Claims for Patent: 9,181,346

Summary for Patent: 9,181,346

Title:	Composition comprising antibody that binds to domain II of HER2 and acidic variants thereof
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.
Inventor(s):	Harris; Reed J. (San Mateo, CA), Motchnik; Paul A. (Belmont, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	14/162,208
Patent Claims:	1. 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 composition comprising a main species HER2 antibody comprising variable light and variable heavy sequences comprising SEQ ID Nos. 3 and 4, respectively, and acidic variants of the main species antibody, wherein the acidic variants include a glycated variant, a deamidated variant, a disulfide reduced variant, a sialylated variant, and a non-reducible variant in a pharmaceutically acceptable carrier. 2. The method of claim 1 wherein the cancer is breast cancer. 3. The method of claim 1 wherein the main species antibody and acidic variants have essentially the same pharmacokinetics. 4. The method of claim 1 wherein the composition comprises less than about 25% acidic variants. 5. The method of claim 1 wherein the main species HER2 antibody and the acidic variants are intact antibodies. 6. The method of claim 1 wherein the main species HER2 antibody comprises light chain and heavy chain amino acid sequences comprising SEQ ID Nos. 15 and 16, respectively. 7. The method of claim 1 wherein the composition further comprises an amino-terminal leader extension variant of the main species antibody. 8. The method of claim 7 wherein the amino-terminal leader extension comprises VHS-. 9. The method of claim 7 wherein the amino-terminal leader extension consists of VHS-. 10. The method of claim 1 wherein the composition further comprises an amino acid sequence variant of the main species HER2 antibody selected from the group consisting of an antibody comprising a C-terminal lysine residue on one or both heavy chains thereof, and an antibody with one or more oxidized methionine residues. 11. A method of treating HER2 positive breast 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 the variable light and variable heavy amino acid sequences comprising SEQ ID Nos. 3 and 4, respectively, and acidic variants thereof comprising a disulfide reduced variant and a non-reducible variant of the main species antibody in a pharmaceutically acceptable carrier. 12. The method of claim 11 wherein the composition further comprises one or more acidic variants of the main species antibody selected from the group consisting of a glycated variant, a deamidated variant, and a sialylated variant. 13. The method of claim 11 wherein the main species antibody and acidic variants have essentially the same pharmacokinetics. 14. The method of claim 11 wherein the main species HER2 antibody comprises light chain and heavy chain amino acid sequences comprising SEQ ID Nos. 15 and 16, respectively. 15. The method of claim 11 wherein the composition further comprises an amino-terminal leader extension variant of the main species antibody, an antibody comprising a C-terminal lysine residue on one or both heavy chains thereof, and an antibody with one or more oxidized methionine residues. 16. A method of treating HER2 positive breast 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 composition comprising a main species HER2 antibody that binds to domain II of HER2 and comprises variable light and variable heavy amino acid sequences comprising SEQ ID Nos. 3 and 4, respectively, and an acidic variant thereof comprising a non-reducible variant of the main species antibody in a pharmaceutically acceptable carrier. 17. The method of claim 16 wherein the composition further comprises one or more acidic variants of the main species antibody selected from the group consisting of a disulfide reduced variant, a glycated variant, a deamidated variant, and a sialylated variant. 18. The method of claim 16 wherein the main species antibody and acidic variants have essentially the same pharmacokinetics. 19. The method of claim 16 wherein the main species HER2 antibody comprises light chain and heavy chain amino acid sequences comprising SEQ ID Nos. 15 and 16, respectively. 20. The method of claim 16 wherein the composition further comprises an amino-terminal leader extension variant of the main species antibody, an antibody comprising a C-terminal lysine residue on one or both heavy chains thereof, and an antibody with one or more oxidized methionine residues. 21. The method of claim 1 further comprising administering an additional HER2 antibody to the patient. 22. The method of claim 21 wherein the additional HER2 antibody comprises Trastuzumab. 23. The method of claim 11 further comprising administering an additional HER2 antibody to the patient. 24. The method of claim 23 wherein the additional HER2 antibody comprises Trastuzumab. 25. The method of claim 16 further comprising administering an additional HER2 antibody to the patient. 26. The method of claim 25 wherein the additional HER2 antibody comprises Trastuzumab.

Details for Patent 9,181,346

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2028-01-30
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2028-01-30
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2028-01-30