AR124067A2 - Formulaciones estables que comprenden un anticuerpo biespecífico para egfr / c-met - Google Patents
Formulaciones estables que comprenden un anticuerpo biespecífico para egfr / c-metInfo
- Publication number
- AR124067A2 AR124067A2 ARP210103156A ARP210103156A AR124067A2 AR 124067 A2 AR124067 A2 AR 124067A2 AR P210103156 A ARP210103156 A AR P210103156A AR P210103156 A ARP210103156 A AR P210103156A AR 124067 A2 AR124067 A2 AR 124067A2
- Authority
- AR
- Argentina
- Prior art keywords
- light chain
- seq
- amino acid
- growth factor
- acid sequences
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 2
- 102000052116 epidermal growth factor receptor activity proteins Human genes 0.000 title 1
- 108700015053 epidermal growth factor receptor activity proteins Proteins 0.000 title 1
- YOHYSYJDKVYCJI-UHFFFAOYSA-N n-[3-[[6-[3-(trifluoromethyl)anilino]pyrimidin-4-yl]amino]phenyl]cyclopropanecarboxamide Chemical compound FC(F)(F)C1=CC=CC(NC=2N=CN=C(NC=3C=C(NC(=O)C4CC4)C=CC=3)C=2)=C1 YOHYSYJDKVYCJI-UHFFFAOYSA-N 0.000 title 1
- 102000001301 EGF receptor Human genes 0.000 abstract 4
- 108060006698 EGF receptor Proteins 0.000 abstract 4
- 150000001413 amino acids Chemical group 0.000 abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 abstract 4
- 108010047041 Complementarity Determining Regions Proteins 0.000 abstract 2
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 abstract 2
- 102000008022 Proto-Oncogene Proteins c-met Human genes 0.000 abstract 2
- 108010089836 Proto-Oncogene Proteins c-met Proteins 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 2
- 229920000053 polysorbate 80 Polymers 0.000 abstract 2
- 229940068968 polysorbate 80 Drugs 0.000 abstract 2
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 abstract 1
- 206010028980 Neoplasm Diseases 0.000 abstract 1
- 229930006000 Sucrose Natural products 0.000 abstract 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 1
- 201000011510 cancer Diseases 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 1
- 150000002410 histidine derivatives Chemical class 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229930182817 methionine Natural products 0.000 abstract 1
- 239000005720 sucrose Substances 0.000 abstract 1
Classifications
-
- 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
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- 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
- 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
-
- 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
-
- 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)
- 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)
Abstract
En la presente descripción se proporcionan composiciones farmacéuticas acuosas estables que comprenden formulaciones de un anticuerpo biespecífico para el receptor del factor de crecimiento epidérmico (EGFR) / receptor del factor de crecimiento de hepatocitos (c-Met) y métodos para prepararlas. También se proporcionan en la presente descripción métodos para tratar el cáncer en un sujeto que lo necesita al administrar al sujeto la composición farmacéutica acuosa estable como se describe en la presente descripción. Además, en la presente descripción se proporcionan kits y artículos de fabricación que comprenden las composiciones farmacéuticas acuosas estables como se describe en la presente descripción. Reivindicación 1: Una composición farmacéutica acuosa estable caracterizada porque comprende: a) aproximadamente 44 mg/ml a aproximadamente 56 mg/ml de un anticuerpo biespecífico para receptor del factor de crecimiento epidérmico (EGFR) / receptor del factor de crecimiento