Granted Patent B2

US 12,679,892 · App. 17/685,056 · Granted Jul 14, 2026

Inventors: Charles Kaplan (San Francisco, CA); Derrick Houser (San Francisco, CA); Luis Borges (San Mateo, CA); Gloria Brattich (San Francisco, CA); David Bellovin (San Jose, CA); Felicia Kemp (San Jose, CA); Majid Ghoddusi (Walnut Creek, CA); Nels P. Nielson (Lebanon, NH); Kathy Miller (San Francisco, CA); Maike Schmidt (San Francisco, CA)

Assignee: FIVE PRIME THERAPEUTICS, INC.

C07K16/2827A61P35/00C07K16/2818G01N33/5759A61K2039/505A61K2039/507C07K2317/21C07K2317/24C07K2317/40C07K2317/41C07K2317/52C07K2317/56C07K2317/565C07K2317/73C07K2317/732C07K2317/74C07K2317/75C07K2317/76C07K2317/92

Abstract

Claims (35)

1 . An isolated antibody or antigen-binding fragment thereof that specifically binds to human B7-H4, comprising heavy chain variable region (VH) complementarity determining region (CDR) 1, VH CDR2, VH CDR3 and light chain variable region (VL) CDR1, CDR2, and CDR3 sequences selected from the group consisting of:

(a) SEQ ID NOs: 95-100, respectively;

(b) SEQ ID NOs: 105-110, respectively; and

(c) SEQ ID NOs: 115-120, respectively.

2 . An isolated antibody or antigen-binding fragment thereof that specifically binds to human B7-H4, comprising a heavy chain variable region and a light chain variable region comprising the amino acid sequences of:

(a) SEQ ID NOs: 101 and 102, respectively;

(b) SEQ ID NOs: 111 and 112, respectively; or

(c) SEQ ID NOs: 121 and 122, respectively.

3 . The antibody or antigen-binding fragment thereof of claim 1 , wherein the antibody or antigen-binding fragment thereof comprises a heavy chain and light chain comprising the amino acid sequences of:

(a) SEQ ID NOs: 103 and 104, respectively;

(b) SEQ ID NOs: 113 and 114, respectively; or

(c) SEQ ID NOs: 123 and 124, respectively.

4 . An isolated antibody or antigen-binding fragment thereof that specifically binds to human B7-H4, wherein the antibody or antigen-binding fragment thereof comprises the VH CDR1, VH CDR2, VH CDR3, VL CDR1, VL CDR2, and VL CDR3 of an antibody selected from the group consisting of 15483, 20513, and 22216.

5 . The antibody or antigen-binding fragment thereof of claim 1 , wherein the antibody or antigen-binding fragment thereof is afucosylated.

6 . An isolated polynucleotide comprising a nucleic acid molecule encoding the heavy chain variable region of the antibody or antigen-binding fragment thereof of claim 1 .

7 . An isolated polynucleotide comprising a nucleic acid molecule encoding the light chain variable region of the antibody or antigen-binding fragment thereof of claim 3 .

8 . An isolated vector comprising the polynucleotide of claim 6 .

9 . A host cell comprising a polynucleotide encoding the heavy chain variable region of claim 3 and a polynucleotide encoding the light chain variable region of claim 3 .

10 . A method of producing an antibody or antigen-binding fragment thereof that binds to human B7-H4 comprising culturing the host cell of claim 9 so that the polynucleotides are expressed and the antibody or antigen-binding fragment thereof is produced.

11 . A pharmaceutical composition comprising the antibody or antigen-binding fragment thereof of claim 1 and a pharmaceutically acceptable excipient.

12 . The pharmaceutical composition of claim 11 , wherein at least 95% of the antibodies or antigen-binding fragments thereof in the composition are afucosylated.

13 . The pharmaceutical composition of claim 11 further comprising an anti-PD-1 antibody or antigen-binding fragment thereof.

14 . The pharmaceutical composition of claim 11 further comprising an anti-PD-L1 antibody or antigen-binding fragment thereof.

15 . A method for killing a cell expressing B7-H4 comprising contacting the cell the antibody or antigen-binding fragment thereof of claim 1 .

16 . A method of treating a B7-H4 expressing cancer in a subject, the method comprising administering to the subject an effective amount of the antibody or antigen-binding fragment thereof of claim 1 .

17 . The method of claim 16 , 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.

18 . The method of claim 16 , wherein the cancer is selected from the group consisting of head and neck cancer, small cell lung cancer, gastric cancer, and melanoma.

19 . The method of claim 16 , further comprising administering to the subject an anti-PD-1 antibody or antigen-binding fragment thereof.

20 . A method for detecting B7-H4 in a sample comprising contacting said sample with the antibody or antigen-binding fragment thereof of claim 1 and detecting the antibody or antigen-binding fragment thereof.

21 . A kit comprising the antibody or antigen-binding fragment thereof of claim 1 and a) a detection reagent, b) a B7-H4 antigen, c) a notice that reflects approval for use or sale for human administration, or d) a combination thereof.

22 . The antibody or antigen-binding fragment thereof of claim 1 , which is an IgG antibody.

23 . The antibody or antigen-binding fragment thereof of claim 1 , which is conjugated to a toxin or radioisotope.

24 . The antibody or antigen-binding fragment thereof of claim 22 , which is conjugated to a toxin or radioisotope.

25 . The antibody or antigen-binding fragment thereof of claim 23 , wherein the antibody or antigen-binding fragment thereof is conjugated to a cytotoxin.

26 . The antibody or antigen-binding fragment thereof of claim 24 , wherein the antibody or antigen-binding fragment thereof is conjugated to a cytotoxin.

Assignments (1)

Continuity (6)

References Cited (400)