IP Library › Granted Patent US 12,268,741
Granted Patent B2
US 12,268,741 · App. 17/421,365 · Granted Apr 8, 2025

Antibodies and chimeric antigen receptors specific for receptor tyrosine kinase like orphan receptor 1 (ROR1)

Inventors: Andreia Costa (Seattle, WA); Rupesh Amin (Seattle, WA); Jenna Bailey (Seattle, WA); Samriti Bedi (Newcastle, WA); Brian Belmont (Seattle, WA); Aye Chen (Seattle, WA); Stephen Jacob Goldfless (Seattle, WA); Eric Jeffery (Seattle, WA); Yue Jiang (Seattle, WA); Yeonjoo Oh (Seattle, WA); Madeline Williams (Seattle, WA); Collin Hauskins (Seattle, WA); Catherine Sierra (Seattle, WA)
Assignee: Juno Therapeutics, Inc.
A61K39/39558A61K39/4611A61K39/4631A61K39/464402A61K47/6851A61P35/00C12N5/0636C12N5/10C12N15/62C12N15/63A61K2239/31A61K2239/38A61K2239/48A61K2239/49A61K2239/55
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Quick Facts
Patent No.
US 12,268,741
App. No.
17/421,365
Filed
Jul 7, 2021
Granted
Apr 8, 2025
Kind
B2
Art Unit
1644
USPC
424/178.1
Abstract

Provided are receptor tyrosine kinase-like orphan receptor 1 (ROR1)-binding molecules, in particular, to human antibodies specific for ROR1, including antibody fragments. The present disclosure further relates to recombinant receptors, including chimeric antigen receptors (CARs) that contain such antibodies or fragments, and polynucleotides that encode the antibodies, antigen-binding fragments or receptors specific for ROR1. The disclosure further relates to genetically engineered cells, containing such ROR1-binding proteins and receptors, and related methods and uses thereof in adoptive cell therapy.

Claims (60)

1. An anti-receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody or antigen-binding fragment thereof comprising: a heavy chain variable (V H ) region and a light chain variable (V L ) region, wherein:

the V H region comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2) and a heavy chain complementarity determining region 3 (CDR-H3) contained within SEQ ID NO: 112, and the V L region comprises a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2) and a light chain complementarity determining region 3 (CDR-L3) contained within SEQ ID NO:115;

the V H region comprises a CDR-H1, a CDR-H2 and a CDR-H3 contained within SEQ ID NO: 121, and the V L region comprises a CDR-L1, a CDR-L2 and a CDR-L3 contained within SEQ ID: NO 124;

the V H region comprises a CDR-H1, a CDR-H2 and a CDR-H3 contained within SEQ ID NO: 103, and the V L region comprises a CDR-L1, a CDR-L2 and a CDR-L3 contained within SEQ ID: NO 106; or

the V H region comprises a CDR-H1, a CDR-H2 and a CDR-H3 contained within SEQ ID NO: 130, and the V L region comprises a CDR-L1, a CDR-L2 and a CDR-L3 contained within SEQ ID: NO 106.

2. An anti-ROR1 antibody or antigen-binding fragment thereof comprising: a heavy chain variable (V H ) region, and a light chain variable (V L ) region, wherein the V H region comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2) and a heavy chain complementarity determining region 3 (CDR-H3) comprising the sequence set forth in SEQ ID NOS: 67, 71 and 73, respectively, and the V L region comprises a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2) and a light chain complementarity determining region 3 (CDR-L3) comprising the sequence set forth in SEQ ID NOS: 75, 77 and 79, respectively;

the V H region comprises a CDR-H1, a CDR-H2 and a CDR-H3 comprising the sequence set forth in SEQ ID NOS: 82, 86 and 88, respectively, and the V L region comprises a CDR-L1, a CDR-L2 and a CDR-L3 comprising the sequence set forth in SEQ ID NOS: 90, 92 and 94, respectively;

the V H region comprises a CDR-H1, a CDR-H2 and a CDR-H3 comprising the sequence set forth in SEQ ID NOS: 52, 56 and 58, respectively, and the V L region comprises a CDR-L1, a CDR-L2 and a CDR-L3 comprising the sequence set forth in SEQ ID NOS: 60, 62 and 64, respectively; or

the V H region comprises a CDR-H1, a CDR-H2 and a CDR-H3 comprising the sequence set forth in SEQ ID NOS: 52, 97 and 99, respectively, and the V L region comprises a CDR-L1, a CDR-L2 and a CDR-L3 comprising the sequence set forth in SEQ ID NOS: 60, 62 and 64, respectively.

