Anti-influenza neuraminidase monoclonal antibodies and uses thereof
Inventors
Kobie, James J. • Martinez-Sobrido, Luis • Piepenbrink, Michael • Nogales, Aitor
Assignees
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Publication Number
US-12421301-B2
Publication Date
2025-09-23
Expiration Date
Abstract
The present invention relates to broadly neutralizing anti-influenza monoclonal antibodies or antigen-binding fragments thereof. The present invention further relates to therapeutic uses of the isolated antibody or the antigen-binding fragment thereof.
Core Innovation
The invention provides neutralizing anti-influenza neuraminidase (NA) monoclonal antibodies and antigen-binding fragments that specifically bind to a neuraminidase of influenza virus. The antibodies include a heavy chain variable region comprising HCDR1, HCDR2, and HCDR3, and a light chain variable region comprising LCDR1, LCDR2, and LCDR3, where the respective CDRs comprise the sequences of specified SEQ ID NOs.
The antibodies are defined by variable-region sequence sets that include SEQ ID NOs: 43-45 for HCDR1, HCDR2, and HCDR3 and SEQ ID NOs: 46-48 for LCDR1, LCDR2, and LCDR3. The disclosed antibody embodiments also include alternatives with other specified variable-region sequence identities, and structural variants such as a variant Fc constant region.
The invention further includes embodiments in which the antibody is presented in multiple therapeutic formats, including antibody conjugates and Fc variants, and pharmaceutical compositions for treating, preventing, or controlling influenza infection by neutralizing influenza virus. The disclosed embodiments are supported by evidence that vaccine-induced NA-specific monoclonal antibodies bind NA across influenza B lineages, inhibit NA enzymatic activity, neutralize influenza B, including oseltamivir-resistant NA mutants, and provide prophylactic and therapeutic protection in mouse models.
Claims Coverage
The independent claim(s) cover broadly neutralizing influenza neuraminidase-binding isolated antibodies or antigen-binding fragments defined by specific heavy-chain and light-chain CDR sequence identities.
Neuraminidase-binding antibody with specified heavy- and light-chain CDR sequences
An isolated antibody or antigen-binding fragment thereof that specifically binds to a neuraminidase of influenza virus, comprising a heavy chain variable region with HCDR1, HCDR2, and HCDR3 comprising the respective sequences of SEQ ID NOs 43-45, and a light chain variable region with LCDR1, LCDR2, and LCDR3 comprising the respective sequences of SEQ ID NOs 46-48.
The core inventive scope is the isolated antibody or antigen-binding fragment that specifically binds influenza virus neuraminidase, with variable regions defined by specified HCDR and LCDR sequences, and the claim set further refines this scope through specified alternative CDR/variable-region sequences and Fc- and format-related refinements as stated in the dependent claims.
Stated Advantages
Neutralizes influenza virus by inhibiting NA enzymatic activity.
Provides prophylactic and therapeutic protection against influenza infection in mouse models.
Binds NA across influenza B lineages.
Neutralizes influenza B neuraminidase, including oseltamivir-resistant NA mutants.
Documented Applications
Medical use of an antibody or antigen-binding fragment to neutralize an influenza virus in a subject by administering a therapeutically effective amount.
Treating, preventing, or controlling influenza infection by neutralizing influenza virus.
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