CA3198742A1 - Lnp compositions comprising rna and methods for preparing, storing and using the same - Google Patents

Lnp compositions comprising rna and methods for preparing, storing and using the same

Info

Publication number
CA3198742A1
CA3198742A1 CA3198742A CA3198742A CA3198742A1 CA 3198742 A1 CA3198742 A1 CA 3198742A1 CA 3198742 A CA3198742 A CA 3198742A CA 3198742 A CA3198742 A CA 3198742A CA 3198742 A1 CA3198742 A1 CA 3198742A1
Authority
CA
Canada
Prior art keywords
composition
rna
lipid
anions
substantially free
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3198742A
Other languages
English (en)
French (fr)
Inventor
Steffen Panzner
Ugur Sahin
Jorrit-Jan KRIJGER
Kaushik THANKI
Bakul Subodh BHATNAGAR
Ramin Darvari
Sumit Luthra
Serguei Tchessalov
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.)
Biontech SE
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/EP2021/059460 external-priority patent/WO2022218503A1/en
Application filed by Individual filed Critical Individual
Publication of CA3198742A1 publication Critical patent/CA3198742A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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

Landscapes

  • 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)
CA3198742A 2020-11-16 2021-11-15 Lnp compositions comprising rna and methods for preparing, storing and using the same Pending CA3198742A1 (en)

Applications Claiming Priority (15)

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
EP2020082602 2020-11-18
US63/115,588 2020-11-18
US63/115,128 2020-11-18
EPPCT/EP2020/082602 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
EPPCT/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
PCT/EP2021/081675 WO2022101470A1 (en) 2020-11-16 2021-11-15 Lnp compositions comprising rna and methods for preparing, storing and using the same

Publications (1)

Publication Number Publication Date
CA3198742A1 true CA3198742A1 (en) 2022-05-19

Family

ID=78621901

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3198742A Pending CA3198742A1 (en) 2020-11-16 2021-11-15 Lnp compositions comprising rna and methods for preparing, storing and using the same

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

Also Published As

Publication number Publication date
KR20230121752A (ko) 2023-08-21
AU2021379090A9 (en) 2025-01-09
EP4243788A1 (en) 2023-09-20
US20230414747A1 (en) 2023-12-28
TW202237148A (zh) 2022-10-01
IL302771A (en) 2023-07-01
WO2022101470A1 (en) 2022-05-19
MX2023005696A (es) 2023-05-29
AU2021379090A1 (en) 2023-06-15
JP2023549266A (ja) 2023-11-22

Similar Documents

Publication Publication Date Title
CA3198742A1 (en) Lnp compositions comprising rna and methods for preparing, storing and using the same
US20240033344A1 (en) Pharmaceutical compositions comprising particles and mrna and methods for preparing and storing the same
US20240408032A1 (en) Lipid-based rna formulations suitable for therapy
AU2022336160B2 (en) Potency assay for therapeutic potential of coding nucleic acid
WO2022218503A1 (en) Lnp compositions comprising rna and methods for preparing, storing and using the same
CN116829134A (zh) 包含rna的lnp组合物及其制备、储存和使用方法
US20250222132A1 (en) Nucleic acid compositions comprising a multivalent anion, such as an inorganic polyphosphate, and methods for preparing, storing and using the same
US20240226132A1 (en) Rna compositions comprising a buffer substance and methods for preparing, storing and using the same
JP2026508330A (ja) 多重コーディング核酸のリンカー配列効力アッセイ
WO2024180363A1 (en) Linker sequence potency assays for multiple coding nucleic acids
HK40100852A (zh) 包含rna的lnp组合物及其制备、储存和使用方法

Legal Events

Date Code Title Description
MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 3RD ANNIV.) - STANDARD

Year of fee payment: 3

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20241105

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20241105

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20241105

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D11-D117 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION RECEIVED

Effective date: 20251029

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-P10-P11-P101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - VOLUNTARY AMENDMENT

Effective date: 20251029

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20251029

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 4TH ANNIV.) - STANDARD

Year of fee payment: 4

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20251103

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20251103

D00 Search and/or examination requested or commenced

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D00-D118 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20260217

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D00-D118 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20260217

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D11-D155 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ALL REQUIREMENTS FOR EXAMINATION DETERMINED COMPLIANT

Effective date: 20260217

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20260217