WT1 HLA class II—binding peptides and compositions and methods comprising same

• US 9,233,149 B2
• Filed: 09/16/2013
• Issued: 01/12/2016
• Est. Priority Date: 10/17/2005
• Status: Active Grant

• Current Assignee: Memorial Hospital For Cancer & Allied Diseases Incorporated
• Original Assignee: Sloan-Kettering Institute For Cancer Research (Memorial Sloan-Kettering Cancer Center)
• Inventors: Scheinberg, David A., Pinilla-Ibarz, Javier, May, Rena
• Primary Examiner(s): Skowronek, Karlheinz R
• Assistant Examiner(s): Lee, Jia-Hai
• Application Number:
  US14/028,329
• Publication Number:
  US 20140220054A1
• Time in Patent Office: 848 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/5158 Antigen-pulsed cells, e.g. T-cells
• CPC Class Codes: A61K 2039/57 characterised by the type of response, e.g. Th1, Th2
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/001153 Wilms tumor 1 [WT1]
• CPC Class Codes: A61K 39/4611 T-cells, e.g. tumor infiltrating lymphocytes [TIL], lymphokine-activated killer cells [LAK] or regulatory T cells [Treg]
• CPC Class Codes: A61K 39/464453 Wilms tumor 1 [WT1]
• CPC Class Codes: A61K 39/464499 Undefined tumor antigens, e.g. tumor lysate or antigens targeted by cells isolated from tumor
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: C07K 14/4748 Tumour specific antigens; Tumour rejection antigen precursors [TRAP], e.g. MAGE

Abstract

This invention provides WT1 peptides and methods of treating, reducing the incidence of, and inducing immune responses against a WT1-expressing cancer, comprising same.

Claims

1. A method of treating a subject with a WT1-expressing cancer, the method comprising administering to said subject a vaccine comprising (a) an isolated WT1 peptide consisting of the amino acid sequence RSDELVRHHNMHQRNMTKL (SEQ ID No:

2) or PGCNKRYFKLSHLQMHSRKHTG (SEQ ID No;

     4) and (b) an adjuvant or a carrier, thereby treating a subject with a WT1-expressing cancer.

2. The method of claim 1, wherein said WT1-expressing cancer is a leukemia, a desmoplastic small round cell tumor, a gastric cancer, a colon cancer, a lung cancer, a breast cancer, a germ cell tumor, an ovarian cancer, a uterine cancer, a thyroid cancer, a liver cancer, a renal cancer, a kaposi'"'"'s sarcoma, a sarcoma, or a hepatocellular carcinoma.

3. The method of claim 1, wherein said WT1-expressing cancer is a Wilms'"'"' tumor, an acute myelogenous leukemia (AML), a myelodysplastic syndrome (MDS), or a non-small cell lung cancer (NSCLC).

4. The method of claim 1, said vaccine comprising (a) an antigen-presenting cell and (b) the peptide sequence of SEQ ID NO:

2 or SEQ ID NO;

4.

5. The method of claim 4, wherein said WT1-expressing cancer is a leukemia, a desmoplastic small round cell tumor, a gastric cancer, a colon cancer, a lung cancer, a breast cancer, a germ cell tumor, an ovarian cancer, a uterine cancer, a thyroid cancer, a liver cancer, a renal cancer, a kaposi'"'"'s sarcoma, a sarcoma, or a hepatocellular carcinoma.

6. The method of claim 4, wherein said WT1-expressing cancer is a Wilms'"'"' tumor, an acute myelogenous leukemia (AML), a myelodysplastic syndrome (MDS), or a non-small cell lung cancer (NSCLC).

7. The method of claim 1, wherein said adjuvant is QS21, Freund'"'"'s incomplete adjuvant, aluminum phosphate, aluminum hydroxide, BCG, alum, a growth factor, a cytokine, a chemokine, an interleukin, Montanide ISA 51, or GM-CSF.

