JP2024512418A - 新規な免疫活性インターロイキン2アナログ結合体及びその製造方法 - Google Patents

新規な免疫活性インターロイキン2アナログ結合体及びその製造方法 Download PDF

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JP2024512418A
JP2024512418A JP2023555563A JP2023555563A JP2024512418A JP 2024512418 A JP2024512418 A JP 2024512418A JP 2023555563 A JP2023555563 A JP 2023555563A JP 2023555563 A JP2023555563 A JP 2023555563A JP 2024512418 A JP2024512418 A JP 2024512418A
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interleukin
amino acid
amino acids
analog
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JP2024512418A5 (https=
JPWO2022211537A5 (https=
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ヨンホ ホ
ウリム オ
ダヒョン パク
ジンヨン キム
ジュンソプ パク
ユヨン キム
アラム リ
サンユン キム
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ハンミ ファーマシューティカル カンパニー リミテッド
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/54Interleukins [IL]
    • C07K14/55IL-2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • A61K38/2013IL-2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6813Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin the drug being a peptidic cytokine, e.g. an interleukin or interferon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6889Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K19/00Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/31Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Toxicology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
JP2023555563A 2021-03-31 2022-03-31 新規な免疫活性インターロイキン2アナログ結合体及びその製造方法 Pending JP2024512418A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20210042305 2021-03-31
KR10-2021-0042305 2021-03-31
PCT/KR2022/004620 WO2022211537A1 (ko) 2021-03-31 2022-03-31 신규한 면역 활성 인터루킨 2 아날로그 결합체 및 이의 제조 방법

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JP2024512418A true JP2024512418A (ja) 2024-03-19
JP2024512418A5 JP2024512418A5 (https=) 2025-04-10
JPWO2022211537A5 JPWO2022211537A5 (https=) 2025-04-10

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US (1) US12599675B2 (https=)
EP (1) EP4316528A4 (https=)
JP (1) JP2024512418A (https=)
KR (2) KR102680146B1 (https=)
CN (1) CN116916969A (https=)
AR (1) AR125263A1 (https=)
AU (1) AU2022209248B2 (https=)
BR (1) BR112023018530A2 (https=)
CA (1) CA3205058C (https=)
CL (1) CL2023002504A1 (https=)
IL (1) IL304365B2 (https=)
MX (1) MX2023010926A (https=)
PE (1) PE20250672A1 (https=)
WO (1) WO2022211537A1 (https=)
ZA (1) ZA202307219B (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022009123A1 (en) * 2020-07-09 2022-01-13 Eutilex Co., Ltd. Il-2 variants
AU2023408268A1 (en) 2022-12-23 2025-07-10 Hanmi Pharm. Co., Ltd. Formulations comprising immune stimulating IL-2 analog conjugates
KR20240137492A (ko) * 2023-03-07 2024-09-20 한미약품 주식회사 암의 예방 또는 치료를 위한 인터루킨 2 아날로그 또는 이의 결합체 및 면역관문 억제제의 병용 요법
JP2026509259A (ja) * 2023-03-07 2026-03-17 ハンミ ファーマシューティカル カンパニー リミテッド インターロイキン2アナログ又はその結合体を含む癌予防又は治療用薬学的組成物

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007528347A (ja) * 2003-04-03 2007-10-11 ハンミ ファーム. シーオー., エルティーディー. 延長された生体内半減期を有するpeg−生理活性ポリペプチド同種二量体結合体及びその製造方法
JP2014506793A (ja) * 2011-02-10 2014-03-20 ロシュ グリクアート アーゲー ミュータントインターロイキン−2ポリペプチド
JP2017506264A (ja) * 2014-02-21 2017-03-02 ネクター セラピューティクス (インディア) プライベート リミテッド 抗CTLA−4抗体又は抗PD−1抗体との併用におけるIL−2Rβ選択的作動薬
JP2017527272A (ja) * 2014-07-21 2017-09-21 デリニア, インコーポレイテッド 自己免疫疾患を治療するために調節性t細胞を選択的に活性化する分子
JP2018512151A (ja) * 2016-05-04 2018-05-17 アムジエン・インコーポレーテツド 制御性t細胞の増殖のためのインターロイキン−2変異タンパク質
WO2019185705A1 (en) * 2018-03-28 2019-10-03 Ascendis Pharma A/S Il-2 conjugates
JP2019536734A (ja) * 2016-08-10 2019-12-19 アジュ ユニバーシティー インダストリー−アカデミック コーオペレイション ファウンデーションAjou University Industry−Academic Cooperation Foundation ヘテロダイマーFc融合サイトカインおよびそれを含む医薬組成物
WO2020020783A1 (en) * 2018-07-24 2020-01-30 Biontech Rna Pharmaceuticals Gmbh Il2 agonists
WO2020057646A1 (zh) * 2018-09-21 2020-03-26 信达生物制药(苏州)有限公司 新型白介素2及其用途
KR20200078312A (ko) * 2018-12-21 2020-07-01 한미약품 주식회사 신규 면역 억제 인터루킨 2 (Interleukin 2) 아날로그
WO2020260270A1 (en) * 2019-06-24 2020-12-30 Biontech Rna Pharmaceuticals Gmbh Il2 agonists
WO2021030633A1 (en) * 2019-08-13 2021-02-18 Elpis Biopharmaceuticals Engineered interleukin-2 receptor beta agonists

