AU2019346134C1 - Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody - Google Patents

Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody Download PDF

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Publication number
AU2019346134C1
AU2019346134C1 AU2019346134A AU2019346134A AU2019346134C1 AU 2019346134 C1 AU2019346134 C1 AU 2019346134C1 AU 2019346134 A AU2019346134 A AU 2019346134A AU 2019346134 A AU2019346134 A AU 2019346134A AU 2019346134 C1 AU2019346134 C1 AU 2019346134C1
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AU
Australia
Prior art keywords
week
antibody
subject
treatment
amino acid
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Ceased
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AU2019346134A
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English (en)
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AU2019346134B2 (en
AU2019346134A1 (en
Inventor
Omoniyi ADEDOKUN
Jewel JOHANNS
Katherine Li
Colleen MARANO
Christopher O'brien
Kimberly SHIELDS-TUTTLE
Richard Strauss
Hongyan Zhang
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Janssen Biotech Inc
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Janssen Biotech Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=69885324&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2019346134(C1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Janssen Biotech Inc filed Critical Janssen Biotech Inc
Publication of AU2019346134A1 publication Critical patent/AU2019346134A1/en
Publication of AU2019346134B2 publication Critical patent/AU2019346134B2/en
Priority to AU2023201217A priority Critical patent/AU2023201217A1/en
Priority to AU2023100041A priority patent/AU2023100041B4/en
Priority to AU2023100042A priority patent/AU2023100042B9/en
Priority to AU2024100007A priority patent/AU2024100007C4/en
Priority to AU2024100006A priority patent/AU2024100006C4/en
Priority to AU2024100016A priority patent/AU2024100016C4/en
Priority to AU2024100017A priority patent/AU2024100017A4/en
Publication of AU2019346134C1 publication Critical patent/AU2019346134C1/en
Application granted granted Critical
Priority to AU2024100044A priority patent/AU2024100044B4/en
Priority to AU2024100045A priority patent/AU2024100045B4/en
Priority to AU2024100046A priority patent/AU2024100046B4/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2019346134A 2018-09-24 2019-09-24 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody Ceased AU2019346134C1 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
AU2023201217A AU2023201217A1 (en) 2018-09-24 2023-02-28 Safe and effective method of treating ulcerative colitis with anti-IL12/IL23 antibody
AU2023100042A AU2023100042B9 (en) 2018-09-24 2023-05-18 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2023100041A AU2023100041B4 (en) 2018-09-24 2023-05-18 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100006A AU2024100006C4 (en) 2018-09-24 2024-02-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100007A AU2024100007C4 (en) 2018-09-24 2024-02-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100016A AU2024100016C4 (en) 2018-09-24 2024-03-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100017A AU2024100017A4 (en) 2018-09-24 2024-03-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100044A AU2024100044B4 (en) 2018-09-24 2024-11-29 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100045A AU2024100045B4 (en) 2018-09-24 2024-11-29 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100046A AU2024100046B4 (en) 2018-09-24 2024-11-29 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201862735501P 2018-09-24 2018-09-24
US62/735,501 2018-09-24
US201862769818P 2018-11-20 2018-11-20
US62/769,818 2018-11-20
US201962895774P 2019-09-04 2019-09-04
US62/895,774 2019-09-04
PCT/IB2019/058098 WO2020065532A1 (en) 2018-09-24 2019-09-24 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2023201217A Division AU2023201217A1 (en) 2018-09-24 2023-02-28 Safe and effective method of treating ulcerative colitis with anti-IL12/IL23 antibody

Publications (3)

Publication Number Publication Date
AU2019346134A1 AU2019346134A1 (en) 2021-04-01
AU2019346134B2 AU2019346134B2 (en) 2023-01-12
AU2019346134C1 true AU2019346134C1 (en) 2024-06-20

Family

ID=69885324

Family Applications (11)

Application Number Title Priority Date Filing Date
AU2019346134A Ceased AU2019346134C1 (en) 2018-09-24 2019-09-24 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2023201217A Pending AU2023201217A1 (en) 2018-09-24 2023-02-28 Safe and effective method of treating ulcerative colitis with anti-IL12/IL23 antibody
AU2023100042A Revoked AU2023100042B9 (en) 2018-09-24 2023-05-18 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2023100041A Revoked AU2023100041B4 (en) 2018-09-24 2023-05-18 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100007A Revoked AU2024100007C4 (en) 2018-09-24 2024-02-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100006A Revoked AU2024100006C4 (en) 2018-09-24 2024-02-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100017A Ceased AU2024100017A4 (en) 2018-09-24 2024-03-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100016A Revoked AU2024100016C4 (en) 2018-09-24 2024-03-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100044A Revoked AU2024100044B4 (en) 2018-09-24 2024-11-29 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100046A Revoked AU2024100046B4 (en) 2018-09-24 2024-11-29 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100045A Revoked AU2024100045B4 (en) 2018-09-24 2024-11-29 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody

