Interferon beta antibodies and uses thereof
Inventors
Gulla, Stefano V. • Huard, Christine • Buhlmann, Janet Elizabeth • Almagro, Juan Carlos • KODANGATTIL, Sreekumar R. • Greenberg, Steven A. • LaVallie, Edward Roland • Bennett, Eric M. • Mosyak, Lidia • Hall, James Perry • Coyle, Anthony John
Assignees
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Publication Number
US-12448439-B2
Publication Date
2025-10-21
Expiration Date
Abstract
The invention relates to antibodies, or antigen-binding fragments thereof, that specifically binds to interferon beta (IFNβ). Such antibodies, or antigen-binding fragments thereof, are are useful for various therapeutic or diagnostic purposes.
Core Innovation
The invention relates to a method of treating a disease, disorder, or condition in which increased activity of IFNβ is pathogenic in a subject in need thereof. The method comprises administering a therapeutically effective amount of an antibody or antigen-binding fragment that specifically binds human IFNβ, defined by specific CDR-H1, CDR-H2, and CDR-H3 sequences and defined CDR-L1, CDR-L2, and CDR-L3 sequences, including multiple alternative light chain CDR sets.
The described antibody targets the IFNβ pathway by neutralizing increased IFNβ activity, and the document frames therapeutic effectiveness in the context of IFNβ/IFNAR/STAT1/STAT2 signaling. The described approach includes competitive binding concepts and assessment of binding inhibition or percent reduction, together with assay modalities such as ELISA and Biacore/SPR.
The invention is further supported by documented experimental characterization of an example antibody, CTI-AF1, including binding affinity measurements by SPR and functional neutralization assays assessing downstream pathway effects. The downstream functional effects described include inhibition in an ISRE luciferase reporter format and inhibition of STAT1 phosphorylation, together with epitope mapping, crystallographic/structural epitope residues, expression profiling showing neutralization of endogenous IFNβ-induced Mx1 across cell types, and translational PK/PD modeling for dermatomyositis.
Claims Coverage
The document includes one independent claim directed to a method of treating dermatomyositis (DM) where increased IFNβ activity is pathogenic, using a specifically defined anti-human IFNβ antibody (or antigen-binding fragment) characterized by specific CDR sequences.
Treating dermatomyositis by administering a therapeutically effective anti-IFNβ antibody defined by specific CDRs
A method of treating a disease, disorder, or condition in which increased activity of IFNβ is pathogenic, comprising administering to a subject a therapeutically effective amount of an antibody or antigen-binding fragment that specifically binds human IFNβ, wherein the antibody or antigen-binding fragment comprises the CDR-H1, CDR-H2, and CDR-H3 sequences of SEQ ID NO: 28 and one of multiple specified sets of CDR-L1, CDR-L2, and CDR-L3 sequences of SEQ ID NOs 2 through 27 and 1; wherein the disease is dermatomyositis (DM), or a pharmaceutical composition comprising the antibody or antigen-binding fragment.
Claim coverage is centered on a dermatomyositis treatment method using an anti-human IFNβ antibody defined by mandatory heavy-chain CDR sequences together with selectable alternative light-chain CDR sequence sets. The claim language ties the therapeutic use to treating a condition where increased IFNβ activity is pathogenic.
Stated Advantages
Provides a method of treating dermatomyositis (DM) where increased activity of IFNβ is pathogenic.
Documented Applications
Treatment of dermatomyositis (DM) where increased activity of IFNβ is pathogenic.
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