TW202237148A - 包含rna之lnp組合物以及製備、儲存及使用彼之方法 - Google Patents

包含rna之lnp組合物以及製備、儲存及使用彼之方法 Download PDF

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Publication number
TW202237148A
TW202237148A TW110142348A TW110142348A TW202237148A TW 202237148 A TW202237148 A TW 202237148A TW 110142348 A TW110142348 A TW 110142348A TW 110142348 A TW110142348 A TW 110142348A TW 202237148 A TW202237148 A TW 202237148A
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Taiwan
Prior art keywords
composition
rna
anions
final
lipid
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TW110142348A
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English (en)
Chinese (zh)
Inventor
史蒂芬 潘茲納
烏古爾 沙欣
約里特 詹恩 克里格
考希克 善奇
巴庫爾 帕特納加爾
拉敏 達瓦里
薩米特 路斯拉
塞爾吉 切薩洛夫
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德商拜恩迪克公司
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Priority claimed from PCT/EP2021/059460 external-priority patent/WO2022218503A1/en
Application filed by 德商拜恩迪克公司 filed Critical 德商拜恩迪克公司
Publication of TW202237148A publication Critical patent/TW202237148A/zh

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    • 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
    • A61P31/14—Antivirals for RNA viruses
    • 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
    • A61K39/12—Viral antigens
    • 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
    • A61K39/12—Viral antigens
    • A61K39/215—Coronaviridae, e.g. avian infectious bronchitis virus
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/5123—Organic compounds, e.g. fats, sugars
    • 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
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/53—DNA (RNA) vaccination
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • 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
    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/20011—Coronaviridae
    • C12N2770/20034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Virology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Organic Chemistry (AREA)
  • Optics & Photonics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nanotechnology (AREA)
  • Oncology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Physics & Mathematics (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
TW110142348A 2020-11-16 2021-11-15 包含rna之lnp組合物以及製備、儲存及使用彼之方法 TW202237148A (zh)

Applications Claiming Priority (14)

Application Number Priority Date Filing Date Title
US202063114478P 2020-11-16 2020-11-16
US63/114,478 2020-11-16
US202063115588P 2020-11-18 2020-11-18
US202063115128P 2020-11-18 2020-11-18
US63/115,588 2020-11-18
WOPCT/EP2020/082602 2020-11-18
EP2020082602 2020-11-18
US63/115,128 2020-11-18
US202163135723P 2021-01-10 2021-01-10
US63/135,723 2021-01-10
US202163149372P 2021-02-15 2021-02-15
US63/149,372 2021-02-15
WOPCT/EP2021/059460 2021-04-12
PCT/EP2021/059460 WO2022218503A1 (en) 2021-04-12 2021-04-12 Lnp compositions comprising rna and methods for preparing, storing and using the same

Publications (1)

Publication Number Publication Date
TW202237148A true TW202237148A (zh) 2022-10-01

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TW110142348A TW202237148A (zh) 2020-11-16 2021-11-15 包含rna之lnp組合物以及製備、儲存及使用彼之方法

Country Status (10)

