AU2018322032B2 - Highly concentrated low viscosity MASP-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome - Google Patents

Highly concentrated low viscosity MASP-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome Download PDF

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Publication number
AU2018322032B2
AU2018322032B2 AU2018322032A AU2018322032A AU2018322032B2 AU 2018322032 B2 AU2018322032 B2 AU 2018322032B2 AU 2018322032 A AU2018322032 A AU 2018322032A AU 2018322032 A AU2018322032 A AU 2018322032A AU 2018322032 B2 AU2018322032 B2 AU 2018322032B2
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Australia
Prior art keywords
masp
antibody
ser
formulation
thr
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AU2018322032A
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AU2018322032A1 (en
Inventor
Gregory A. Demopulos
Kenneth M. Ferguson
William Joseph Lambert
John Steven Whitaker
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Omeros Corp
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Omeros Medical Systems Inc
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/06—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
    • 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
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
AU2018322032A 2017-08-25 2018-08-21 Highly concentrated low viscosity MASP-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome Active AU2018322032B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762550328P 2017-08-25 2017-08-25
US62/550,328 2017-08-25
PCT/US2018/047255 WO2019040453A1 (en) 2017-08-25 2018-08-21 HIGHLY CONCENTRATED MASP-2 INHIBITOR ANTIBODY FORMULATIONS WITH LOW VISCOSITY, KITS AND METHODS FOR TREATING SUBJECTS SUFFERING FROM ATYPICAL HEMOLYTIC SYNDROME

Publications (2)

Publication Number Publication Date
AU2018322032A1 AU2018322032A1 (en) 2020-03-12
AU2018322032B2 true AU2018322032B2 (en) 2025-04-17

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018322032A Active AU2018322032B2 (en) 2017-08-25 2018-08-21 Highly concentrated low viscosity MASP-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome

Country Status (15)

Country Link
US (2) US20190062455A1 (enExample)
EP (1) EP3672994A4 (enExample)
JP (1) JP2020531523A (enExample)
KR (1) KR20200037863A (enExample)
CN (1) CN111278863A (enExample)
AU (1) AU2018322032B2 (enExample)
BR (1) BR112020003632A2 (enExample)
CA (1) CA3072913A1 (enExample)
CL (1) CL2020000397A1 (enExample)
IL (1) IL272673B2 (enExample)
MA (1) MA49960A (enExample)
MX (1) MX2020002077A (enExample)
RU (1) RU2020111574A (enExample)
TW (1) TW201925224A (enExample)
WO (1) WO2019040453A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4057980A1 (en) * 2019-11-15 2022-09-21 F. Hoffmann-La Roche AG Prevention of visible particle formation in aqueous protein solutions
TW202135860A (zh) * 2019-12-10 2021-10-01 美商再生元醫藥公司 含有抗ｃｄ２０ｘ抗ｃｄ３雙特異性抗體之穩定調配物
WO2022026914A1 (en) * 2020-07-31 2022-02-03 Alamab Therapeutics, Inc. Anti-connexin antibody formulations
US20230416406A1 (en) * 2022-03-10 2023-12-28 Omeros Corporation Masp-2 and masp-3 inhibitors, and related compositions and methods, for treatment of sickle cell disease

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017083371A1 (en) * 2015-11-09 2017-05-18 Omeros Corporation Methods for treating conditions associated with masp-2 dependent complement activation

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101875155B1 (ko) * 2011-05-02 2018-07-09 밀레니엄 파머슈티컬스 인코퍼레이티드 항-α4β7 항체에 대한 제형
EP2704743B1 (en) * 2011-05-04 2020-03-11 Omeros Corporation Compositions for inhibiting masp-2 dependent complement acitivation
CN118924900A (zh) * 2012-06-18 2024-11-12 奥默罗斯公司 抑制masp-1和/或masp-2和/或masp-3的组合物和方法
WO2015058143A1 (en) * 2013-10-17 2015-04-23 Omeros Corporation Methods for treating conditions associated with masp-2 dependent complement activation
WO2016094834A2 (en) * 2014-12-12 2016-06-16 Alexion Pharmaceuticals, Inc. A method for treating a complement mediated disorder caused by an infectious agent in a patient
JOP20170170B1 (ar) * 2016-08-31 2022-09-15 Omeros Corp صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017083371A1 (en) * 2015-11-09 2017-05-18 Omeros Corporation Methods for treating conditions associated with masp-2 dependent complement activation

Also Published As

Publication number Publication date
BR112020003632A2 (pt) 2020-10-27
CL2020000397A1 (es) 2020-07-10
US20190062455A1 (en) 2019-02-28
MA49960A (fr) 2021-06-02
IL272673B1 (en) 2024-06-01
RU2020111574A3 (enExample) 2021-11-17
MX2020002077A (es) 2020-03-24
KR20200037863A (ko) 2020-04-09
TW201925224A (zh) 2019-07-01
AU2018322032A1 (en) 2020-03-12
RU2020111574A (ru) 2021-09-27
US20240247078A1 (en) 2024-07-25
JP2020531523A (ja) 2020-11-05
IL272673A (en) 2020-03-31
WO2019040453A1 (en) 2019-02-28
CN111278863A (zh) 2020-06-12
CA3072913A1 (en) 2019-02-28
IL272673B2 (en) 2024-10-01
EP3672994A4 (en) 2021-06-02
EP3672994A1 (en) 2020-07-01

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