JP2023512454A - タンパク質治療のための製剤 - Google Patents

タンパク質治療のための製剤 Download PDF

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JP2023512454A
JP2023512454A JP2022542670A JP2022542670A JP2023512454A JP 2023512454 A JP2023512454 A JP 2023512454A JP 2022542670 A JP2022542670 A JP 2022542670A JP 2022542670 A JP2022542670 A JP 2022542670A JP 2023512454 A JP2023512454 A JP 2023512454A
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binding domain
administered
day
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JP2023512454A5 (enExample
Inventor
クラッパー，ジョナサン
ビアンヴニュ，デイビッド
ストロマット，スコット
ジェイ． マクマハン，キャサリン
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アプティーボ リサーチ アンド デベロップメント エルエルシー
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Publication of JP2023512454A publication Critical patent/JP2023512454A/ja
Publication of JP2023512454A5 publication Critical patent/JP2023512454A5/ja
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    • 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
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional 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
    • 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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • C07K16/2809—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 the T-cell receptor (TcR)-CD3 complex
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • 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
    • C07K2317/71—Decreased effector function due to an Fc-modification
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2022542670A 2020-01-13 2021-01-13 タンパク質治療のための製剤 Pending JP2023512454A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025184163A JP2026021465A (ja) 2020-01-13 2025-10-31 タンパク質治療のための製剤

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202062960562P 2020-01-13 2020-01-13
US62/960,562 2020-01-13
US202063121633P 2020-12-04 2020-12-04
US63/121,633 2020-12-04
PCT/US2021/013294 WO2021146328A1 (en) 2020-01-13 2021-01-13 Formulations for protein therapeutics

Related Child Applications (1)

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JP2025184163A Division JP2026021465A (ja) 2020-01-13 2025-10-31 タンパク質治療のための製剤

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JP2023512454A true JP2023512454A (ja) 2023-03-27
JP2023512454A5 JP2023512454A5 (enExample) 2024-01-22

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JP2022542670A Pending JP2023512454A (ja) 2020-01-13 2021-01-13 タンパク質治療のための製剤
JP2025184163A Pending JP2026021465A (ja) 2020-01-13 2025-10-31 タンパク質治療のための製剤

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US (1) US20230303720A1 (enExample)
EP (1) EP4090367A1 (enExample)
JP (2) JP2023512454A (enExample)
KR (1) KR20220127843A (enExample)
CN (1) CN115279406A (enExample)
AU (1) AU2021207470A1 (enExample)
BR (1) BR112022013725A2 (enExample)
CA (1) CA3164385A1 (enExample)
IL (1) IL294458A (enExample)
MX (1) MX2022008654A (enExample)
WO (1) WO2021146328A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3515491A4 (en) 2016-09-21 2020-09-16 Aptevo Research and Development LLC CD123 BINDING PROTEINS AND RELATED COMPOSITIONS AND PROCESSES
RS67656B1 (sr) 2018-05-10 2026-02-27 Regeneron Pharma Formulacije koje sadrže visoke koncentracije fuzionog proteina vegf receptora
JP7137696B2 (ja) 2019-05-14 2022-09-14 プロヴェンション・バイオ・インコーポレイテッド １型糖尿病を予防するための方法および組成物
KR20230092863A (ko) 2020-06-11 2023-06-26 프로벤션 바이오, 인코포레이티드 제1형 당뇨병을 예방하기 위한 방법 및 조성물
MX2023013851A (es) 2021-05-24 2023-12-08 Provention Bio Inc Metodos para el tratamiento de diabetes tipo 1.

