IP Library › Granted Patent US 10,584,171
Granted Patent B2
US 10,584,171 · App. 15/315,371 · Granted Mar 10, 2020

Anti-epidermal growth factor receptor (EGFR) antibodies

Inventors: Wei-Dong Jiang (San Jose, CA); Pei-Hua Lin (Sunnyvale, CA)
Assignee: Henlix Biotech Co., Ltd.
C07K16/2863A61K39/39591A61K47/6803A61K47/6849G01N33/5748A61K2039/505C07K2317/24C07K2317/31C07K2317/41C07K2317/565C07K2317/71C07K2317/73C07K2317/732C07K2317/92G01N2333/71
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,584,171
App. No.
15/315,371
Granted
Mar 10, 2020
Kind
B2
Abstract

Provided are anti-epidermal growth factor receptor (EGFR) antibodies, aglycosylated CDR-H2 anti-EGFR antibodies, and antigen binding fragments thereof. Also provided are isolated nucleic acid molecules that encode the anti-EGFR antibodies or antigen binding fragments thereof, related expression vectors, and host cells. Provided are methods of making anti-epidermal growth factor receptor (EGFR) antibodies, aglycosylated CDR-H2 anti-EGFR antibodies, and antigen binding fragments thereof. Also provided are related pharmaceutical compositions and methods of their use to treat subjects.

Claims (77)

1. An anti-EGFR antibody or antigen binding fragment thereof, comprising

a heavy chain variable domain sequence comprising (1) a CDR-H1 comprising the amino acid sequence NYGVH (SEQ ID NO: 1); (2) a CDR-H2 comprising the amino acid sequence YNTPFTSRF (SEQ ID NO: 5); and (3) a CDR-H3 comprising the amino acid sequence DYYDYEFAY (SEQ ID NO: 11); and a light chain variable domain sequence comprising (1) a CDR-L1 comprising the amino acid sequence IGTNIH (SEQ ID NO: 15); (2) a CDR-L2 comprising the amino acid sequence KYASESIS (SEQ ID NO: 21); and (3) a CDR-L3 comprising the amino acid sequence NWPTS (SEQ ID NO: 27).

2. The anti-EGFR antibody or antigen binding fragment thereof of claim 1 , wherein the antibody comprises an Fc sequence of a human IgG.

3. The antigen binding fragment of the anti-EGFR antibody according to claim 1 , wherein the antigen binding fragment is selected from the group consisting of a Fab, Fab′, a F(ab)′ 2, a single-chain Fv (scFv), an Fv fragment, a diabody, and a linear antibody.

4. The anti-EGFR antibody of claim 1 , wherein the antibody is a multispecific antibody.

5. The anti-EGFR antibody of claim 1 , wherein the antibody is an afucosylated antibody.

6. The anti-EGFR antibody or antigen binding fragment thereof of claim 1 conjugated to a therapeutic agent.

7. The anti-EGFR antibody or antigen binding fragment thereof of claim 1 conjugated to a label.

8. A composition comprising the anti-EGFR antibody or antigen binding fragment thereof of claim 1 and a pharmaceutically acceptable carrier.

9. An anti-EGFR antibody or antigen binding fragment thereof, comprising a heavy chain variable domain sequence comprising (1) a CDR-H1 comprising the amino acid sequence NYGVH (SEQ ID NO: 1); (2) a CDR-H2 comprising the amino acid sequence YGNEFTSRF (SEQ ID NO: 8); and (3) a CDR-H3 comprising the amino acid sequence DYYDYEFAY (SEQ ID NO: 11); and a light chain variable domain sequence comprising (1) a CDR-L1 comprising the amino acid sequence IGTNIH (SEQ ID NO: 15); (2) a CDR-L2 comprising the amino acid sequence KYASESIS (SEQ ID NO: 21) ; and (3) a CDR-L3 comprising the amino acid sequence NWPTS (SEQ ID NO: 27).

10. An anti-EGFR antibody or antigen binding fragment thereof, comprising a heavy chain variable domain sequence comprising (1) a CDR-H1 comprising the amino acid sequence NYGVH (SEQ ID NO: 1); (2) a CDR-H2 comprising the amino acid sequence YATEFTSRF (SEQ ID NO: 7); and (3) a CDR-H3 comprising the amino acid sequence DYYDYEFAY (SEQ ID NO: 11); and a light chain variable domain sequence comprising (1) a CDR-L1 comprising the amino acid sequence IGTNIH (SEQ ID NO: 15); (2) a CDR-L2 comprising the amino acid sequence KYASESIS (SEQ ID NO: 21); and (3) a CDR-L3 comprising the amino acid sequence NWPTS (SEQ ID NO: 27).

