US2016291025A1PendingUtilityA1

Autoantibody biomarkers of ovarian cancer

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Assignee: Adelaide res & innovation pty ltdPriority: Sep 18, 2013Filed: Sep 18, 2014Published: Oct 6, 2016
Est. expirySep 18, 2033(~7.1 yrs left)· nominal 20-yr term from priority
Inventors:Peter HoffmannMartin OehlerKarina Martin
G01N 33/57545C07K 16/3069G01N 33/564G01N 2500/00G01N 33/6854G01N 33/57449
57
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Claims

Abstract

The present invention relates to the identification of biological markers of ovarian cancer. Specifically, cancer-associated autoantibodies to ANXA1, ARP3, SAHH, SERPH, ARAP1, OTUB1, ATP1A1, UBA1, and CFAH have been identified in subjects with early stage ovarian cancer. These autoantibodies can be utilised for a range of purposes including methods for detecting ovarian cancer, methods for screening for early stage ovarian cancer, and methods for assessing treatment response as well as disease progression and recurrence. The autoantibodies also represent prognostic markers of ovarian cancer development.

Claims

exact text as granted — not AI-modified
1 . A method of detecting ovarian cancer in a subject, of screening for early stage ovarian cancer in a subject, or of assessing progression or recurrence of ovarian cancer in a subject, the method including the step of detecting the presence of one or more ovarian cancer-associated autoantibodies in the subject, wherein the one or more ovarian cancer-associated autoantibodies are selected from the group consisting of an autoantibody to ANXA1, an autoantibody to ARP3, an autoantibody to SAHH, an autoantibody to SERPH, an autoantibody to ARAP1, an autoantibody to OTUB1, an autoantibody to ATP1A1, an autoantibody to UBA1, and an autoantibody to CFAH. 
     
     
         2 . The method according to  claim 1 , wherein the presence of the one or more ovarian cancer-associated autoantibodies is detected in a sample obtained from the subject, wherein the sample is selected from any one or more of the group consisting of serum, whole blood, blood plasma, saliva, buccal swab, cervical pap smears, stool, urine, bladder washing, uterine washing, sputum, lymphatic fluid, cerebrospinal fluid, semen, and a tissue sample from one or both ovaries or metastatic tumour tissue of the subject. 
     
     
         3 . (canceled) 
     
     
         4 . The method according to  claim 1 , wherein the presence of the one or more ovarian cancer-associated autoantibodies is detected by an agent that binds to, or interacts with, the one or more ovarian cancer-associated autoantibodies. 
     
     
         5 . The method according to  claim 4 , wherein the agent is an antigen from which the one or more ovarian cancer-associated autoantibodies was derived or is an antibody specific for the one or more ovarian cancer-associated autoantibodies. 
     
     
         6 . (canceled) 
     
     
         7 . The method according to  claim 1 , wherein the presence of an autoantibody to ANXA1, an autoantibody to ARP3, and an autoantibody to SAHH is detected. 
     
     
         8 . The method according to  claim 7 , further comprising detecting the presence of an autoantibody to SERPH, or detecting the presence of tumour associated antigen CA125. 
     
     
         9 - 12 . (canceled) 
     
     
         13 . The method according to  claim 1 , wherein the early stage ovarian cancer is stage I carcinoma. 
     
     
         14 - 20 . (canceled) 
     
     
         21 . The method according to  claim 1 , wherein assessing progression or recurrence of ovarian cancer in the subject comprises:
 (a) detecting the level of the one or more ovarian cancer-associated autoantibodies in the subject;   (b) comparing the level of the one or more ovarian cancer-associated autoantibodies in the subject to a reference level for the or each ovarian cancer-associated autoantibody; and   (c) assessing the progression or recurrence of ovarian cancer in the subject on the basis of the comparison.   
     
     
         22 - 27 . (canceled) 
     
     
         28 . The method according to  claim 21 , wherein a level of the one or more ovarian cancer-associated autoantibodies in the subject that is higher than the reference level for the, or each, ovarian cancer-associated autoantibody is indicative of the progression or recurrence of ovarian cancer in the subject. 
     
