Anti-KIR antibodies, formulations, and uses thereof

Patent metadata

Field	Value
Publication number	US-9879082-B2
Application number	US-201514606814-A
Country	US
Kind code	B2
Filing date	Jan 27, 2015
Priority date	Jan 11, 2007
Publication date	Jan 30, 2018
Grant date	Jan 30, 2018

Abstract

A novel IgG4 isotype anti-KIR antibody, novel formulations of this and other IgG4 anti-KIR antibodies, and methods of using such formulations are provided. Also described are compositions, formulations, dosages, and administration regimens suitable for NK cell activation and therapeutic applications of anti-KIR antibodies, as well as kits comprising one or more anti-KIR antibodies with instructions for use in treating cancer.

First claim

What is claimed is:

1. An isolated anti-KIR antibody or antigen-binding fragment thereof comprising a heavy chain having the amino acid sequence set forth in SEQ ID NO:1 and a light chain variable region having the amino acid sequence set forth in SEQ ID NO:2.

2. A pharmaceutical composition comprising an isolated anti-KIR antibody or antigen-binding fragment thereof comprising a heavy chain having the amino acid sequence set forth in SEQ ID NO:1 and a light chain variable region having the amino acid sequence set forth in SEQ ID NO:2.

3. The composition of claim 2 , which includes another therapeutic agent that is not an anti-KIR antibody.

4. The composition of claim 2 , which comprises a pH of about 7.

5. The composition of claim 2 , which comprises a dosage of said anti-KIR antibody of about 0.0003 mg (antibody)/kg (patient weight) to about 3 mg/kg.

6. The composition of claim 2 , which comprises a dosage of said anti-KIR antibody of about 0.015 to about 3 mg/kg, about 0.075 mg to about 3 mg/kg, about 0.3 mg/kg to about 3 mg/kg, about 1 mg/kg to about 3 mg/kg, or any of about 0.0003 mg/kg, about 0.003 mg/kg, about 0.015 mg/kg, about 0.075 mg/kg, about 0.3 mg/kg, about 1 mg/kg, or about 3 mg/kg.

7. The composition of claim 2 , which comprises (a) about 0.05 mg/mL to about 10 mg/mL of said anti-KIR antibody which comprises an IgG4 antibody; (b) about 10-50 mM sodium phosphate; (c) about 160-250 mM sucrose or about 100 mM NaCl; and (d) polysorbate 80, at a pH of about 7.

8. The composition of claim 2 , which comprises about 0.05 mg/mL to about 10 mg/mL of said anti-KIR antibody which comprises an IgG4 antibody.

9. The composition of claim 2 , which comprises (a) about 0.05 mg/mL to about 10 mg/mL of said anti-KIR antibody which comprises an IgG4 antibody; (b) about 5-20 mM sodium phosphate, about 5 mM sodium phosphate, about 10 mM sodium phosphate, about 15 mM sodium phosphate, or about 20 mM sodium phosphate; (c) about 180 to about 250 mM sucrose; and (d) about 0.001% or about 0.01-0.1% polysorbate 80, wherein the formulation has a pH of about 7.

10. The composition of claim 2 , which comprises less than about 35 mM sodium phosphate.

11. The composition of claim 2 , which comprises more than about 0.005% polysorbate 80.

12. The composition of claim 2 , which is isotonic.

Assignees

• Novo Nordisk As

Inventors

• Wagtmann Peter Andreas Nicolai Reumert
• Svendsen Ivan
• Sten Rozana
• Alifrangis Lene Hjorth
• Overgaard Rune Viig

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61P35/02

  specific for leukemia · CPC title

• A61K39/3955

  against proteinaceous materials, e.g. enzymes, hormones, lymphokines · CPC title

• A61P13/12

  of the kidneys · CPC title