11. An anti-EGFR antibody or antigen binding fragment thereof, comprising a heavy chain variable domain sequence comprising (1) a CDR-H1 comprising the amino acid sequence NYGVH (SEQ ID NO: 1); (2) a CDR-H2 comprising the amino acid sequence YDDKFTSRF (SEQ ID NO: 6); and (3) a CDR-H3 comprising the amino acid sequence DYYDYEFAY (SEQ ID NO: 11); and a light chain variable domain sequence comprising (1) a CDR-L1 comprising the amino acid sequence IGTNIH (SEQ ID NO: 15); (2) a CDR-L2 comprising the amino acid sequence KYASESIS (SEQ ID NO: 21); and (3) a CDR-L3 comprising the amino acid sequence NWPTS (SEQ ID NO: 27).

12. An anti-EGFR antibody or antigen binding fragment thereof, comprising a heavy chain variable domain sequence comprising (1) a CDR-H1 comprising the amino acid sequence TYGVH (SEQ ID NO: 3); (2) a CDR-H2 comprising the amino acid sequence YGNEFTSRF (SEQ ID NO: 8); and (3) a CDR-H3 comprising the amino acid sequence DYYDYEFAY (SEQ ID NO: 11); and a light chain variable domain sequence comprising (1) a CDR-L1 comprising the amino acid sequence IRTNIH (SEQ ID NO: 16); (2) a CDR-L2 comprising the amino acid sequence KYGSESIS (SEQ ID NO: 22); and (3) a CDR-L3 comprising the amino acid sequence NWPTS (SEQ ID NO: 27).

13. An anti-EGFR antibody or antigen binding fragment thereof, comprising a heavy chain variable domain sequence comprising (1) a CDR-H1 comprising the amino acid sequence TYGVH (SEQ ID NO: 3); (2) a CDR-H2 comprising the amino acid sequence YGNEFTSRF (SEQ ID NO: 8); and (3) a CDR-H3 comprising the amino acid sequence DYYDYEFAY (SEQ ID NO: 11); and a light chain variable domain sequence comprising (1) a CDR-L1 comprising the amino acid sequence ISTNIH (SEQ ID NO: 19); (2) a CDR-L2 comprising the amino acid sequence KYGSESIS (SEQ ID NO: 22); and (3) a CDR-L3 comprising the amino acid sequence NWPTS (SEQ ID NO: 27).

14. An anti-EGFR antibody or antigen binding fragment thereof, comprising a heavy chain variable domain sequence comprising (1) a CDR-H1 comprising the amino acid sequence NYGVH (SEQ ID NO: 1); (2) a CDR-H2 comprising the amino acid sequence YGNEFTSRF (SEQ ID NO: 8); and (3) a CDR-H3 comprising the amino acid sequence DYYDYEFAY (SEQ ID NO: 11); and a light chain variable domain sequence comprising (1) a CDR-L1 comprising the amino acid sequence IRTNIH (SEQ ID NO: 16); (2) a CDR-L2 comprising the amino acid sequence KYGSESIS (SEQ ID NO: 22); and (3) a CDR-L3 comprising the amino acid sequence NWPTS (SEQ ID NO: 27).

15. An anti-EGFR antibody or antigen binding fragment thereof, comprising a heavy chain variable domain sequence comprising (1) a CDR-H1 comprising the amino acid sequence TYGVH (SEQ ID NO: 3); (2) a CDR-H2 comprising the amino acid sequence YGNEFTSRF (SEQ ID NO: 8); and (3) a CDR-H3 comprising the amino acid sequence DYYDYEFAY (SEQ ID NO: 11); and a light chain variable domain sequence comprising (1) a CDR-L1 comprising the amino acid sequence IGPNIH (SEQ ID NO: 18); (2) a CDR-L2 comprising the amino acid sequence KYASETIR (SEQ ID NO: 23); and (3) a CDR-L3 comprising the amino acid sequence NWPTS (SEQ ID NO: 27).

16. An anti-EGFR antibody or antigen binding fragment thereof, comprising a heavy chain variable domain sequence comprising (1) a CDR-H1 comprising the amino acid sequence NYGVH (SEQ ID NO: 1); (2) a CDR-H2 comprising the amino acid sequence YGNEFTSRF (SEQ ID NO: 8); and (3) a CDR-H3 comprising the amino acid sequence DYYDYEFAY (SEQ ID NO: 11); and a light chain variable domain sequence comprising (1) a CDR-L1 comprising the amino acid sequence ISTNIH (SEQ ID NO: 19); (2) a CDR-L2 comprising the amino acid sequence KYGSESIS (SEQ ID NO: 22); and (3) a CDR-L3 comprising the amino acid sequence NWPTS (SEQ ID NO: 27).

