Formulations of antibody molecules to dengue virus
Inventors
HAY, Catherine • Sloan, Susan • Xu, Bi
Assignees
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Publication Number
US-11918651-B2
Publication Date
2024-03-05
Expiration Date
Abstract
Formulations of peptide agents, such as antibodies and antigen-binding fragments thereof, that bind dengue viruses, and methods of their use, are provided.
Core Innovation
The disclosure relates to an anti-dengue antibody formulation comprising an anti-dengue antibody molecule and defined pharmaceutical excipients. The formulation includes histidine, sodium chloride, arginine and/or sucrose, and polysorbate 80, and has a pH of 6 to 7.
The antibody molecule is defined by immunoglobulin variable region segments using Kabat numbering. The heavy chain variable region segment includes HC CDR1 DVYMS, HC CDR2 RIDPENGDTKYDPKLQG, and HC CDR3 GWEGFAY, and the light chain variable region segment includes LC CDR1 RASENVDKYGNSFMH, LC CDR2 RASELQW, and LC CDR3 QRSNEVPWT.
The disclosure further characterizes the formulation by a molecular species quality requirement, including that the level of high molecular weight species is less than 2% and, in another aspect, that 97% or more of the antibody molecules are present as monomers. The description also refers to analytical characterization of HMW and monomer levels and identifies use in treating and preventing dengue, with therapeutic, prophylactic, and diagnostic use described.
Claims Coverage
Two independent claims are identified. Both claims cover an anti-dengue antibody formulation with specified HC/LC CDR sequences, histidine, sodium chloride, arginine and/or sucrose, and polysorbate 80 at pH 6 to 7, together with quantitative antibody species requirements.
Anti-dengue antibody formulation with limited high molecular weight species
A formulation comprising 25 mg/mL of an anti-dengue antibody molecule, 25 mM histidine, 50 mM to 150 mM sodium chloride, 75 mM arginine and/or 100 mM sucrose, and polysorbate 80 at 0.02% w/v, having a pH of 6 to 7; wherein the antibody molecule comprises HC CDR1 DVYMS, HC CDR2 RIDPENGDTKYDPKLQG, HC CDR3 GWEGFAY, and LC CDR1 RASENVDKYGNSFMH, LC CDR2 RASELQW, LC CDR3 QRSNEVPWT as numbered according to the Kabat numbering system; wherein the level of high molecular weight species is less than 2%.
Anti-dengue antibody formulation with monomer requirement
A formulation comprising 25 mg/mL of an anti-dengue antibody molecule, 25 mM histidine, 50 mM to 150 mM sodium chloride, 75 mM arginine and/or 100 mM sucrose, and polysorbate 80 at 0.02% w/v, having a pH of 6 to 7; wherein the antibody molecule comprises HC CDR1 DVYMS, HC CDR2 RIDPENGDTKYDPKLQG, HC CDR3 GWEGFAY, and LC CDR1 RASENVDKYGNSFMH, LC CDR2 RASELQW, LC CDR3 QRSNEVPWT as numbered according to the Kabat numbering system; wherein 97% or more of the antibody molecules in the formulation are present as monomers.
The coverage centers on an anti-dengue antibody formulation defined by Kabat-numbered HC/LC CDR sequences and a specified excipient set at pH 6 to 7, with either an HMW species limit of less than 2% or a monomer content requirement of 97% or more.
Stated Advantages
Provides a formulation with a low level of high molecular weight species of the antibody molecule.
Provides a formulation in which 97% or more of the antibody molecules are present as monomers.
Documented Applications
Treating and preventing dengue.
Diagnostic detection of dengue, including associated kits/devices such as a container and an injection device.
Therapeutic use, prophylactic use, and diagnostic use for the anti-dengue antibody formulations.
An animal model and treatment/diagnosis context related to dengue.
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