CA2997958A1 - Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device - Google Patents

Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device Download PDF

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Publication number
CA2997958A1
CA2997958A1 CA2997958A CA2997958A CA2997958A1 CA 2997958 A1 CA2997958 A1 CA 2997958A1 CA 2997958 A CA2997958 A CA 2997958A CA 2997958 A CA2997958 A CA 2997958A CA 2997958 A1 CA2997958 A1 CA 2997958A1
Authority
CA
Canada
Prior art keywords
antibody
preparation
patient
intestinal wall
tissue penetrating
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
CA2997958A
Other languages
English (en)
French (fr)
Inventor
Mir Imran
Radhika KORUPOLU
Elaine TO
Joel Harris
Mir Hashim
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.)
Rani Therapeutics LLC
Original Assignee
Incube Laboratories LLC
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 US15/150,379 external-priority patent/US11548940B2/en
Application filed by Incube Laboratories LLC filed Critical Incube Laboratories LLC
Publication of CA2997958A1 publication Critical patent/CA2997958A1/en
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/713—Double-stranded nucleic acids or oligonucleotides
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • A61K2039/541—Mucosal route
    • A61K2039/542—Mucosal route oral/gastrointestinal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • Anesthesiology (AREA)
  • Genetics & Genomics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Obesity (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Materials For Medical Uses (AREA)
CA2997958A 2015-09-08 2016-09-08 Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device Pending CA2997958A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562215586P 2015-09-08 2015-09-08
US62/215,586 2015-09-08
US15/150,379 2016-05-09
US15/150,379 US11548940B2 (en) 2014-05-15 2016-05-09 Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
PCT/US2016/050832 WO2017044665A1 (en) 2015-09-08 2016-09-08 Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Publications (1)

Publication Number Publication Date
CA2997958A1 true CA2997958A1 (en) 2017-03-16

Family

ID=58240088

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2997958A Pending CA2997958A1 (en) 2015-09-08 2016-09-08 Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Country Status (7)

Country Link
EP (1) EP3347050B1 (https=)
JP (3) JP2018526403A (https=)
CN (1) CN108401419A (https=)
AU (2) AU2016320867B2 (https=)
CA (1) CA2997958A1 (https=)
DK (1) DK3347050T3 (https=)
WO (1) WO2017044665A1 (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10689460B2 (en) 2014-05-15 2020-06-23 Incube Labs, Llc PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
EP3142645A4 (en) 2014-05-15 2017-12-27 Rani Therapeutics, LLC Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins
WO2018213579A1 (en) 2017-05-17 2018-11-22 Massachusetts Institute Of Technology Self-actuating articles
US11541015B2 (en) 2017-05-17 2023-01-03 Massachusetts Institute Of Technology Self-righting systems, methods, and related components
AU2019269636A1 (en) 2018-05-17 2020-11-19 Massachusetts Institute Of Technology Systems for electrical stimulation
US12128133B2 (en) 2018-09-25 2024-10-29 Rani Therapeutics, Llc Ingestible device with expandable enclosure
CN117100683A (zh) * 2018-12-31 2023-11-24 拉尼医疗有限公司 使用可吞服药物递送装置递送到肠道内腔的治疗剂制剂
EP4696361A3 (en) 2019-02-01 2026-04-15 Massachusetts Institute of Technology Systems and methods for liquid injection
EP3962516B1 (en) * 2019-05-03 2026-04-29 Rani Therapeutics, LLC Clotting factor viii preparations for delivery through tissue of the intestinal tract using a swallowable drug delivery device
US11541216B2 (en) 2019-11-21 2023-01-03 Massachusetts Institute Of Technology Methods for manufacturing tissue interfacing components

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2785168C (en) * 2009-12-24 2018-04-17 Incube Labs, Llc Swallowable drug delivery device and methods of drug delivery
US8721620B2 (en) * 2009-12-24 2014-05-13 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
US9149617B2 (en) * 2010-12-23 2015-10-06 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
ES2773115T3 (es) * 2011-06-29 2020-07-09 Rani Therapeutics Llc Preparados de agentes terapéuticos para la administración hacia el interior de una luz del tubo intestinal utilizando un dispositivo tragable para la administración de fármacos
PT3653223T (pt) * 2011-06-29 2021-12-06 Rani Therapeutics Llc Dispositivo para a entrega oral de compostos terapêuticos
CN104093423A (zh) 2011-07-14 2014-10-08 辉瑞公司 使用抗pcsk9抗体的治疗
CN106029096A (zh) 2014-02-14 2016-10-12 瑞泽恩制药公司 用于治疗具有未被中等剂量他汀疗法充分控制的高胆固醇血症的患者的方法
AU2016261599B2 (en) * 2015-05-08 2021-08-26 Rani Therapeutics, Llc Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Also Published As

Publication number Publication date
CN108401419A (zh) 2018-08-14
JP2018526403A (ja) 2018-09-13
AU2023204153A1 (en) 2023-07-20
EP3347050A1 (en) 2018-07-18
AU2016320867A1 (en) 2018-04-05
WO2017044665A1 (en) 2017-03-16
JP2021169530A (ja) 2021-10-28
DK3347050T3 (da) 2025-04-14
EP3347050A4 (en) 2019-05-22
EP3347050B1 (en) 2025-01-15
JP2023104992A (ja) 2023-07-28
AU2016320867B2 (en) 2023-03-30

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