Antibodies targeting pulmonary nodule specific biomarkers and uses thereof
Inventors
PESTANO, Gary A. • Meliert, Hestia
Assignees
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Publication Number
US-11542340-B1
Publication Date
2023-01-03
Expiration Date
Abstract
Provided are monoclonal antibodies, or antigen-binding fragments thereof, that bind to specific peptides of C163A or LG3BP, compositions comprising such antibodies and/or fragments, as well as methods of use and devices employing such antibodies and/or fragments.
Core Innovation
The invention provides monoclonal antibodies, or antigen-binding fragments thereof, that specifically bind pulmonary-nodule biomarkers C163A and LG3BP. The antibodies are defined by specific heavy chain complementarity determining regions and light chain complementarity determining regions, each given by amino acid sequences associated with SEQ ID NOs, and the binding specificities are tied to peptide or protein epitopes including INPASLDK for C163A and VEIFYR for LG3BP.
The disclosed embodiments include nucleotide sequences, vectors, and host cells related to producing the monoclonal antibodies or antigen-binding fragments. The disclosure also includes devices and kits that incorporate the monoclonal antibodies or antigen-binding fragments for diagnostic use, including formats that enable detection of C163A and LG3BP levels.
The invention is positioned for non-invasive lung nodule discrimination by classifying lung nodules as benign versus malignant based on detecting C163A and LG3BP levels in subject samples. The disclosure references performance-oriented lung-cancer risk modeling, including comparison and evaluation using sensitivity, specificity, negative predictive value, AUC, and ROC curve concepts.
Claims Coverage
The provided claim set includes two independent claims that define monoclonal antibodies, or antigen-binding fragments, by the amino acid sequences of their HC-CDRs and LC-CDRs, while dependent claims refine binding specificity to particular peptide or protein sequences and targets.
CDR-defined monoclonal antibody for C163A/INPASLDK
A monoclonal antibody, or antigen-binding fragment thereof, comprising HC-CDR1 GFTFSSYA, HC-CDR2 ISSSGSYT, HC-CDR3 ARQEGLWSFAY, LC-CDR1 QSLLDSDGKTY, LC-CDR2 LVS, and LC-CDR3 WQGTHFPWT.
CDR-defined monoclonal antibody for LG3BP/VEIFYR
A monoclonal antibody, or antigen-binding fragment thereof, comprising HC-CDR1 GYTFSSYW, HC-CDR2 INRSNGRT, HC-CDR3 TKWGVTSDY, LC-CDR1 SNVNY, LC-CDR2 DTS, and LC-CDR3 FQGSGYPRT.
Across the two independent claims, the core coverage is the definition of monoclonal antibodies, or antigen-binding fragments, by specific HC-CDR and LC-CDR amino acid sequences. Dependent claim refinement narrows binding specificity to INPASLDK for C163A and to VEIFYR for LG3BP, and further constrains variable regions, fragment format types, and selected structural features.
Stated Advantages
Supports non-invasive nodule discrimination by enabling classification of lung nodules as benign versus malignant based on detecting C163A and LG3BP levels.
Aims to reduce unnecessary invasive procedures for lung nodule evaluation.
Documented Applications
Diagnostic use for detecting C163A and LG3BP levels in subject samples to classify lung nodules as benign versus malignant (lung cancer).
Use with immunoassays and immunodetection formats including ELISA, RIA, immunohistochemistry, and Western blot.
Use with intracellular flow assay options.
Use with mass spectrometry selected reaction monitoring (LC-SRM-MS).
Use with blood-based multiplex/proteomic classifier concepts.
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