Capture antibody and detection antibody binding MMP9 protein
Inventors
Rigau Resina, Marina • COLÁS ORTEGA, Eva • De Martí Villalva, Maria
Assignees
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Publication Number
US-12510542-B1
Publication Date
2025-12-30
Expiration Date
Abstract
Disclosed herein are antibodies binding to MMP9 protein, and use thereof for detecting or diagnosing endometrial cancer, preferably in a gynecological fluid, preferably uterine or cervical fluids.
Core Innovation
The invention relates to an immunoassay test device or kit comprising a capture antibody that specifically binds an epitope of the MMP9 protein and a detection antibody that specifically binds an epitope of the MMP9 protein. The capture antibody includes a light chain variable region (VL) comprising LCDR1, LCDR2, and LCDR3, and a heavy chain variable region (VH) comprising HCDR1, HCDR2, and HCDR3, with the capture antibody defined by specified LCDR and HCDR sequences.
The disclosed capture/detector pair is exemplified by capture antibody 3C2 #8 (MMP9_3C2 #8) and detector antibody 7E10 #18 (MMP9_7E10 #18) for use in a sandwich immunoassay. The disclosed capture epitope is defined by SEQ ID NO:1 with a stated ≥95% identity threshold, and the antibody examples provide CDR sequences with SEQ ID numbers, including conservative amino acid substitutions in CDRs.
The immunoassay is described as a solid-support sandwich format suitable for diagnostic/prognostic use for endometrial cancer in gynecological fluids, including uterine fluid/uterine aspirate and cervical fluid/cervical secretions. Detection and readout are described in the context of ELISA development using Streptavidin-HRP and TMB, with the reported diagnostic performance based on a cohort of 210 uterine fluid samples (93 benign and 117 endometrial cancer) yielding an ROC AUC of 0.82.
Claims Coverage
The partial content includes three independent claims covering a sandwich immunoassay test device or kit with a specified MMP9 capture antibody, a detection antibody, and a solid support, plus two isolated antibody definitions with specified CDRs. Overall, the inventive coverage centers on the MMP9-specific capture antibody CDR sequence definitions and the combination with a detection antibody in a solid-support immunoassay format, plus two alternative isolated antibody CDR sets.
MMP9 capture antibody defined by VL/VH CDR SEQ ID numbers with a solid support and a detection antibody
An immunoassay test device or kit comprising a capture antibody that specifically binds an epitope of the MMP9 protein, where the antibody comprises a light chain variable region (VL) with LCDR1, LCDR2, and LCDR3 and a heavy chain variable region (VH) with HCDR1, HCDR2, and HCDR3, wherein LCDR1 is SEQ ID NO: 2, LCDR2 is SEQ ID NO: 3, LCDR3 is SEQ ID NO: 4, HCDR1 is SEQ ID NO: 5, HCDR2 is SEQ ID NO: 6, and HCDR3 is SEQ ID NO: 7; a detection antibody that specifically binds an epitope of the MMP9 protein; and a solid support.
Isolated MMP9-binding antibody defined by VL/VH CDR SEQ ID numbers
An isolated antibody that specifically binds an epitope of the MMP9 protein, the isolated antibody comprising a light chain variable region (VL) comprising LCDR1, LCDR2, and LCDR3 and a heavy chain variable region (VH) comprising HCDR1, HCDR2, and HCDR3, wherein LCDR1 is SEQ ID NO: 2, LCDR2 is SEQ ID NO: 3, LCDR3 is SEQ ID NO: 4, HCDR1 is SEQ ID NO: 5, HCDR2 is SEQ ID NO: 6, and HCDR3 is SEQ ID NO: 7.
Isolated MMP9-binding antibody defined by an alternative VL/VH CDR SEQ ID numbers set
An isolated antibody that specifically binds an epitope of the MMP9 protein, the isolated antibody comprising a light chain variable region (VL) comprising LCDR1, LCDR2, and LCDR3 and a heavy chain variable region (VH) comprising HCDR1, HCDR2, and HCDR3, wherein LCDR1 is SEQ ID NO: 8, LCDR2 is SEQ ID NO: 9, LCDR3 is SEQ ID NO: 10, HCDR1 is SEQ ID NO: 11, HCDR2 is SEQ ID NO: 12, and HCDR3 is SEQ ID NO: 13.
The independent claims provide coverage for a sandwich immunoassay test device or kit using a defined MMP9 capture antibody CDR sequence set in combination with an MMP9 detection antibody and a solid support, and for isolated MMP9-binding antibodies defined by specified VL/VH CDR sequence sets, including an alternative CDR SEQ ID number set.
Stated Advantages
Reported diagnostic performance with ROC AUC 0.82 on a uterine fluid cohort (93 benign, 117 endometrial cancer).
Documented Applications
Diagnostic/prognostic use of an MMP9 sandwich immunoassay for endometrial cancer in gynecological fluids including uterine fluid/uterine aspirate and cervical fluid/cervical secretions.
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