Cancer Vaccines And Methods Of Treatment Using The Same

• US 20160030536A1
• Filed: 03/14/2014
• Published: 02/04/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: David Weiner, Jewell Walters, Jian Yan, Karuppiah Muthumani
• Original Assignee: David Weiner, Jewell Walters, Jian Yan, Karuppiah Muthumani
• Inventors: Weiner, David, Yan, Jian, Muthumani, Karuppiah, Walters, Jewell
• Granted Patent: US 11,419,925 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/53 DNA (RNA) vaccination
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/55522 Cytokines; Lymphokines; Interferons
• CPC Class Codes: A61K 2039/55527 Interleukins
• CPC Class Codes: A61K 2039/575 humoral response
• CPC Class Codes: A61K 39/0011 Cancer antigens
• CPC Class Codes: A61K 39/001144 Hormones, e.g. calcitonin
• CPC Class Codes: A61K 39/001153 Wilms tumor 1 [WT1]
• CPC Class Codes: A61K 39/001156 Tyrosinase and tyrosinase related proteinases [TRP-1 or TRP-2]
• CPC Class Codes: A61K 39/001157 Telomerase or TERT [telomerase reverse transcriptase]
• CPC Class Codes: A61K 39/001186 MAGE
• CPC Class Codes: A61K 39/001188 NY-ESO
• CPC Class Codes: A61K 39/001189 PRAME
• CPC Class Codes: A61K 39/001191 Melan-A/MART
• CPC Class Codes: A61K 39/001192 Glycoprotein 100 [Gp100]
• CPC Class Codes: A61K 39/001193 Prostate associated antigens e.g. Prostate stem cell antigen [PSCA]; Prostate carcinoma tumor antigen [PCTA]; PAP or PSGR
• CPC Class Codes: A61K 39/001194 Prostate specific antigen [PSA]
• CPC Class Codes: A61K 39/001195 Prostate specific membrane antigen [PSMA]
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61P 1/00 : Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/16 : for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/08 : of the prostate
• CPC Class Codes: A61P 15/00 : Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 17/00 : Drugs for dermatological disorders
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 35/02 : specific for leukemia
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C12N 2710/20034 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2730/10111 : Orthohepadnavirus, e.g. hepatitis B virus
• CPC Class Codes: C12N 2770/24234 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 9/0071 : acting on paired donors with incorporation of molecular oxygen (1.14)
• CPC Class Codes: C12Y 114/18001 : Tyrosinase (1.14.18.1)

Abstract

Disclosed herein are compositions and methods for treating cancer and in particular vaccines that treat and provide protection against tumor growth.

Claims

1. A vaccine comprising

(a) a nucleic acid encoding one or more amino acid sequence(s) selected from the group consisting of:

(i) amino acid sequence of tyrosinase (Tyr) (SEQ ID NO;

2);

(ii) amino acid sequence of tyrosinase-related protein 1 (TYRP1) (SEQ ID NO;

4);

(iii) amino acid sequence of tyrosinase-related protein 2 (TYRP2) (SEQ ID NO;

6);

(iv) amino acid sequence of melanoma-associated antigen 4 protein (MAGEA4) (SEQ ID NO;

8);

(v) amino acid sequence of growth hormone release hormone (GHRH) (SEQ ID NO;

10);

(vi) amino acid sequence of MART-1/melan-A antigen (MART-1/Melan-A) (SEQ ID NO;

12);

(vii) amino acid sequence of cancer testis antigen (NY-ESO-1) (SEQ ID NO;

     14);

(viii) amino acid sequence of cancer testis antigen II (NY-ESO-2)(SEQ ID NO;

16);

(ix) amino acid sequence of PRAME (SEQ ID NO;

18)

(x) amino acid sequence of WT1 (SEQ ID NO;

20);

(xi) amino acid sequence of WT1 (SEQ ID NO;

22); and

(xii) amino acid sequence of hTERT (SEQ ID NO;

24);

(b) a nucleic acid encoding one or more amino acid sequence(s) selected from the group consisting of;

(i) amino acid sequence that is 95% identical or greater to the amino acid sequence of tyrosinase (Tyr) (SEQ ID NO;

2);

(ii) amino acid sequence that is 95% identical or greater to the amino acid sequence of tyrosinase-related protein 1 (TYRP1) (SEQ ID NO;

     4);

(iii) amino acid sequence that is 95% identical or greater to the amino acid sequence of tyrosinase-related protein 2 (TYRP2) (SEQ ID NO;

     6);

(iv) amino acid sequence that is 95% identical or greater to the amino acid sequence of melanoma-associated antigen 4 protein (MAGEA4) (SEQ ID NO;

     8);

