PE20231370A1 - Formulaciones estables que comprenden un anticuerpo biespecifico para egfr/c-met - Google Patents

Formulaciones estables que comprenden un anticuerpo biespecifico para egfr/c-met

Info

Publication number
PE20231370A1
PE20231370A1 PE2023000717A PE2023000717A PE20231370A1 PE 20231370 A1 PE20231370 A1 PE 20231370A1 PE 2023000717 A PE2023000717 A PE 2023000717A PE 2023000717 A PE2023000717 A PE 2023000717A PE 20231370 A1 PE20231370 A1 PE 20231370A1
Authority
PE
Peru
Prior art keywords
egfr
met
bispecific antibody
stable formulations
aqueous pharmaceutical
Prior art date
Application number
PE2023000717A
Other languages
English (en)
Spanish (es)
Inventor
Melissa Schreyer
Patrick Stahl
Satyen Torne
Jessica Kupec
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 PE20231370A1 publication Critical patent/PE20231370A1/es

Links

Classifications

    • 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
    • C07K16/2863Immunoglobulins [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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1406Septums, pierceable membranes
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K47/20Organic 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
    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PE2023000717A 2020-08-26 2021-08-26 Formulaciones estables que comprenden un anticuerpo biespecifico para egfr/c-met PE20231370A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063070440P 2020-08-26 2020-08-26
PCT/IB2021/057802 WO2022043900A1 (en) 2020-08-26 2021-08-26 Stable formulations comprising a bispecific egfr/c-met antibody

Publications (1)

Publication Number Publication Date
PE20231370A1 true PE20231370A1 (es) 2023-09-07

Family

ID=80352835

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2023000717A PE20231370A1 (es) 2020-08-26 2021-08-26 Formulaciones estables que comprenden un anticuerpo biespecifico para egfr/c-met

Country Status (17)

Country Link
US (1) US20220064307A1 (https=)
EP (1) EP4204456A4 (https=)
JP (1) JP2023540025A (https=)
KR (1) KR20230057400A (https=)
CN (1) CN116194485A (https=)
AR (2) AR123340A1 (https=)
AU (1) AU2021333882A1 (https=)
BR (1) BR112023003373A2 (https=)
CA (1) CA3192630A1 (https=)
CR (1) CR20230102A (https=)
EC (1) ECSP23013655A (https=)
IL (1) IL300895A (https=)
JO (1) JOP20230040A1 (https=)
MX (1) MX2023002367A (https=)
PE (1) PE20231370A1 (https=)
TW (1) TWI907491B (https=)
WO (1) WO2022043900A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202308689A (zh) * 2021-04-21 2023-03-01 美商健生生物科技公司 高濃度的雙特異性抗體調配物
WO2024003837A1 (en) 2022-06-30 2024-01-04 Janssen Biotech, Inc. Use of anti-egfr/anti-met antibody to treat gastric or esophageal cancer
AU2024287954A1 (en) * 2023-07-07 2026-01-22 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Egfr/c-met bispecific binding protein and use thereof
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
CN121045388A (zh) * 2024-05-30 2025-12-02 英百瑞(杭州)生物医药有限公司 针对人c-Met和人EGFR的双特异性抗体及其用途

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2569409T3 (es) * 2005-03-08 2016-05-10 Pfizer Products Inc. Composiciones de anticuerpo anti-CTLA-4
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.
TW201922780A (zh) * 2017-09-25 2019-06-16 美商健生生物科技公司 以抗il12/il23抗體治療狼瘡之安全且有效之方法
JP2020535181A (ja) * 2017-09-29 2020-12-03 ヤンセン バイオテツク,インコーポレーテツド 低用量抗体組成物を安定化する新規製剤
TW202308689A (zh) * 2021-04-21 2023-03-01 美商健生生物科技公司 高濃度的雙特異性抗體調配物

Also Published As

Publication number Publication date
CA3192630A1 (en) 2022-03-03
AU2021333882A1 (en) 2023-05-11
CN116194485A (zh) 2023-05-30
ECSP23013655A (es) 2023-03-31
AR124067A2 (es) 2023-02-08
EP4204456A1 (en) 2023-07-05
KR20230057400A (ko) 2023-04-28
WO2022043900A1 (en) 2022-03-03
AR123340A1 (es) 2022-11-23
IL300895A (en) 2023-04-01
JOP20230040A1 (ar) 2023-02-23
TWI907491B (zh) 2025-12-11
US20220064307A1 (en) 2022-03-03
JP2023540025A (ja) 2023-09-21
MX2023002367A (es) 2023-05-22
AU2021333882A9 (en) 2023-07-13
EP4204456A4 (en) 2024-09-04
BR112023003373A2 (pt) 2023-04-11
CR20230102A (es) 2023-06-23
TW202227129A (zh) 2022-07-16

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