8. The method of claim 1 wherein the vaccine further comprises an antigen presenting cell.

9. A method of reducing an incidence of a WT1-expressing cancer, or its relapse, in a subject, the method comprising administering to said subject a vaccine comprising (a) an isolated WT1 peptide consisting of the amino acid sequence RSDELVRHHNMHQRNMTKL (SEQ ID No:

2) or PGCNKRYFKLSHLQMHSRKHTG (SEQ ID No;

     4) and (b) an adjuvant or a carrier, thereby reducing an incidence of a WT1-expressing cancer, or its relapse, in a subject.

10. The method of claim 9, wherein said WT1-expressing cancer is a leukemia, a desmoplastic small round cell tumor, a gastric cancer, a colon cancer, a lung cancer, a breast cancer, a germ cell tumor, an ovarian cancer, a uterine cancer, a thyroid cancer, a liver cancer, a renal cancer, a kaposi'"'"'s sarcoma, a sarcoma, or a hepatocellular carcinoma.

11. The method of claim 9, wherein said WT1-expressing cancer is a Wilms'"'"' tumor, an acute myelogenous leukemia (AML), a myelodysplastic syndrome (MDS), or a non-small cell lung cancer (NSCLC).

12. The method of claim 9, said vaccine comprising (a) an antigen-presenting cell and (b) the peptide sequence of SEQ ID NO:

2 or SEQ ID NO;

4.

13. The method of claim 12, wherein said WT1-expressing cancer is a leukemia, a desmoplastic small round cell tumor, a gastric cancer, a colon cancer, a lung cancer, a breast cancer, a germ cell tumor, an ovarian cancer, a uterine cancer, a thyroid cancer, a liver cancer, a renal cancer, a kaposi'"'"'s sarcoma, a sarcoma, or a hepatocellular carcinoma.

14. The method of claim 12, wherein said WT1-expressing cancer is a Wilms'"'"' tumor, an acute myelogenous leukemia (AML), a myelodysplastic syndrome (MDS), or a non-small cell lung cancer (NSCLC).

15. The method of claim 9, wherein said adjuvant is QS21, Freund'"'"'s incomplete adjuvant, aluminum phosphate, aluminum hydroxide, BCG, alum, a growth factor, a cytokine, a chemokine, an interleukin, Montanide ISA 51, or GM-CSF.

16. The method of claim 9 wherein the vaccine further comprises an antigen presenting cell.

17. A method of inducing the formation and proliferation of CTL specific for a WT1-expressing cancer, the method comprising administering to said subject a vaccine comprising (a) an isolated WT1 peptide consisting of the amino acid sequence RSDELVRHHNMHQRNMTKL (SEQ ID No:

2) or PGCNKRYFKLSHLQMHSRKHTG (SEQ ID No;

     4) and (b) an adjuvant or a carrier, thereby inducing the formation and proliferation of CTL specific for a WT1-expressing cancer.

18. The method of claim 17, wherein said WT1-expressing cancer is a leukemia, a desmoplastic small round cell tumor, a gastric cancer, a colon cancer, a lung cancer, a breast cancer, a germ cell tumor, an ovarian cancer, a uterine cancer, a thyroid cancer, a liver cancer, a renal cancer, a kaposi'"'"'s sarcoma, a sarcoma, or a hepatocellular carcinoma.

19. The method of claim 17, wherein said WT1-expressing cancer is a Wilms'"'"' tumor, an acute myelogenous leukemia (AML), a myelodysplastic syndrome (MDS), or a non-small cell lung cancer (NSCLC).

20. The method of claim 17, wherein said adjuvant is QS21, Freund'"'"'s incomplete adjuvant, aluminum phosphate, aluminum hydroxide, BCG, alum, a growth factor, a cytokine, a chemokine, an interleukin, Montanide ISA 51, or GM-CSF.

21. The method of claim 17 wherein the vaccine further comprises an antigen presenting cell.