CA3185091A1 - Stabilized formulations containing anti-ctla-4 antibodies - Google Patents

Stabilized formulations containing anti-ctla-4 antibodies

Info

Publication number
CA3185091A1
CA3185091A1 CA3185091A CA3185091A CA3185091A1 CA 3185091 A1 CA3185091 A1 CA 3185091A1 CA 3185091 A CA3185091 A CA 3185091A CA 3185091 A CA3185091 A CA 3185091A CA 3185091 A1 CA3185091 A1 CA 3185091A1
Authority
CA
Canada
Prior art keywords
pharmaceutical formulation
antibody
stable pharmaceutical
seq
amino acid
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
CA3185091A
Other languages
English (en)
French (fr)
Inventor
Yuan Cheng
David B. LUDWIG
Xiaolin Tang
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.)
Regeneron Pharmaceuticals Inc
Original Assignee
Regeneron Pharmaceuticals Inc
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
Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of CA3185091A1 publication Critical patent/CA3185091A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
CA3185091A 2020-07-08 2021-07-07 Stabilized formulations containing anti-ctla-4 antibodies Pending CA3185091A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063049540P 2020-07-08 2020-07-08
US63/049,540 2020-07-08
PCT/US2021/040648 WO2022010988A1 (en) 2020-07-08 2021-07-07 Stabilized formulations containing anti-ctla-4 antibodies

Publications (1)

Publication Number Publication Date
CA3185091A1 true CA3185091A1 (en) 2022-01-13

Family

ID=77207237

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3185091A Pending CA3185091A1 (en) 2020-07-08 2021-07-07 Stabilized formulations containing anti-ctla-4 antibodies

Country Status (10)

Country Link
US (1) US20220031843A1 (enExample)
EP (1) EP4178983A1 (enExample)
JP (1) JP2023533963A (enExample)
KR (1) KR20230035595A (enExample)
CN (1) CN115812080A (enExample)
AU (1) AU2021305093A1 (enExample)
CA (1) CA3185091A1 (enExample)
IL (1) IL299152A (enExample)
MX (1) MX2022016218A (enExample)
WO (1) WO2022010988A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112022015272A2 (pt) 2020-02-04 2022-09-20 Regeneron Pharma Teor de umidade residual alvo para produto de fármaco liofilizado

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
JO3417B1 (ar) * 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
NZ609557A (en) * 2010-10-06 2014-12-24 Regeneron Pharma Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
KR102063028B1 (ko) * 2012-01-23 2020-01-07 리제너론 파아마슈티컬스, 인크. 항-ang2 항체를 함유하는 안정화된 제형
EP2633874A1 (en) * 2012-03-02 2013-09-04 Sanofi-Aventis Deutschland GmbH Fixed-dose medicament delivery device
AR092325A1 (es) * 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
KR20250004095A (ko) * 2015-04-17 2025-01-07 브리스톨-마이어스 스큅 컴퍼니 항-pd-1 항체 및 또 다른 항체의 조합물을 포함하는 조성물
JP2020518598A (ja) * 2017-05-02 2020-06-25 メルク・シャープ・アンド・ドーム・コーポレーションMerck Sharp & Dohme Corp. 単独およびプログラム死受容体1(pd−1)抗体と組み合わされた抗ctla4抗体の安定な製剤、ならびにその使用方法
TWI799432B (zh) 2017-07-27 2023-04-21 美商再生元醫藥公司 抗ctla-4抗體及其用途
US20210317220A1 (en) * 2018-09-24 2021-10-14 Janssen Biotech, Inc. Method of providing safe administration of an anti-cd154 antibody
EP4082572A4 (en) * 2019-12-25 2024-03-06 Bio-Thera Solutions, Ltd. ANTI-CTLA-4 MONOCLONAL ANTIBODY, PREPARATION METHOD AND ITS APPLICATION

Also Published As

Publication number Publication date
US20220031843A1 (en) 2022-02-03
CN115812080A (zh) 2023-03-17
WO2022010988A1 (en) 2022-01-13
IL299152A (en) 2023-02-01
MX2022016218A (es) 2023-03-31
AU2021305093A1 (en) 2023-03-09
EP4178983A1 (en) 2023-05-17
JP2023533963A (ja) 2023-08-07
KR20230035595A (ko) 2023-03-14

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Legal Events

Date Code Title Description
W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20260106