IP Library Granted Patent US 11,020,495
Granted Patent B2
US 11,020,495 · App. 16/530,336 · Granted Jun 1, 2021

Humanized low affinity FCγR mouse cells

Inventors: Lynn MacDonald (Harrison, NY); Naxin Tu (Pleasantville, NY); Cagan Gurer (Chappaqua, NY); Sean Stevens (Del Mar, CA); Andrew J. Murphy (Croton-On-Hudson, NY)
Assignee: Regeneron Pharmaceuticals, Inc.
A61K49/0008A01K67/0276A01K67/0278C07K14/70535G01N33/5014A01K2207/15A01K2217/072A01K2217/075A01K2217/15A01K2227/105A01K2267/03A01K2267/0387
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Quick Facts
Patent No.
US 11,020,495
App. No.
16/530,336
Granted
Jun 1, 2021
Kind
B2
Abstract

Genetically modified non-human animals and methods and compositions for making and using them are provided, wherein the genetic modification comprises a deletion of the endogenous low affinity FcγR locus, and wherein the mouse is capable of expressing a functional FcRγ-chain. Genetically modified mice are described, including mice that express low affinity human FcγR genes from the endogenous FcγR locus, and wherein the mice comprise a functional FcRγ-chain. Genetically modified mice that express up to five low affinity human FcγR genes on accessory cells of the host immune system are provided.

Claims (35)

1. A mouse lymphocyte having a genome that comprises at least one human low affinity FcγR α-chain gene encoding a human low affinity FcγR α-chain with a polymorphism, wherein the human low affinity FcγR α-chain gene replaces an endogenous low affinity FcγR α-chain gene, and wherein the mouse lymphocyte comprises a functional endogenous FcR γ-chain and functionally expresses the human low affinity FcγR α-chain gene.

2. The mouse lymphocyte of claim 1 , wherein the human low affinity FcγR α-chain is a low affinity FcγRIIA α-chain.

3. The mouse lymphocyte of claim 2 , wherein the polymorphism is a 131His polymorphism.

4. The mouse lymphocyte of claim 2 , wherein the polymorphism is a 131Arg polymorphism.

5. The mouse lymphocyte of claim 1 , wherein the human low affinity FcγR α-chain is a low affinity FcγRIIB α-chain.

6. The mouse lymphocyte of claim 5 , wherein the polymorphism is a 232Ile polymorphism.

7. The mouse lymphocyte of claim 5 , wherein the polymorphism is a 232Thr polymorphism.

8. The mouse lymphocyte of claim 1 , wherein the human low affinity FcγR α-chain is a low affinity FcγRIIIA α-chain.

9. The mouse lymphocyte of claim 8 , wherein the polymorphism is a 158Val polymorphism.

10. The mouse lymphocyte of claim 8 , wherein the polymorphism is a 158Phe polymorphism.

11. The mouse lymphocyte of claim 1 , wherein the mouse lymphocyte is a mouse natural killer (NK) cell, a mouse B cell, or a mouse T cell.

12. A mouse embryonic stem (ES) cell having a genome that comprises at least one human low affinity FcγR α-chain gene encoding a human low affinity FcγR α-chain with a polymorphism, wherein the human low affinity FcγR α-chain gene replaces an endogenous low affinity FcγR α-chain gene, and wherein the mouse ES cell comprises a functional endogenous FcR γ-chain gene.

13. The mouse ES cell of claim 12 , wherein the human low affinity FcγR α-chain is a low affinity FcγRIIA α-chain.

14. The mouse ES cell of claim 13 , wherein the polymorphism is a 131His polymorphism.

15. The mouse ES cell of claim 13 , wherein the polymorphism is a 131Arg polymorphism.

16. The mouse ES cell of claim 12 , wherein the human low affinity FcγR α-chain is a low affinity FcγRIIB α-chain.

17. The mouse of claim 16 , wherein the polymorphism is a 232Ile polymorphism.

18. The mouse of claim 16 , wherein the polymorphism is a 232Thr polymorphism.

19. The mouse ES cell of claim 12 , wherein the human low affinity FcγR α-chain is a low affinity FcγRIIIA α-chain.

20. The mouse ES cell of claim 19 , wherein the polymorphism is a 158Val polymorphism.

21. The mouse ES cell of claim 19 , wherein the polymorphism is a 158Phe polymorphism.

22. A mouse embryo comprising the mouse ES cell of claim 12 .

23. A method of testing an agent comprising an Fc region of a human antibody, the method comprising:

(a) administering an agent comprising an Fc region of a human antibody to a genetically modified mouse whose genome comprises at least one human low affinity FcγR α-chain gene encoding a human low affinity FcγR α-chain with a polymorphism, wherein the human low affinity FcγR α-chain gene replaces an endogenous low affinity FcγR α-chain gene, wherein the mouse comprises a functional endogenous FcR γ-chain and functionally expresses the human low affinity FcγR α-chain gene, wherein the agent comprising an Fc region of a human antibody binds to a target cell in the mouse; and

(b) measuring the cell-mediated immunity elicited by the agent comprising an Fc region of a human antibody in the mouse.

24. The method of claim 23 , wherein the cell-mediated immunity elicited by the agent comprising an Fc region of a human antibody is measured in a blood sample of the mouse.

25. The method of claim 23 , wherein the human low affinity FcγR α-chain is a low affinity FcγRIIA α-chain.

26. The method of claim 25 , wherein the polymorphism is a 131His polymorphism.

27. The method of claim 25 , wherein the polymorphism is a 131Arg polymorphism.

28. The method of claim 23 , wherein the human low affinity FcγR α-chain is a low affinity FcγRIIB α-chain.

29. The method of claim 28 , wherein the polymorphism is a 232Ile polymorphism.

30. The method of claim 28 , wherein the polymorphism is a 232Thr polymorphism.

31. The method of claim 23 , wherein the human low affinity FcγR α-chain is a low affinity FcγRIIIA α-chain.

32. The method of claim 31 , wherein the polymorphism is a 158Val polymorphism.

33. The method of claim 31 , wherein the polymorphism is a 158Phe polymorphism.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 14, 2020
From: MACDONALD, LYNN; TU, NAXIN; GURER, CAGAN; STEVENS, SEAN; MURPHY, ANDREW J.
To: REGENERON PHARMACEUTICALS, INC.
Reel/Frame 051823/0490 →
Continuity (7)
Continuation 15601363 · May 22, 2017
Continuation 14800253 · Jul 15, 2015
Continuation 14152106 · Jan 10, 2014
Division 13466225 · May 8, 2012
Continuation 12971080 · Dec 17, 2010
Provisional Application 61288562 · Dec 21, 2009
Related Publication 20200061213A1 · Feb 27, 2020