IP Library › Granted Patent US 12,295,997
Granted Patent B2
US 12,295,997 · App. 17/366,946 · Granted May 13, 2025

Prostate neoantigens and their uses

Inventors: Jason Lee DeHart (San Diego, CA); Vipul Bhargava (Warrington, PA); Manuel Alejandro Sepulveda (West Windsor, NJ)
Assignee: Janssen Biotech, Inc.
A61K39/001193A61K9/5123A61K39/0011A61K45/06A61P35/00C07K14/005C07K14/4748C12N7/00C12N15/86A61K2039/5254A61K2039/5256A61K2039/53A61K2039/884C12N2710/24034C12N2710/24043C12N2710/24071C12N2750/14134C12N2750/14143C12N2750/14171
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Quick Facts
Patent No.
US 12,295,997
App. No.
17/366,946
Granted
May 13, 2025
Kind
B2
Abstract

Disclosed herein are self-replicating RNA molecules encoding prostate neoantigens, vaccines, and methods of treating and preventing prostate cancer.

Claims (48)

1. A self-replicating RNA molecule comprising an RNA encoding the polypeptides of SEQ ID NOs: 1001, 1003, 275, 381, 333, 337, 269, 253, 309, 325, 271, 305, 251, 245, 261, 265, 317, 255, 277, 297, 285, 437, 439, 442, 444, 379, 343, 211, 349, 213, 215, 221, 219, 225, 345, 353, 235, 223, 167, 171, 19, 23, and 177.

2. The self-replicating RNA molecule of claim 1 , wherein the RNA comprises the polynucleotides of SEQ ID NOs: 1000, 1002, 276, 382, 334, 338, 270, 254, 310, 326, 272, 306, 252, 246, 262, 266, 318, 256, 278, 298, 286, 448, 450, 453, 455, 380, 344, 212, 350, 214, 216, 222, 220, 226, 346, 354, 236, 224, 168, 172, 20, 24, and 178.

3. The self-replicating RNA molecule of claim 1 , further comprising one or more of the following:

a. one or more nonstructural genes selected from nsP1, nsP2, nsP3, and nsP4;

b. at least one of a DLP motif, a 5′ UTR, a 3′UTR, and a Poly A; and

c. a subgenomic promoter.

4. A DNA construct comprising the vector of SEQ ID NO: 981 and the self-replicating RNA molecule of claim 1 .

5. A composition comprising the self-replicating RNA molecule of claim 1 and a pharmaceutically acceptable carrier.

6. The composition of claim 5 , wherein the self-replicating RNA molecule is encapsulated in, bound to, or adsorbed on a liposome, a lipoplex, a lipid nanoparticle, or combinations thereof.

7. The composition of claim 6 , wherein the self-replicating RNA molecule is encapsulated in a lipid nanoparticle.

8. A polynucleotide encoding the polypeptides of SEQ ID NOs: 1001, 1003, 275, 381, 333, 337, 269, 253, 309, 325, 271, 305, 251, 245, 261, 265, 317, 255, 277, 297, 285, 437, 439, 442, 444, 379, 343, 211, 349, 213, 215, 221, 219, 225, 345, 353, 235, 223, 167, 171, 19, 23, and 177.

9. The polynucleotide of claim 8 , comprising the polynucleotides of SEQ ID NOs: 1000, 1002, 276, 382, 334, 338, 270, 254, 310, 326, 272, 306, 252, 246, 262, 266, 318, 256, 278, 298, 286, 448, 450, 453, 455, 380, 344, 212, 350, 214, 216, 222, 220, 226, 346, 354, 236, 224, 168, 172, 20, 24, and 178.

10. A composition comprising the polynucleotide of claim 8 and a pharmaceutically acceptable carrier.

11. A recombinant virus comprising the polynucleotide of claim 8 .

12. The recombinant virus of claim 11 , wherein the recombinant virus is derived from GAd20, Ad26, or MVA.

13. A method of treating prostate cancer in a subject, the method comprising administering to the subject the recombinant virus of claim 11 .

14. The method of claim 13 , wherein the prostate cancer is a relapsed prostate cancer, a refractory prostate cancer, a metastatic prostate cancer, a castration resistant prostate cancer, or any combination thereof.

15. The method of claim 13 , further comprising administering to the subject an additional cancer therapeutic agent selected from a CTLA-4 antibody, a CTLA4 ligand, a PD-1 axis inhibitor, a PD-L1 axis inhibitor, a TLR agonist, a CD40 agonist, an OX40 agonist, hydroxyurea, ruxolitinib, fedratinib, a 41BB agonist, a CD28 agonist, a STING antagonist, a RIG-1 antagonist, a TCR-T therapy, a CAR-T therapy, a FLT3 ligand, aluminum sulfate, a BTK inhibitor, a CD38 antibody, a CDK inhibitor, a CD33 antibody, a CD37 antibody, a CD25 antibody, a GM-CSF inhibitor, IL-2, IL-15, IL-7, CD3 redirection molecules, pomalimib, IFNγ, IFNα, TNFα, a VEGF antibody, a CD70 antibody, a CD27 antibody, a BCMA antibody, a GPRC5D antibody, or any combination thereof.

