Granted Patent B2

US 12,509,509 · App. 14/651,946 · Granted Dec 30, 2025

Inventors: Ramesh S. Kashi (Kenilworth, NJ); Aniket Badkar (Portage, MI)

Assignee: Merck Sharp & Dohme LLC

C07K16/244A61K39/39591A61K2039/505C07K2317/24C07K2317/51C07K2317/515C07K2317/56C07K2317/94

Abstract

Claims (22)

1 . A stable solution formulation of anti-IL-23p19 antibody hum13B8-b comprising:

a) 100 mg/ml anti-IL-23p19 antibody hum13B8-b;

b) about 10 mM histidine buffer, pH 6.0±0.3;

c) 0.05% polysorbate 80; and

d) 7% sucrose;

wherein the anti-IL-23p19 antibody hum13B8-b comprises:

i) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and

ii) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and

wherein the formulation is stable for at least 18 months at 5°±3° C.

2 . The stable solution formulation of claim 1 , wherein the histidine comprises L-histidine and L-histidine HCl.

3 . A method of treating psoriasis comprising subcutaneous administration of the stable solution formulation of claim 1 at quarterly intervals.

4 . The method of treating psoriasis of claim 3 , wherein the subcutaneous administration is performed by injection using a syringe, an autoinjector, an injector pen or a needleless injection device.

5 . A stable solution formulation of anti-IL-23p19 antibody hum13B8-b comprising:

a) 100 mg/ml anti-IL-23p19 antibody hum13B8-b;

b) about 10 mM histidine buffer, pH 6.0±0.3;

c) 0.05% polysorbate 80; and

d) 7% sucrose;

wherein the anti-IL-23p19 antibody hum13B8-b comprises:

i) a heavy chain polypeptide comprising the amino acid sequence of SEQ ID NO: 1; and

ii) a light chain polypeptide comprising the amino acid sequence of SEQ ID NO: 2; and

wherein the formulation is stable for at least 3 months at 25°±5° C. and 60% relative humidity.

6 . The stable solution formulation of claim 5 , wherein the histidine comprises L-histidine and L-histidine HCl.

Assignments (2)

Continuity (2)

References Cited (400)