3. The anti-ROR1 antibody or antigen-binding fragment thereof of claim 2 , wherein the V H region comprises a CDR-H1, a CDR-H2 and a CDR-H3 comprising the sequence set forth in SEQ ID NOS: 67, 71 and 73, respectively, and the V L region comprises a CDR-L1, a CDR-L2 and a CDR-L3 comprising the sequence set forth in SEQ ID NOS: 75, 77 and 79, respectively.

4. The anti-ROR1 antibody or antigen-binding fragment thereof of claim 2 , wherein:

the V H region comprises an amino acid sequence having at least 85% identity to SEQ ID NO: 112, and the V L region comprises an amino acid sequence having at least 85% identity to SEQ ID NO: 115;

the V H region comprises an amino acid sequence having at least 85% identity to SEQ ID NO: 121, and the V L region comprises an amino acid sequence having at least 85% identity to SEQ ID NO: 124;

the V H region comprises an amino acid sequence having at least 85% identity to SEQ ID NO: 103, and the V L region comprises an amino acid sequence having at least 85% identity to SEQ ID NO: 106; or

the V H region comprises an amino acid sequence having at least at or about 85% identity to SEQ ID NO: 130, and the V L region comprises an amino acid sequence having at least 85% identity to SEQ ID NO:106.

5. The anti-ROR1 antibody or antigen-binding fragment thereof of claim 2 , wherein the V H region and the V L region comprise the sequence set forth in SEQ ID NOS: 112 and 115, respectively.

6. The anti-ROR1 antibody or antigen-binding fragment thereof of claim 2 , wherein the antibody is a full length antibody.

7. The anti-ROR1 antibody or antigen-binding fragment thereof of claim 2 , wherein the anti-ROR1 antibody or antigen binding fragment thereof is an antigen-binding fragment thereof, and wherein the antigen-binding fragment thereof comprises a single chain Fv (scFv).

8. The anti-ROR1 antibody or antigen-binding fragment thereof of claim 7 , wherein the scFv comprises an amino acid sequence having at least 85% sequence identity to SEQ ID NO: 118, 127, 109 or 134.

9. The anti-ROR1 antibody or antigen-binding fragment thereof of claim 7 , wherein the scFv comprises the sequence set forth in SEQ ID NO: 118.

10. A single chain cell-surface protein, comprising the anti-ROR1 antibody or antigen-binding fragment thereof of claim 2 .

11. A conjugate, comprising the anti-ROR1 antibody or antigen-binding fragment thereof of claim 2 .

12. An anti-ROR1 chimeric antigen receptor (CAR) comprising an extracellular antigen-binding domain comprising the anti-ROR1 antibody or antigen-binding fragment thereof of claim 2 , a transmembrane region and an intracellular signaling region.

13. The anti-ROR1 chimeric antigen receptor of claim 12 , further comprising a spacer between the extracellular antigen-binding domain and the transmembrane region.

14. The anti-ROR1 chimeric antigen receptor of claim 13 , wherein the spacer comprises at least a portion of a hinge region of an immunoglobulin or a variant thereof.

15. The anti-ROR1 chimeric antigen receptor of claim 14 , wherein the at least a portion of a hinge region comprises all or a portion of an IgG4 hinge region.

16. The anti-ROR1 chimeric antigen receptor of claim 13 , wherein the spacer comprises an amino acid sequence having at least 85% identity to SEQ ID NO: 1, 26, 27, 29, 31, 32, 33 or 135.

17. The anti-ROR1 chimeric antigen receptor of claim 13 , wherein the spacer comprises the sequence set forth in SEQ ID NO: 135.

18. The anti-ROR1 chimeric antigen receptor of claim 13 , wherein the chimeric antigen receptor comprises from its N to C terminus in order: the extracellular antigen-binding domain, the spacer, the transmembrane region and the intracellular signaling region.

19. The anti-ROR1 chimeric antigen receptor of claim 12 , wherein the transmembrane region comprises a transmembrane domain from CD28.

20. The anti-ROR1 chimeric antigen receptor of claim 12 , wherein the transmembrane region comprises an amino acid sequence having at least 90% sequence identity to SEQ ID NO: 8.

21. The anti-ROR1 chimeric antigen receptor of claim 12 , wherein the intracellular signaling region comprises a cytoplasmic signaling domain of a CD3-zeta (CD3ζ) chain.

22. The anti-ROR1 chimeric antigen receptor of claim 21 , wherein the intracellular signaling region is or comprises the sequence set forth in SEQ ID NO: 13.

