Biomarkers for prostate cancer and methods for their detection
AssigneeThe United States of America, as represented by the Secretary, Department of Health and Human Services
InventorsJeffrey Gildersleeve, Christopher Campbell, Oyindasola Oyelaran, James Gulley, Jeffrey Schlom
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Abstract
The invention provides a method for predicting the clinical response to a cancer vaccine in a patient having cancer, a method for determining the immune response to a cancer vaccine in a patient having cancer who has been administered a cancer vaccine, a method for determining the long-term survival in a patient having cancer, corresponding kits therefor, as well as methods of for improving the efficacy of a virus-based vaccine.
Claims42
A method for predicting the clinical response to a cancer vaccine in a patient having cancer comprising:
- obtaining a serum sample from a patient who has not been previously administered the cancer vaccine;
- assaying the serum sample to determine the levels of antibodies in the patient to at least one glycan and/or glycoprotein antigen selected from the group consisting of Sialylα2-6Galβ1-4Glc-(6′SLac), Sialylα2-3Galβ1-4(Fucα1-3)GlcNAc-(SLeX), Sialylα2-3Galβ1-4Glc-(GM3), Fucα1-2Galβ1-3GlcNAcβ1-3Galβ1-4Glcβ-(BG-H1), GalNAcβ1-4Galβ-(GA2di), Galβ1-4GlcNAcβ1-6(Galβ1-4GlcNAcβ1-3)Galβ-(LNnH), Galα1-3Gal-(Bdi), Ac-Ser-(GalNAcα)Thr-Gly-Gly-(Ac-S-Tn (Thr)-G-G), BSM, Lactose, Galβ1-3GlcNAcβ1-3Galβ-(LNT), Fuc-b, Fuc-a, Galβ1-6Man-α-(Galb1-6Man-a), Galβ1-3GalNAcβ1-4Galβ31-(GA1), Galα1-4Galβ-(Galα1-4Galb), Manα1-6[Manα1-3]Manβ-(ManT), Galβ1-3GlcNAcβ1-3Galβ1-4GlcNAcβ1-3Galβ1-(pLNH), Rha-α-, GalNAcα1-3Galβ-(Adi), GalNAcα1-3(Fucα1-2)Galβ-(BG-A), Galβ1-3GalNAcβ1-4Galβ1-(GA1), fetuin, and Ac-Ser-(GalNAcα)Ser-Ser-Gly-(Ac-S-Tn(Ser)-S-G);
- and
- comparing the determined levels of antibodies to the at least one glycan and/or glycoprotein antigen to a control, so as to predict the clinical response to the cancer vaccine in the patient.
A method for determining the immune response to a cancer vaccine in a patient having cancer comprising:
- obtaining a first serum sample from a patient who has not been previously administered the cancer vaccine;
- obtaining a second serum sample from the patient after administration of the cancer vaccine,
- assaying the first and second serum samples to determine the first and second levels of antibodies, respectively, to at least one glycan and/or glycoprotein antigen selected from the group consisting of the Forssman antigen, GalNAcα1-3Galβ-(Adi), GalNAcα1-3(Fucα1-2)Galβ-(BG-A), the Tn antigen, the TF antigen, Sialylα2-3Galβ1-4(Fuca1-3)GlcNAc-(SLeX), Siaα2-3Galβ-3[Fucα1-4]GlcNAcβ1-(SLeA), Fucα1-2Galβ1-4(Fucα1-3)GlcNAc-(LeY), Sialylα2-6Galβ1-4Glc-(6′SLac), Sialylα2-3Galβ1-4Glc-(GM3), Fucα1-2Galβ1-3GlcNAcβ1-3Galβ1-4Glcβ-(BG-H1), GalNAcβ1-4Galβ-(GA2di), Galβ1-4GlcNAcβ1-6(Galβ1-4GlcNAcβ1-3)Galβ-(LNnH), Galα1-3Gal-(Bdi), GalNAcα1-3(Fucα1-2)Galβ1-3(Fucα1-4)GlcNAcβ1-3Galβ-(A-LeB), and fetuin;
- and
- comparing the determined first and second levels of antibodies to the at least one glycan and/or glycoprotein antigen, so as to determine the immune response to the cancer vaccine in the patient.