Family Cites Families (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5283173A (en) 1990-01-24 1994-02-01 The Research Foundation Of State University Of New York System to detect protein-protein interactions
GB9518220D0 (en) 1995-09-06 1995-11-08 Medical Res Council Checkpoint gene
US6440418B1 (en) 1995-11-07 2002-08-27 Idec Pharmaceuticals Corporation Methods of treating autoimmune diseases with gp39-specific antibodies
US6660843B1 (en) 1998-10-23 2003-12-09 Amgen Inc. Modified peptides as therapeutic agents
AU2004242846A1 (en) 2003-05-31 2004-12-09 Micromet Ag Pharmaceutical compositions comprising bispecific anti-CD3, anti-CD19 antibody constructs for the treatment of B-cell related disorders
AU2004242845B2 (en) 2003-05-31 2011-06-02 Amgen Research (Munich) Gmbh Human-anti-human CD3 binding molecules
US8076459B2 (en) 2003-10-16 2011-12-13 Micromet Ag Multispecfic deimmunized CD3-binders
US7393662B2 (en) 2004-09-03 2008-07-01 Centocor, Inc. Human EPO mimetic hinge core mimetibodies, compositions, methods and uses
CN105837690A (zh) 2006-06-12 2016-08-10 新兴产品开发西雅图有限公司 具有效应功能的单链多价结合蛋白
CA2665567C (en) * 2006-10-06 2012-07-03 Amgen Inc. Stable formulations
PL2155788T3 (pl) 2007-04-03 2013-02-28 Amgen Res Munich Gmbh Swoiste międzygatunkowe bispecyficzne czynniki wiążące
KR20110044991A (ko) 2008-07-02 2011-05-03 이머전트 프로덕트 디벨롭먼트 시애틀, 엘엘씨 ＴＮＦ-α 길항제 다-표적 결합 단백질
MX2011003502A (es) 2008-10-01 2011-09-01 Micromet Ag Anticuerpo de cadena sencilla biespecifica de psmaxcd3 especifico a traves de especies.
AU2009298131B2 (en) 2008-10-02 2016-07-14 Aptevo Research And Development Llc CD86 antagonist multi-target binding proteins
US20130129723A1 (en) 2009-12-29 2013-05-23 Emergent Product Development Seattle, Llc Heterodimer Binding Proteins and Uses Thereof
US20130089554A1 (en) 2009-12-29 2013-04-11 Emergent Product Development Seattle, Llc RON Binding Constructs and Methods of Use Thereof
TWI653333B (zh) 2010-04-01 2019-03-11 安進研究（慕尼黑）有限責任公司 跨物種專一性之ＰＳＭＡｘＣＤ３雙專一性單鏈抗體
ES2667100T3 (es) 2010-08-02 2018-05-09 Macrogenics, Inc. Diacuerpos covalentes y sus usos
BR112013027224A8 (pt) * 2011-04-22 2018-08-14 Emergent Product Dev Seattle Proteínas de ligação de antígeno de membrana específico de próstata e composições e métodos relacionados
WO2012162067A2 (en) 2011-05-21 2012-11-29 Macrogenics, Inc. Cd3-binding molecules capable of binding to human and non-human cd3
IN2014MN02293A (enExample) 2012-04-20 2015-08-07 Emergent Product Dev Seattle
WO2015200027A1 (en) * 2014-06-26 2015-12-30 Amgen Inc. Protein formulations
WO2016094873A2 (en) 2014-12-12 2016-06-16 Emergent Product Development Seattle, Llc Receptor tyrosine kinase-like orphan receptor 1 binding proteins and related compositions and methods
BR112017024770A2 (pt) 2015-05-21 2018-07-31 Alligator Bioscience Ab polipeptídeos inovadores
HK1251480A1 (zh) 2015-09-21 2019-02-01 Aptevo Research And Development Llc Cd3结合多肽
TWI790206B (zh) * 2016-07-18 2023-01-21 法商賽諾菲公司 特異性結合至ｃｄ３和ｃｄ１２３的雙特異性抗體樣結合蛋白
EP3515491A4 (en) * 2016-09-21 2020-09-16 Aptevo Research and Development LLC CD123 BINDING PROTEINS AND RELATED COMPOSITIONS AND PROCESSES
WO2019050521A1 (en) * 2017-09-07 2019-03-14 Macrogenics, Inc. DOSAGE SCHEMES OF BISPECIFIC DIACORPS CD123 X CD3 IN THE TREATMENT OF HEMATOLOGICAL MALIGNANCIES

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
J. PHARM. SCI., vol. vol.109, issue 1, JPN6024050238, 2019, pages 220 - 232, ISSN: 0005630865 *

Also Published As

Publication number Publication date
AU2021207470A1 (en) 2022-07-07
IL294458A (en) 2022-09-01
MX2022008654A (es) 2022-08-18
US20230303720A1 (en) 2023-09-28
EP4090367A1 (en) 2022-11-23
CN115279406A (zh) 2022-11-01
JP2026021465A (ja) 2026-02-10
BR112022013725A2 (pt) 2022-10-11
CA3164385A1 (en) 2021-07-22
KR20220127843A (ko) 2022-09-20
WO2021146328A1 (en) 2021-07-22

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