Human hendra virus and nipah virus antibodies and methods of use therefor

Inventors

Crowe, Jr., James E.

Assignees

Vanderbilt University

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Publication Number

US-12559545-B2

Patent

Publication Date

2026-02-24

Expiration Date


Abstract

The present disclosure is directed to antibodies binding to and neutralizing henipavirus and methods for use thereof. Thus, in accordance with the present disclosure, there is provided a method of detecting a henipavirus infection in a subject comprising (a) contacting a sample from said subject with an antibody or antibody fragment having clone-paired heavy and light chain CDR sequences from Tables 3 and 4, respectively; and (b) detecting henipavirus in said sample by binding of said antibody or antibody fragment to a henipavirus antigen in said sample.

Core Innovation

The disclosure relates to human henipavirus antibodies for Hendra virus and Nipah virus, including antibodies and antibody fragments comprising heavy and light chain Complementarity Determining Regions 1-3 selected from specified SEQ ID NOS. The antibodies are provided as clone-paired heavy and light CDR antibodies, with variable-region identity variants defined by the disclosed sequence sets.

The disclosure specifies selectable antibody formats including IgG, recombinant IgG, and antibody fragments, including scFv, Fab, F(ab')2, and Fv. It further characterizes antibody attributes including Fc portion engineering and glycoengineering to alter FcR interactions and half-life and/or therapeutic efficacy.

The disclosure states that the antibodies can be used for diagnostic detection by detecting binding to henipavirus antigens. It also states that the same antibodies are used for therapeutic and prophylactic treatment by delivering the antibodies to infected subjects or subjects at risk of contracting henipavirus, and it references structural and functional characterization including receptor-blocking and competition/neutralization-related data.

The disclosed embodiments also include determining antigen integrity, conformation, and sequence in vaccine production and antigenic stability assays using the antibodies. Delivery is described as possible by direct administration or by genetic delivery using RNA, DNA, or vector.

Claims Coverage

The independent claims cover four groups: treatment or reduction of infection likelihood, monoclonal antibody or fragment molecules with Fc or glycan engineering, expression by hybridoma or engineered cell, and vaccine formulation comprising the specified antibodies or fragments. The core coverage centers on antibodies or fragments with heavy- and light-chain CDR1-3 selected from enumerated SEQ ID NOS pairs, with additional claims for IgG/FcR interaction engineering and expression or formulation context.

Cdr1-3 selected antibody delivery for treatment or infection-likelihood reduction

Delivering to a subject infected with henipavirus, or reducing the likelihood of infection of a subject at risk, an antibody or antibody fragment comprising heavy and light chain CDR1-3 selected from the enumerated pairs of SEQ ID NOS for the heavy and light chains.

Engineered IgG fc or glycan modified for FcR interaction tuning

Providing a monoclonal antibody or antibody fragment with heavy and light chain CDR1-3 selected from the enumerated SEQ ID NOS pairs, where the antibody is an IgG or a recombinant IgG antibody or antibody fragment comprising an Fc portion mutated to eliminate or enhance FcR interactions to increase half-life and/or increase therapeutic efficacy, or glycan modified to eliminate or enhance FcR interactions.

Hybridoma or engineered cell expressing CDR1-3 selected antibody

Providing a hybridoma or engineered cell expressing an antibody or antibody fragment comprising heavy and light chain CDR1-3 selected from the enumerated SEQ ID NOS pairs.

Vaccine formulation including CDR1-3 selected antibodies or fragments

Providing a vaccine formulation comprising one or more antibodies or antibody fragments comprising heavy and light chain CDR1-3 of the enumerated SEQ ID NOS pairs.

The independent claims are grounded in antibodies or fragments defined by heavy- and light-chain CDR1-3 selected from enumerated SEQ ID NOS pairs, with added claim coverage for IgG/FcR interaction engineering and glycan modification, for expression by hybridoma or engineered cells, and for inclusion in vaccine formulations.

Stated Advantages

Increase half-life

Increase therapeutic efficacy

Eliminate or enhance FcR interactions

Documented Applications

Diagnostic detection by contacting subject samples with clone-paired heavy/light CDR antibodies and detecting binding to henipavirus antigens.

Therapeutic treatment by delivering the antibodies to a subject infected with henipavirus.

Prophylactic treatment by reducing the likelihood of infection of a subject at risk of contracting henipavirus.

Vaccine production and antigenic stability assays involving antigen integrity, conformation, and sequence determination using the antibodies.

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