IP Library Granted Patent US 11,492,411
Granted Patent B2
US 11,492,411 · App. 16/673,234 · Granted Nov 8, 2022

Antibodies directed to the deletion mutants of epidermal growth factor receptor and uses thereof

Inventors: Richard F. Weber (San Francisco, CA); Xiao Feng (Elk Grove, CA); Orit Foord (Foster City, CA); Larry L. Green (San Francisco, CA); Jean M. Gudas (Los Angeles, CA); Bruce A. Keyt (Hillsborough, CA); Ying Liu (Palo Alto, CA); Palaniswami Rathanaswami (Vancouver, CA); Robert Raya (Fremont, CA); Xiao Dong Yang (Palo Alto, CA); Jose R. F. Corvalan (Foster City, CA); Ian Foltz (Burnaby, CA); Xiao-Chi Jia (Los Angeles, CA); Jaspal Singh Kang (Surrey, CA); Chadwick Terence King (North Vancouver, CA); Scott L. Klakamp (Fremont, CA); Qiaojuan Jane Su (San Jose, CA)
Assignee: Amgen Fremont Inc.
C07K16/30A61K47/6803A61K47/6849A61K47/6897B82Y5/00C07K16/2863A61K2039/505C07K2317/21C07K2317/34C07K2317/77C07K2317/92Y10S435/81
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Quick Facts
Patent No.
US 11,492,411
App. No.
16/673,234
Granted
Nov 8, 2022
Kind
B2
Abstract

The present invention relates to novel antibodies, particularly antibodies directed against deletion mutants of epidermal growth factor receptor and particularly to the type III deletion mutant, EGFRvIII. The invention also relates to human monoclonal antibodies directed against deletion mutants of epidermal growth factor receptor and particularly to EGFRvIII. Diagnostic and therapeutic formulations of such antibodies, and immunoconjugates thereof, are also provided.

Claims (50)

1. A monoclonal antibody that binds to EGFRvIII comprising:

a heavy chain polypeptide comprising the following complementarity determining regions (CDRs): a heavy chain CDR1 that is a CDR1 in SEQ ID NO: 142; a heavy chain CDR2 that is a CDR2 in SEQ ID NO: 142; and a heavy chain CDR3 that is a CDR3 in SEQ ID NO: 142; and

a light chain polypeptide comprising the following CDRs: a light chain CDR1 that is a CDR1 in SEQ ID NO: 144; a light chain CDR2 that is a CDR2 in SEQ ID NO: 144; and a light chain CDR3 that is a CDR3 in SEQ ID NO: 144.

2. The monoclonal antibody of claim 1 , wherein the heavy chain polypeptide is part of a murine IgG1 isotype heavy chain.

3. The monoclonal antibody of claim 1 , wherein the light chain polypeptide is part of a kappa light chain.

4. The monoclonal antibody of claim 1 , wherein the heavy chain polypeptide comprises all three of the following amino acid sequences: SEQ ID NO: 121, SEQ ID NO: 123, and SEQ ID NO: 125.

5. The monoclonal antibody of claim 1 , wherein the light chain polypeptide comprises all three of the following amino acid sequences: SEQ ID NO: 101, SEQ ID NO: 116, and SEQ ID NO: 118.

6. The monoclonal antibody of claim 1 , wherein each CDR is defined in accordance with the CDR definition of Kabat.

7. The monoclonal antibody of claim 1 , wherein each CDR is defined in accordance with the CDR definition of Chothia.

8. The monoclonal antibody of claim 1 , wherein the heavy chain polypeptide comprises an amino acid sequence that is at least 90 percent identical to the heavy chain variable region amino acid sequence in SEQ ID NO: 142.

9. The monoclonal antibody of claim 1 , wherein the light chain polypeptide comprises an amino acid sequence that is at least 90 percent identical to the light chain variable region amino acid sequence in SEQ ID NO: 144.