23. The anti-ROR1 chimeric antigen receptor of claim 12 , wherein the intracellular signaling region comprises an amino acid sequence having at least at 90% sequence identity to SEQ ID NO: 13, 14 or 15.

24. The anti-ROR1 chimeric antigen receptor of claim 12 , wherein the intracellular signaling region further comprises a costimulatory signaling region.

25. The anti-ROR1 chimeric antigen receptor of claim 24 , wherein the costimulatory signaling region is between the transmembrane region and the intracellular signaling region.

26. The anti-ROR1 chimeric antigen receptor of claim 24 , wherein the costimulatory signaling region comprises an intracellular signaling domain of a T cell costimulatory molecule or a signaling portion thereof.

27. The anti-ROR1 chimeric antigen receptor of claim 26 , wherein the costimulatory signaling region comprises an intracellular signaling domain of CD28, 4-1BB, or ICOS.

28. The anti-ROR1 chimeric antigen receptor of claim 27 , wherein the costimulatory signaling region comprises an intracellular signaling domain of a human CD28.

29. The anti-ROR1 chimeric antigen receptor of claim 27 , wherein the costimulatory signaling region comprises an intracellular signaling domain of a human 4-1BB.

30. The anti-ROR1 chimeric antigen receptor of claim 27 , wherein the costimulatory signaling region comprises an amino acid sequence having at least 90% sequence identity to SEQ ID NO: 12.

31. The anti-ROR1 chimeric antigen receptor of claim 24 , wherein the antigen-binding domain is an scFv and the chimeric antigen receptor comprises from its N to C terminus in order: an extracellular antigen-binding domain comprising the scFv, a spacer comprising a modified IgG4 hinge-CH3; a transmembrane domain an intracellular signaling region comprising a cytoplasmic signaling domain of a CD3-zeta (CD3ζ) chain; and an intracellular signaling domain of a costimulatory signaling region.

32. The anti-ROR1 chimeric antigen receptor of claim 12 , wherein the anti-ROR1 chimeric antigen receptor comprises a sequence that exhibits at least 85% sequence identity to the sequence set forth in SEQ ID NO: 184, 185, 186, 187, 188 or 189.

33. The anti-ROR1 chimeric antigen receptor of claim 32 , wherein the anti-ROR1 chimeric antigen receptor comprises a sequence that exhibits at least 85% sequence identity to the sequence set forth in SEQ ID NO: 184.

34. The anti-ROR1 chimeric antigen receptor of claim 33 , wherein the anti-ROR1 chimeric antigen receptor comprises the sequence set forth in SEQ ID NO: 184.

35. A polynucleotide comprising a nucleic acid encoding the anti-ROR1 chimeric antigen receptor of claim 12 .

36. A vector, comprising the polynucleotide of claim 35 .

37. A cell comprising the polynucleotide of claim 35 .

38. A cell comprising the anti-ROR1 chimeric antigen receptor of claim 12 .

39. The cell of claim 38 , that is a lymphocyte.

40. The cell of claim 39 , that is an NK cell or a T cell.

41. The cell of claim 40 , wherein the cell is a T cell and the T cell is a CD4+ T cell or a CD8+ T cell.

42. The cell of claim 41 , wherein the cell is a primary cell obtained from a subject.

43. A composition comprising the cell of claim 38 .

44. A method of treatment comprising administering the cell of claim 38 to a subject having a disease or disorder associated with ROR1.

45. A polynucleotide comprising a nucleic acid encoding the anti-ROR1 antibody or antigen-binding domain thereof of claim 2 .

46. A cell comprising the polynucleotide of claim 45 .

47. A vector comprising the polynucleotide of claim 45 .

48. A composition comprising the anti-ROR1 antibody or antigen-binding fragment thereof of any of claim 2 .

49. A method of treatment comprising administering the anti-ROR1 antibody or antigen-binding fragment thereof of claim 2 to a subject having a disease or disorder associated with ROR1.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 28, 2021
From: AMIN, RUPESH; BAILEY, JENNA; BEDI, SAMRITI; BELMONT, BRIAN; CHEN, AYE; COSTA, ANDREIA; GOLDFLESS, STEPHEN JACOB; HAUSKINS, COLLIN; JEFFERY, ERIC; JIANG, YUE; OH, YEONJOO; SIERRA, CATHERINE; WILLIAMS, MADELINE
To: JUNO THERAPEUTICS, INC.
Reel/Frame 057638/0899 →
Continuity (2)
Provisional Application 62798456 · Jan 29, 2019
Related Publication 20220096651A1 · Mar 31, 2022
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