17. The anti-EGFR antibody or antigen binding fragment thereof of claim 9 , wherein the antibody comprises an Fc sequence of a human IgG.

18. The antigen binding fragment of the anti-EGFR antibody according to claim 9 , wherein the antigen binding fragment is selected from the group consisting of a Fab, Fab ′, a F(ab)′ 2, a single-chain Fv (scFv), an Fv fragment, a diabody, and a linear antibody.

19. The anti-EGFR antibody of claim 9 , wherein the antibody is a multispecific antibody.

20. The anti-EGFR antibody of claim 9 , wherein the antibody is an afucosylated antibody.

21. The anti-EGFR antibody or antigen binding fragment thereof of claim 9 conjugated to a therapeutic agent.

22. The anti-EGFR antibody or antigen binding fragment thereof of claim 9 conjugated to a label.

23. A composition comprising the anti-EGFR antibody or antigen binding fragment thereof of claim 9 and a pharmaceutically acceptable carrier.

24. The anti-EGFR antibody or antigen binding fragment thereof of claim 10 , wherein the antibody comprises an Fc sequence of a human IgG.

25. The antigen binding fragment of the anti-EGFR antibody according to claim 10 , wherein the antigen binding fragment is selected from the group consisting of a Fab, Fab ′, a F(ab)′ 2, a single-chain Fv (scFv), an Fv fragment, a diabody, and a linear antibody.

26. The anti-EGFR antibody of claim 10 , wherein the antibody is a multispecific antibody.

27. The anti-EGFR antibody of claim 10 , wherein the antibody is an afucosylated antibody.

28. The anti-EGFR antibody or antigen binding fragment thereof of claim 10 conjugated to a therapeutic agent.

29. The anti-EGFR antibody or antigen binding fragment thereof of claim 10 conjugated to a label.

30. A composition comprising the anti-EGFR antibody or antigen binding fragment thereof of claim 10 and a pharmaceutically acceptable carrier.

31. The anti-EGFR antibody or antigen binding fragment thereof of claim 11 , wherein the antibody comprises an Fc sequence of a human IgG.

32. The antigen binding fragment of the anti-EGFR antibody according to claim 11 , wherein the antigen binding fragment is selected from the group consisting of a Fab, Fab ′, a F(ab)′ 2, a single-chain Fv (scFv), an Fv fragment, a diabody, and a linear antibody.

33. The anti-EGFR antibody of claim 11 , wherein the antibody is a multispecific antibody.

34. The anti-EGFR antibody of claim 11 , wherein the antibody is an afucosylated antibody.

35. The anti-EGFR antibody or antigen binding fragment thereof of claim 11 conjugated to a therapeutic agent.

36. The anti-EGFR antibody or antigen binding fragment thereof of claim 11 conjugated to a label.

37. A composition comprising the anti-EGFR antibody or antigen binding fragment thereof of claim 11 and a pharmaceutically acceptable carrier.

38. The anti-EGFR antibody or antigen binding fragment thereof of claim 12 , wherein the antibody comprises an Fc sequence of a human IgG.

39. The antigen binding fragment of the anti-EGFR antibody according to claim 12 , wherein the antigen binding fragment is selected from the group consisting of a Fab, Fab ′, a F(ab)′ 2, a single-chain Fv (scFv), an Fv fragment, a diabody, and a linear antibody.

40. The anti-EGFR antibody of claim 12 , wherein the antibody is a multispecific antibody.

41. The anti-EGFR antibody of claim 12 , wherein the antibody is an afucosylated antibody.

42. The anti-EGFR antibody or antigen binding fragment thereof of claim 12 conjugated to a therapeutic agent.

43. The anti-EGFR antibody or antigen binding fragment thereof of claim 12 conjugated to a label.

44. A composition comprising the anti-EGFR antibody or antigen binding fragment thereof of claim 12 and a pharmaceutically acceptable carrier.

45. The anti-EGFR antibody or antigen binding fragment thereof of claim 13 , wherein the antibody comprises an Fc sequence of a human IgG.

46. The antigen binding fragment of the anti-EGFR antibody according to claim 13 , wherein the antigen binding fragment is selected from the group consisting of a Fab, Fab ′, a F(ab)′ 2, a single-chain Fv (scFv), an Fv fragment, a diabody, and a linear antibody.