(v) amino acid sequence that is 95% identical or greater to the amino acid sequence of growth hormone release hormone (GHRH) (SEQ ID NO;

     10);

(vi) amino acid sequence that is 95% identical or greater to the amino acid sequence of MART-1/melan-A antigen (MART-1/Melan-A)(SEQ ID NO;

     12);

(vii) amino acid sequence that is 95% identical or greater to the amino acid sequence of cancer testis antigen (NY-ESO-1)(SEQ ID NO;

     14);

(viii) amino acid sequence that is 95% identical or greater to the amino acid sequence of cancer testis antigen II (NY-ESO-2)(SEQ ID NO;

16);

(ix) amino acid sequence that is 95% identical or greater to the amino acid sequence of PRAME (SEQ ID NO;

     18);

(x) amino acid sequence that is 95% identical or greater to the amino acid sequence of WT1 (SEQ ID NO;

20);

(xi) amino acid sequence that is 95% identical or greater to the amino acid sequence of WT1 (SEQ ID NO;

22); and

(xii) amino acid sequence that is 95% identical or greater to the amino acid sequence of hTERT (SEQ ID NO;

24);

or

(c) combination of (a) and (b).

2. The vaccine of claim 1 further comprising a nucleic acid encoding one or more antigens selected from the group consisting of:

PSA, PSMA, STEAP, PSCA, MAGE A1, gp100, a viral antigen, and combinations thereof.

3. The vaccine of claim 2, wherein the viral antigen is an antigen from Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Papilloma Virus (HPV).

4. The vaccine of claim 3, wherein the HBV antigen is an HBV core antigen or a HBV surface antigen, or a combination thereof;

wherein the HCV antigen is an HCV NS34A antigen, an HCV NS5A antigen, an HCV NS5B antigen, an HCV NS4B antigen, or a combination thereof and wherein the HPV antigen is an HPV type 6 E6 antigen, an HPV type 6 E7 antigen, an HPV type 11 E6 antigen, an HPV type 11 E7 antigen, an HPV type 16 E6 antigen, an HPV type 16 E7 antigen, an HPV type 18 E6 antigen, an HPV type 18 E7 antigen, or a combination thereof.

7. The vaccine of claim 1, further comprising an immune checkpoint inhibitor selected from the group consisting of:

anti-PD-1 antibody, anti-PD-L1 antibody, and a combination thereof.

8. The vaccine of claim 1, wherein the nucleic acid molecule comprises one or more nucleotide sequences selected from the group consisting of:

SEQ ID NO;

1, SEQ ID NO;

3, SEQ ID NO;

5, SEQ ID NO;

7, SEQ ID NO;

9, SEQ ID NO;

11, SEQ ID NO;

13, SEQ ID NO;

15, SEQ ID NO;

17, SEQ ID NO;

19, SEQ ID NO;

21, and SEQ ID NO;

23.

10. The vaccine of claim 1, wherein the nucleic acid is one or more plasmids.

11. The vaccine of claim 1, further comprising an adjuvant.

12. The vaccine of claim 11, wherein the adjuvant is IL-12, IL-15, IL-28, or RANTES.

13. A method of treating cancer in a subject in need thereof, the method comprising administering the vaccine of claim 1 to the subject.

14. The method of claim 13, wherein administration includes an electroporation step.

15. The method of claim 13, further comprising administering an immune checkpoint inhibitor to the subject.

16. The method of claim 15, wherein the immune checkpoint inhibitor is selected from the group consisting of:

anti-PD-1 antibody, anti-PD-L1 antibody, and a combination thereof.

17. The method of claim 15, wherein the vaccine and immune checkpoint inhibitor are administered in a single formulation to the subject.

18. The method of claim 15, wherein the vaccine and immune checkpoint inhibitor are administered separately to the subject.

19. The method of claim 13, wherein the cancer is selected from the group consisting of:

melanoma, head and neck cancer, prostate cancer, liver cancer, cervical cancer, recurrent respiratory papillomatosis (RRP), anal cancer, a blood cancer, and a combination thereof.

5. (canceled)

6. (canceled)

9. (canceled)

20. A nucleic acid molecule comprising one or more nucleotide sequences selected from the group consisting of:

SEQ ID NO;

1, SEQ ID NO;

3, SEQ ID NO;

5, SEQ ID NO;

7, SEQ ID NO;

9, SEQ ID NO;

11, SEQ ID NO;

13, SEQ ID NO;

15, SEQ ID NO;

17, SEQ ID NO;

19, SEQ ID NO;

21, SEQ ID NO;

23, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

1, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

3, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

5, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

7, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

9, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

11, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

13, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

15, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

17, an nucleotide sequence that is 95% identical or greater to SEQ ID NO;

19, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

21, a nucleotide sequence that is 95% identical or greater to SEQ ID NO;

23, and a combination thereof.

