AU2009288419B2 - Lyophilized formulatons of engineered anti-IL-23p19 antibodies - Google Patents

Lyophilized formulatons of engineered anti-IL-23p19 antibodies Download PDF

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Publication number
AU2009288419B2
AU2009288419B2 AU2009288419A AU2009288419A AU2009288419B2 AU 2009288419 B2 AU2009288419 B2 AU 2009288419B2 AU 2009288419 A AU2009288419 A AU 2009288419A AU 2009288419 A AU2009288419 A AU 2009288419A AU 2009288419 B2 AU2009288419 B2 AU 2009288419B2
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Australia
Prior art keywords
antibody
binding fragment
human
lyophilized
antigen binding
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AU2009288419A
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AU2009288419A1 (en
Inventor
Aniket Badkar
Ramesh S. Kashi
Xuhong Li
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Merck Sharp and Dohme LLC
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Merck Sharp and Dohme LLC
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Assigned to MERCK SHARP & DOHME LLC reassignment MERCK SHARP & DOHME LLC Request to Amend Deed and Register Assignors: MERCK SHARP & DOHME CORP.
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    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Rheumatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Endocrinology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Virology (AREA)
  • Physical Education & Sports Medicine (AREA)
AU2009288419A 2008-08-27 2009-08-25 Lyophilized formulatons of engineered anti-IL-23p19 antibodies Active AU2009288419B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US9232608P 2008-08-27 2008-08-27
US61/092,326 2008-08-27
PCT/US2009/054842 WO2010027766A1 (en) 2008-08-27 2009-08-25 Lyophilized formulatons of engineered anti-il-23p19 antibodies

Publications (2)

Publication Number Publication Date
AU2009288419A1 AU2009288419A1 (en) 2010-03-11
AU2009288419B2 true AU2009288419B2 (en) 2015-08-06

Family

ID=41495339

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2009288419A Active AU2009288419B2 (en) 2008-08-27 2009-08-25 Lyophilized formulatons of engineered anti-IL-23p19 antibodies

Country Status (8)

Country Link
US (1) US8263748B2 (enExample)
EP (1) EP2331078B1 (enExample)
JP (2) JP5931442B2 (enExample)
CN (1) CN102202655B (enExample)
AU (1) AU2009288419B2 (enExample)
CA (1) CA2734919C (enExample)
MX (1) MX2011002159A (enExample)
WO (1) WO2010027766A1 (enExample)

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WO2012009760A1 (en) * 2010-07-20 2012-01-26 Cephalon Australia Pty Ltd Anti-il-23 heterodimer specific antibodies
PT2635601T (pt) 2010-11-04 2016-09-27 Boehringer Ingelheim Int Anticorpos anti-il-23
IN2014CN03555A (enExample) 2011-10-25 2015-07-03 Onclave Therapeutics Ltd
EP2798077A2 (en) 2011-12-31 2014-11-05 Allergan, Inc. Highly Sensitive Cell-Based Assay to Detect the Presence of Active Botulinum Neurotoxin Serotype-A
US10316095B2 (en) * 2012-02-16 2019-06-11 Santarus, Inc. Antibody formulations
EP4039275A1 (en) 2012-05-03 2022-08-10 Boehringer Ingelheim International GmbH Anti-il-23p19 antibodies
CZ2012829A3 (cs) 2012-11-23 2014-06-11 Biotechnologický Ústav Av Čr, V.V.I. Polypeptidy pro léčbu autoimunitních chorob založenou na blokaci receptoru pro lidský cytokin IL-23
UA117466C2 (uk) * 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
EP3693007A1 (en) 2013-03-15 2020-08-12 Amgen, Inc Methods for treating crohn's disease using an anti-il23 antibody
KR20150128858A (ko) 2013-03-15 2015-11-18 암젠 인크 항-il-23 항체를 사용한 건선의 치료 방법
US10507241B2 (en) 2014-07-24 2019-12-17 Boehringer Ingelheim International Gmbh Biomarkers useful in the treatment of IL-23A related diseases
EA039598B9 (ru) 2014-09-03 2022-03-10 Бёрингер Ингельхайм Интернациональ Гмбх Соединение, нацеленное на ил-23а и фно-альфа, и его применение
AR102417A1 (es) 2014-11-05 2017-03-01 Lilly Co Eli Anticuerpos biespecíficos anti-tnf- / anti-il-23
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HK1258292A1 (zh) 2015-09-17 2019-11-08 Amgen Inc. 使用il23途徑生物標誌物預測il23拮抗劑的臨床應答
CA3002761A1 (en) 2015-11-04 2017-05-11 Astrazeneca Ab Dipeptidyl peptidase-4 and periostin as predictors of clinical response to eosinophil-targeted therapeutic agents in eosinophilic diseases
RU2018124603A (ru) 2015-12-22 2020-01-24 Эмджен Инк. Ccl20 как прогностический фактор клинического ответа на антагонисты ил-23
DK3405400T3 (da) 2016-01-22 2020-04-27 Baxter Int Fremgangsmåde og maskine til fremstilling af sterilopløsningsproduktposer
PL3405161T3 (pl) 2016-01-22 2020-07-13 Baxter International Inc Woreczek do wyrobu w postaci roztworu sterylnego
US10940185B2 (en) 2016-12-28 2021-03-09 Jcr Pharmaceuticals Co., Ltd. Lyophilized preparation
CA3060581A1 (en) 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
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AU2019386021B2 (en) 2018-11-27 2024-02-15 Innovent Biologics (Suzhou) Co., Ltd. Anti-il-23p19 antibody and uses thereof
JP7266108B2 (ja) 2019-02-18 2023-04-27 イーライ リリー アンド カンパニー 治療用抗体製剤
WO2020212874A1 (en) * 2019-04-15 2020-10-22 Sun Pharma Global Fze Methods for treatment of subjects with psoriatic arthritis
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Also Published As

Publication number Publication date
AU2009288419A1 (en) 2010-03-11
WO2010027766A1 (en) 2010-03-11
MX2011002159A (es) 2011-03-29
JP2012501332A (ja) 2012-01-19
US20110229490A1 (en) 2011-09-22
EP2331078B1 (en) 2012-09-19
JP5931442B2 (ja) 2016-06-08
CA2734919C (en) 2016-08-16
EP2331078A1 (en) 2011-06-15
CA2734919A1 (en) 2010-03-11
CN102202655A (zh) 2011-09-28
CN102202655B (zh) 2013-06-19
JP2016028086A (ja) 2016-02-25
US8263748B2 (en) 2012-09-11

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FGA Letters patent sealed or granted (standard patent)
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Owner name: MERCK SHARP & DOHME LLC

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