10. An monoclonal antibody that binds to EGFRvIII comprising:

a heavy chain variable region, wherein CDR3 of the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 125, wherein CDR2 of the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 123, wherein CDR1 of the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 121, and wherein the heavy chain variable region comprises an amino acid sequence that is at least 90 percent identical to the light chain variable region of the amino acid sequence in SEQ ID NO: 142; and

a light chain variable region, wherein CDR3 of the light chain variable region comprises the amino acid sequence of SEQ ID NO: 118, wherein CDR2 of the light chain variable region comprises the amino acid sequence of SEQ ID NO: 116, wherein CDR1 of the light chain variable region comprises the amino acid sequence of SEQ ID NO: 101, and wherein the light chain variable region comprises an amino acid sequence that is at least 90 percent identical to the light chain variable region of the amino acid sequence in SEQ ID NO: 144,

wherein the monoclonal antibody comprises a murine IgG1 isotype heavy chain comprising the heavy chain variable region,

wherein the monoclonal antibody comprises a kappa light chain comprising the light chain variable region,

and wherein the monoclonal antibody does not occur in nature.

11. A monoclonal antibody that binds to EGFRvIII comprising:

a heavy chain polypeptide comprising the following complementarity determining regions (CDRs): a heavy chain CDR1 that is a CDR1 in SEQ ID NO: 2; a heavy chain CDR2 that is a CDR2 in SEQ ID NO: 2; a heavy chain CDR3 that is a CDR3 in SEQ ID NO: 2; and

a light chain polypeptide comprising the following CDRs: a light chain CDR1 that is a CDR1 in SEQ ID NO: 19; a light chain CDR2 that is a CDR2 in SEQ ID NO: 19; and a light chain CDR3 that is a CDR3 in SEQ ID NO: 19.

12. The monoclonal antibody of claim 11 , wherein the heavy chain polypeptide is part of a murine IgG1 isotype heavy chain.

13. The monoclonal antibody of claim 11 , wherein the light chain polypeptide is part of a kappa light chain.

14. The monoclonal antibody of claim 11 , wherein the heavy chain polypeptide comprises all three of the following amino acid sequences: SEQ ID NO: 108, SEQ ID NO: 110, and SEQ ID NO: 112.

15. The monoclonal antibody of claim 11 , wherein the light chain polypeptide comprises all three of the following amino acid sequences: SEQ ID NO: 101, SEQ ID NO: 103, and SEQ ID NO: 105.

16. The monoclonal antibody of claim 11 , wherein the heavy chain polypeptide comprises an amino acid sequence that is at least 90 percent identical to the heavy chain variable region amino acid sequence in SEQ ID NO: 2.

17. The monoclonal antibody of claim 11 , wherein the light chain polypeptide comprises an amino acid sequence that is at least 90 percent identical to the light chain variable region amino acid sequence in SEQ ID NO: 19.

18. A monoclonal antibody that binds to EGFRvIII comprising:

a heavy chain variable region, wherein CDR3 of the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 112, wherein CDR2 of the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 110, wherein CDR1 of the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 108, and wherein the heavy chain variable region comprises an amino acid sequence that is at least 90 percent identical to the heavy chain variable region of the amino acid sequence in SEQ ID NO: 2; and

a light chain variable region, wherein CDR3 of the light chain variable region comprises the amino acid sequence of SEQ ID NO: 105, wherein CDR2 of the light chain variable region comprises the amino acid sequence of SEQ ID NO: 103, wherein CDR1 of the light chain variable region comprises the amino acid sequence of SEQ ID NO: 101, and wherein the light chain variable region comprises an amino acid sequence that is at least 90 percent identical to the light chain variable region amino acid sequence in SEQ ID NO: 19,

wherein the monoclonal antibody comprises a murine IgG1 isotype heavy chain comprising the heavy chain variable region,

wherein the monoclonal antibody comprises a kappa light chain comprising the light chain variable region, and

wherein the monoclonal antibody does not occur in nature.

