CA3166964A1 - Formulations of human anti-tslp antibodies and methods of treating inflammatory disease - Google Patents

Formulations of human anti-tslp antibodies and methods of treating inflammatory disease Download PDF

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Publication number
CA3166964A1
CA3166964A1 CA3166964A CA3166964A CA3166964A1 CA 3166964 A1 CA3166964 A1 CA 3166964A1 CA 3166964 A CA3166964 A CA 3166964A CA 3166964 A CA3166964 A CA 3166964A CA 3166964 A1 CA3166964 A1 CA 3166964A1
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CA
Canada
Prior art keywords
aqueous composition
calcium
arginine
glutamate
salt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3166964A
Other languages
English (en)
French (fr)
Inventor
Alexis Lueras
Christopher Sloey
Clea TALLY
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amgen Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA3166964A1 publication Critical patent/CA3166964A1/en
Pending legal-status Critical Current

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Classifications

    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • C07K2317/90—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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
CA3166964A 2020-02-13 2021-02-12 Formulations of human anti-tslp antibodies and methods of treating inflammatory disease Pending CA3166964A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202062976007P 2020-02-13 2020-02-13
US62/976,007 2020-02-13
US202163148105P 2021-02-10 2021-02-10
US63/148,105 2021-02-10
PCT/US2021/017880 WO2021163504A1 (en) 2020-02-13 2021-02-12 Formulations of human anti-tslp antibodies and methods of treating inflammatory disease

Publications (1)

Publication Number Publication Date
CA3166964A1 true CA3166964A1 (en) 2021-08-19

Family

ID=74858823

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3166964A Pending CA3166964A1 (en) 2020-02-13 2021-02-12 Formulations of human anti-tslp antibodies and methods of treating inflammatory disease

Country Status (18)

Country Link
US (1) US20230078678A1 (cg-RX-API-DMAC10.html)
EP (1) EP4103235A1 (cg-RX-API-DMAC10.html)
JP (2) JP2023513312A (cg-RX-API-DMAC10.html)
KR (1) KR20220140772A (cg-RX-API-DMAC10.html)
CN (1) CN115279404A (cg-RX-API-DMAC10.html)
AU (1) AU2021219839A1 (cg-RX-API-DMAC10.html)
BR (1) BR112022016010A2 (cg-RX-API-DMAC10.html)
CA (1) CA3166964A1 (cg-RX-API-DMAC10.html)
CL (1) CL2022002193A1 (cg-RX-API-DMAC10.html)
CO (1) CO2022012868A2 (cg-RX-API-DMAC10.html)
CR (1) CR20220457A (cg-RX-API-DMAC10.html)
IL (1) IL295042A (cg-RX-API-DMAC10.html)
JO (1) JOP20220183A1 (cg-RX-API-DMAC10.html)
MX (1) MX2022010012A (cg-RX-API-DMAC10.html)
PE (1) PE20230112A1 (cg-RX-API-DMAC10.html)
PH (1) PH12022552050A1 (cg-RX-API-DMAC10.html)
UY (1) UY39083A (cg-RX-API-DMAC10.html)
WO (1) WO2021163504A1 (cg-RX-API-DMAC10.html)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI917325B (zh) 2019-06-04 2026-03-11 大陸商江蘇恆瑞醫藥股份有限公司 能結合胸腺基質淋巴細胞生成素的抗體及其應用
MX2023006596A (es) * 2020-12-03 2023-06-19 Jiangsu Hengrui Pharmaceuticals Co Ltd Composicion farmaceutica de anticuerpo anti-tslp y uso de la misma.
US12110324B2 (en) 2022-07-22 2024-10-08 Flagship Pioneering Innovations Vi, Llc Antigen binding molecules targeting thymic stromal lymphopoietin (TSLP)
TW202529809A (zh) * 2023-10-17 2025-08-01 大陸商江蘇恆瑞醫藥股份有限公司 一種抗tslp抗體的醫藥組成物及其用途

Family Cites Families (28)

