AU2019312139B2 - Compositions of FcRn antibodies and methods of use thereof - Google Patents

Compositions of FcRn antibodies and methods of use thereof Download PDF

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Publication number
AU2019312139B2
AU2019312139B2 AU2019312139A AU2019312139A AU2019312139B2 AU 2019312139 B2 AU2019312139 B2 AU 2019312139B2 AU 2019312139 A AU2019312139 A AU 2019312139A AU 2019312139 A AU2019312139 A AU 2019312139A AU 2019312139 B2 AU2019312139 B2 AU 2019312139B2
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AU
Australia
Prior art keywords
formulations
antibody
pharmaceutical composition
lot
trehalose
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AU2019312139A
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English (en)
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AU2019312139A1 (en
Inventor
Siddhesh PATIL
Narinder Singh
Gregory St. Louis
Eva WILLIAMS
Zhongli ZHANG
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Momenta Pharmaceuticals Inc
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Momenta Pharmaceuticals Inc
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Publication of AU2019312139A1 publication Critical patent/AU2019312139A1/en
Assigned to MOMENTA PHARMACEUTICALS, INC. reassignment MOMENTA PHARMACEUTICALS, INC. Request for Assignment Assignors: MOMENTA PHARMACEUTICALS, INC., ST. LOUIS, GREGORY, ZHANG, Zhongli
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Publication of AU2019312139B2 publication Critical patent/AU2019312139B2/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/283—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
AU2019312139A 2018-07-20 2019-07-19 Compositions of FcRn antibodies and methods of use thereof Active AU2019312139B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862701467P 2018-07-20 2018-07-20
US62/701,467 2018-07-20
PCT/US2019/042597 WO2020023310A1 (en) 2018-07-20 2019-07-19 Compositions of fcrn antibodies and methods of use thereof

Publications (2)

Publication Number Publication Date
AU2019312139A1 AU2019312139A1 (en) 2021-02-04
AU2019312139B2 true AU2019312139B2 (en) 2025-02-06

Family

ID=69180697

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019312139A Active AU2019312139B2 (en) 2018-07-20 2019-07-19 Compositions of FcRn antibodies and methods of use thereof

Country Status (16)

Country Link
US (1) US20210299255A1 (enExample)
EP (1) EP3826641A4 (enExample)
JP (1) JP7457704B2 (enExample)
KR (1) KR20210105872A (enExample)
CN (1) CN113301903A (enExample)
AU (1) AU2019312139B2 (enExample)
BR (1) BR112021001017A2 (enExample)
CA (1) CA3106669A1 (enExample)
CR (1) CR20210088A (enExample)
EA (1) EA202190335A1 (enExample)
IL (1) IL280280B2 (enExample)
JO (2) JOP20210015A1 (enExample)
MX (1) MX2021000790A (enExample)
PH (1) PH12021550096A1 (enExample)
SG (1) SG11202100420UA (enExample)
WO (1) WO2020023310A1 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6853178B2 (ja) 2015-01-30 2021-03-31 モメンタ ファーマシューティカルズ インコーポレイテッド ＦｃＲｎ抗体およびその使用方法
BR112019001806A2 (pt) 2016-07-29 2019-05-07 Momenta Pharmaceuticals, Inc. anticorpos para fcrn e métodos de uso dos mesmos
BR112020011310A2 (pt) 2017-12-13 2020-11-17 Momenta Pharmaceuticals, Inc. anticorpos contra fcrn e seus métodos de uso
EA202190264A1 (ru) 2018-07-20 2021-05-20 Момента Фармасьютикалз, Инк. КОМПОЗИЦИИ АНТИТЕЛ ПРОТИВ FcRn
CN116782939A (zh) * 2020-11-06 2023-09-19 动量制药公司 FcRn抗体及其使用方法
CA3200972A1 (en) * 2020-11-06 2022-05-12 Momenta Pharmaceuticals, Inc. Fcrn antibodies and methods of use thereof
MX2023012032A (es) * 2021-04-12 2023-12-08 Momenta Pharmaceuticals Inc Composiciones y métodos para tratar la miastenia gravis pediátrica.
EP4658368A1 (en) 2023-02-04 2025-12-10 Momenta Pharmaceuticals, Inc. Compositions and methods for treating hemolytic disease of the fetus and newborn
CN116539488B (zh) * 2023-05-11 2023-11-24 中国食品药品检定研究院 一种体外评价生物制品稳定性的方法、系统及设备
TW202527982A (zh) * 2023-09-11 2025-07-16 美商默門塔醫藥公司 Fcrn抗體之醫藥組成物
WO2025163617A1 (en) 2024-02-04 2025-08-07 Momenta Pharmaceuticals, Inc. Compositions and methods for treating sjögren's disease
WO2025186787A1 (en) 2024-03-08 2025-09-12 Momenta Pharmaceuticals, Inc. Compositions and methods for treating fetal and neonatal alloimmune thrombocytopenia
WO2025259928A1 (en) * 2024-06-13 2025-12-18 Obi Pharma, Inc. Improved trop2 conjugated biological molecules, pharmaceutical compositions and applications thereof
WO2026083290A1 (en) 2024-10-16 2026-04-23 Momenta Pharmaceuticals, Inc. Compositions and methods for treating sjögren's disease