19. An assay kit for the detection of EGFRvIII in mammalian tissues or cells, the assay kit comprising:

a first monoclonal antibody that binds to EGFRvIII comprising:

(a) a heavy chain polypeptide comprising the following complementarity determining regions (CDRs): a heavy chain CDR1 that is a CDR1 in SEQ ID NO: 142; a heavy chain CDR2 that is a CDR2 in SEQ ID NO: 142; a heavy chain CDR3 that is a CDR3 in SEQ ID NO: 142; and

a light chain polypeptide comprising the following CDRs: a light chain CDR1 that is a CDR1 in SEQ ID NO: 144; a light chain CDR2 that is a CDR2 in SEQ ID NO: 144; and a light chain CDR3 that is a CDR3 in SEQ ID NO: 144; or

(b) a heavy chain polypeptide comprising the following complementarity determining regions (CDRs): a heavy chain CDR1 that is a CDR1 in SEQ ID NO: 2; a heavy chain CDR2 that is a CDR2 in SEQ ID NO: 2; a heavy chain CDR3 that is a CDR3 in SEQ ID NO: 2; and

a light chain polypeptide comprising the following CDRs: a light chain CDR1 that is a CDR1 in SEQ ID NO: 19; a light chain CDR2 that a CDR2 in SEQ ID NO: 19; and a light chain CDR3 that is a CDR3 in SEQ ID NO: 19; and

a labeled second antibody that is anti-immunoglobulin.

20. A method of using an assay kit for patient selection, the method comprising:

providing an assay kit for the detection of EGFRvIII in mammalian tissues or cells, the assay kit comprising:

a first monoclonal antibody that binds to EGFRvIII comprising:

(a) a heavy chain polypeptide comprising the following complementarity determining regions (CDRs): a heavy chain CDR1 that is a CDR1 in SEQ ID NO: 142; a heavy chain CDR2 that is a CDR2 in SEQ ID NO: 142; a heavy chain CDR3 that is a CDR3 in SEQ ID NO: 142; and

a light chain polypeptide comprising the following CDRs: a light chain CDR1 that is a CDR1 in SEQ ID NO: 144; a light chain CDR2 that is a CDR2 in SEQ ID NO: 144; and a light chain CDR3 that is a CDR3 in SEQ ID NO: 144; or

(b) a heavy chain polypeptide comprising the following complementarity determining regions (CDRs): a heavy chain CDR1 that is a CDR1 in SEQ ID NO: 2; a heavy chain CDR2 that is a CDR2 in SEQ ID NO: 2; a heavy chain CDR3 that is a CDR3 in SEQ ID NO: 2; and

a light chain polypeptide comprising the following CDRs: a light chain CDR1 that is a CDR1 in SEQ ID NO: 19; a light chain CDR2 that is a CDR2 in SEQ ID NO: 19; and a light chain CDR3 that is a CDR3 in SEQ ID NO: 19; and

a labeled second antibody that is anti-immunoglobulin;

binding the first monoclonal antibody to an EGFRvIII antigen in patient tissues or cells;

detecting a reaction of the first monoclonal antibody with the EGFRvIII antigen, thereby screening the patient tissues or cells for epithelial cancer; and

selecting the patient as having the epithelial cancer.

Assignments (2)
CHANGE OF NAME Recorded May 2, 2022
From: ABGENIX, INC.
To: AMGEN FREMONT INC.
Reel/Frame 059783/0087 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 2, 2022
From: WEBER, RICHARD; FENG, XIAO; FOORD, ORIT; GREEN, LARRY; GUDAS, JEAN M.; KEYT, BRUCE; LIU, YING; RATHANASWAMI, PALANISWAMI; RAYA, ROBERT; YANG, XIAO DONG; CORVALAN, JOSE; FOLTZ, IAN; JIA, XIAO-CHI; KANG, JASPAL S.; KING, CHADWICK T.; KLAKAMP, SCOTT L.; SU, QIAOJUAN JANE
To: ABGENIX, INC.
Reel/Frame 059783/0337 →
Continuity (7)
Continuation 14743886 · Jun 18, 2015
Division 12268352 · Nov 10, 2008
Division 10877774 · Jun 25, 2004
Provisional Application 60562453 · Apr 15, 2004
Provisional Application 60525570 · Nov 26, 2003
Provisional Application 60483145 · Jun 27, 2003
Related Publication 20200062860A1 · Feb 27, 2020