions and dosing regimens for treating or preventing interferon-gamma related indications

Inventors: Cristina De Min (Basel, CH); Walter Ferlin (Basel, CH); Fabrizio De Benedetti (Basel, CH)
Assignee: SWEDISH ORPHAN BIOVITRUM AG
C07K16/249A61K9/0019A61K9/08A61K39/3955A61K45/06A61K47/02A61K47/22A61K47/26A61P7/00A61P29/00A61P37/00A61P37/06A61K2039/505A61K2039/54A61K2039/545C07K2317/21C07K2317/56C07K2317/565C07K2317/76C07K2317/92
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Quick Facts
Patent No.
US 12,297,264
App. No.
18/358,833
Filed
Jul 25, 2023
Granted
May 13, 2025
Kind
B2
Art Unit
1644
USPC
424/142.1
Abstract

The disclosure relates generally to methods compositions and dosing regimens for treating, preventing and/or delaying the onset or progression of, or alleviating a symptom associated with elevated IFN-γ levels.

Claims (30)

1. An injectable pharmaceutical formulation comprising:

a) 25 mg/mL of a fully human anti-interferon gamma (IFNγ) monoclonal antibody; and

b) 1.55 mg/mL L-histidine, 3.14 mg/mL L-histidine monohydrochloride, monohydrate, 0.05 mg/mL Polysorbate 80, and 7.31 mg/mL sodium chloride (NaCl),

wherein the pH is between 5.8 and 6.2, and

wherein the antibody comprises

a variable heavy chain complementarity determining region 1 (VH CDR1) comprising the amino acid sequence of SEQ ID NO: 1;

a variable heavy chain complementarity determining region 2 (VH CDR2) comprising the amino acid sequence of SEQ ID NO: 2;

a variable heavy chain complementarity determining region 3 (VH CDR3) comprising the amino acid sequence of SEQ ID NO: 3;

a variable light chain complementarity determining region 1 (VL CDR1) comprising the amino acid sequence of SEQ ID NO: 4;

a variable light chain complementarity determining region 2 (VL CDR2) region comprising the amino acid sequence of SEQ ID NO: 5; and

a variable light chain complementarity determining region 3 (VL CDR3) region comprising the amino acid sequence of SEQ ID NO: 6.

2. The formulation of claim 1 , wherein the antibody comprises a heavy chain variable region comprising an amino acid sequence of SEQ ID NO: 47, and a light chain variable region comprising an amino acid sequence of SEQ ID NO: 48.

3. The unit dose vial of claim 1 , wherein the antibody is solubilized in the solution such that the solution is clear, colorless, and without precipitate.

4. A method of treating a condition in a human subject by administering the formulation of claim 1 , wherein the condition is primary hemophagocytic lymphohistiocytosis (HLH) or secondary HLH.

5. The method of claim 4 , wherein the human subject is pediatric or adult.

6. A unit dose vial comprising, 2 mL, 10 mL or 20 mL of a fully human anti-interferon gamma (IFNγ) monoclonal antibody solution suitable for injection,

wherein the solution comprises 1.55 mg/mL L-histidine, 3.14 mg/mL L-histidine monohydrochloride, monohydrate, 0.05 mg/mL Polysorbate 80, and 7.31 mg/mL sodium chloride (NaCl),

wherein the pH of the solution is between 5.8 and 6.2,

wherein the concentration of antibody is at 25 mg/mL, and

wherein the antibody comprises:

a VH CDR1 comprising the amino acid sequence of SEQ ID NO: 1;

a VH CDR2 comprising the amino acid sequence of SEQ ID NO: 2;

a VH CDR3 comprising the amino acid sequence of SEQ ID NO: 3;

a VL CDR1 comprising the amino acid sequence of SEQ ID NO: 4;

a VL CDR2 region comprising the amino acid sequence of SEQ ID NO: 5; and

a VL CDR3 region comprising the amino acid sequence of SEQ ID NO: 6.

7. The unit dose vial of claim 6 , wherein the antibody comprises a heavy chain variable region comprising an amino acid sequence of SEQ ID NO: 47, and a light chain variable region comprising an amino acid sequence of SEQ ID NO: 48.

8. The unit dose vial of claim 6 , wherein the antibody is solubilized in the solution such that the solution is clear, colorless, and without precipitate.

9. A method of treating a condition in a human subject by administering the unit dose vial of claim 6 , wherein the condition is primary hemophagocytic lymphohistiocytosis (HLH) or secondary HLH.

10. The method of claim 9 , wherein the human subject is pediatric or adult.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 26, 2023
From: DE MIN, CRISTINA; FERLIN, WALTER; DE BENEDETTI, FABRIZIO
To: NOVIMMUNE SA
Reel/Frame 065354/0436 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 26, 2023
From: NOVIMMUNE SA
To: EMACO SA
Reel/Frame 065354/0472 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 26, 2023
From: EMACO SA
To: SWEDISH ORPHAN BIOVITRUM AG
Reel/Frame 065363/0185 →
Continuity (9)
Continuation 17561065 · Dec 23, 2021
Continuation 16831351 · Mar 26, 2020
Division 15792702 · Oct 24, 2017
Continuation In Part 15149633 · May 9, 2016
Provisional Application 62411783 · Oct 24, 2016
Provisional Application 62246949 · Oct 27, 2015
Provisional Application 62221393 · Sep 21, 2015
Provisional Application 62158153 · May 7, 2015
Related Publication 20240010719A1 · Jan 11, 2024
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