PE20221281A1 - Formulaciones de anticuerpos anti-pd-l1 - Google Patents

Formulaciones de anticuerpos anti-pd-l1

Info

Publication number
PE20221281A1
PE20221281A1 PE2022001036A PE2022001036A PE20221281A1 PE 20221281 A1 PE20221281 A1 PE 20221281A1 PE 2022001036 A PE2022001036 A PE 2022001036A PE 2022001036 A PE2022001036 A PE 2022001036A PE 20221281 A1 PE20221281 A1 PE 20221281A1
Authority
PE
Peru
Prior art keywords
hvr
seq
amino acid
acid sequence
concentration
Prior art date
Application number
PE2022001036A
Other languages
English (en)
Inventor
Ada Hui
Judith Zhu-Shimoni
Original Assignee
Genentech 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 Genentech Inc filed Critical Genentech Inc
Publication of PE20221281A1 publication Critical patent/PE20221281A1/es

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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
    • A61K47/20Organic 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
    • A61K47/22Heterocyclic 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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
    • C07K16/2827Immunoglobulins [IGs], 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 B7 molecules, e.g. CD80, CD86
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Referida a una formulacion farmaceutica liquida que comprende un anticuerpo monoclonal anti-PD-L1 en una concentracion de 100 g/l a 150 g/l, acetato de histidina en una concentracion de 15 mM a 25 mM, sacarosa en una concentracion de 200 mM a 280 mM, polisorbato en una concentracion de 0,04 % (p/v) a 0,08 % (p/v), metionina en una concentracion de 5 mM a 15 mM y pH de 5,6 a 6,0, en la que el anticuerpo monoclonal comprende (a) una region variable de la cadena ligera que comprende: (1) HVR-L1 que comprende la secuencia de aminoacidos RASQDVSTAVA (SEQ ID NO: 1); (2) HVR-L2 que comprende la secuencia de aminoacidos SASFLYS (SEQ ID NO:2); (3) HVR-L3 que comprende la secuencia de aminoacidos QQYLYHPAT (SEQ ID NO:3); y (b) una region variable de la cadena pesada que comprende: (1) HVR-H1 que comprende la secuencia de aminoacidos GFTFSDSWIH (SEQ ID NO:4); (2) HVR-H2 que comprende la secuencia de aminoacidos AWISPYGGSTYYADSVKG (SEQ ID NO:5); (3) HVR-H3 que comprende la secuencia de aminoacidos WPGGFDY (SEQ ID NO:6).
PE2022001036A 2019-12-09 2020-12-07 Formulaciones de anticuerpos anti-pd-l1 PE20221281A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962945730P 2019-12-09 2019-12-09
PCT/US2020/063620 WO2021118930A2 (en) 2019-12-09 2020-12-07 Anti-pd-l1 antibody formulations

Publications (1)

Publication Number Publication Date
PE20221281A1 true PE20221281A1 (es) 2022-09-05

Family

ID=74206149

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2022001036A PE20221281A1 (es) 2019-12-09 2020-12-07 Formulaciones de anticuerpos anti-pd-l1

Country Status (15)

Country Link
US (1) US20230039268A1 (es)
EP (1) EP4073120A2 (es)
JP (1) JP2023504748A (es)
KR (1) KR20220113414A (es)
CN (1) CN114787191A (es)
AU (1) AU2020399619A1 (es)
BR (1) BR112022011228A2 (es)
CA (1) CA3158987A1 (es)
CL (2) CL2022001486A1 (es)
CR (1) CR20220322A (es)
IL (1) IL293580A (es)
MX (1) MX2022006784A (es)
PE (1) PE20221281A1 (es)
TW (1) TW202128223A (es)
WO (1) WO2021118930A2 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023122665A1 (en) 2021-12-22 2023-06-29 Genentech, Inc. Clinical formulations of anti-tigit antibodies

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US4675187A (en) 1983-05-16 1987-06-23 Bristol-Myers Company BBM-1675, a new antibiotic complex
US6548640B1 (en) 1986-03-27 2003-04-15 Btg International Limited Altered antibodies
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
DE3920358A1 (de) 1989-06-22 1991-01-17 Behringwerke Ag Bispezifische und oligospezifische, mono- und oligovalente antikoerperkonstrukte, ihre herstellung und verwendung
SG48759A1 (en) 1990-01-12 2002-07-23 Abgenix Inc Generation of xenogenic antibodies
US6150584A (en) 1990-01-12 2000-11-21 Abgenix, Inc. Human antibodies derived from immunized xenomice
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
US5625126A (en) 1990-08-29 1997-04-29 Genpharm International, Inc. Transgenic non-human animals for producing heterologous antibodies
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EP0546073B1 (en) 1990-08-29 1997-09-10 GenPharm International, Inc. production and use of transgenic non-human animals capable of producing heterologous antibodies
US5633425A (en) 1990-08-29 1997-05-27 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
US5661016A (en) 1990-08-29 1997-08-26 Genpharm International Inc. Transgenic non-human animals capable of producing heterologous antibodies of various isotypes
GB9114948D0 (en) 1991-07-11 1991-08-28 Pfizer Ltd Process for preparing sertraline intermediates
EP1978033A3 (en) 1995-04-27 2008-12-24 Amgen Fremont Inc. Human antibodies derived from immunized xenomice
CA2219486A1 (en) 1995-04-28 1996-10-31 Abgenix, Inc. Human antibodies derived from immunized xenomice
ES2301183T3 (es) 1996-12-03 2008-06-16 Amgen Fremont Inc. Anticuerpo completamente humano que se une al receptor del egfr.
IL136544A0 (en) 1997-12-05 2001-06-14 Scripps Research Inst Humanization of murine antibody
US20060104968A1 (en) 2003-03-05 2006-05-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminogly ycanases
US7871607B2 (en) 2003-03-05 2011-01-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases
SG177008A1 (en) 2003-03-05 2012-01-30 Halozyme Inc Soluble hyaluronidase glycoprotein (shasegp), process for preparing the same, uses and pharmaceutical compositions comprising thereof
TWI686405B (zh) 2008-12-09 2020-03-01 建南德克公司 抗pd-l1抗體及其於增進t細胞功能之用途
US9345661B2 (en) * 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
AR078161A1 (es) * 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
MA38960A1 (fr) 2013-09-27 2017-10-31 Genentech Inc Formulations d'anticorps anti-pdl1
CN110167594B (zh) * 2017-01-17 2023-11-21 豪夫迈·罗氏有限公司 皮下her2抗体配制剂

Also Published As

Publication number Publication date
IL293580A (en) 2022-08-01
CR20220322A (es) 2022-07-28
KR20220113414A (ko) 2022-08-12
JP2023504748A (ja) 2023-02-06
AU2020399619A1 (en) 2022-06-09
WO2021118930A2 (en) 2021-06-17
WO2021118930A3 (en) 2021-08-19
EP4073120A2 (en) 2022-10-19
CN114787191A (zh) 2022-07-22
CA3158987A1 (en) 2021-06-17
US20230039268A1 (en) 2023-02-09
CL2023001140A1 (es) 2023-10-06
CL2022001486A1 (es) 2023-01-20
TW202128223A (zh) 2021-08-01
BR112022011228A2 (pt) 2022-10-11
MX2022006784A (es) 2022-07-11

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