Antibodies and use thereof
Inventors
Tessier, Peter Matthew • Stimple, Samuel D. • Staby, Arne
Assignees
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Publication Number
US-12492249-B2
Publication Date
2025-12-09
Expiration Date
Abstract
The present invention relates to specific antibodies and use thereof, such as for identifying and/or quantifying liraglutide fibrils and/or semaglutide fibrils.
Core Innovation
The invention relates to fibril-specific antibodies that bind irreversibly formed liraglutide or semaglutide fibrils. The antibodies bind fibrils with greatly improved sensitivity compared to Thioflavin T (ThT), and provide specificity for fibrils over soluble or monomeric liraglutide or semaglutide.
A key aspect is that the binding is directed to liraglutide fibrils and semaglutide fibrils, while maintaining improved detection performance in the presence of soluble or monomeric drug. The disclosed approach supports detection in mixtures and includes very low detection limits for fibrils.
The document describes antibody formats and sequence-based variants, including an antibody or an antigen-binding fragment comprising specified heavy chain variable region CDR1, CDR2, and CDR3 sequences and specified light chain variable region CDR1, CDR2, and CDR3 sequences. The antibodies are implemented in workflows that identify and optionally quantify liraglutide fibrils by binding and detection, with supporting performance comparisons to ThT.
Claims Coverage
The provided claim material includes one independent claim focused on an antibody or antigen-binding fragment binding liraglutide fibrils, and dependent claims that refine sequence composition and method or assay coverage for selective detection with low-concentration sensitivity ranges.
Cdr sequence-defined antibody binding liraglutide fibrils
An antibody or an antigen-binding fragment comprising a heavy chain variable region with CDR1 of SEQ ID NO: 120, CDR2 of SEQ ID NO: 119, and CDR3 of SEQ ID NO: 118; and a light chain variable region with CDR1 of SEQ ID NO: 117, CDR2 of SEQ ID NO: 116, and CDR3 of SEQ ID NO: 115; wherein the antibody binds liraglutide fibrils.
Selective fibril detection with low-concentration sensitivity ranges
An assay that selectively detects liraglutide fibrils over soluble and or monomeric therapeutic peptides using the antibody or antigen-binding fragment, with sensitivity down to specified low fibril concentration ranges, including 1 to 10 ppm, 10 to 100 ppm, and 100 to 1000 ppm.
Sequence identity constrained variants relative to a specified SEQ ID
An antibody or an antigen-binding fragment whose sequence has about 80% to about 100% sequence identity to SEQ ID NO: 109.
Identification and optional quantification via antibody binding to fibrils
A method identifies and optionally quantifies liraglutide fibrils by binding an antibody or antigen-binding fragment to liraglutide and optionally detecting and or quantifying the antibody bound to the fibrils, optionally using a fibril standard.
Overall, the claim material covers a CDR sequence-defined antibody or antigen-binding fragment that binds liraglutide fibrils, selective fibril detection with explicit low-concentration sensitivity ranges, variants constrained by sequence identity relative to a specified SEQ ID, and identification and optional quantification methods based on antibody binding and optional detection or quantification with an optional fibril standard.
Stated Advantages
Greatly improved sensitivity compared to Thioflavin T (ThT).
Specificity for fibrils over soluble or monomeric liraglutide and semaglutide.
Detection of fibrils in mixtures at low fibril concentration ranges.
Documented Applications
Identification and optional quantification of liraglutide fibrils by antibody binding with optional detection or quantification, optionally using a fibril standard.
Assay workflows for selectively detecting liraglutide fibrils over soluble and or monomeric therapeutic peptides, including sensitivity down to specified low concentration ranges.
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