A method for predicting the clinical response to a cancer vaccine in a patient having cancer comprising:
- obtaining a serum sample from a patient to which the cancer vaccine was administered;
- assaying the serum sample to determine the levels of antibodies in the patient to at least one glycan and/or glycoprotein antigen selected from the group consisting of the Forssman antigen, GalNAcα1-3Galβ-(Adi), GalNAcα1-3(Fucα1-2)Galβ-(BG-A), fetuin, Ac-Ser-(GalNAcα)Ser-Ser-Gly-, Sialylα2-6Galβ1-4Glc-(6′SLac), Sialylα2-3Galβ-4Glc-(GM3), Fuc-a, and GalNAcα1-3(Fuca1-2)Galβ1-3(Fucα1-4)GlcNAcβ1-3Galβ1-(A-LeB);
- and comparing the determined levels of antibodies to the at least one glycan and/or glycoprotein antigen to a control, so as to predict the clinical response to the cancer vaccine in the patient.
A method of predicting long-term survival in a patient having cancer comprising:
- obtaining a serum sample from a patient which has not been previously administered cancer treatment;
- assaying the serum sample to determine the levels of antibodies in the patient to at least one glycan and/or glycoprotein antigen selected from the group consisting of GalNAcβ1-4Galβ-(GA2di-), Galβ1-4GlcNAcβ1-6(Galβ1-4GlcNAcβ1-3)Galβ-(LNnH), Sialylα2-3Galβ1-4(Fucα1-3)GlcNAc-(SLeX), Ac-Ser-(GalNAcα)Thr-Gly-Gly-(Ac-S-Tn(Thr)-G-G), Fuc-a, Fuc-b, Galβ1-3GalNAcβ1-4Galβ1-(GA1), Galβ-6Man-α-(Galβ1-6Man-a), Galα1-4Galβ-(Gala1-4Galb), Manα1-6[Manα1-3]Manβ-(ManT), Man-α (Man-a), Glcα1-6Glcβ-(isomaltose), Araα1-5Araα1-5Araα1-5Araα1-5Araα1-(Ara5), Manα1-2Manα1-6(Manα1-2Manα1-3)Manα1-6(Manα1-2Manα1-2Manα1-3)Manβ1-4GlcNAc-(Man9), GalNAc-β(GalNAc-b), Fuca1-2Galβ1-4GlcNAcβ-(BG-H2), Galβ1-4GlcNAcβ1-3Galβ1-4GlcNAcβ1-3Galβ1-4GlcNAcβ-(LacNAc (trimeric)), Galα1-4Galβ-4Glc-(Pk or Gb3), Glcβ1-4Glcβ-(cellobiose), Galβ1-4GlcNAcβ1-3Galβ1 (LNnT), Manα1-6Man-α (Mana1-6Man-a) Galα1-3Galβ1-4Galα-(Gal3), Galβ1-3(Siaα2-6)GlcNAcβ1-3Galβ1-(LSTb), GalNAc-α-(GalNAc-a), Galβ1-3(Fucα1-4)GlcNAcβ1-3Galβ1-4(Fucα1-3)GlcNAcβ1-3Galβ1-(LeA-LeX), Forssman antigen, and Ac(Galβ1-3GalNAcα)Ser-Gly-(Ac-TF(Ser)-G);
- and
- comparing the determined levels of antibodies to the at least one glycan and/or glycoprotein antigen to a control, so as to predict the long-term survival in the patient.
A kit for predicting the clinical response to a cancer vaccine in a patient sample from a patient having prostate cancer comprising a composition including at least one glycan and/or glycoprotein antigen selected from the group consisting of Sialylα2-6Galβ1-4Glc-(6′SLac), Sialylα2-3Galβ1-4(Fucα1-3)GlcNAc-(SLeX), Sialylα2-3Galβ1-4Glc-(GM3), Fucα1-2Galβ1-3GlcNAcβ1-3Galβ1-4Glcβ-(BG-H1), GalNAcβ1-4Galβ-(GA2di), Galβ-4GlcNAcβ1-6(Galβ1-4GlcNAcβ1-3)Galβ-(LNnH), Gala1-3Gal-(Bdi), Ac-Ser-(GalNAcα)Thr-Gly-Gly-(Ac-S-Tn (Thr)-G-G), BSM, Lactose, Galβ1-3GlcNAcβ1-3Galβ-(LNT), Fuc-b, Fuc-a, Galβ1-6Man-α-(Galb1-6Man-a), Galβ1-3GalNAcβ1-4Galβ1-(GA1), Galα1-4Galβ3-(Galα1-4Galb), Manα1-6[Manα1-3]Manβ-(ManT), Galβ1-3GlcNAcβ1-3Galβ1-4GlcNAcβ1-3Galβ1-(pLNH), Rha-α-, GalNAcα1-3Galβ-(Adi), GalNAcα1-3(Fucα1-2)Galβ-(BG-A), Galβ1-3GalNAcβ1-4Galβ1-(GA1), and Ac-Ser-(GalNAcα)Ser-Ser-Gly-(Ac-S-Tn(Ser)-S-G).