de hepatocitos (c-Met), el anticuerpo biespecífico comprende: una primera cadena pesada (HC1) que comprende una región variable 1 de HC1 (VH1); una primera cadena ligera (LC1) que comprende una región variable 1 de cadena ligera (VL1); una segunda cadena pesada (HC2) que comprende una región variable 2 de HC2 (VH2); y una segunda cadena ligera (LC2) que comprende una región variable 2 de cadena ligera (VL2), en donde la VH1 comprende secuencias de aminoácidos de una región determinante de complementariedad de cadena pesada 1 (HCDR1), una HCDR2 y una HCDR3 de las SEQ ID Nº 1, 2 y 3, respectivamente; la VL1 comprende secuencias de aminoácidos de una región determinante de complementariedad de cadena ligera 1 (LCDR1), una LCDR2 y una LCDR3 de las SEQ ID Nº 4, 5 y 6, respectivamente, la VH2 comprende las secuencias de aminoácidos de la HCDR1, la HCDR2 y la HCDR3 de las SEQ ID Nº 7, 8 y 9, respectivamente; y la VL comprende las secuencias de aminoácidos de la LCDR1, la LCDR2 y la LCDR3 de las SEQ ID Nº 10, 11 y 12, respectivamente; b) aproximadamente 8 mM a aproximadamente 12 mM de histidina y/o sal de histidina farmacéuticamente aceptable, c) aproximadamente 6,8 % (p/v) a aproximadamente 10,2 % (p/v) de sacarosa, d) aproximadamente 0,036 % (p/v) a aproximadamente 0,084 % (p/v) de polisorbato 80 (PS80), e) aproximadamente 0,8 mg/ml a aproximadamente 1,2 mg/ml de metionina, f) aproximadamente 16 mg/ml a aproximadamente 24 mg/ml de ácido etilendiaminotetraacético (EDTA); y g) un pH de aproximadamente 5,2 a aproximadamente 6,2.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063070440P | 2020-08-26 | 2020-08-26 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR124067A2 true AR124067A2 (es) | 2023-02-08 |
Family
ID=80352835
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP210102390A AR123340A1 (es) | 2020-08-26 | 2021-08-24 | FORMULACIONES ESTABLES QUE COMPRENDEN UN ANTICUERPO BIESPECÍFICO PARA EGFR / c-MET |
| ARP210103156A AR124067A2 (es) | 2020-08-26 | 2021-11-15 | Formulaciones estables que comprenden un anticuerpo biespecífico para egfr / c-met |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP210102390A AR123340A1 (es) | 2020-08-26 | 2021-08-24 | FORMULACIONES ESTABLES QUE COMPRENDEN UN ANTICUERPO BIESPECÍFICO PARA EGFR / c-MET |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US20220064307A1 (es) |
| EP (1) | EP4204456A4 (es) |
| JP (1) | JP2023540025A (es) |
| KR (1) | KR20230057400A (es) |
| CN (1) | CN116194485A (es) |
| AR (2) | AR123340A1 (es) |
| AU (1) | AU2021333882A1 (es) |
| BR (1) | BR112023003373A2 (es) |
| CA (1) | CA3192630A1 (es) |
| CR (1) | CR20230102A (es) |
| EC (1) | ECSP23013655A (es) |
| IL (1) | IL300895A (es) |
| MX (1) | MX2023002367A (es) |
| PE (1) | PE20231370A1 (es) |
| WO (1) | WO2022043900A1 (es) |
Families Citing this family (4)
| 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 |
| KR20250029927A (ko) | 2022-06-30 | 2025-03-05 | 얀센 바이오테크 인코포레이티드 | 위암 또는 식도암을 치료하기 위한 항-egfr/항-met 항체의 용도 |
| WO2025011471A1 (en) * | 2023-07-07 | 2025-01-16 | 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 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT2620450T (pt) * | 2005-03-08 | 2018-12-17 | Pfizer Prod Inc | Composições de anticorpos anti-ctla-4 |
| ES2700231T3 (es) * | 2012-11-21 | 2019-02-14 | Janssen Biotech Inc | Anticuerpos de 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 |
| EP3688033A4 (en) * | 2017-09-29 | 2021-06-23 | Janssen Biotech, Inc. | Novel formulations which stabilize low dose antibody compositions |
| 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 |
-
2021
- 2021-08-24 AR ARP210102390A patent/AR123340A1/es unknown
