AU2021237518B2 - Interleukin-2 mutant and use thereof - Google Patents

Interleukin-2 mutant and use thereof Download PDF

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Publication number
AU2021237518B2
AU2021237518B2 AU2021237518A AU2021237518A AU2021237518B2 AU 2021237518 B2 AU2021237518 B2 AU 2021237518B2 AU 2021237518 A AU2021237518 A AU 2021237518A AU 2021237518 A AU2021237518 A AU 2021237518A AU 2021237518 B2 AU2021237518 B2 AU 2021237518B2
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glu
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AU2021237518A1 (en
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Fenggen FU
Kaijie HE
Junjian Liu
Weiwei Wu
Shuaixiang ZHOU
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Fortvita Biologics Singapore Pte Ltd
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Fortvita Biologics Singapore Pte Ltd
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Assigned to Fortvita Biologics (Singapore) Pte.Ltd. reassignment Fortvita Biologics (Singapore) Pte.Ltd. Amend patent request/document other than specification (104) Assignors: INNOVENT BIOLOGICS (SINGAPORE) PTE. LTD.
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    • 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
    • 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
    • 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
    • A61P37/04—Immunostimulants
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0681—Cells of the genital tract; Non-germinal cells from gonads
    • C12N5/0682—Cells of the female genital tract, e.g. endometrium; Non-germinal cells from ovaries, e.g. ovarian follicle cells
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0684—Cells of the urinary tract or kidneys
    • C12N5/0686—Kidney cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2510/00—Genetically modified cells
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2800/00—Nucleic acids vectors
    • C12N2800/10—Plasmid DNA
    • C12N2800/106—Plasmid DNA for vertebrates
    • C12N2800/107—Plasmid DNA for vertebrates for mammalian

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biochemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Toxicology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Urology & Nephrology (AREA)
  • Cell Biology (AREA)
  • Reproductive Health (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)
AU2021237518A 2020-03-19 2021-03-19 Interleukin-2 mutant and use thereof Active AU2021237518B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202010196689 2020-03-19
CN202010196689.5 2020-03-19
PCT/CN2021/081841 WO2021185362A1 (zh) 2020-03-19 2021-03-19 白介素2突变体及其用途

Publications (2)

Publication Number Publication Date
AU2021237518A1 AU2021237518A1 (en) 2022-10-13
AU2021237518B2 true AU2021237518B2 (en) 2024-08-15

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Application Number Title Priority Date Filing Date
AU2021237518A Active AU2021237518B2 (en) 2020-03-19 2021-03-19 Interleukin-2 mutant and use thereof

Country Status (9)

Country Link
US (1) US20230174604A1 (https=)
EP (1) EP4122951A4 (https=)
JP (1) JP2023518443A (https=)
KR (1) KR20220155317A (https=)
CN (2) CN121574230A (https=)
AU (1) AU2021237518B2 (https=)
CA (1) CA3175728A1 (https=)
TW (1) TWI834031B (https=)
WO (1) WO2021185362A1 (https=)

