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US 2022/0089738 A1Published application
Stable Formulations of Programmed Death Receptor 1 (PD-1) Antibodies and Hyaluronidase Variants and Fragments Thereof and Methods of Use Thereof
AssigneeMerck Sharp & Dohme Corp.
InventorsYogita Krishnamachari, Sachin Mittal, Sahil S. Sangani, William P. Forrest, JR., Yongchao Su, Xi Zhao
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Abstract
The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof and a PH20 variant or fragment thereof. The invention further provides methods for treating various cancers with formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by subcutaneous administration.
Claims57
A formulation comprising:
- a) about 20 mg/mL to about 200 mg/mL of an anti-human PD-1 antibody, or antigen binding fragment thereof;
- b) about 0.0009-0.050 mg/ml of a PH20 variant or fragment thereof;
- c) about 5 mM to about 20 mM buffer;
- d) about 3% to about 10% weight/volume (w/v) of a non-reducing dissacharide selected from the group consisting of sucrose and trehalose;
- e) about 0.005% to about 0.10% (w/v) non-ionic surfactant;
- and, optionally
- f) about 1 mM to about 30 mM anti-oxidant.
4 more elements
Dependencies are inferred from the claim text.