22. The nucleic acid molecule of claim 20, wherein the nucleotide sequence is one or more plasmids.

21. (canceled)

23. An amino acid molecule comprising one or more amino acid sequences selected from the group consisting of:

SEQ ID NO;

2, SEQ ID NO;

4, SEQ ID NO;

6, SEQ ID NO;

8, SEQ ID NO;

10, SEQ ID NO;

12, SEQ ID NO;

14, SEQ ID NO;

16, SEQ ID NO;

18, SEQ ID NO;

20, SEQ ID NO;

22, SEQ ID NO;

24, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

2, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

4, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

6, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

8, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

10, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

12, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

14, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

16, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

18, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

20, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

22, an amino acid sequence that is 95% identical or greater to SEQ ID NO;

24, and a combination thereof.

24. A method for preventing or treating cancer in a subject in need thereof, the method comprising:

(a) administering to a subject in need thereof a vaccine comprising a CMV cancer antigen to treat or prevent gliobastoma, or administering to a subject in need thereof a vaccine comprising CMV cancer antigen in combination with any one or more of cancer antigens hTERT, NY-ESO-1, MAGE-A1, or WT1;

(b) administering to a subject in need thereof a vaccine comprising one or more cancer antigens PSA, PSMA, or STEAP to treat or prevent prostate cancer, or administering to a subject in need thereof a vaccine comprising PSA, PSMA, or STEAP in combination with any one or more of cancer antigens hTERT, NY-ESO-1, MAGE-A1 or WT1 to treat or prevent prostate cancer;

(c) administering to a subject in need thereof a vaccine comprising one or more cancer antigens tyrosinase, PRAME, or GP-100 to treat or prevent melanoma, or administering to a subject in need thereof a vaccine comprising tyrosinase, PRAME, or GP-100 in combination with any one or more of cancer antigens hTERT, NY-ESO-1, MAGE-A1 or WT1 to treat or prevent melanoma;

(d) administering to a subject in need thereof a vaccine comprising one or more cancer antigen HPV 16 E6 or HPV 16 E7 to treat or prevent head and neck cancer, or administering to a subject in need thereof a vaccine comprising HPV 16 E6 or HPV 16 E7 in combination with any one or more of cancer antigens hTERT, NY-ESO-1, MAGE-A1 or WT1 to treat or prevent head and neck cancer;

(e) administering to a subject in need thereof a vaccine comprising one or more cancer antigens tyrosinase, PRAME, or GP-100 to treat or prevent melanoma, or administering to a subject in need thereof a vaccine comprising tyrosinase, PRAME, or GP-100 in combination with any one or more of cancer antigens hTERT, NY-ESO-1, MAGE-A1 or WT1 to treat or prevent melanoma;

(f) administering to a subject in need thereof a vaccine comprising one or more cancer antigens HPV 6, HPV 11, or HPV 16 to treat or prevent anal cancer, or administering to a subject in need thereof a vaccine comprising HPV 6, HPV 11, or HPV 16 in combination with any one or more of cancer antigens hTERT, NY-ESO-1, MAGE-A1 or WT1 to treat or prevent anal cancer;

(g) administering to a subject in need thereof a vaccine comprising one or more cancer antigens HBV core, HBV surface antigen, HCV NS34A, HCV NS5A, HCV NS5B, or HCV NS4B to treat or prevent liver, or administering to a subject in need thereof a vaccine comprising HBV core, HBV surface antigen, HCV NS34A, HCV NS5A, HCV NS5B, or HCV NS4B in combination with any one or more of cancer antigens hTERT, NY-ESO-1, MAGE-A1 or WT1 to treat or prevent liver;

(h) administering to a subject in need thereof a vaccine comprising one or more cancer antigens HPV 16 E6/E7 or HPV 18 E6/E7 to treat or prevent cervical cancer, or administering to a subject in need thereof a vaccine comprising HPV 16 E6/E7 or HPV 18 E6/E7 in combination with any one or more of cancer antigens hTERT, NY-ESO-1, MAGE-A1 or WT1 to treat or prevent cervical cancer;

or

(i) administering to a subject in need thereof a vaccine comprising one or more cancer antigens PRAME, WT-1, or hTERT to treat or prevent blood cancers, or administering to a subject in need thereof a vaccine comprising PRAME, WT-1, or hTERT in combination with any one or more of cancer antigens NY-ESO-1 or MAGE-A1 to treat or prevent blood cancers,

wherein the method may further comprise combining the administrative steps of (a)-(i) with an immune checkpoint inhibitor is selected from the group consisting of;

anti-PD-1 antibody, anti-PD-L1 antibody, and a combination thereof.