CA3217191A1 - High concentration bispecific antibody formulations - Google Patents

High concentration bispecific antibody formulations Download PDF

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Publication number
CA3217191A1
CA3217191A1 CA3217191A CA3217191A CA3217191A1 CA 3217191 A1 CA3217191 A1 CA 3217191A1 CA 3217191 A CA3217191 A CA 3217191A CA 3217191 A CA3217191 A CA 3217191A CA 3217191 A1 CA3217191 A1 CA 3217191A1
Authority
CA
Canada
Prior art keywords
seq
pharmaceutical composition
amino acid
egfr
storage
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
CA3217191A
Other languages
English (en)
French (fr)
Inventor
Roland Knoblauch
Satyen Torne
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.)
Janssen Biotech Inc
Original Assignee
Janssen Biotech 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 Janssen Biotech Inc filed Critical Janssen Biotech Inc
Publication of CA3217191A1 publication Critical patent/CA3217191A1/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
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2474—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
    • 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
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • C07K2317/56—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
    • C07K2317/90—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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
CA3217191A 2021-04-21 2022-04-21 High concentration bispecific antibody formulations Pending CA3217191A1 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US202163177518P 2021-04-21 2021-04-21
US63/177,518 2021-04-21
US202163180690P 2021-04-28 2021-04-28
US63/180,690 2021-04-28
US202263309230P 2022-02-11 2022-02-11
US63/309,230 2022-02-11
PCT/IB2022/053733 WO2022224187A1 (en) 2021-04-21 2022-04-21 High concentration bispecific antibody formulations

Publications (1)

Publication Number Publication Date
CA3217191A1 true CA3217191A1 (en) 2022-10-27

Family

ID=81579656

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3217191A Pending CA3217191A1 (en) 2021-04-21 2022-04-21 High concentration bispecific antibody formulations

Country Status (17)

Country Link
US (2) US20220395573A1 (https=)
EP (1) EP4326242A1 (https=)
JP (1) JP2024514344A (https=)
KR (1) KR20230174239A (https=)
AU (1) AU2022260814A1 (https=)
BR (1) BR112023021549A2 (https=)
CA (1) CA3217191A1 (https=)
CR (1) CR20230497A (https=)
EC (1) ECSP23080283A (https=)
IL (1) IL307879A (https=)
JO (1) JOP20230263A1 (https=)
MX (1) MX2023012508A (https=)
PE (1) PE20240805A1 (https=)
PH (1) PH12023552883A1 (https=)
TW (1) TW202308689A (https=)
UY (1) UY39734A (https=)
WO (1) WO2022224187A1 (https=)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI907491B (zh) * 2020-08-26 2025-12-11 美商健生生物科技公司 包括雙特異性egfr/c-met抗體之穩定調配物
WO2024003837A1 (en) 2022-06-30 2024-01-04 Janssen Biotech, Inc. Use of anti-egfr/anti-met antibody to treat gastric or esophageal cancer
CA3228195A1 (en) 2023-05-23 2025-06-30 Janssen Biotech, Inc. Methods for treatment of non-small cell lung cancer (nsclc)
AU2024337472A1 (en) 2023-09-05 2026-04-16 Janssen Biotech, Inc. Methods of treating non-small cell lung cancer
CN119700964A (zh) * 2023-09-28 2025-03-28 上海翰森生物医药科技有限公司 一种双特异性抗体在制备治疗癌症的药物中的用途
WO2025079020A1 (en) 2023-10-12 2025-04-17 Janssen Biotech, Inc. First line treatment in egfr exon 20 insertion-mutated advanced non-small cell lung cancer
WO2025158277A1 (en) 2024-01-22 2025-07-31 Janssen Biotech, Inc. Use of amivantamab to treat head and neck cancer
WO2025191459A1 (en) 2024-03-11 2025-09-18 Janssen Biotech, Inc. Use of bispecific anti-egfr/c-met antibodies to treat solid tumors
WO2025227052A1 (en) * 2024-04-26 2025-10-30 Cephalon Llc Doses and formulations of anti-il-15 antibody for the treatment of immune diseases
WO2026022733A1 (en) 2024-07-23 2026-01-29 Janssen Biotech, Inc. Combination therapies for the treatment of colorectal cancer
WO2026022739A1 (en) 2024-07-23 2026-01-29 Janssen Biotech, Inc. Combination therapies for the treatment of colorectal cancer
WO2026042017A1 (en) 2024-08-19 2026-02-26 Janssen Biotech, Inc. Amivantamab in combination with lazertinib for the treatment of non-small cell lung cancer (nsclc)

