IP Library Granted Patent US 12677813
Granted Patent B2
US 12677813 · App. 18/316,461 · Granted Jul 14, 2026

Genetically modified mice having a humanized programmed cell death 1 gene

Inventors: Elena Burova (Mount Kisco, NY); Alexander O. Mujica (Elmsford, NY); Ka-Man Venus Lai (Seattle, WA); Andrew J. Murphy (Croton-on-Hudson, NY)
Assignee: Regeneron Pharmaceuticals, Inc.
A01K67/0278A61K49/0008C07K14/4747C07K16/2803C12Q1/6886G01N33/5038A01K2207/15A01K2217/05A01K2217/072A01K2227/105A01K2267/0331C07K14/435C07K2319/00C07K2319/02C07K2319/03C12Q2600/106C12Q2600/158G01N2333/57G01N2333/70503G01N2500/10
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Quick Facts
Patent No.
US 12677813
App. No.
18/316,461
Granted
Jul 14, 2026
Kind
B2
Abstract

Non-human animals, and methods and compositions for making and using the same, are provided, wherein the non-human animals comprise a humanization of a Programmed cell death 1 (Pdcd1) gene. The non-human animals, in some embodiments, comprise a genetic modification to an endogenous Pdcd1 gene so that the non-human animals express a PD-1 polypeptide that includes a human portion and an endogenous portion (e.g., a non-human portion).

Claims (23)

1 . A genetically modified mouse embryonic stem(ES) cell whose genome comprises a humanized Programmed cell death 1 (Pdcd1) gene comprising a replacement of exon 2 and at least part of exon 3 of an endogenous Pdcd1 gene with exon 2 and at least part of exon 3 of a human Pdcd1 gene, wherein expression of the humanized Pdcd1 gene is under the control of an endogenous Pdcd1 promoter, and the humanized Pdcd1 gene encodes a humanized PD-1 polypeptide comprising an N-terminal immunoglobulin variable (V) domain of a human PD-1 polypeptide and an intracellular domain of a mouse PD-1 polypeptide.

2 . The mouse ES cell of claim 1 , wherein the humanized PD-1 polypeptide comprises a mouse signal peptide.

3 . The mouse ES cell of claim 1 , wherein the humanized PD-1 polypeptide comprises the transmembrane sequence of the endogenous mouse PD-1 polypeptide.

4 . The mouse ES cell of claim 1 , wherein the humanized PD-1 polypeptide comprises amino acids 26-169 of a human PD-1 polypeptide.

5 . The genetically modified mouse ES cell of claim 1 , wherein the humanized Pdcd1 gene comprises exon 1, exon 4, exon 5, and at least part of exon 3 of the endogenous Pdcd1 gene.

6 . The mouse ES cell of claim 1 , wherein the mouse ES cell is homozygous for the humanized Pdcd1 gene.

7 . A mouse embryo comprising the mouse ES cell of claim 1 .

8 . The mouse embryo of claim 7 , wherein the humanized PD-1 polypeptide comprises a mouse signal peptide.

9 . The mouse embryo of claim 7 , wherein the humanized PD-1 polypeptide comprises the transmembrane sequence of the endogenous mouse PD-1 polypeptide.

10 . The mouse embryo of claim 7 , wherein the humanized PD-1 polypeptide comprises amino acids 26-169 of a human PD-1 polypeptide.

11 . The mouse embryo of claim 7 , wherein the humanized Pdcd1 gene comprises exon 1, exon 4, exon 5, and at least part of exon 3 of the endogenous Pdcd1 gene.

12 . The mouse embryo of claim 7 , wherein the mouse ES cell is homozygous for the humanized Pdcd1 gene.

13 . A method of making a genetically modified mouse, the method comprising:

a) introducing the genetically modified mouse ES cell of claim 1 into a mouse embryo;

b) implanting the mouse embryo obtained in step a) into a female mouse for gestation; and

c) obtaining a genetically modified mouse whose genome comprises said humanized Pdcd1 gene, wherein the genetically modified mouse expresses said humanized PD-1 polypeptide.

14 . A method of making a genetically modified mouse embryonic stem(ES) cell, the method comprising:

replacing exon 2 and at least part of exon 3 of an endogenous Programmed cell death 1 (Pdcd1) gene in a mouse ES cell with exon 2 and at least part of exon 3 of a human Pdcd1 gene such that a genetically modified mouse ES cell is obtained whose genome comprises a humanized Programmed cell death 1 (Pdcd1) gene comprising a replacement of exon 2 and at least part of exon 3 of the endogenous Pdcd1 gene with exon 2 and at least part of exon 3 of the human Pdcd1 gene, wherein expression of the humanized Pdcd1 gene is under the control of an endogenous Pdcd1 promoter, and the humanized Pdcd1 gene encodes a humanized PD-1 polypeptide comprising an N-terminal immunoglobulin variable (V) domain of a human PD-1 polypeptide and an intracellular domain of a mouse PD-1 polypeptide.

15 . The method of claim 14 , wherein the humanized PD-1 polypeptide comprises a mouse signal peptide.

16 . The method of claim 14 , wherein the humanized PD-1 polypeptide comprises the transmembrane sequence of the endogenous mouse PD-1 polypeptide.

17 . The method of claim 14 , wherein the humanized PD-1 polypeptide comprises amino acids 26-169 of a human PD-1 polypeptide.

18 . The method of claim 14 , wherein the humanized Pdcd1 gene comprises exon 1, exon 4, exon 5, and at least part of exon 3 of the endogenous Pdcd1 gene.

19 . The method of claim 14 , wherein the mouse ES cell is homozygous for the humanized Pdcd1 gene.