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* Cited by examiner, † Cited by third party
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EP3854805A4 (en) 2018-09-21 2022-08-24 Innovent Biologics (Suzhou) Co., Ltd. NOVEL INTERLEUKIN 2 AND ITS USE
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
JP2023518434A (ja) * 2020-03-19 2023-05-01 イノベント バイオロジクス（スーチョウ）カンパニー，リミティド インターロイキン２変異体およびその使用
TWI815194B (zh) 2020-10-22 2023-09-11 美商基利科學股份有限公司 介白素2-Fc融合蛋白及使用方法
KR20240082364A (ko) * 2021-09-22 2024-06-10 포트비타 바이오로직스 (싱가포르) 피티이. 리미티드 인터루킨-2 돌연변이 및 이의 융합 단백질
EP4460512A4 (en) * 2022-01-07 2026-01-14 Cure Genetics Co Ltd NEW INTERLEUKIN-2 POLYPEPTIDES
US20250215452A1 (en) 2022-03-25 2025-07-03 Universität Zürich Adenoviral Mediated Targeting of Activated Immune Cells
CN114853909A (zh) * 2022-05-13 2022-08-05 南京吉盛澳玛生物医药有限公司 新型IL-2与INFα和Fc融合蛋白的设计、制备及用途
CN116041539B (zh) * 2022-10-31 2023-07-21 山东博安生物技术股份有限公司 Il-2突变体免疫缀合物
KR102629162B1 (ko) 2022-11-04 2024-01-29 한국기초과학지원연구원 바이오의약품 품질관리를 위한 잔류 숙주세포 단백질 정량 분석 방법 및 시스템
WO2024146575A1 (zh) * 2023-01-04 2024-07-11 北京晶泰科技有限公司 白细胞介素-2变体及其应用
CN118680877A (zh) * 2023-03-21 2024-09-24 信达生物制药(苏州)有限公司 抗pd-1与突变il-2免疫缀合物制剂
WO2025010341A2 (en) * 2023-07-05 2025-01-09 The Trustees Of Dartmouth College Cytokine hybrid proteins and methods related thereto

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US4518584A (en) 1983-04-15 1985-05-21 Cetus Corporation Human recombinant interleukin-2 muteins
NZ234674A (en) * 1989-08-02 1992-02-25 Seragen Inc Mutant interleukin-2,dna encoding it, host cells, cytotoxic and toxin-mutant il-2 conjugates
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US6960652B2 (en) * 1999-03-30 2005-11-01 Board Of Regents, The University Of Texas System Compositions and methods for modifying toxic effects of proteinaceous compounds
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BRPI0508470A (pt) * 2004-03-05 2007-07-31 Chiron Corp sistema de teste in vitro para prever toleráncia do paciente aos agentes terapêuticos
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HUE029139T2 (hu) * 2011-02-10 2017-02-28 Roche Glycart Ag Mutáns interleukin-2 polipeptidek
WO2012119093A1 (en) * 2011-03-03 2012-09-07 Board Of Trustees Of The Leland Stanford Junior University Superagonists and antagonists of interleukin-2
US9580486B2 (en) * 2013-03-14 2017-02-28 Amgen Inc. Interleukin-2 muteins for the expansion of T-regulatory cells
CN104231068A (zh) * 2014-01-27 2014-12-24 苏州发士达生物科技有限公司 人白细胞介素ii突变体及其应用
KR102042246B1 (ko) * 2014-02-06 2019-11-28 에프. 호프만-라 로슈 아게 인터류킨-2 융합 단백질 및 이의 용도
WO2015164815A1 (en) * 2014-04-24 2015-10-29 The Board Of Trustees Of The Leland Stanford Junior University Superagonists, partial agonists and antagonists of interleukin-2
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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
EP3854805A4 (en) * 2018-09-21 2022-08-24 Innovent Biologics (Suzhou) Co., Ltd. NOVEL INTERLEUKIN 2 AND ITS USE
JP2023518434A (ja) * 2020-03-19 2023-05-01 イノベント バイオロジクス（スーチョウ）カンパニー，リミティド インターロイキン２変異体およびその使用
EP4273161A4 (en) * 2020-12-31 2025-04-02 Innovent Biologics (Suzhou) Co., Ltd. Protein with heterodimeric antibody FC and manufacturing method therefor

Also Published As

Publication number Publication date
KR20220155317A (ko) 2022-11-22
EP4122951A1 (en) 2023-01-25
JP2023518443A (ja) 2023-05-01
AU2021237518A1 (en) 2022-10-13
CA3175728A1 (en) 2021-09-23
CN121574230A (zh) 2026-02-27
TW202144391A (zh) 2021-12-01
WO2021185362A1 (zh) 2021-09-23
EP4122951A4 (en) 2024-05-29
CN115315437B (zh) 2025-10-17
CN115315437A (zh) 2022-11-08
TWI834031B (zh) 2024-03-01
US20230174604A1 (en) 2023-06-08

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