BR112023021549A2 - Formulações de anticorpo biespecífico de alta concentração - Google Patents
Formulações de anticorpo biespecífico de alta concentraçãoInfo
- Publication number
- BR112023021549A2 BR112023021549A2 BR112023021549A BR112023021549A BR112023021549A2 BR 112023021549 A2 BR112023021549 A2 BR 112023021549A2 BR 112023021549 A BR112023021549 A BR 112023021549A BR 112023021549 A BR112023021549 A BR 112023021549A BR 112023021549 A2 BR112023021549 A2 BR 112023021549A2
- Authority
- BR
- Brazil
- Prior art keywords
- high concentration
- antibody formulations
- formulations
- methods
- pharmaceutical compositions
- Prior art date
Links
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)
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 |
|---|---|
| BR112023021549A2 true BR112023021549A2 (pt) | 2023-12-19 |
Family
ID=81579656
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112023021549A BR112023021549A2 (pt) | 2021-04-21 | 2022-04-21 | Formulações de anticorpo biespecífico de alta concentração |
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)
| 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)
| 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 |
-
2022
- 2022-04-20 TW TW111114958A patent/TW202308689A/zh unknown
- 2022-04-21 JP JP2023564087A patent/JP2024514344A/ja active Pending
- 2022-04-21 EP EP22720780.0A patent/EP4326242A1/en active Pending
- 2022-04-21 US US17/725,755 patent/US20220395573A1/en not_active Abandoned
- 2022-04-21 CA CA3217191A patent/CA3217191A1/en active Pending
- 2022-04-21 AU AU2022260814A patent/AU2022260814A1/en active Pending
- 2022-04-21 PH PH1/2023/552883A patent/PH12023552883A1/en unknown
- 2022-04-21 CR CR20230497A patent/CR20230497A/es unknown
- 2022-04-21 BR BR112023021549A patent/BR112023021549A2/pt unknown
- 2022-04-21 KR KR1020237039536A patent/KR20230174239A/ko active Pending
- 2022-04-21 WO PCT/IB2022/053733 patent/WO2022224187A1/en not_active Ceased
- 2022-04-21 UY UY0001039734A patent/UY39734A/es unknown
- 2022-04-21 MX MX2023012508A patent/MX2023012508A/es unknown
- 2022-04-21 IL IL307879A patent/IL307879A/en unknown
- 2022-04-21 PE PE2023002909A patent/PE20240805A1/es unknown
-
2023
- 2023-10-19 JO JOJO/P/2023/0263A patent/JOP20230263A1/ar unknown
- 2023-10-20 EC ECSENADI202380283A patent/ECSP23080283A/es unknown
-
2025
- 2025-03-06 US US19/072,332 patent/US20250195649A1/en active Pending
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 |
| CA3217191A1 (en) | 2022-10-27 |
| ECSP23080283A (es) | 2023-11-30 |
| UY39734A (es) | 2022-10-31 |
| PE20240805A1 (es) | 2024-04-18 |
| PH12023552883A1 (en) | 2024-05-20 |
| 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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