- 2021-08-26 EP EP21860689.5A patent/EP4204456A4/en active Pending
- 2021-08-26 US US17/412,346 patent/US20220064307A1/en active Pending
- 2021-08-26 CR CR20230102A patent/CR20230102A/es unknown
- 2021-08-26 AU AU2021333882A patent/AU2021333882A1/en active Pending
- 2021-08-26 JP JP2023513278A patent/JP2023540025A/ja active Pending
- 2021-08-26 KR KR1020237009728A patent/KR20230057400A/ko active Pending
- 2021-08-26 IL IL300895A patent/IL300895A/en unknown
- 2021-08-26 CA CA3192630A patent/CA3192630A1/en active Pending
- 2021-08-26 PE PE2023000717A patent/PE20231370A1/es unknown
- 2021-08-26 MX MX2023002367A patent/MX2023002367A/es unknown
- 2021-08-26 BR BR112023003373A patent/BR112023003373A2/pt unknown
- 2021-08-26 WO PCT/IB2021/057802 patent/WO2022043900A1/en not_active Ceased
- 2021-08-26 CN CN202180052293.6A patent/CN116194485A/zh active Pending
- 2021-11-15 AR ARP210103156A patent/AR124067A2/es unknown
-
2023
- 2023-02-24 EC ECSENADI202313655A patent/ECSP23013655A/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| KR20230057400A (ko) | 2023-04-28 |
| CR20230102A (es) | 2023-06-23 |
| IL300895A (en) | 2023-04-01 |
| JP2023540025A (ja) | 2023-09-21 |
| EP4204456A1 (en) | 2023-07-05 |
| TW202227129A (zh) | 2022-07-16 |
| BR112023003373A2 (pt) | 2023-04-11 |
| CA3192630A1 (en) | 2022-03-03 |
| WO2022043900A1 (en) | 2022-03-03 |
| AU2021333882A1 (en) | 2023-05-11 |
| EP4204456A4 (en) | 2024-09-04 |
| MX2023002367A (es) | 2023-05-22 |
| CN116194485A (zh) | 2023-05-30 |
| ECSP23013655A (es) | 2023-03-31 |
| AR123340A1 (es) | 2022-11-23 |
| AU2021333882A9 (en) | 2023-07-13 |
| US20220064307A1 (en) | 2022-03-03 |
| PE20231370A1 (es) | 2023-09-07 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AR124067A2 (es) | Formulaciones estables que comprenden un anticuerpo biespecífico para egfr / c-met | |
| PE20240814A1 (es) | Formulaciones estables de anticuerpos contra el receptor de muerte programada 1 (pd-1) y metodos para su uso | |
| CO6230999A2 (es) | Anticuerpo anti-esclerostina | |
| PE20212088A1 (es) | Anticuerpos anti-tau y uso de los mismos | |
| AR110017A1 (es) | Anticuerpos de pd-1 y usos de estos | |
| AR127344A2 (es) | Conjugados anticuerpo-fármaco que comprenden agonistas de sting | |
| CN111971062A (zh) | 一种抗人pd-1的单克隆抗体制剂、联合用药物及其用途 | |
| FI4249512T3 (fi) | Stabiili vasta-aineformulaatio | |
| PE20190630A1 (es) | Anticuerpos de anti-tim-3 | |
| PE20170900A1 (es) | Metodos y formulaciones para tratar enfermedades vasculares de los ojos | |
| IL273841B1 (en) | Antibodies targeting cd137 and methods of use thereof | |
| PE20231049A1 (es) | Conjugados de anticuerpo y farmaco basados en eribulina y metodos para su uso | |
| PE20200294A1 (es) | Anticuerpos que se unen especificamente a pd-1 y metodos de uso | |
| PE20201503A1 (es) | Formulaciones de inmunoconjugado anti-cd79b estables | |
| AR079903A1 (es) | Formulacion de anticuerpo y regimenes terapeuticos. envase farmaceutico. kit. | |
| JP2022119854A5 (es) | ||
| CN114616249A (zh) | 含有抗pd-l1抗体的稳定制剂 | |
| JP2020518598A5 (es) | ||
| IL259036A (en) | asct2-specific binding molecules and their uses | |
| AR102592A1 (es) | Anticuerpos biespecíficos y métodos de uso en oftalmología | |
| PE20220487A1 (es) | Anticuerpos anti-ms4a4a y metodos de uso de los mismos | |
| CL2024000232A1 (es) | Composición farmacéutica de anticuerpo anti-pd-1 y uso de la misma | |
| PE20221151A1 (es) | Anticuerpos anti-cd96 y sus metodos de uso | |
| PE20221281A1 (es) | Formulaciones de anticuerpos anti-pd-l1 | |
| AR129935A1 (es) | Anticuerpo, enlazadores, carga activa, conjugados y aplicaciones de los mismos |