Serine protease inhibitor kazal (SPIK) compositions and methods
AssigneeImCare Biotech, LLC
InventorsXuanyong Lu, Felix Lu
Life of this patent
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Abstract
Anti-AS-SPIK antibodies are disclosed, along with methods of making such antibodies, compositions, including pharmaceutical compositions, comprising such antibodies, and their use to diagnose disorders characterized by the expression of AS-SPIK (e.g., liver cancer). Diagnostic methods and kits comprising the anti-AS-SPIK antibodies are also disclosed.
Claims14
An isolated anti-Abnormal Secreted Serine Protease Inhibitor Kazal (anti-AS-SPIK) antibody, or an antigen-binding fragment thereof, that specifically binds to Abnormal Secreted Serine Protease Inhibitor Kazal (AS-SPIK), and does not bind to Normal Secreted Serine Protease Inhibitor Kazal (NS-SPIK), comprising:
- (a) a CDRH1 sequence comprising SEQ ID NO:
- 15, a CDRH2 sequence comprising SEQ ID NO:
- 19, a CDRH3 sequence comprising SEQ ID NO:
- 23, a CDRL1 sequence comprising SEQ ID NO:
- 27, a CDRL2 sequence comprising SEQ ID NO:
- 31, and a CDRL3 sequence comprising SEQ ID NO:
- 35;
- or
- (b) a CDRH1 sequence comprising SEQ ID NO:
- 16, a CDRH2 sequence comprising SEQ ID NO:
- 20, a CDRH3 sequence comprising SEQ ID NO:
- 24, a CDRL1 sequence comprising SEQ ID NO:
- 28, a CDRL2 sequence comprising SEQ ID NO:
- 32, and a CDRL3 sequence comprising SEQ ID NO:
- 36;
- or
- (c) a CDRH1 sequence comprising SEQ ID NO:
- 17, a CDRH2 sequence comprising SEQ ID NO:
- 21, a CDRH3 sequence comprising SEQ ID NO:
- 25, a CDRL1 sequence comprising SEQ ID NO:
- 29, a CDRL2 sequence comprising SEQ ID NO:
- 33, and a CDRL3 sequence comprising SEQ ID NO:
- 37;
- or
- (d) a CDRH1 sequence comprising SEQ ID NO:
- 18, a CDRH2 sequence comprising SEQ ID NO:
- 22, a CDRH3 sequence comprising SEQ ID NO:
- 26, a CDRL1 sequence comprising SEQ ID NO:
- 30, a CDRL2 sequence comprising SEQ ID NO:
- 34, and a CDRL3 sequence comprising SEQ ID NO:
- 38.
A diagnostic method for determining whether a subject has hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or cirrhosis of the liver, the method comprising:
- (a) contacting a biological test sample from the subject with an anti-Abnormal Secreted Serine Protease Inhibitor Kazal (anti-AS-SPIK) antibody, or an antigen-binding fragment thereof, that specifically binds to AS-SPIK, and does not bind to Normal Secreted Serine Protease Inhibitor Kazal (NS-SPIK), to generate an AS-SPIK-antibody complex, wherein the anti-AS-SPIK antibody or antigen-binding fragment thereof comprises:
- (i) a CDRH1 sequence comprising SEQ ID NO:
- 15, a CDRH2 sequence comprising SEQ ID NO:
- 19, a CDRH3 sequence comprising SEQ ID NO:
- 23, a CDRL1 sequence comprising SEQ ID NO:
- 27, a CDRL2 sequence comprising SEQ ID NO:
- 31, and a CDRL3 sequence comprising SEQ ID NO:
- 35;
- or
- (ii) a CDRH1 sequence comprising SEQ ID NO:
- 16, a CDRH2 sequence comprising SEQ ID NO:
- 20, a CDRH3 sequence comprising SEQ ID NO:
- 24, a CDRL1 sequence comprising SEQ ID NO:
- 28, a CDRL2 sequence comprising SEQ ID NO:
- 32, and a CDRL3 sequence comprising SEQ ID NO:
- 36;
- or
- (iii) a CDRH1 sequence comprising SEQ ID NO:
- 17, a CDRH2 sequence comprising SEQ ID NO:
- 21, a CDRH3 sequence comprising SEQ ID NO:
- 25, a CDRL1 sequence comprising SEQ ID NO:
- 29, a CDRL2 sequence comprising SEQ ID NO:
- 33, and a CDRL3 sequence comprising SEQ ID NO:
- 37;
- or
- (iv) a CDRH1 sequence comprising SEQ ID NO:
- 18, a CDRH2 sequence comprising SEQ ID NO:
- 22, a CDRH3 sequence comprising SEQ ID NO:
- 26, a CDRL1 sequence comprising SEQ ID NO:
- 30, a CDRL2 sequence comprising SEQ ID NO:
- 34, and a CDRL3 sequence comprising SEQ ID NO:
- 38;
- (b) detecting a concentration of the AS-SPIK-antibody complex in the biological test sample;
- and
- (c) comparing the concentration of the AS-SPIK-antibody complex to a reference value to determine whether the subject has hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or cirrhosis of the liver.
A kit comprising an anti-Abnormal Secreted Serine Protease Inhibitor Kazal (anti-AS-SPIK) antibody, or an antigen-binding fragment thereof, that specifically binds to Abnormal Secreted Serine Protease Inhibitor Kazal (AS-SPIK), and does not bind to Normal Secreted Serine Protease Inhibitor Kazal (NS-SPIK), comprising:
- (a) a CDRH1 sequence comprising SEQ ID NO:
- 15, a CDRH2 sequence comprising SEQ ID NO:
- 19, a CDRH3 sequence comprising SEQ ID NO:
- 23, a CDRL1 sequence comprising SEQ ID NO:
- 27, a CDRL2 sequence comprising SEQ ID NO:
- 31, and a CDRL3 sequence comprising SEQ ID NO:
- 35;
- or
- (b) a CDRH1 sequence comprising SEQ ID NO:
- 16, a CDRH2 sequence comprising SEQ ID NO:
- 20, a CDRH3 sequence comprising SEQ ID NO:
- 24, a CDRL1 sequence comprising SEQ ID NO:
- 28, a CDRL2 sequence comprising SEQ ID NO:
- 32, and a CDRL3 sequence comprising SEQ ID NO:
- 36;
- or
- (c) a CDRH1 sequence comprising SEQ ID NO:
- 17, a CDRH2 sequence comprising SEQ ID NO:
- 21, a CDRH3 sequence comprising SEQ ID NO:
- 25, a CDRL1 sequence comprising SEQ ID NO:
- 29, a CDRL2 sequence comprising SEQ ID NO:
- 33, and a CDRL3 sequence comprising SEQ ID NO:
- 37;
- or
- (d) a CDRH1 sequence comprising SEQ ID NO:
- 18, a CDRH2 sequence comprising SEQ ID NO:
- 22, a CDRH3 sequence comprising SEQ ID NO:
- 26, a CDRL1 sequence comprising SEQ ID NO:
- 30, a CDRL2 sequence comprising SEQ ID NO:
- 34, and a CDRL3 sequence comprising SEQ ID NO:
- 38.
Dependencies are inferred from the claim text.