Granted Patent B2

US 12,435,145 · App. 16/997,577 · Granted Oct 7, 2025

Inventors: Yong Quan (South San Francisco, CA); Chin-Yi Huang (South San Francisco, CA); Harjeet Singh Ganda (South San Francisco, CA)

Assignee: Five Prime Therapeutics, Inc.

C07K16/2827A61K47/02A61K47/12A61K47/22A61K47/26A61K2039/505C07K2317/51C07K2317/515C07K2317/565C07K2317/94

Abstract

Claims (19)

1. A pharmaceutical composition comprising (i) an antibody or antigen-binding fragment thereof that specifically binds to human B7-H4 and comprises the VH CDR1, VH CDR2, VH CDR3 and VL CDR1, CDR2, and CDR3 sequences of SEQ ID NOs: 5-10, respectively, (ii) a buffer, and (iii) a pH of about 4.5 to about 6.

2. The composition of claim 1 , wherein the buffer is acetate or citrate and the composition comprises about 30% to about 40% of acidic variants of the antibody or antigen-binding fragment thereof after 6 months at 5° C.

3. The composition of claim 1 , wherein the buffer is acetate or citrate and the composition comprises about 10% to about 17% of basic variants of the antibody or antigen-binding fragment thereof after 6 months at 5° C.

4. The composition of claim 1 , wherein the buffer is acetate or citrate and the composition comprises no more than 55% of acidic and basic variants of the antibody or antigen-binding fragment thereof after 6 months at 5° C.

5. The composition of claim 1 , wherein the composition further comprises a sugar.

6. The composition of claim 1 , wherein the concentration of the buffer is about 15 to about 25 mM.

7. The composition of claim 5 , wherein the concentration of the sugar is about 225 mM to about 300 mM.

8. The composition of claim 1 , wherein the composition further comprises a surfactant.

9. The composition of claim 1 , wherein the concentration of the antibody or antigen-binding fragment thereof is about 5 mg/ml to about 30 mg/ml.

10. The composition of claim 1 comprising about 20 mM acetate, about 270 mM sucrose, about 20 mg/ml of the antibody or antigen-binding fragment thereof, and about 0.05% polysorbate 20, wherein the pH is about 5.0.

11. The composition of claim 1 , comprising about 20 mM citrate, about 270 mM sucrose, about 20 mg/ml of the antibody or antigen-binding fragment thereof, and about 0.05% polysorbate 20, wherein the pH is about 5.5.

12. The composition of claim 1 , wherein the antibody comprises a VH comprising the amino acid sequence set forth in SEQ ID NO:11 and/or a VL comprising the amino acid sequence set forth in SEQ ID NO:12.

13. The composition of claim 12 , wherein the antibody or antigen-binding fragment thereof comprises a heavy chain comprising the amino acid sequence set forth in SEQ ID NO:21 and/or a light chain comprising the amino acid sequence set forth in SEQ ID NO:22.

14. The composition of claim 1 , wherein at least 95% of the antibodies or antigen-binding fragments thereof in the composition are afucosylated.

15. A pharmaceutical composition consisting of (i) an antibody comprising a heavy chain comprising the amino acid sequence set forth in SEQ ID NO: 21 and/or a light chain comprising the amino acid sequence set forth in SEQ ID NO:22, (ii) about 20 mM acetate, (iii) about 270 mM sucrose, and (iv) about 0.05% weight/volume polysorbate 20, wherein the pH of the composition is about 5.0 to about 5.5.

16. A syringe or vial comprising the pharmaceutical composition of claim 1 .

17. A method of treating a B7-H4 expressing cancer in a subject, the method comprising administering to the subject the pharmaceutical composition of claim 1 .

18. The method of claim 17 , wherein the cancer is selected from the group consisting of breast cancer, ductal carcinoma, endometrial carcinoma, ovarian cancer, non-small cell lung cancer, pancreatic cancer, thyroid cancer, kidney cancer, and bladder cancer.

19. The method of claim 17 , wherein the pharmaceutical composition is administered parenterally or intravenously.

Assignments (1)

Continuity (3)

References Cited (400)