Family Applications After (10)

Application Number Title Priority Date Filing Date
AU2023201217A Pending AU2023201217A1 (en) 2018-09-24 2023-02-28 Safe and effective method of treating ulcerative colitis with anti-IL12/IL23 antibody
AU2023100042A Revoked AU2023100042B9 (en) 2018-09-24 2023-05-18 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2023100041A Revoked AU2023100041B4 (en) 2018-09-24 2023-05-18 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100007A Revoked AU2024100007C4 (en) 2018-09-24 2024-02-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100006A Revoked AU2024100006C4 (en) 2018-09-24 2024-02-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100017A Ceased AU2024100017A4 (en) 2018-09-24 2024-03-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100016A Revoked AU2024100016C4 (en) 2018-09-24 2024-03-21 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100044A Revoked AU2024100044B4 (en) 2018-09-24 2024-11-29 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100046A Revoked AU2024100046B4 (en) 2018-09-24 2024-11-29 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
AU2024100045A Revoked AU2024100045B4 (en) 2018-09-24 2024-11-29 Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody

Country Status (25)

Country Link
US (3) US10961307B2 (enExample)
EP (1) EP3883606B9 (enExample)
JP (4) JP7359845B2 (enExample)
KR (2) KR20230148273A (enExample)
CN (2) CN120514845A (enExample)
AU (11) AU2019346134C1 (enExample)
BR (1) BR112021005467A2 (enExample)
CA (2) CA3160103A1 (enExample)
CZ (1) CZ38255U1 (enExample)
DE (1) DE202019006083U1 (enExample)
DK (3) DK3883606T5 (enExample)
ES (1) ES2959463T3 (enExample)
FI (2) FI3883606T3 (enExample)
HR (1) HRP20230886T1 (enExample)
HU (1) HUE063462T2 (enExample)
IL (2) IL326284A (enExample)
LT (1) LT3883606T (enExample)
MD (1) MD3883606T3 (enExample)
MX (1) MX2021003411A (enExample)
PL (1) PL3883606T3 (enExample)
PT (1) PT3883606T (enExample)
RS (1) RS64552B9 (enExample)
SI (1) SI3883606T1 (enExample)
SM (1) SMT202300262T1 (enExample)
WO (1) WO2020065532A1 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL326284A (en) 2018-09-24 2026-04-01 Janssen Biotech Inc A safe and effective method for treating ulcerative colitis with an anti-IL12/IL23 antibody
JP7805788B2 (ja) 2019-05-23 2026-01-26 ヤンセン バイオテツク，インコーポレーテツド Ｉｌ－２３及びｔｎｆアルファに対する抗体の併用療法による炎症性腸疾患の治療方法
EP4424381A3 (en) * 2019-10-18 2024-11-13 Janssen Biotech, Inc. Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody
US20210347880A1 (en) * 2020-05-05 2021-11-11 Janssen Biotech, Inc. Methods of Treating Crohn's Disease with Anti-IL23 Specific Antibody
IL298389A (en) 2020-05-21 2023-01-01 Janssen Biotech Inc Method of treating inflammatory bowel disease with a combination therapy of antibodies to il-23 and tnf alpha
WO2022013745A1 (en) * 2020-07-13 2022-01-20 Janssen Biotech, Inc. Safe and effective method of treating psoriatic arthritis with anti-il23 specific antibody
US20220073603A1 (en) * 2020-07-30 2022-03-10 Janssen Biotech, Inc. Method of Treating Psoriasis in Pediatric Subjects with Anti-IL12/IL23 Antibody
US20220102008A1 (en) * 2020-09-30 2022-03-31 Genentech, Inc. Methods and systems for placebo response modeling
WO2022184114A1 (zh) * 2021-03-03 2022-09-09 苏州盛迪亚生物医药有限公司 抗il-17抗体治疗自身免疫性疾病和炎症的方法
EP4376888A4 (en) * 2021-07-26 2025-07-02 Avalo Therapeutics Inc METHODS OF TREATING ULCERATIVE COLITIS WITH ANTI-LIGHT ANTIBODIES
WO2023056417A1 (en) * 2021-09-30 2023-04-06 Eli Lilly And Company Anti-il-23p19 antibody regulation of genes involved in bowel urgency in ulcerative colitis
WO2025062347A1 (en) * 2023-09-21 2025-03-27 Janssen Pharmaceutica Nv Interleukin-23 receptor antagonist for use in the treatment of ulcerative colitis
CA3258952A1 (en) * 2024-06-27 2026-03-01 Janssen Biotech, Inc. Methods of treating ulcerative colitis with anti-il23 specific antibody
WO2026058045A1 (en) 2024-09-12 2026-03-19 Takeda Pharmaceutical Company Limited Alpha4beta7 inhibitor and il-23 inhibitor combination therapy

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