AU2016320867B2 - 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
AU2016320867B2
AU2016320867B2 AU2016320867A AU2016320867A AU2016320867B2 AU 2016320867 B2 AU2016320867 B2 AU 2016320867B2 AU 2016320867 A AU2016320867 A AU 2016320867A AU 2016320867 A AU2016320867 A AU 2016320867A AU 2016320867 B2 AU2016320867 B2 AU 2016320867B2
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AU
Australia
Prior art keywords
antibody
capsule
preparation
tissue site
delivery
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.)
Active
Application number
AU2016320867A
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English (en)
Other versions
AU2016320867A1 (en
Inventor
Joel Harris
Mir Hashim
Mir Imran
Radhika KORUPOLU
Elaine TO
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
Rani Therapeutics 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 Rani Therapeutics LLC filed Critical Rani Therapeutics LLC
Publication of AU2016320867A1 publication Critical patent/AU2016320867A1/en
Assigned to RANI THERAPEUTICS, LLC reassignment RANI THERAPEUTICS, LLC Request for Assignment Assignors: INCUBE LABS, LLC
Application granted granted Critical
Publication of AU2016320867B2 publication Critical patent/AU2016320867B2/en
Priority to AU2023204153A priority Critical patent/AU2023204153A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Anesthesiology (AREA)
  • Obesity (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Mycology (AREA)
  • Cardiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2016320867A 2015-09-08 2016-09-08 PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device Active AU2016320867B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2023204153A AU2023204153A1 (en) 2015-09-08 2023-06-29 PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2023204153A Division AU2023204153A1 (en) 2015-09-08 2023-06-29 PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Publications (2)

Publication Number Publication Date
AU2016320867A1 AU2016320867A1 (en) 2018-04-05
AU2016320867B2 true AU2016320867B2 (en) 2023-03-30

Family

ID=58240088

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2016320867A Active AU2016320867B2 (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
AU2023204153A Pending AU2023204153A1 (en) 2015-09-08 2023-06-29 PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2023204153A Pending AU2023204153A1 (en) 2015-09-08 2023-06-29 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 (enExample)
JP (3) JP2018526403A (enExample)
CN (1) CN108401419A (enExample)
AU (2) AU2016320867B2 (enExample)
CA (1) CA2997958A1 (enExample)
DK (1) DK3347050T3 (enExample)
WO (1) WO2017044665A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
US11541015B2 (en) 2017-05-17 2023-01-03 Massachusetts Institute Of Technology Self-righting systems, methods, and related components
IL301683B2 (en) 2017-05-17 2025-02-01 Massachusetts Inst Technology Self-healing systems and related components and methods
EP3793667A1 (en) 2018-05-17 2021-03-24 Massachusetts Institute of Technology Systems for electrical stimulation
US12128133B2 (en) 2018-09-25 2024-10-29 Rani Therapeutics, Llc Ingestible device with expandable enclosure
EP3905999A4 (en) * 2018-12-31 2022-09-28 Rani Therapeutics, LLC THERAPEUTIC AGENT PREPARATIONS TO BE DELIVERED INTO A Lumen OF THE INTESTINAL TRACT BY MEANS OF A SWALLOWED DRUG DELIVERY DEVICE
US11771829B2 (en) 2019-02-01 2023-10-03 Massachusetts Institute Of Technology Systems and methods for liquid injection
EP3962516A4 (en) * 2019-05-03 2023-01-04 Rani Therapeutics, LLC COAGAGING FACTOR PREPARATIONS FOR ADMINISTRATION INTO TISSUES OF THE INTESTINAL TRACT USING AN INGESTIONABLE DRUG DELIVERY DEVICE
US11541216B2 (en) 2019-11-21 2023-01-03 Massachusetts Institute Of Technology Methods for manufacturing tissue interfacing components

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013008185A1 (en) * 2011-07-14 2013-01-17 Pfizer Inc. Treatment with anti-pcsk9 antibodies
US20130165859A1 (en) * 2010-12-23 2013-06-27 Incube Labs, Llc Device, system and methods for the oral delivery of therapeutic compounds
US20140221912A1 (en) * 2009-12-24 2014-08-07 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
US20150231236A1 (en) * 2014-02-14 2015-08-20 Regeneron Pharmaceuticals, Inc. Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2010336330B2 (en) * 2009-12-24 2016-04-28 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
PL2726091T3 (pl) * 2011-06-29 2020-08-10 Rani Therapeutics, Llc Preparaty lecznicze dostarczane do kanału przewodu jelitowego za pomocą połykalnego urządzenia dostarczającego lek
PL3653223T3 (pl) * 2011-06-29 2021-12-20 Rani Therapeutics, Llc Urządzenie do doustnego dostarczania związków leczniczych
CA2984422C (en) * 2015-05-08 2023-10-17 Incube Labs, Llc Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140221912A1 (en) * 2009-12-24 2014-08-07 Rani Therapeutics, Llc Swallowable drug delivery device and methods of drug delivery
US20130165859A1 (en) * 2010-12-23 2013-06-27 Incube Labs, Llc Device, system and methods for the oral delivery of therapeutic compounds
WO2013008185A1 (en) * 2011-07-14 2013-01-17 Pfizer Inc. Treatment with anti-pcsk9 antibodies
US20150231236A1 (en) * 2014-02-14 2015-08-20 Regeneron Pharmaceuticals, Inc. Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy

Also Published As

Publication number Publication date
DK3347050T3 (da) 2025-04-14
JP2021169530A (ja) 2021-10-28
JP2023104992A (ja) 2023-07-28
CN108401419A (zh) 2018-08-14
EP3347050A1 (en) 2018-07-18
WO2017044665A1 (en) 2017-03-16
EP3347050B1 (en) 2025-01-15
CA2997958A1 (en) 2017-03-16
JP2018526403A (ja) 2018-09-13
AU2016320867A1 (en) 2018-04-05
AU2023204153A1 (en) 2023-07-20
EP3347050A4 (en) 2019-05-22

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PC1 Assignment before grant (sect. 113)

Owner name: RANI THERAPEUTICS, LLC

Free format text: FORMER APPLICANT(S): INCUBE LABS, LLC

FGA Letters patent sealed or granted (standard patent)