     
         29 - 31 . (canceled) 
     
     
         32 . A method of screening a candidate therapeutic agent useful for treating ovarian cancer in a subject, the method including the step of assaying the candidate therapeutic agent for activity in reducing a level of one or more ovarian cancer-associated autoantibodies in the subject, wherein the one or more ovarian cancer-associated autoantibodies are selected from the group consisting of an autoantibody to ANXA1, an autoantibody to ARP3, an autoantibody to SAHH, an autoantibody to SERPH, an autoantibody to ARAP1, an autoantibody to OTUB1, an autoantibody to ATP1A1, an autoantibody to UBA1, and an autoantibody to CFAH. 
     
     
         33 . The method according to  claim 32 , the method including:
 (a) administering the candidate therapeutic agent to the subject;   (b) detecting the level of the one or more ovarian cancer-associated autoantibodies in the subject; and   (c) comparing the level of the one or more ovarian cancer-associated autoantibodies in the subject to the level of the one or more ovarian cancer-associated autoantibodies in an untreated subject having ovarian cancer,   wherein if the level of the one or more ovarian cancer-associated autoantibodies in the subject is lower than the level of the one or more ovarian cancer-associated autoantibodies in the untreated subject, the candidate therapeutic agent is useful for treating ovarian cancer.   
     
     
         34 . The method according to  claim 32 , wherein the level of the one or more ovarian cancer-associated autoantibodies is detected in a sample obtained from the subject, wherein the sample is selected from any one or more of the group consisting of serum, whole blood, blood plasma, saliva, buccal swab, cervical pap smears, stool, urine, bladder washing, uterine washing sputum, lymphatic fluid, cerebrospinal fluid, semen, and a tissue sample from one or both ovaries or metastatic tumour tissue of the subject. 
     
     
         35 . (canceled) 
     
     
         36 . The method according to  claim 32 , wherein the level of the one or more ovarian cancer-associated autoantibodies in the subject is detected by an agent that binds to, or interacts with, the one or more ovarian cancer-associated autoantibodies. 
     
     
         37 . The method according to  claim 36 , wherein the agent is an antigen from which the one or more ovarian cancer-associated autoantibodies was derived or is an antibody specific for the one or more ovarian cancer-associated autoantibodies. 
     
     
         38 . (canceled) 
     
     
         39 . The method according to  claim 32 , wherein the level of an autoantibody to ANXA1, an autoantibody to ARP3, and an autoantibody to SAHH is detected in the subject. 
     
     
         40 . The method according to  claim 39 , further comprising detecting the level of an autoantibody to SERPH, or detecting the level of tumour associated antigen CA125. 
     
     
         41 . (canceled) 
     
     
         42 . A composition for detecting ovarian cancer in a subject, for screening for early stage ovarian cancer in a subject and/or for assessing progression of ovarian cancer in a subject, the composition including an agent that binds to, or interacts with, one or more ovarian cancer-associated autoantibodies in the subject, wherein the one or more ovarian cancer-associated autoantibodies are selected from the group consisting of an autoantibody to ANXA1, an autoantibody to ARP3, an autoantibody to SAHH, an autoantibody to SERPH, an autoantibody to ARAP1, an autoantibody to OTUB1, an autoantibody to ATP1A1, an autoantibody to UBA1, and an autoantibody to CFAH. 
     
     
         43 . The composition according to  claim 42 , wherein the agent is an antigen from which the one or more ovarian cancer-associated autoantibodies was derived or is an antibody specific for the one or more ovarian cancer-associated autoantibodies. 
     
     
         44 . (canceled) 
     
     
         45 . The composition according to  claim 42 , wherein the composition comprises: an autoantibody to ANXA1, an autoantibody to ARP3, and an autoantibody to SAHH; and optionally an autoantibody to SERPH, and/or an agent that binds to, or interacts with tumour associated antigen CA125. 
     
     
         46 - 47 . (canceled) 
     
     
         48 . A kit for detecting ovarian cancer in a subject, for screening for early stage ovarian cancer in a subject, and/or for assessing progression of ovarian cancer in a subject, the kit including means for detecting the presence of one or more ovarian cancer-associated autoantibodies in the subject, wherein the one or more ovarian cancer-associated autoantibodies are selected from the group consisting of an autoantibody to ANXA1, an autoantibody to ARP3, an autoantibody to SAHH, an autoantibody to SERPH, an autoantibody to ARAP1, an autoantibody to OTUB1, an autoantibody to ATP1A1, an autoantibody to UBA1, and an autoantibody to CFAH. 
     
     
         49 . (canceled)

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