Country Link
US (1) US20230414747A1 (https=)
EP (1) EP4243788A1 (https=)
JP (1) JP2023549266A (https=)
KR (1) KR20230121752A (https=)
AU (1) AU2021379090A1 (https=)
CA (1) CA3198742A1 (https=)
IL (1) IL302771A (https=)
MX (1) MX2023005696A (https=)
TW (1) TW202237148A (https=)
WO (1) WO2022101470A1 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CZ310613B6 (cs) 2020-09-23 2026-01-28 Ústav organické chemie a biochemie AV ČR, v. v. i. Lipidoidy pro transfekci nukleových kyselin a jejich použití
CZ310443B6 (cs) 2021-07-19 2025-06-25 Ústav organické chemie a biochemie AV ČR, v. v. i. Cyklohexanové lipidoidy pro transfekci nukleových kyselin a jejich použití
US12449081B2 (en) 2021-09-24 2025-10-21 Cosmo Koki Co., Ltd. Boring machine
CN118488834A (zh) * 2021-11-23 2024-08-13 赛欧生物医药股份有限公司 细菌源性脂质组合物和其用途
US20250302747A1 (en) * 2022-06-08 2025-10-02 Academia Sinica Lipids, nanoparticles comprising the same and uses thereof
CN114989182B (zh) * 2022-06-23 2023-06-23 尧唐(上海)生物科技有限公司 脂质化合物、包含其的组合物及应用
EP4604927A1 (en) * 2022-10-17 2025-08-27 Agilent Technologies, Inc. Methods of analyzing lipid nanoparticles in physiological fluids
EP4637787A2 (en) * 2022-12-20 2025-10-29 Seqirus Inc. Lipid nanoparticle composition
WO2024131874A1 (en) * 2022-12-21 2024-06-27 Abogen Biosciences (Shanghai) Co., Ltd. Polynucleotides encoding cd19/cd3 bispecific antibodies
WO2024193827A1 (en) * 2023-03-23 2024-09-26 BioNTech SE Stabilized nucleic acid compositions and methods for preparing, storing and using the same
WO2024203660A1 (ja) * 2023-03-29 2024-10-03 国立大学法人東北大学 核酸内封脂質ナノ粒子の製造方法
US12311033B2 (en) 2023-05-31 2025-05-27 Capstan Therapeutics, Inc. Lipid nanoparticle formulations and compositions
WO2025068553A1 (en) 2023-09-28 2025-04-03 Universität Basel Catalytic moieties for treating cancer
WO2025080672A1 (en) * 2023-10-09 2025-04-17 The Trustees Of The University Of Pennsylvania Immune cell targeted delivery vehicles and methods of use thereof
GB202404607D0 (en) * 2024-03-29 2024-05-15 Glaxosmithkline Biologicals Sa RNA formulation

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102005046490A1 (de) 2005-09-28 2007-03-29 Johannes-Gutenberg-Universität Mainz Modifikationen von RNA, die zu einer erhöhten Transkriptstabilität und Translationseffizienz führen
WO2016005004A1 (en) 2014-07-11 2016-01-14 Biontech Rna Pharmaceuticals Gmbh Stabilization of poly(a) sequence encoding dna sequences
US20180303925A1 (en) 2015-04-27 2018-10-25 The Trustees Of The University Of Pennsylvania Nucleoside-Modified RNA For Inducing an Adaptive Immune Response
IL307179A (en) * 2015-10-28 2023-11-01 Acuitas Therapeutics Inc Novel lipids and lipid nanoparticle formulations for delivery of nucleic acids
BR112018069417A2 (pt) 2016-04-22 2019-01-22 Biontech Rna Pharmaceuticals Gmbh método para fornecer rna fita simples e ssrna
WO2017218704A1 (en) * 2016-06-14 2017-12-21 Modernatx, Inc. Stabilized formulations of lipid nanoparticles
BR112019008481A2 (pt) 2016-10-26 2020-03-03 Curevac Ag Vacinas de mrna de nanopartículas lipídicas
WO2020072605A1 (en) * 2018-10-02 2020-04-09 Intellia Therapeutics, Inc. Ionizable amine lipids
JP2023511633A (ja) * 2020-01-28 2023-03-20 モデルナティエックス インコーポレイテッド コロナウイルスｒｎａワクチン
EP3865122A1 (en) * 2020-02-11 2021-08-18 Pantherna Therapeutics GmbH Lipid composition and use thereof for delivery of a therapeutically active agent to endothelium
US20240033344A1 (en) * 2020-11-16 2024-02-01 BioNTech SE Pharmaceutical compositions comprising particles and mrna and methods for preparing and storing the same
AU2021376893A1 (en) * 2020-11-16 2023-06-15 BioNTech SE Enhanced formulation stabilization and improved lyophilization processes

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Publication number Publication date
KR20230121752A (ko) 2023-08-21
AU2021379090A9 (en) 2025-01-09
EP4243788A1 (en) 2023-09-20
US20230414747A1 (en) 2023-12-28
IL302771A (en) 2023-07-01
WO2022101470A1 (en) 2022-05-19
MX2023005696A (es) 2023-05-29
AU2021379090A1 (en) 2023-06-15
CA3198742A1 (en) 2022-05-19
JP2023549266A (ja) 2023-11-22

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