16. The method of claim 13 , further comprising administering to the subject a checkpoint inhibitor selected from ipilimumab, cetrelimab, pembrolizumab, nivolumab, sintilimab, cemiplimab, toripalimab, camrelizumab, tislelizumab, dostralimab, spartalizumab, prolgolimab, balstilimab, budigalimab, sasanlimab, avelumab, atezolizumab, durvalumab, envafolimab, iodapolimab, or any combination thereof.

17. A method of treating a prostate cancer in a subject, the method comprising administering to the subject:

a. a first vaccine comprising a polynucleotide encoding the polypeptides of SEQ ID NOs: 1001, 1003, 275, 381, 333, 337, 269, 253, 309, 325, 271, 305, 251, 245, 261, 265, 317, 255, 277, 297, 285, 437, 439, 442, 444, 379, 343, 211, 349, 213, 215, 221, 219, 225, 345, 353, 235, 223, 167, 171, 19, 23, and 177; and

b. a second vaccine comprising a polynucleotide encoding the polypeptides of SEQ ID NOs: 1001, 1003, 275, 381, 333, 337, 269, 253, 309, 325, 271, 305, 251, 245, 261, 265, 317, 255, 277, 297, 285, 437, 439, 442, 444, 379, 343, 211, 349, 213, 215, 221, 219, 225, 345, 353, 235, 223, 167, 171, 19, 23, and 177.

18. The method of claim 17 , wherein the first vaccine and the second vaccine are recombinant viruses derived from GAd20, MVA, Ad26, or a self-replicating RNA molecule.

19. The method of claim 17 , wherein the first vaccine, the second vaccine, or both the first vaccine and the second vaccine is an RNA vaccine.

20. The method of claim 19 , wherein the first vaccine, the second vaccine, or both the first vaccine and the second vaccine is a self-replicating RNA molecule.

21. The method of claim 20 , wherein the first vaccine is a recombinant virus derived from GAd20, Ad26, or MVA, and the second vaccine is a self-replicating RNA molecule.

22. The method of claim 21 , wherein:

the first vaccine is a recombinant virus derived from Ad26; and

the second vaccine is a self-replicating RNA molecule.

23. The method of claim 21 , wherein:

the first vaccine is a recombinant virus derived from GAd20; and

the second vaccine is a self-replicating RNA molecule.

24. The method of claim 21 , wherein:

the first vaccine is a recombinant virus derived from MVA; and

the second vaccine is a self-replicating RNA molecule.

25. The method of claim 20 , wherein the first vaccine is a self-replicating RNA molecule and the second vaccine is a recombinant virus derived from Ad26, GAd20, or MVA.

26. The method of claim 25 , wherein:

the first vaccine is a self-replicating RNA molecule; and

the second vaccine is a recombinant virus derived from Ad26.

27. The method of claim 25 , wherein:

the first vaccine is a self-replicating RNA molecule; and

the second vaccine is a recombinant virus derived from GAd20.

28. The method of claim 25 , wherein:

the first vaccine is a self-replicating RNA molecule; and

the second vaccine is a recombinant virus derived from MVA.

29. The method of claim 17 , further comprising administering to the subject an additional cancer therapeutic agent selected from a CTLA-4 antibody, a CTLA4 ligand, a PD-1 axis inhibitor, a PD-L1 axis inhibitor, a TLR agonist, a CD40 agonist, an OX40 agonist, hydroxyurea, ruxolitinib, fedratinib, a 41BB agonist, a CD28 agonist, a STING antagonist, a RIG-1 antagonist, a TCR-T therapy, a CAR-T therapy, a FLT3 ligand, aluminum sulfate, a BTK inhibitor, a CD38 antibody, a CDK inhibitor, a CD33 antibody, a CD37 antibody, a CD25 antibody, a GM-CSF inhibitor, IL-2, IL-15, IL-7, CD3 redirection molecules, pomalimib, IFNγ, IFNα, TNFα, a VEGF antibody, a CD70 antibody, a CD27 antibody, a BCMA antibody, a GPRC5D antibody, or any combination thereof.

30. The method of claim 17 , further comprising administering to the subject a checkpoint inhibitor selected from ipilimumab, cetrelimab, pembrolizumab, nivolumab, sintilimab, cemiplimab, toripalimab, camrelizumab, tislelizumab, dostralimab, spartalizumab, prolgolimab, balstilimab, budigalimab, sasanlimab, avelumab, atezolizumab, durvalumab, envafolimab, iodapolimab, or any combination thereof.

31. A method of treating a prostate cancer in a subject, the method comprising administering to the subject a self-replicating RNA molecule comprising an RNA encoding the polypeptides of SEQ ID NOs: 1001, 1003, 275, 381, 333, 337, 269, 253, 309, 325, 271, 305, 251, 245, 261, 265, 317, 255, 277, 297, 285, 437, 439, 442, 444, 379, 343, 211, 349, 213, 215, 221, 219, 225, 345, 353, 235, 223, 167, 171, 19, 23, and 177.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 2, 2021
From: DEHART, JASON LEE; BHARGAVA, VIPUL; SEPULVEDA, MANUEL ALEJANDRO
To: JANSSEN BIOTECH, INC.
Reel/Frame 056747/0165 →
Continuity (2)
Provisional Application 63048509 · Jul 6, 2020
Related Publication 20230029453A1 · Feb 2, 2023
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