CA3145621A1 - High concentration anti-c5 formulations - Google Patents

High concentration anti-c5 formulations Download PDF

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Publication number
CA3145621A1
CA3145621A1 CA3145621A CA3145621A CA3145621A1 CA 3145621 A1 CA3145621 A1 CA 3145621A1 CA 3145621 A CA3145621 A CA 3145621A CA 3145621 A CA3145621 A CA 3145621A CA 3145621 A1 CA3145621 A1 CA 3145621A1
Authority
CA
Canada
Prior art keywords
pharmaceutical formulation
antigen
formulation
disease
h4h12166p
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
CA3145621A
Other languages
English (en)
French (fr)
Inventor
Mary Kleppe
Mayank PATEL
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
Individual
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 Individual filed Critical Individual
Publication of CA3145621A1 publication Critical patent/CA3145621A1/en
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • 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
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
CA3145621A 2019-08-16 2020-08-14 High concentration anti-c5 formulations Pending CA3145621A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962888086P 2019-08-16 2019-08-16
US62/888,086 2019-08-16
PCT/US2020/046314 WO2021034639A1 (en) 2019-08-16 2020-08-14 High concentration anti-c5 formulations

Publications (1)

Publication Number Publication Date
CA3145621A1 true CA3145621A1 (en) 2021-02-25

Family

ID=72560889

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3145621A Pending CA3145621A1 (en) 2019-08-16 2020-08-14 High concentration anti-c5 formulations

Country Status (15)

Country Link
US (1) US20210046182A1 (OSRAM)
EP (1) EP4013784A1 (OSRAM)
JP (2) JP7813222B2 (OSRAM)
KR (1) KR20220047826A (OSRAM)
CN (1) CN116782876A (OSRAM)
AU (1) AU2020334880A1 (OSRAM)
BR (1) BR112022002831A2 (OSRAM)
CA (1) CA3145621A1 (OSRAM)
CL (1) CL2022000340A1 (OSRAM)
CO (1) CO2022001097A2 (OSRAM)
IL (1) IL290034A (OSRAM)
JO (1) JOP20220030A1 (OSRAM)
MX (1) MX2022001896A (OSRAM)
PH (1) PH12022550167A1 (OSRAM)
WO (1) WO2021034639A1 (OSRAM)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ME03043B (me) 2013-03-14 2018-10-20 Alnylam Pharmaceuticals Inc Irnk sastavi komponente komplementa c5 i metode za njihovu upotrebu
WO2016145206A1 (en) 2015-03-10 2016-09-15 Regeneron Pharmaceuticals, Inc. Aseptic piercing system and method
WO2017218515A1 (en) 2016-06-14 2017-12-21 Regeneron Pharmaceuticals, Inc. Anti-c5 antibodies and uses thereof
ES2919934T3 (es) 2017-05-05 2022-07-29 Regeneron Pharma Autoinyector y procedimientos de uso relacionados
MX2020006113A (es) 2017-12-13 2020-08-24 Regeneron Pharma Combinaciones de anticuerpos anti-c5 y usos de las mismas.
JP2024540086A (ja) 2021-10-28 2024-10-31 リジェネロン・ファーマシューティカルズ・インコーポレイテッド Ｃ５をノックアウトするためのｃｒｉｓｐｒ／ｃａｓ関連方法及び組成物
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector
IL318297A (en) * 2022-07-27 2025-03-01 Cephalon Llc Anti-TL1A antibody formulations
CA3262839A1 (en) * 2022-07-27 2024-02-01 Cephalon Llc ANTI-TL1A ANTIBODIES FOR THE TREATMENT OF ULCERATIVE COLITIS AND CROHN'S DISEASE
WO2024092232A1 (en) * 2022-10-28 2024-05-02 Regeneron Pharmaceuticals, Inc. Anti-c5 antibody/c5 irna co-formulations and combination therapies
KR20260025363A (ko) 2023-06-16 2026-02-24 리제너론 파아마슈티컬스, 인크. 의료 디바이스 패키징 및 관련 방법
CN116712390B (zh) * 2023-08-04 2023-11-14 上海览屹医药科技有限公司 一种高浓度高稳定性的抗体制剂及其制备方法
WO2025075970A1 (en) 2023-10-02 2025-04-10 Regeneron Pharmaceuticals, Inc. Drug delivery device safety system
CN118460651B (zh) * 2024-07-10 2025-03-18 凯莱英医药集团（天津）股份有限公司 制备Cemdisiran的方法
CN119454939A (zh) * 2024-11-28 2025-02-18 北海康成(苏州)生物制药有限公司 一种欧莫扑拜单抗原液及其制备方法