Family Cites Families (13)

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Publication number Priority date Publication date Assignee Title
EP0281604B1 (en) 1986-09-02 1993-03-31 Enzon Labs Inc. Single polypeptide chain binding molecules
GB9015198D0 (en) 1990-07-10 1990-08-29 Brien Caroline J O Binding substance
ES2156149T3 (es) 1992-12-04 2001-06-16 Medical Res Council Proteinas de union multivalente y multiespecificas, su fabricacion y su uso.
AUPO591797A0 (en) 1997-03-27 1997-04-24 Commonwealth Scientific And Industrial Research Organisation High avidity polyvalent and polyspecific reagents
CA2450285C (en) * 2001-06-13 2016-08-02 Genmab A/S Human monoclonal antibodies to epidermal growth factor receptor (egfr)
NZ542873A (en) 2003-03-05 2008-07-31 Halozyme Inc Soluble, neutral-active hyaluronidase activity glycoprotein (sHASEGP) that is produced with high yield in a mammalian expression system by introducing nucleic acids that lack a narrow region encoding amino acids in the carboxy terminus of the human PH20 cDNA
ES2569409T3 (es) * 2005-03-08 2016-05-10 Pfizer Products Inc. Composiciones de anticuerpo anti-CTLA-4
TWI395593B (zh) * 2008-03-06 2013-05-11 Halozyme Inc 可活化的基質降解酵素之活體內暫時性控制
BR112012013148A2 (pt) * 2009-12-29 2017-03-21 F Hoffmann - La Roche Ag formulação farmacêutica e uso
HRP20241208T1 (hr) * 2010-04-20 2024-11-22 Genmab A/S Heterodimerni proteini koji sadrže fc fragment protutijela i postupci za njihovu proizvodnju
MX361088B (es) * 2012-11-21 2018-11-26 Janssen Biotech Inc Anticuerpos del receptor del factor de crecimiento epidérmico aislado/del receptor del factor de crecimiento de hepatocitos (egfr/c-met) biespecíficos.
TWI907491B (zh) * 2020-08-26 2025-12-11 美商健生生物科技公司 包括雙特異性egfr/c-met抗體之穩定調配物
EP4210702A1 (en) * 2020-09-14 2023-07-19 JANSSEN Pharmaceutica NV Fgfr inhibitor combination therapies

Also Published As

Publication number Publication date
IL307879A (en) 2023-12-01
EP4326242A1 (en) 2024-02-28
TW202308689A (zh) 2023-03-01
JOP20230263A1 (ar) 2023-10-19
WO2022224187A1 (en) 2022-10-27
ECSP23080283A (es) 2023-11-30
UY39734A (es) 2022-10-31
PE20240805A1 (es) 2024-04-18
PH12023552883A1 (en) 2024-05-20
BR112023021549A2 (pt) 2023-12-19
AU2022260814A9 (en) 2023-12-14
KR20230174239A (ko) 2023-12-27
CR20230497A (es) 2023-11-15
US20220395573A1 (en) 2022-12-15
JP2024514344A (ja) 2024-04-01
US20250195649A1 (en) 2025-06-19
MX2023012508A (es) 2023-12-15
AU2022260814A1 (en) 2023-12-07

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