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017015622A2 (en) * 2015-07-22 2017-01-26 Scholar Rock, Inc Gdf11 binding proteins and uses thereof
WO2018023136A1 (en) * 2016-07-29 2018-02-01 Momenta Pharmaceuticals, Inc. Fcrn antibodies and methods of use thereof

Family Cites Families (11)

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JPH03504499A (ja) * 1988-05-27 1991-10-03 セントカー・インコーポレーテツド 抗体試薬のための配合物
US20030138417A1 (en) * 2001-11-08 2003-07-24 Kaisheva Elizabet A. Stable liquid pharmaceutical formulation of IgG antibodies
WO2003068260A1 (fr) * 2002-02-14 2003-08-21 Chugai Seiyaku Kabushiki Kaisha Produits pharmaceutiques en solution contenant des anticorps
EP1865986B1 (en) * 2005-03-08 2016-02-17 Pfizer Products Inc. Anti-ctla-4 antibody compositions
EP2225269A2 (en) * 2007-11-09 2010-09-08 Anaphore, Inc. Fusion proteins of mannose binding lectins for treatment of disease
WO2009124294A2 (en) 2008-04-05 2009-10-08 Lpath, Inc. Pharmaceutical compositions for binding sphingosine-1-phosphate
WO2010056804A1 (en) 2008-11-12 2010-05-20 Medimmune, Llc Antibody formulation
US20130323242A1 (en) * 2012-06-01 2013-12-05 Ophthotech Corp. Compositions comprising an anti-pdgf aptamer and a vegf antagonist
US9844594B2 (en) * 2012-12-18 2017-12-19 Merck Sharp & Dohme Corp. Liquid formulations for an anti-TNF α antibody
EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
JP6853178B2 (ja) * 2015-01-30 2021-03-31 モメンタ ファーマシューティカルズ インコーポレイテッド ＦｃＲｎ抗体およびその使用方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017015622A2 (en) * 2015-07-22 2017-01-26 Scholar Rock, Inc Gdf11 binding proteins and uses thereof
WO2018023136A1 (en) * 2016-07-29 2018-02-01 Momenta Pharmaceuticals, Inc. Fcrn antibodies and methods of use thereof

Also Published As

Publication number Publication date
PH12021550096A1 (en) 2022-03-28
JOP20210014A1 (ar) 2021-01-19
KR20210105872A (ko) 2021-08-27
CA3106669A1 (en) 2020-01-30
WO2020023310A1 (en) 2020-01-30
JP7457704B2 (ja) 2024-03-28
US20210299255A1 (en) 2021-09-30
MX2021000790A (es) 2021-07-21
SG11202100420UA (en) 2021-02-25
EP3826641A1 (en) 2021-06-02
BR112021001017A2 (pt) 2021-05-04
EP3826641A4 (en) 2022-04-20
JOP20210015A1 (ar) 2021-01-19
AU2019312139A1 (en) 2021-02-04
JP2021531346A (ja) 2021-11-18
IL280280B2 (en) 2024-11-01
IL280280A (en) 2021-03-25
IL280280B1 (en) 2024-07-01
CN113301903A (zh) 2021-08-24
EA202190335A1 (ru) 2021-06-11
CR20210088A (es) 2021-09-02

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PC1 Assignment before grant (sect. 113)

Owner name: MOMENTA PHARMACEUTICALS, INC.

Free format text: FORMER APPLICANT(S): MOMENTA PHARMACEUTICALS, INC.; ZHANG, ZHONGLI; ST. LOUIS, GREGORY

FGA Letters patent sealed or granted (standard patent)