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Publication Number
US-10047150-B2
Publication Date
2018-08-14
Expiration Date
Abstract
Antibodies and antigen binding fragments that bind to neublastin polypeptides are disclosed. Also disclosed are methods of using the antibodies and antigen binding fragments in assays for detecting the presence or amount of endogenous and/or exogenous neublastin in a sample and in methods of antagonizing neublastin bioactivity.
Core Innovation
The invention provides anti-neublastin (artemin/enovin) monoclonal antibodies and antigen-binding fragments that selectively bind the polypeptide of SEQ ID NO:1. The antibodies are produced by hybridoma deposited at ATCC under Accession No. PTA-7624 or PTA-7625, and include hybridoma-derived antibodies such as P1H1.G7 and P3B3.6.
The invention further provides immunoassays in which the disclosed antibodies are used to detect endogenous and/or exogenous neublastin in samples. The disclosure describes sandwich and competition formats, with solid-phase and solution/FRET immunoassay concepts and detection approaches, and reports antibody performance examples including P3B3 for exogenous-only sensitivity and P1H1 for both exogenous and endogenous sensitivity.
In addition to binding, the invention describes functional antagonism in which the antibodies inhibit neublastin-mediated RET activation, including neublastin-mediated RET autophosphorylation. This antagonism supports therapeutic uses, including treating cancers by reducing neublastin bioactivity, with context including pharmaceutical composition embodiments for treatment.
Claims Coverage
The independent claim coverage centers on one core antibody concept: an isolated monoclonal antibody, or antigen-binding fragment thereof, that selectively binds the polypeptide of SEQ ID NO:1 and is produced by a specific ATCC-deposited hybridoma (PTA-7624 or PTA-7625). Dependent claims extend coverage to antigen-binding fragment formats, labeled conjugates, pharmaceutical compositions, and assay methods for determining neublastin presence and/or amount in a sample.
Isolated antibody or antigen-binding fragment from ATCC-deposited hybridoma
An isolated monoclonal antibody, or antigen-binding fragment thereof, that selectively binds to the polypeptide of SEQ ID NO:1 and is produced by the hybridoma deposited in the ATCC under Accession No. PTA-7624 or PTA-7625.
Antigen-binding fragment format limitations
An antigen-binding fragment limited to specified immunoglobulin fragment types, including Fab, F(ab’)2, Fab’, Fsc, or Fv fragment variants.
Detectable label conjugate using enzyme labels
A conjugate embodiment with a detectable label selected from horseradish peroxidase or alkaline phosphatase.
Pharmaceutical composition with pharmaceutically acceptable carrier
A pharmaceutical composition including the antibody, or an antigen-binding fragment thereof, together with a pharmaceutically acceptable carrier.
Assay for determining neublastin presence and/or amount via binding detection
A method that determines whether and/or how much a neublastin polypeptide is present in a sample by contacting the sample with the specified antibody, or antigen-binding fragment, and detecting how much of that antibody or fragment binds to the neublastin polypeptide.
Two-antibody detection scheme for neublastin detection
A method further contacting a sample with a second antibody, or antigen-binding fragment, that selectively binds to the polypeptide of SEQ ID NO:1, followed by detecting the presence or amount of the second antibody or fragment bound to the neublastin polypeptide.
Overall, the claims focus on SEQ ID NO:1-selective anti-neublastin antibodies produced by specific ATCC-deposited hybridomas, with dependent coverage extending to defined antigen-binding fragment embodiments, detectable labeled conjugates, pharmaceutical compositions, and assay methods that determine neublastin presence or amount using single- and two-antibody detection approaches.
Stated Advantages
Inhibits neublastin-mediated RET activation, including neublastin-mediated RET autophosphorylation.
Supports therapeutic use by reducing neublastin bioactivity for treating cancers.
Enables detection of endogenous and/or exogenous neublastin in samples using immunoassays.
Documented Applications
Detecting endogenous and/or exogenous neublastin in samples using immunoassays, including sandwich and competition concepts and solid-phase or solution/FRET concepts.
Therapeutic treatment context for cancers by reducing neublastin bioactivity, including pharmaceutical composition embodiments.
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