Dosing regimen for treating influenza virus diseases
Inventors
Kim, Sung Hyun • An, Hyun Chul • Lee, Sang Joon • LEE, Se Won • JEON, Da Bee
Assignees
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Publication Number
US-12157764-B2
Publication Date
2024-12-03
Expiration Date
Abstract
The present invention pertains to a dosing regimen for treating influenza virus diseases, and more specifically, to a method for treating influenza virus-related diseases through the administration of a mixed composition of monoclonal antibodies having a neutralizing activity against the influenza A virus. The treatment method according to the present invention enables influenza A virus-related diseases to be treated through the intravenous administration of a mixed composition of monoclonal antibodies having a neutralizing activity against the influenza A virus. In addition, the treatment method according to the present invention can satisfy unmet medical needs for biological therapeutic agents for influenza virus-related diseases.
Core Innovation
The disclosed subject matter relates to a method for treating influenza virus-related diseases by administering to a patient a composition comprising a mixture of two or more different anti-influenza virus antibodies or antigen-binding fragments thereof. The mixture is administered at a dose of 10 to 120 mg/kg, and the anti-influenza activity is defined by specific light chain variable regions and heavy chain variable regions. The light chain variable regions include CDR1, CDR2, and CDR3 regions assigned to SEQ ID NOs 1, 2, and 3 for one antibody set, and assigned to SEQ ID NOs 7, 8, and 9 for a second antibody set.
The heavy chain variable regions in the mixture include corresponding CDR1, CDR2, and CDR3 regions assigned to SEQ ID NOs 4, 5, and 6 for the first antibody set, and assigned to SEQ ID NOs 10, 11, and 12 for the second antibody set. The document further describes additional defined antibody components based on other SEQ ID NO sets that specify particular light chain variable regions and heavy chain variable regions within the mixture. In the described clinical study, CT-P27 is evaluated, with the composition indicated by CT-P22 and CT-P23 in a defined ratio.
The document describes use of the antibody mixture as part of a stable liquid pharmaceutical formulation suitable for intravenous administration, and includes clinical evaluation of efficacy and safety. The described efficacy outcomes include reduced time to relieve influenza symptoms and reduced time to relieve symptoms and fever, with fever threshold criteria including a temperature of less than 37.8°C. The document also presents safety and adverse event information and immunogenicity results, including ADA and Nab.
Claims Coverage
The provided independent claims cover 2 inventive features: a treatment method and a kit. Across the independent claims, the core inventive coverage is the use of a mixture of two or more anti-influenza antibodies or antigen-binding fragments defined by specific light and heavy chain CDR sequence assignments to particular SEQ ID NOs, administered at 10 to 120 mg/kg.
Treating influenza virus-related diseases with a defined antibody mixture at 10 to 120 mg/kg
A method comprising administering to a patient a composition comprising a mixture of two or more different anti-influenza virus antibodies or antigen-binding fragments thereof at a dose of 10 to 120 mg/kg, where the mixture comprises antibodies or antigen-binding fragments having specific light chain variable region CDR1/CDR2/CDR3 regions (SEQ ID NOs 1, 2, 3 and SEQ ID NOs 7, 8, 9) and specific heavy chain variable region CDR1/CDR2/CDR3 regions (SEQ ID NOs 4, 5, 6 and SEQ ID NOs 10, 11, 12).
Influenza antibody mixture kit with defined composition and 10 to 120 mg/kg instructions
A kit comprising a composition comprising a mixture of two or more different anti-influenza virus antibodies or antigen-binding fragments thereof and instructions for administering the mixture at a dose of 10 to 120 mg/kg to treat a patient with an influenza virus-related disease, where the mixture comprises antibodies or antigen-binding fragments having the specific light chain variable region CDR1/CDR2/CDR3 regions (SEQ ID NOs 1, 2, 3 and SEQ ID NOs 7, 8, 9) and specific heavy chain variable region CDR1/CDR2/CDR3 regions (SEQ ID NOs 4, 5, 6 and SEQ ID NOs 10, 11, 12).
Across both independent claims, the central claim coverage is the same defined antibody-mixture concept: two or more different anti-influenza virus antibodies or antigen-binding fragments in a mixture, characterized by particular light chain and heavy chain variable regions with CDR1/CDR2/CDR3 sequence assignments to SEQ ID NOs 1–12, administered or instructed for administration at 10 to 120 mg/kg to treat an influenza virus-related disease.
Stated Advantages
Reduced time to relieve influenza symptoms.
Reduced time to relieve symptoms and fever (<37.8°C).
Safety and adverse event evaluation is presented for the described treatment context.
Immunogenicity (ADA and Nab) evaluation is presented for the described treatment context.
Documented Applications
Clinical evaluation in a randomized double-blind multicenter phase 2b placebo-controlled trial for acute influenza A, using a liquid monoclonal antibody mixture (CT-P27) administered intravenously and assessed using symptom relief endpoints and fever thresholds.
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