CR20230497A - Formulaciones de anticuerpos biespecificos de alta concentración - Google Patents
Formulaciones de anticuerpos biespecificos de alta concentraciónInfo
- Publication number
- CR20230497A CR20230497A CR20230497A CR20230497A CR20230497A CR 20230497 A CR20230497 A CR 20230497A CR 20230497 A CR20230497 A CR 20230497A CR 20230497 A CR20230497 A CR 20230497A CR 20230497 A CR20230497 A CR 20230497A
- Authority
- CR
- Costa Rica
- Prior art keywords
- high concentration
- bispecific antibody
- antibody formulations
- subject
- methods
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- 102000001301 EGF receptor Human genes 0.000 abstract 2
- 108060006698 EGF receptor Proteins 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 206010028980 Neoplasm Diseases 0.000 abstract 1
- 102000008022 Proto-Oncogene Proteins c-met Human genes 0.000 abstract 1
- 108010089836 Proto-Oncogene Proteins c-met Proteins 0.000 abstract 1
- 201000011510 cancer Diseases 0.000 abstract 1
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 [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IGs], 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)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Abstract
En la presente descripción se proporcionan composiciones farmacéuticas acuosas estables que comprenden formulaciones de alta concentración de un anticuerpo biespecífico del receptor del factor de crecimiento epidérmico (EGFR)/receptor del factor de crecimiento de hepatocitos (c-Met) y métodos para preparar las mismas. En la presente descripción también se proporcionan métodos para tratar el cáncer en un sujeto que lo necesita mediante la administración por vía subcutánea al sujeto de composiciones farmacéuticas acuosas estables como se describe en la presente descripción
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US202163177518P | 2021-04-21 | 2021-04-21 | |
US202163180690P | 2021-04-28 | 2021-04-28 | |
US202263309230P | 2022-02-11 | 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 |
---|---|
CR20230497A true CR20230497A (es) | 2023-11-15 |
Family
ID=81579656
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CR20230497A CR20230497A (es) | 2021-04-21 | 2022-04-21 | Formulaciones de anticuerpos biespecificos de alta concentración |
Country Status (15)
Country | Link |
---|---|
US (1) | US20220395573A1 (es) |
EP (1) | EP4326242A1 (es) |
JP (1) | JP2024514344A (es) |
KR (1) | KR20230174239A (es) |
AU (1) | AU2022260814A1 (es) |
BR (1) | BR112023021549A2 (es) |
CA (1) | CA3217191A1 (es) |
CR (1) | CR20230497A (es) |
EC (1) | ECSP23080283A (es) |
IL (1) | IL307879A (es) |
MX (1) | MX2023012508A (es) |
PE (1) | PE20240805A1 (es) |
TW (1) | TW202308689A (es) |
UY (1) | UY39734A (es) |
WO (1) | WO2022224187A1 (es) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TW202227129A (zh) * | 2020-08-26 | 2022-07-16 | 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 |
US20240317866A1 (en) | 2022-06-30 | 2024-09-26 | Janssen Biotech, Inc. | Use of Anti-EGFR/Anti-Met Antibody to Treat Gastric or Esophageal Cancer |
Family Cites Families (12)
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 |
EP0672142B1 (en) | 1992-12-04 | 2001-02-28 | Medical Research Council | Multivalent and multispecific binding proteins, their manufacture and use |
AUPO591797A0 (en) | 1997-03-27 | 1997-04-24 | Commonwealth Scientific And Industrial Research Organisation | High avidity polyvalent and polyspecific reagents |
US7247301B2 (en) * | 2001-06-13 | 2007-07-24 | 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 |
MX2007010970A (es) * | 2005-03-08 | 2007-09-19 | Pharmacia & Upjohn Co Llc | Composiciones de anticuerpo anti-molecula de adhesion celular adresina de mucosas. |
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 |
JP2013515754A (ja) * | 2009-12-29 | 2013-05-09 | エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト | 新規な抗体製剤 |
MX353144B (es) * | 2010-04-20 | 2017-12-20 | Genmab As | Proteinas que contienen fc de anticuerpos heterodimericos y metodos para produccion de las mismas. |
TW202227129A (zh) * | 2020-08-26 | 2022-07-16 | 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 |
JP2023542296A (ja) * | 2020-09-14 | 2023-10-06 | ヤンセン ファーマシューティカ エヌ.ベー. | Fgfr阻害剤の併用療法 |
-
2022
- 2022-04-20 TW TW111114958A patent/TW202308689A/zh unknown
- 2022-04-21 PE PE2023002909A patent/PE20240805A1/es unknown
- 2022-04-21 IL IL307879A patent/IL307879A/en unknown
- 2022-04-21 AU AU2022260814A patent/AU2022260814A1/en active Pending
- 2022-04-21 BR BR112023021549A patent/BR112023021549A2/pt unknown
- 2022-04-21 KR KR1020237039536A patent/KR20230174239A/ko unknown
- 2022-04-21 US US17/725,755 patent/US20220395573A1/en active Pending
- 2022-04-21 MX MX2023012508A patent/MX2023012508A/es unknown
- 2022-04-21 WO PCT/IB2022/053733 patent/WO2022224187A1/en active Application Filing
- 2022-04-21 CA CA3217191A patent/CA3217191A1/en active Pending
- 2022-04-21 CR CR20230497A patent/CR20230497A/es unknown
- 2022-04-21 JP JP2023564087A patent/JP2024514344A/ja active Pending
- 2022-04-21 UY UY0001039734A patent/UY39734A/es unknown
- 2022-04-21 EP EP22720780.0A patent/EP4326242A1/en active Pending
-
2023
- 2023-10-20 EC ECSENADI202380283A patent/ECSP23080283A/es unknown
Also Published As
Publication number | Publication date |
---|---|
PE20240805A1 (es) | 2024-04-18 |
AU2022260814A9 (en) | 2023-12-14 |
EP4326242A1 (en) | 2024-02-28 |
US20220395573A1 (en) | 2022-12-15 |
MX2023012508A (es) | 2023-12-15 |
BR112023021549A2 (pt) | 2023-12-19 |
TW202308689A (zh) | 2023-03-01 |
JP2024514344A (ja) | 2024-04-01 |
KR20230174239A (ko) | 2023-12-27 |
IL307879A (en) | 2023-12-01 |
ECSP23080283A (es) | 2023-11-30 |
UY39734A (es) | 2022-10-31 |
WO2022224187A1 (en) | 2022-10-27 |
AU2022260814A1 (en) | 2023-12-07 |
CA3217191A1 (en) | 2022-10-27 |
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