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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Australia
Prior art keywords
formulations
antibody
pharmaceutical composition
lot
trehalose
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AU2019312139A
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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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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)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (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 (https=)
EP (1) EP3826641A4 (https=)
JP (1) JP7457704B2 (https=)
KR (1) KR20210105872A (https=)
CN (1) CN113301903A (https=)
AU (1) AU2019312139B2 (https=)
BR (1) BR112021001017A2 (https=)
CA (1) CA3106669A1 (https=)
CR (1) CR20210088A (https=)
EA (1) EA202190335A1 (https=)
IL (1) IL280280B2 (https=)
JO (2) JOP20210015A1 (https=)
MX (1) MX2021000790A (https=)
PH (1) PH12021550096A1 (https=)
SG (1) SG11202100420UA (https=)
WO (1) WO2020023310A1 (https=)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20250052465A (ko) 2015-01-30 2025-04-18 모멘타 파머슈티컬스 인코포레이티드 ＦｃＲｎ 항체 및 이의 사용 방법
KR102904658B1 (ko) 2017-12-13 2025-12-29 모멘타 파머슈티컬스 인코포레이티드 FcRn 항체 및 이의 사용 방법
KR102921210B1 (ko) 2018-07-20 2026-01-30 모멘타 파머슈티컬스 인코포레이티드 Fcrn 항체 조성물
IL302516A (en) * 2020-11-06 2023-07-01 Janssen Biotech Inc FCRN antibodies and methods of using them
BR112023021046A2 (pt) * 2021-04-12 2023-12-19 Momenta Pharmaceuticals Inc Composições e métodos para tratamento de miastenia grave pediátrica
WO2024163894A1 (en) 2023-02-04 2024-08-08 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

Citations (2)

* Cited by examiner, † Cited by third party
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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

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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
JP5290489B2 (ja) * 2001-11-08 2013-09-18 アッヴィ・バイオセラピューティクス・インコーポレイテッド Ｉｇｇ抗体の安定な液体医薬製剤
AU2003211990A1 (en) * 2002-02-14 2003-09-04 Chugai Seiyaku Kabushiki Kaisha Antibody-containing solution pharmaceuticals
EP1871806A2 (en) * 2005-03-08 2008-01-02 Pharmacia & Upjohn Company LLC ANTI-MAdCAM ANTIBODY COMPOSITIONS
CN101918439A (zh) * 2007-11-09 2010-12-15 阿纳福公司 用于治疗疾病的甘露糖结合凝集素融合蛋白
WO2009124294A2 (en) 2008-04-05 2009-10-08 Lpath, Inc. Pharmaceutical compositions for binding sphingosine-1-phosphate
JP5933975B2 (ja) 2008-11-12 2016-06-15 メディミューン，エルエルシー 抗体製剤
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
KR20250052465A (ko) * 2015-01-30 2025-04-18 모멘타 파머슈티컬스 인코포레이티드 ＦｃＲｎ 항체 및 이의 사용 방법

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

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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)