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US6096871A (en) 1995-04-14 2000-08-01 Genentech, Inc. Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life
JP4046354B2 (ja) 1996-03-18 2008-02-13 ボード オブ リージェンツ,ザ ユニバーシティ オブ テキサス システム 増大した半減期を有する免疫グロブリン様ドメイン
EP3943101A1 (en) 2014-10-21 2022-01-26 SciClone Pharmaceuticals International Ltd. Treatment of cancer with immune stimulator alpha thymosin peptide
WO2017052329A1 (en) * 2015-09-24 2017-03-30 Hanmi Pharm. Co., Ltd. Protein complex by use of a specific site of an immunoglobulin fragment for linkage
US11077172B2 (en) * 2016-11-08 2021-08-03 Delinia, Inc. IL-2 variants for the treatment of psoriasis
US20200299349A1 (en) * 2017-11-21 2020-09-24 The Board Of Trustees Of The Leland Stanford Junior University Partial agonists of interleukin-2

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007528347A (ja) * 2003-04-03 2007-10-11 ハンミ ファーム. シーオー., エルティーディー. 延長された生体内半減期を有するpeg−生理活性ポリペプチド同種二量体結合体及びその製造方法
JP2014506793A (ja) * 2011-02-10 2014-03-20 ロシュ グリクアート アーゲー ミュータントインターロイキン−2ポリペプチド
JP2017506264A (ja) * 2014-02-21 2017-03-02 ネクター セラピューティクス (インディア) プライベート リミテッド 抗CTLA−4抗体又は抗PD−1抗体との併用におけるIL−2Rβ選択的作動薬
JP2017527272A (ja) * 2014-07-21 2017-09-21 デリニア, インコーポレイテッド 自己免疫疾患を治療するために調節性t細胞を選択的に活性化する分子
JP2018512151A (ja) * 2016-05-04 2018-05-17 アムジエン・インコーポレーテツド 制御性t細胞の増殖のためのインターロイキン−2変異タンパク質
JP2019536734A (ja) * 2016-08-10 2019-12-19 アジュ ユニバーシティー インダストリー−アカデミック コーオペレイション ファウンデーションAjou University Industry−Academic Cooperation Foundation ヘテロダイマーFc融合サイトカインおよびそれを含む医薬組成物
WO2019185705A1 (en) * 2018-03-28 2019-10-03 Ascendis Pharma A/S Il-2 conjugates
WO2020020783A1 (en) * 2018-07-24 2020-01-30 Biontech Rna Pharmaceuticals Gmbh Il2 agonists
WO2020057646A1 (zh) * 2018-09-21 2020-03-26 信达生物制药(苏州)有限公司 新型白介素2及其用途
KR20200078312A (ko) * 2018-12-21 2020-07-01 한미약품 주식회사 신규 면역 억제 인터루킨 2 (Interleukin 2) 아날로그
WO2020260270A1 (en) * 2019-06-24 2020-12-30 Biontech Rna Pharmaceuticals Gmbh Il2 agonists
WO2021030633A1 (en) * 2019-08-13 2021-02-18 Elpis Biopharmaceuticals Engineered interleukin-2 receptor beta agonists

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CA3205058C (en) 2024-04-09
ZA202307219B (en) 2024-10-30
PE20250672A1 (es) 2025-03-04
KR20240099117A (ko) 2024-06-28
EP4316528A4 (en) 2026-03-11
CA3205058A1 (en) 2022-10-26
AU2022209248B2 (en) 2023-06-29
CN116916969A (zh) 2023-10-20
US20240009317A1 (en) 2024-01-11
AR125263A1 (es) 2023-06-28
EP4316528A1 (en) 2024-02-07
CL2023002504A1 (es) 2024-01-26
KR20220136285A (ko) 2022-10-07
IL304365A (en) 2023-09-01
AU2022209248A1 (en) 2022-10-20
IL304365B1 (en) 2024-12-01
IL304365B2 (en) 2025-04-01
MX2023010926A (es) 2023-09-27
KR102680146B1 (ko) 2024-07-04
WO2022211537A1 (ko) 2022-10-06
US12599675B2 (en) 2026-04-14
BR112023018530A2 (pt) 2023-10-10
TW202304521A (zh) 2023-02-01

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