Family Cites Families (21)

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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US5981501A (en) 1995-06-07 1999-11-09 Inex Pharmaceuticals Corp. Methods for encapsulating plasmids in lipid bilayers
WO1998051278A2 (en) 1997-05-14 1998-11-19 Inex Pharmaceuticals Corporation High efficiency encapsulation of charged therapeutic agents in lipid vesicles
US8101348B2 (en) 2002-07-10 2012-01-24 Max-Planck-Gesellschaft Zur Foerderung Der Wissenschaften E.V. RNA-interference by single-stranded RNA molecules
ITMI20021527A1 (it) 2002-07-11 2004-01-12 Consiglio Nazionale Ricerche Anticorpi anti componente c5 del complemento e loro uso
JP2009525986A (ja) * 2006-02-03 2009-07-16 メディミューン，エルエルシー タンパク質製剤
WO2008086395A2 (en) * 2007-01-09 2008-07-17 Wyeth Anti-il-13 antibody formulations and uses thereof
NZ588583A (en) 2008-04-15 2012-08-31 Protiva Biotherapeutics Inc Novel lipid formulations for nucleic acid delivery
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
BRPI1006519A2 (pt) * 2009-03-06 2016-08-09 Genentech Inc formulação de anticorpos
TR201811076T4 (tr) 2009-06-10 2018-08-27 Arbutus Biopharma Corp Geliştirilmiş lipit formulasyonu.
ME03043B (me) 2013-03-14 2018-10-20 Alnylam Pharmaceuticals Inc Irnk sastavi komponente komplementa c5 i metode za njihovu upotrebu
WO2015103438A2 (en) * 2014-01-02 2015-07-09 Genelux Corporation Oncolytic virus adjunct therapy with agents that increase virus infectivity
JP6718379B2 (ja) 2014-03-20 2020-07-08 インフラルクス ゲーエムベーハー ウイルス性肺炎治療のためのＣ５ａの阻害剤
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US20190225678A1 (en) 2016-06-07 2019-07-25 Novartis Ag Anti-c5 antibody for treating patients with complement c5 polymorphism
WO2017218515A1 (en) * 2016-06-14 2017-12-21 Regeneron Pharmaceuticals, Inc. Anti-c5 antibodies and uses thereof
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EP3700928A1 (en) * 2017-10-26 2020-09-02 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus)
MX2020006113A (es) * 2017-12-13 2020-08-24 Regeneron Pharma Combinaciones de anticuerpos anti-c5 y usos de las mismas.

Also Published As

Publication number Publication date
JOP20220030A1 (ar) 2023-01-30
BR112022002831A2 (pt) 2022-06-28
CL2022000340A1 (es) 2022-10-07
WO2021034639A1 (en) 2021-02-25
EP4013784A1 (en) 2022-06-22
KR20220047826A (ko) 2022-04-19
CO2022001097A2 (es) 2022-03-08
US20210046182A1 (en) 2021-02-18
JP2026003133A (ja) 2026-01-09
IL290034A (en) 2022-03-01
JP2022544589A (ja) 2022-10-19
JP7813222B2 (ja) 2026-02-12
WO2021034639A4 (en) 2021-04-15
AU2020334880A1 (en) 2022-03-24
PH12022550167A1 (en) 2023-05-08
MX2022001896A (es) 2022-06-02
CN116782876A (zh) 2023-09-19

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