Anti-KIR antibodies, formulations, and uses thereof

Patent metadata

Field	Value
Publication number	US-10815299-B2
Application number	US-201715849128-A
Country	US
Kind code	B2
Filing date	Dec 20, 2017
Priority date	Jan 11, 2007
Publication date	Oct 27, 2020
Grant date	Oct 27, 2020

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

The invention claimed is:

1. A method of treating cancer in a patient, comprising administering to the patient a pharmaceutical composition comprising an isolated anti-KIR antibody, or an 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. The method of claim 1 , wherein the pharmaceutical composition includes another therapeutic agent that is not an anti-KIR antibody.

3. The method of claim 1 , wherein the pharmaceutical composition comprises a pH of about 7.

4. The method of claim 1 , wherein the pharmaceutical composition comprises a dosage of said anti-KIR antibody of about 0.0003 mg (antibody)/kg (patient weight) to about 3 mg/kg.

5. The method of claim 1 , wherein the pharmaceutical composition 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.

6. The method of claim 1 , wherein the pharmaceutical composition comprises about 0.05 mg/mL to about 10 mg/mL of said anti-KIR antibody, and (a) about 10-50 mM sodium phosphate or less than about 35 mM sodium phosphate; (b) about 160-250 mM sucrose or about 100 mM NaCl; and/or (c) more than about 0.005% polysorbate 80, wherein the composition has a pH of about 7 or is isotonic.

7. The method of claim 1 , wherein the pharmaceutical composition comprises about 0.05 mg/mL to about 10 mg/mL of said anti-KIR antibody.

8. The method of claim 1 , wherein the pharmaceutical composition comprises about 0.05 mg/mL to about 10 mg/mL of said anti-KIR antibody, and (a) 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; (b) about 180 to about 250 mM sucrose; and/or (c) about 0.001% or about 0.01-0.1% polysorbate 80, wherein the composition has a pH of about 7.

9. The method of claim 1 , wherein the pharmaceutical composition is administered at a dosing frequency of about once every 2 weeks to about once every 2 months, about once every 2 weeks, about once every 4 weeks, about once every 6 weeks, about once per month, or about once every 2 months.

10. The method of claim 1 , wherein the pharmaceutical composition comprises a dosage of said anti-KIR antibody and is administered at a dosing frequency selected from any one of the following combinations:
(i) the dosage is about 0.075 to about 0.3 mg/kg, and the dosing frequency is from about once every two weeks to about once per month;
(ii) the dosage is about 0.3 mg/kg, and the dosing frequency is from about once every two weeks to about once per month;
(iii) the dosage is about 0.3 to about 1 mg/kg, and the dosing frequency is from about once to about twice per month;
(iv) the dosage is about 1 mg/kg, and the dosing frequency is about once per month;
(v) the dosage is about 1 to about 3 mg/kg, and the dosing frequency is from about once per month to about once every 2 months; and
(vi) the dosage is about 3 mg/kg, and the dosing frequency is from about once per month to about once every 2 months.

11. The method of claim 1 , wherein the pharmaceutical composition is administered at least 3 times or at least 6 times.

Assignees

• Novo Nordisk As

Inventors

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

Classifications

• A61K39/39541 Primary

  against normal tissues, cells · CPC title

• A61P35/02

  specific for leukemia · CPC title

• C07K16/2803

  against the immunoglobulin superfamily · CPC title

• A61P13/12

  of the kidneys · CPC title

• A61K2039/505

  comprising antibodies · CPC title