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

Info

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)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (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 (cg-RX-API-DMAC7.html)
JP (3) JP2018526403A (cg-RX-API-DMAC7.html)
CN (1) CN108401419A (cg-RX-API-DMAC7.html)
AU (2) AU2016320867B2 (cg-RX-API-DMAC7.html)
CA (1) CA2997958A1 (cg-RX-API-DMAC7.html)
DK (1) DK3347050T3 (cg-RX-API-DMAC7.html)
WO (1) WO2017044665A1 (cg-RX-API-DMAC7.html)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10220076B2 (en) 2014-05-15 2019-03-05 Incube Labs, Llc Pharmaceutical compositions and methods for fabrication of solid masses comprising glucose regulating 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
US11207272B2 (en) 2017-05-17 2021-12-28 Massachusetts Institute Of Technology Tissue anchoring 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
US20200206132A1 (en) * 2018-12-31 2020-07-02 Incube Labs, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
EP3917598B1 (en) 2019-02-01 2025-10-29 Massachusetts Institute of Technology Systems for liquid injection
KR20220004148A (ko) * 2019-05-03 2022-01-11 라니 테라퓨틱스, 엘엘씨 삼킬 수 있는 약물 전달 장치를 사용하여 장관 조직으로 전달하기 위한 응고인자 제제
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
CN102905753B (zh) * 2009-12-24 2016-06-29 因卡伯实验室有限责任公司 可吞咽式药剂递送装置和药剂递送方法
US8759284B2 (en) * 2009-12-24 2014-06-24 Rani Therapeutics, Llc Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US9149617B2 (en) * 2010-12-23 2015-10-06 Rani Therapeutics, Llc Device, system and methods for the oral delivery of therapeutic compounds
PL2726091T3 (pl) * 2011-06-29 2020-08-10 Rani Therapeutics, Llc Preparaty lecznicze dostarczane do kanału przewodu jelitowego za pomocą połykalnego urządzenia dostarczającego lek
EP3653223B1 (en) * 2011-06-29 2021-08-25 Rani Therapeutics, LLC Device for the oral delivery of therapeutic compounds
BR112014000392A2 (pt) * 2011-07-14 2017-02-21 Pfizer tratamento com anticorpos anti-pcsk9
EA201691320A1 (ru) * 2014-02-14 2016-11-30 Ридженерон Фармасьютикалз, Инк. Способы лечения пациентов с гиперхолестеринемией, которая устойчива к терапии умеренными дозами статинов
EP3294273A4 (en) * 2015-05-08 2018-12-05 Incube Labs, 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
JP2023104992A (ja) 2023-07-28
AU2016320867B2 (en) 2023-03-30
AU2016320867A1 (en) 2018-04-05
DK3347050T3 (da) 2025-04-14
JP2021169530A (ja) 2021-10-28
WO2017044665A1 (en) 2017-03-16
EP3347050A1 (en) 2018-07-18
AU2023204153A1 (en) 2023-07-20
JP2018526403A (ja) 2018-09-13
EP3347050A4 (en) 2019-05-22
CN108401419A (zh) 2018-08-14
EP3347050B1 (en) 2025-01-15

Similar Documents

Publication Publication Date Title
US12018090B2 (en) PCSK9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US20230174639A1 (en) Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
EP3347050B1 (en) Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US12201721B2 (en) Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device
US11814427B2 (en) Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
AU2021269453B2 (en) Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
AU2012275112B2 (en) Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
US20230374155A1 (en) Pcsk9 antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20210908

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 8TH ANNIV.) - STANDARD

Year of fee payment: 8

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20240805

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20240805

D22 Grant of ip right intended

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D22-D128 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ALLOWANCE REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20250812

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: 20250812

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: 20260226