A kit for determining the immune response to a cancer vaccine in a patient sample from a patient having prostate cancer comprising a composition including at least one glycan and/or glycoprotein antigen selected from the group consisting of the Forssman antigen, GaINAcα1-3Galβ-(Adi), GalNAcα1-3(Fuca1-2)Galβ-(BG-A), the Tn antigen, the TF antigen, Sialylα2-3Galβ1-4(Fucα1-3)GlcNAc-(SLeX), Siaα2-3Galβ1-3[Fucα1-4]GlcNAcβ1-(SLeA), Fucα1-2Galβ1-4(Fuca1-3)GlcNAc-(LeY), Sialylα2-6Galβ1-4Glc-(6′SLac), Sialylα2-3Galβ1-4Glc-(GM3), Fucα1-2Galβ1-3GlcNAcβ1-3Gal1-3Galβ1-4Glcβ-(BG-H1), GalNAcβ1-4Galβ-(GA2di), Galβ1-4GlcNAcβ1-6(Galβ1-4GlcNAcβ1-3)Galβ-(LNnH), Galα1-3Gal-(Bdi), GalNAcα1-3(Fucα1-2)Galβ1-3(Fucα1-4)GlcNAcβ1-3Galβ1-(A-LeB), and fetuin.
A kit for predicting the clinical response to a cancer vaccine in a patient sample from a patient having prostate cancer comprising a composition including at least one glycan and/or glycoprotein antigen selected from the group consisting of the Forssman antigen (e.g., the Forssman disaccharide), GalNAcα1-3Galβ-(Adi), GalNAcα1-3(Fucα1-2)Galβ-(BG-A), fetuin, Ac-Ser-(GalNAcα)Ser-Ser-Gly-, Sialylα2-6Galβ1-4Glc-(6′ SLac), Sialylα2-3Galβ1-4Glc-(GM3), Fuc-a, and GalNAcα1-3(Fucα1-2)Gal1-3(Fucα1-4)GlcNAcβ1-3Galβ1-(A-LeB).
A kit for predicting the long-term survival in a patient sample from a patient having prostate cancer comprising a composition including at least one glycan and/or glycoprotein antigen selected from the group consisting of GalNAcβ1-4Galβ-(GA2di), Galβ1-4GlcNAcβ1-6(Galβ1-4GlcNAcβ1-3)Galβ-(LNnH), Sialylα2-3Galβ1-4(Fucα1-3)GlcNAc-(SLeX), Ac-Ser-(GalNAcα)Thr-Gly-Gly-(Ac-S-Tn(Thr)-G-G), Fuc-a, Fuc-b, Galβ-3GalNAcβ1-4Galβ1-(GA1), Galβ1-6Man-α-(Galb1-6Man-a), Galα1-4Galβ-(Galα1-4Galb), Manα1-6[Manα1-3]Manβ-(ManT), Man-α (Man-a), Glcα1-6Glcβ-(isomaltose), Araα1-5Araα1-5Araα1-5Araα1-5Araα1-(Ara5), Manα1-2Manα1-6(Manα1-2Manα1-3)Manα1-6(Manα1-2Manα1-2Manα1-3)Manβ1-4GlcNAc-(Man9), GalNAc-β (GalNAc-b), Fucα1-2Galβ1-4GlcNAcβ-(BG-H2), Galβ1-4GlcNAcβ1-3Galβ1-4GlcNAcβ1-3Galβ1-4GlcNAcβ-(LacNAc (trimeric)), Galα1-4Galβ-4Glc-(Pk or Gb3), Glcβ1-4Glcβ-(cellobiose), Galβ1-4GlcNAcβ1-3Galβ1 (LNnT), Manα1-6Man-α (Mana1-6Man-a) Galα1-3Galβ1-4Galα-(Gal3), Galβ1-3(Siaα2-6)GlcNAcβ1-3Galβ1-(LSTb), GalNAc-α-(GalNAc-a), Galβ1-3(Fucα1-4)GlcNAcβ1-3Galβ1-4(Fucα1-3)GlcNAcβ1-3Galβ1-(LeA-LeX), Forssman antigen, and Ac(Galβ1-3GalNAcα)Ser-Gly-(Ac-TF(Ser)-G).
A method for improving the efficacy of a virus-based vaccine in a patient comprising enhancing antibody responses to one or more glycans and/or glycoprotein antigens.
A method for improving the efficacy of a virus-based vaccine in a patient comprising altering levels of antibodies in the patient prior to vaccine therapy.
A method for improving the efficacy of a virus-based vaccine in a patient comprising increasing the amounts of one or more glycans and/or glycoprotein antigens in the patient.
Dependencies are inferred from the claim text.