47. The anti-EGFR antibody of claim 13 , wherein the antibody is a multispecific antibody.

48. The anti-EGFR antibody of claim 13 , wherein the antibody is an afucosylated antibody.

49. The anti-EGFR antibody or antigen binding fragment thereof of claim 13 conjugated to a therapeutic agent.

50. The anti-EGFR antibody or antigen binding fragment thereof of claim 13 conjugated to a label.

51. A composition comprising the anti-EGFR antibody or antigen binding fragment thereof of claim 13 and a pharmaceutically acceptable carrier.

52. The anti-EGFR antibody or antigen binding fragment thereof of claim 14 , wherein the antibody comprises an Fc sequence of a human IgG.

53. The antigen binding fragment of the anti-EGFR antibody according to claim 14 , wherein the antigen binding fragment is selected from the group consisting of a Fab, Fab ′, a F(ab)′ 2, a single-chain Fv (scFv), an Fv fragment, a diabody, and a linear antibody.

54. The anti-EGFR antibody of claim 14 , wherein the antibody is a multispecific antibody.

55. The anti-EGFR antibody of claim 14 , wherein the antibody is an afucosylated antibody.

56. The anti-EGFR antibody or antigen binding fragment thereof of claim 14 conjugated to a therapeutic agent.

57. The anti-EGFR antibody or antigen binding fragment thereof of claim 14 conjugated to a label.

58. A composition comprising the anti-EGFR antibody or antigen binding fragment thereof of claim 14 and a pharmaceutically acceptable carrier.

59. The anti-EGFR antibody or antigen binding fragment thereof of claim 15 , wherein the antibody comprises an Fc sequence of a human IgG.

60. The antigen binding fragment of the anti-EGFR antibody according to claim 15 , wherein the antigen binding fragment is selected from the group consisting of a Fab, Fab ′, a F(ab)′ 2, a single-chain Fv (scFv), an Fv fragment, a diabody, and a linear antibody.

61. The anti-EGFR antibody of claim 15 , wherein the antibody is a multispecific antibody.

62. The anti-EGFR antibody of claim 15 , wherein the antibody is an afucosylated antibody.

63. The anti-EGFR antibody or antigen binding fragment thereof of claim 15 conjugated to a therapeutic agent.

64. The anti-EGFR antibody or antigen binding fragment thereof of claim 15 conjugated to a label.

65. A composition comprising the anti-EGFR antibody or antigen binding fragment thereof of claim 15 and a pharmaceutically acceptable carrier.

66. The anti-EGFR antibody or antigen binding fragment thereof of claim 16 , wherein the antibody comprises an Fc sequence of a human IgG.

67. The antigen binding fragment of the anti-EGFR antibody according to claim 16 , wherein the antigen binding fragment is selected from the group consisting of a Fab, Fab ′, a F(ab)′ 2, a single-chain Fv (scFv), an Fv fragment, a diabody, and a linear antibody.

68. The anti-EGFR antibody of claim 16 , wherein the antibody is a multispecific antibody.

69. The anti-EGFR antibody of claim 16 , wherein the antibody is an afucosylated antibody.

70. The anti-EGFR antibody or antigen binding fragment thereof of claim 16 conjugated to a therapeutic agent.

71. The anti-EGFR antibody or antigen binding fragment thereof of claim 16 conjugated to a label.

72. A composition comprising the anti-EGFR antibody or antigen binding fragment thereof of claim 16 and a pharmaceutically acceptable carrier.

73. An isolated nucleic acid molecule that encodes the anti-EGFR antibody or antigen binding fragment thereof of claim 9 .

74. An expression vector encoding the nucleic acid molecule of claim 73 .

75. A cell comprising the expression vector of claim 74 .

76. A method of producing an antibody comprising culturing the cell of claim 75 and recovering the antibody from the cell culture.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 23, 2020
From: HENLIX BIOTECH CO., LTD.
To: SHANGHAI HENLIUS BIOTECH, INC.
Reel/Frame 054743/0862 →
CHANGE OF NAME Recorded Jan 22, 2020
From: HENLIUS BIOTECH CO., LTD.
To: HENLIX BIOTECH CO., LTD
Reel/Frame 051666/0526 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2019
From: HENLIUS BIOPHARMACEUTICALS, INC.
To: HENLIUS BIOTECH CO., LTD
Reel/Frame 051237/0566 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2019
From: JIANG, WEI-DONG; LIN, PEI-HUA
To: HENLIUS BIOPHARMACEUTICALS, INC.
Reel/Frame 051244/0737 →
Continuity (2)
Provisional Application 62005887 · May 30, 2014
Related Publication 20170218073A1 · Aug 3, 2017