Stable formulations of antibodies to human programmed death receptor pd-1 and related treatments
AssigneeMerck Sharp & Dohme Corp.
InventorsManoj K. Sharma, Chakravarthy Nachu Narasimhan, Kevin James Gergich, Soonmo Peter Kang
Life of this patent
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Abstract
The present invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof. The present invention further provides methods for treating various cancers and chronic infections with stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof.
Claims16
1-30. (canceled)
A lyophilized formulation of an anti-human PD-1 antibody, or antigen binding fragment thereof, made by lyophilizing an aqueous solution comprising:
- a) 25-100 mg/mL of the anti-human PD-1 antibody, or antigen binding fragment thereof;
- b) about 70 mg/mL sucrose;
- c) about 0.2 mg/mL polysorbate 80;
- and
- d) about 10 mM Histidine buffer at about pH 5.0-pH 6.0, and
- wherein the antibody, or antigen binding fragment thereof, comprises:
- i) a light chain comprising three CDR sequences SEQ ID NOs:
- 15, 16, and 17;
- and
- ii) a heavy chain comprising three CDR sequences SEQ ID NOs:
- 18, 19, and 20.
A liquid pharmaceutical formulation of an anti-human PD-1 antibody, or antigen binding fragment thereof comprising:
- a) 25-100 mg/mL of the anti-human PD-1 antibody, or antigen binding fragment thereof;
- b) about 70 mg/mL sucrose;
- c) about 0.2 mg/mL polysorbate 80;
- and
- d) about 10 mM histidine buffer at pH 5.0-6.0,
- wherein the antibody, or antigen binding fragment thereof, comprises:
- i) a light chain comprising three CDR sequences SEQ ID NOs:
- 15, 16, and 17;
- and
- ii) a heavy chain comprising three CDR sequences SEQ ID NOs:
- 18, 19, and 20.
A method of treating cancer in a mammalian subject in need thereof, the method comprising administering an effective amount of a pharmaceutical formulation of an anti-human PD-1 antibody, or antigen binding fragment thereof comprising:
- a) 25-100 mg/mL of the anti-human PD-1 antibody, or antigen binding fragment thereof;
- b) about 70 mg/mL sucrose;
- c) about 0.2 mg/mL polysorbate 80;
- and
- d) about 10 mM histidine buffer at pH 5.0-6.0,
- wherein the antibody, or antigen binding fragment thereof, comprises:
- i) a light chain comprising three CDR sequences SEQ ID NOs:
- 15, 16, and 17;
- and
- ii) a heavy chain comprising three CDR sequences SEQ ID NOs:
- 18, 19, and 20.
Dependencies are inferred from the claim text.