Composition comprising antibody that binds to domain II of HER2 and acidic variants thereof
AssigneeGenentech, Inc.
InventorsReed J. Harris, Paul A. Motchnik
Life of this patent
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Abstract
A composition comprising a main species HER2 antibody that binds to domain II of HER2 and acidic variants thereof is described. Pharmaceutical formulations comprising the composition, and therapeutic uses for the composition are also disclosed.
Claims30
A method of treating HER2 positive cancer in a patient comprising administering a pharmaceutical formulation to the patient in an amount effective to treat the cancer, wherein the pharmaceutical formulation comprises:
- (i) a composition comprising:
- (a) a main species HER2 antibody comprising light chain and heavy chain amino acid sequences set forth in SEQ ID Nos. 15 and 16, respectively;
- and
- (b) acidic variants of the main species antibody, comprising a disulfide reduced variant, and:
- (ii) a pharmaceutically acceptable carrier.
A method of treating HER2 positive cancer in a patient comprising administering a pharmaceutical formulation to the patient in an amount effective to treat the cancer, wherein the pharmaceutical formulation comprises:
- (i) a composition comprising a main species HER2 antibody comprising light chain and heavy chain amino acid sequences set forth in SEQ ID Nos. 15 and 16, respectively, and acidic variants of the main species antibody, the acidic variants comprising a disulfide reduced variant;
- and
- (ii) a pharmaceutically acceptable carrier,
- wherein disulfide reduced variants in the pharmaceutical formulation comprise no more than 6% of the pharmaceutical formulation, when measured by non-reduced CE-SDS.
A method of treating HER2 positive cancer in a patient comprising administering pharmaceutical formulation to the patient in an amount effective to treat the cancer, wherein the pharmaceutical formulation comprises:
- (i) a composition comprising:
- (a) a main species HER2 antibody comprising light chain and heavy chain amino acid sequences set forth in SEQ ID Nos. 15 and 16, respectively;
- and
- (b) variants that elute earlier than the main species antibody upon separation by cation exchange chromatography, the variants comprising a disulfide reduced variant;
- and
- (ii) a pharmaceutically acceptable carrier.
A method of treating HER2 positive cancer in a patient comprising administering a pharmaceutical formulation to the patient in an amount effective to treat the cancer, wherein the pharmaceutical formulation comprises a main species HER2 antibody comprising light chain and heavy chain amino acid sequences set forth in SEQ ID Nos. 15 and 16, respectively, and variants that elute earlier than the main species antibody upon separation by cation exchange chromatography, the variants comprising disulfide reduced variant, glycated variant, deamidated variant, sialylated variant, and non-reducible variant constituting at least 75 to 80% of the acidic variants in the pharmaceutical formulation.
Dependencies are inferred from the claim text.