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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
ES2246502T3 (es) 1990-08-29 2006-02-16 Genpharm International, Inc. Animales no humanos transgenicos capaces de producir anticuerpos heterologos.
US7982016B2 (en) 2007-09-10 2011-07-19 Amgen Inc. Antigen binding proteins capable of binding thymic stromal lymphopoietin
US8359965B2 (en) 2007-09-17 2013-01-29 Oxford J Craig Apparatus and method for broad spectrum radiation attenuation
TW201018482A (en) 2008-08-08 2010-05-16 Glaxo Wellcome Mfg Pte Ltd Novel treatment
EP3594356A1 (en) 2009-11-04 2020-01-15 Merck Sharp & Dohme Corp. Engineered anti-tslp antibody
AR080428A1 (es) * 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
SMT202000095T1 (it) * 2010-05-14 2020-03-13 Amgen Inc Formulazioni di anticorpi anti-sclerostina ad alta concentrazione
AR082163A1 (es) 2010-07-15 2012-11-14 Hoffmann La Roche Anticuerpos especificamente ligantes del tslpr humano y metodos de utilizacion de los mismos
AT510032B1 (de) 2010-11-30 2012-01-15 Steiner Erwin Ing Montageeinrichtung für fassadenelemente
US9100245B1 (en) 2012-02-08 2015-08-04 Amazon Technologies, Inc. Identifying protected media files
WO2014031718A1 (en) * 2012-08-23 2014-02-27 Merck Sharp & Dohme Corp. Stable formulations of antibodies to tslp
US9306926B2 (en) 2013-03-15 2016-04-05 Brian A. Truong User authentication using unique hidden identifiers
ES2964713T3 (es) * 2014-10-23 2024-04-09 Amgen Inc Reducción de la viscosidad de formulaciones farmacéuticas
CN107428828A (zh) 2015-03-11 2017-12-01 葛兰素史密斯克莱知识产权发展有限公司 Tslp结合蛋白
EA038332B1 (ru) 2015-09-09 2021-08-10 Новартис Аг Молекулы, связывающиеся с тимусным стромальным лимфопоэтином (tslp), и способы применения таких молекул
US10994011B2 (en) * 2015-12-18 2021-05-04 Astellas Pharma Inc. Pharmaceutical composition comprising anti-human TSLP receptor antibody
EP3609917A1 (en) * 2017-04-12 2020-02-19 Amgen Inc. Treatment of asthma with anti-tslp antibody
MA48461A (fr) * 2017-04-28 2020-03-04 Amgen Inc Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation
CA3066399A1 (en) 2017-06-08 2018-12-13 Amgen Inc. Torque driven drug delivery device
KR20200034748A (ko) * 2017-07-27 2020-03-31 지앙수 헨그루이 메디슨 컴퍼니 리미티드 Sost 항체 약학적 조성물 및 그의 용도
IL319987A (en) 2017-11-10 2025-06-01 Amgen Inc Plungers for drug delivery devices
WO2019178151A1 (en) 2018-03-13 2019-09-19 Amgen Inc. Methods for the preparation of trypsin-resistant polypeptides for mass spectrometric analysis
JP7719714B2 (ja) 2018-10-15 2025-08-06 アムジエン・インコーポレーテツド ダンピング機構を有する薬物送達装置
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AU2020397170A1 (en) * 2019-12-05 2022-07-21 Sanofi-Aventis U.S. Llc Formulations of anti-CD38 antibodies for subcutaneous administration

Also Published As

Publication number Publication date
CR20220457A (es) 2023-01-09
JP2026074118A (ja) 2026-05-01
WO2021163504A1 (en) 2021-08-19
IL295042A (en) 2022-09-01
AU2021219839A1 (en) 2022-08-25
EP4103235A1 (en) 2022-12-21
CN115279404A (zh) 2022-11-01
PH12022552050A1 (en) 2024-02-12
UY39083A (es) 2021-08-31
JOP20220183A1 (ar) 2023-01-30
CO2022012868A2 (es) 2022-12-09
US20230078678A1 (en) 2023-03-16
MX2022010012A (es) 2022-09-07
KR20220140772A (ko) 2022-10-18
PE20230112A1 (es) 2023-01-27
BR112022016010A2 (pt) 2022-12-20
CL2022002193A1 (es) 2023-03-24
JP2023513312A (ja) 2023-03-30

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