CA3205058C - Conjugate of immune-stimulating il-2 analog and preparation method thereof - Google Patents

Conjugate of immune-stimulating il-2 analog and preparation method thereof Download PDF

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Publication number
CA3205058C
CA3205058C CA3205058A CA3205058A CA3205058C CA 3205058 C CA3205058 C CA 3205058C CA 3205058 A CA3205058 A CA 3205058A CA 3205058 A CA3205058 A CA 3205058A CA 3205058 C CA3205058 C CA 3205058C
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Canada
Prior art keywords
interleukin
analog
amino acids
amino acid
substituted
Prior art date
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Active
Application number
CA3205058A
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English (en)
French (fr)
Other versions
CA3205058A1 (en
Inventor
Yong Ho Heo
Euh Lim Oh
Da Hyeon Park
Jin Young Kim
Jun Sub Park
Yu Yon Kim
A Ram Lee
Sang Yun Kim
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.)
Hanmi Pharmaceutical Co Ltd
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Hanmi Pharmaceutical Co Ltd
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Publication date
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Publication of CA3205058A1 publication Critical patent/CA3205058A1/en
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/54—Interleukins [IL]
    • C07K14/55—IL-2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • A61K38/2013—IL-2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 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
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6813—Drugs 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 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
    • A61K47/6889—Conjugates 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

Landscapes

  • 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)
CA3205058A 2021-03-31 2022-03-31 Conjugate of immune-stimulating il-2 analog and preparation method thereof Active CA3205058C (en)

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

Publications (2)

Publication Number Publication Date
CA3205058A1 CA3205058A1 (en) 2022-10-26
CA3205058C true CA3205058C (en) 2024-04-09

Family

ID=83459706

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3205058A Active CA3205058C (en) 2021-03-31 2022-03-31 Conjugate of immune-stimulating il-2 analog and preparation method thereof

Country Status (16)

Country Link
US (1) US12599675B2 (enExample)
EP (1) EP4316528A4 (enExample)
JP (1) JP2024512418A (enExample)
KR (2) KR102680146B1 (enExample)
CN (1) CN116916969A (enExample)
AR (1) AR125263A1 (enExample)
AU (1) AU2022209248B2 (enExample)
BR (1) BR112023018530A2 (enExample)
CA (1) CA3205058C (enExample)
CL (1) CL2023002504A1 (enExample)
IL (1) IL304365B2 (enExample)
MX (1) MX2023010926A (enExample)
PE (1) PE20250672A1 (enExample)
TW (1) TWI922649B (enExample)
WO (1) WO2022211537A1 (enExample)
ZA (1) ZA202307219B (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7819944B2 (ja) * 2020-07-09 2026-02-25 ユーティレックス カンパニー リミテッド Ｉｌ－２バリアント
EP4640210A1 (en) 2022-12-23 2025-10-29 Hanmi Pharm. Co., Ltd. Formulation containing immunoactive interleukin 2 analog conjugate
TW202502372A (zh) * 2023-03-07 2025-01-16 南韓商韓美藥品股份有限公司 包含ｉｌ－２類似物或其接合物之用於預防或治療癌症之醫藥組成物
TW202525327A (zh) * 2023-03-07 2025-07-01 南韓商韓美藥品股份有限公司 Ｉｌ－２類似物或其接合物與免疫檢查點抑制劑用於預防或治療癌症的組合療法

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CA2249195A1 (en) 1996-03-18 1997-09-25 Board Of Regents, The University Of Texas System Immunoglobin-like domains with increased half lives
KR100507796B1 (ko) * 2003-04-03 2005-08-17 한미약품 주식회사 생체내 반감기가 증가된 ｐｅｇ-생리활성 폴리펩티드 동종이량체 결합체 및 이의 제조방법
CN105440123B (zh) * 2011-02-10 2020-10-09 罗切格利卡特公司 突变体白介素-2多肽
PT3134123T (pt) * 2014-02-21 2021-03-22 Nektar Therapeutics India Pvt Ltd Agonistas seletivos de il-2rbeta em combinação com um anticorpo anti-ctla-4 ou um anticorpo anti-pd-1
KR102493543B1 (ko) * 2014-07-21 2023-01-30 데리니아, 인크. 자가면역 질환의 치료를 위한 조절 t 세포를 선택적으로 활성화시키는 분자
CN107148279B (zh) 2014-10-21 2021-09-03 赛生药品股份国际有限公司 用免疫刺激剂治疗癌症
IL304950A (en) * 2015-04-10 2023-10-01 Amgen Inc Interleukin for the expansion of myotonic control T-2 cells
CN108136276B (zh) * 2015-09-24 2023-02-28 韩美药品株式会社 通过使用免疫球蛋白片段的特异性位点进行连接的蛋白质复合物
KR20240115933A (ko) * 2016-05-04 2024-07-26 암젠 인크 T-조절 세포의 증식을 위한 인터류킨-2 뮤테인
EP3511340B1 (en) * 2016-08-10 2024-10-02 Ajou University Industry-Academic Cooperation Foundation Heterodimeric fc-fused cytokine and pharmaceutical composition comprising the same
EP3538548A4 (en) * 2016-11-08 2020-08-19 Delinia, Inc. IL-2 VARIANTS FOR THE TREATMENT OF AUTOIMMUNE DISEASES
KR102777151B1 (ko) * 2017-11-21 2025-03-05 더 보드 어브 트러스티스 어브 더 리랜드 스탠포드 주니어 유니버시티 인터루킨-2의 부분 효능제
US12565525B2 (en) * 2018-03-28 2026-03-03 Ascendis Pharma Oncology Division A/S IL-2 conjugates
US12522640B2 (en) 2018-07-24 2026-01-13 BioNTech SE IL2 agonists
CA3098930A1 (en) * 2018-09-21 2020-03-26 Innovent Biologics (Suzhou) Co., Ltd. Novel interleukin-2 and use thereof
US20220025007A1 (en) * 2018-12-21 2022-01-27 Hanmi Pharm. Co., Ltd. Novel immunosuppressive interleukin 2
TW202115105A (zh) * 2019-06-24 2021-04-16 德商拜恩迪克Ｒｎａ製藥有限公司 Ｉｌ２激動劑
CN114787182A (zh) * 2019-08-13 2022-07-22 艾佩斯瑞生物制药公司 工程化的白细胞介素-2受体β激动剂

Also Published As

Publication number Publication date
TW202304521A (zh) 2023-02-01
IL304365A (en) 2023-09-01
AR125263A1 (es) 2023-06-28
EP4316528A1 (en) 2024-02-07
US20240009317A1 (en) 2024-01-11
CL2023002504A1 (es) 2024-01-26
KR20220136285A (ko) 2022-10-07
MX2023010926A (es) 2023-09-27
US12599675B2 (en) 2026-04-14
TWI922649B (zh) 2026-04-21
BR112023018530A2 (pt) 2023-10-10
EP4316528A4 (en) 2026-03-11
AU2022209248B2 (en) 2023-06-29
CN116916969A (zh) 2023-10-20
IL304365B1 (en) 2024-12-01
IL304365B2 (en) 2025-04-01
KR102680146B1 (ko) 2024-07-04
CA3205058A1 (en) 2022-10-26
JP2024512418A (ja) 2024-03-19
AU2022209248A1 (en) 2022-10-20
KR20240099117A (ko) 2024-06-28
PE20250672A1 (es) 2025-03-04
ZA202307219B (en) 2024-10-30
WO2022211537A1 (ko) 2022-10-06

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