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1. WO2021062041 - NOVEL ANTIBODIES FOR DETECTING GASTRIC CANCER

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[ EN ]

CLAIMS

We claim:

1. A method for identifying a subject having increased risk of developing gastric cancer, the method comprising:

(a) reacting a biological sample obtained from a subject with a reagent composition that comprises components for detecting in the biological sample the presence of one or more antibodies selected from anti-HP1118/Ggt, anti-HP0516/HslU, anti-HP0243/NapA, anti-HP1293/RpoA, anti-HP0371/FabE, and anti-HP0875/KatA; and

(b) detecting the presence of the antibodies in the sample, wherein reduced seroreactivity relative to a control for one or more of the antibodies is indicative of a 2- to 8-fold increased risk of gastric cancer.

2. The method according to claim 1, wherein the detected antibodies comprise anti-HP1118, anti-HP0516, and anti-HP0243.

3. The method according to claim 1, wherein the detected antibodies comprise anti-HP1118/Ggt, anti-HP0516/HslU, anti-HP0243/NapA, anti-HP 1293/RpoA, anti-HP0371/FabE, and anti-HP0875/KatA.

4. The method according to claim 1, wherein the reagent composition further comprises a component for detecting the presence and level of anti-CagA antibodies in the sample, and wherein increased seroreactivity for anti-CagA antibodies is indicative of an increased risk of gastric cancer relative to a control.

5. The method according to claim 4, wherein the detected antibodies comprise anti-HP1118/Ggt, anti-HP0516/HslU, anti-HP0243/NapA, and anti-CagA.

6. The method according to claim 5, wherein the detected antibodies comprise anti-HP1118/Ggt, anti-HP0516/HslU, anti-HP0243/NapA, anti-HP 1293/RpoA, anti-HP0371/FabE, anti-HP0875/KatA, and anti-CagA.

7. The method according to claim 1, further comprising identifying the subject has having an increased risk of developing a diffuse-type gastric cancer tumor if the subject has a higher anti-HPl 118/Ggt response relative to an intestinal-type cancer control.

8. The method according to claim 1, further comprising identifying the subject has having an increased risk of developing a noncardiac-type gastric cancer tumor if the subject has a higher anti-HPl 118/Ggt response relative to a cardiac-type gastric cancer control.

9. The method according to claim 1, further comprising administering a vaccine-based gastric cancer treatment to the subject if identified as having an increased risk of gastric cancer.

10. The method of claim 1, wherein the biological sample is one or more of a whole blood sample, a serum sample, and a plasma sample.

11. The method of claim 1, wherein the method detects gastric cancer prior to symptom onset.

12. A method to detect gastric cancer comprising:

(a) reacting a biological sample obtained from a subject with a reagent composition that comprises components for determining a level of antibodies to one or more of 53 H. pylori proteins listed in Table 1 are present in the sample;

(b) determining levels of the antibodies in the biological sample; and

(c) comparing the levels to predetermined values indicative of gastric cancer, wherein if the level of antibodies in the biological sample falls within the predetermined values indicative of gastric cancer, the level in the biological sample indicates that the subject has gastric cancer.

13. The method according to claim 12, wherein the antibodies comprise anti-HPl 118/Ggt, anti-HP0516/HslU, anti-HP0243/NapA.

14. The method according to claim 13, wherein the detected antibodies comprise anti-HP1118/Ggt, anti-HP0516/HslU, anti-HP0243/NapA, anti-HP 1293/RpoA, anti-HP0371/FabE, and anti-HP0875/KatA.

15. The method of claim 12, wherein the reagent composition further comprises a component for determining a level of anti-CagA antibodies in the sample, wherein if the level of anti-CagA antibodies in the biological sample falls within anti-CagA antibody levels of a reference sample obtained from an individual having gastric cancer, the level in the biological sample indicates that the subject has gastric cancer.

16. The method of claim 12, wherein the predetermined values are obtained from a reference sample obtained from an individual or a group of individuals having gastric cancer.

17. The method of claim 12, further comprising administering a gastric cancer treatment to the subject if identified as having gastric cancer.

18. The method of claim 1, wherein the biological sample is one or more of a whole blood sample, a serum sample, and a plasma sample.

19. The method of claim 1, wherein the determining step is carried out using an ELISA assay or a Western Blot assay.

20. A method of determining an H. pylori antibody signature comprising antibodies, contained in a biological sample from an individual, that specifically bind to immobilized H. pylori antigens, the method comprising:

(a) contacting the sample to a panel of immobilized H. pylori antigens under conditions that promote formation of antigen-antibody complexes; and

(b) identifying complexes formed by immobilized H. pylori antigens and antibody in the sample, to determine an H. pylori antibody signature.

21. The method of claim 20, wherein the antibody signature is expressed as a level of antibody specifically binding to each immobilized antigen.

22. The method of claim 20, further comprising comparing an antibody signature from one individual to the antibody signature from another individual.

23. The method of claim 22, wherein one individual has a disease process, and one individual is a healthy individual and the method allows comparison of the antibody signature in the healthy individual and the individual with a disease.

24. The method of claim 23, wherein the disease process comprises gastric cancer.

25. The method of claim 20, wherein the immobilized H. pylori antigens comprise one or more of HP1118/Ggt, HP0516/HslU, HP0243/NapA, HP1293/RpoA, HP0371/FabE, and HP0875/KatA.

26. A kit for determining and/or detecting at least one biomarker associated with gastric cancer, the kit comprising a reagent composition that comprises components for detecting in a biological sample the presence of one or more antibodies selected from anti -HP1118/Ggt, anti-HP0516/HslU, anti-HP0243/NapA, anti-HP1293/RpoA, anti-HP0371/FabE, and anti-HP0875/KatA.

27. A kit for diagnosing a gastric cancer in a subject, the kit comprising a reagent composition that comprises components for detecting in a biological sample obtained from the subject the presence of one or more antibodies selected from anti -HP1118/Ggt, anti-HP0516/HslU, anti-HP0243/NapA, anti-HP1293/RpoA, anti-HP0371/FabE, and anti-HP0875/KatA.