EP4199965A4 - Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases - Google Patents
Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseasesInfo
- Publication number
- EP4199965A4 EP4199965A4 EP21857698.1A EP21857698A EP4199965A4 EP 4199965 A4 EP4199965 A4 EP 4199965A4 EP 21857698 A EP21857698 A EP 21857698A EP 4199965 A4 EP4199965 A4 EP 4199965A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- treating
- humanized antibodies
- high concentrations
- related diseases
- liquid formulations
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
Classifications
-
- 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
- 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
- A61K47/08—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
- A61K47/26—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
- C07K16/2866—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 cytokines, lymphokines, interferons
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Rheumatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2020109965 | 2020-08-19 | ||
| PCT/CN2021/113241 WO2022037606A1 (en) | 2020-08-19 | 2021-08-18 | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP4199965A1 EP4199965A1 (en) | 2023-06-28 |
| EP4199965A4 true EP4199965A4 (en) | 2025-03-26 |
Family
ID=80322555
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP21857698.1A Pending EP4199965A4 (en) | 2020-08-19 | 2021-08-18 | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4199965A4 (en) |
| CN (1) | CN116261448A (en) |
| WO (1) | WO2022037606A1 (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10961314B2 (en) * | 2016-09-27 | 2021-03-30 | Fresenius Kabi Deutschland Gmbh | Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody |
| WO2023020563A1 (en) * | 2021-08-18 | 2023-02-23 | Bio-Thera Solutions, Ltd. | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases |
| WO2024245170A1 (en) * | 2023-05-26 | 2024-12-05 | Bio-Thera Solutions, Ltd. | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10022319B2 (en) * | 2010-01-20 | 2018-07-17 | Chugai Seiyaku Kabushiki Kaisha | Stabilized antibody-containing liquid formulations |
| WO2019105450A1 (en) * | 2017-11-30 | 2019-06-06 | 百奥泰生物制药股份有限公司 | Liquid preparation of humanized antibody for treating il-6-related disease |
| WO2023020563A1 (en) * | 2021-08-18 | 2023-02-23 | Bio-Thera Solutions, Ltd. | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20160058863A1 (en) * | 2014-09-03 | 2016-03-03 | Board Of Regents, The University Of Texas System | Low viscosity concentrated protein dispersions |
| CN108718522A (en) * | 2016-02-23 | 2018-10-30 | 赛森生物股份有限公司 | IL-6 antagonist formulations and application thereof |
| WO2017201731A1 (en) * | 2016-05-27 | 2017-11-30 | Beijing Vdjbio Co., Ltd. | Antibodies, composition and kits comprising same, and methods of use thereof |
| US10961314B2 (en) * | 2016-09-27 | 2021-03-30 | Fresenius Kabi Deutschland Gmbh | Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody |
| CN111432828A (en) * | 2017-05-26 | 2020-07-17 | 约翰霍普金斯大学 | Multifunctional Antibody-Ligand Capture Agents for Modulating Immune Tolerance |
| CN111110841A (en) * | 2018-10-31 | 2020-05-08 | 上海君实生物医药科技股份有限公司 | Stable formulation containing anti-PCSK9 antibody |
-
2021
- 2021-08-18 EP EP21857698.1A patent/EP4199965A4/en active Pending
- 2021-08-18 WO PCT/CN2021/113241 patent/WO2022037606A1/en not_active Ceased
- 2021-08-18 CN CN202180051028.6A patent/CN116261448A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10022319B2 (en) * | 2010-01-20 | 2018-07-17 | Chugai Seiyaku Kabushiki Kaisha | Stabilized antibody-containing liquid formulations |
| WO2019105450A1 (en) * | 2017-11-30 | 2019-06-06 | 百奥泰生物制药股份有限公司 | Liquid preparation of humanized antibody for treating il-6-related disease |
| WO2023020563A1 (en) * | 2021-08-18 | 2023-02-23 | Bio-Thera Solutions, Ltd. | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases |
Non-Patent Citations (2)
| Title |
|---|
| KANG JICHAO ET AL: "Rapid Formulation Development for Monoclonal Antibodies", vol. 14, no. 4, 12 April 2016 (2016-04-12), pages 40, 42, 44, 46, XP009532716, ISSN: 1542-6319, Retrieved from the Internet <URL:https://bioprocessintl.com/manufacturing/formulation/rapid-formulation-development-for-monoclonal-antibodies/> * |
| See also references of WO2022037606A1 * |
Also Published As
| Publication number | Publication date |
|---|---|
| EP4199965A1 (en) | 2023-06-28 |
| WO2022037606A1 (en) | 2022-02-24 |
| CN116261448A (en) | 2023-06-13 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP4199965A4 (en) | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases | |
| MX2021014804A (en) | Antibody capable of binding to thymic stromal lymphopoietin and use thereof. | |
| EP3986392A4 (en) | Compounds for treatment of pd-l1 diseases | |
| WO2008110885A3 (en) | Methods of treating ophthalmic diseases | |
| EP3718531A4 (en) | Liquid preparation of humanized antibody for treating il-6-related disease | |
| CY1122456T1 (en) | MONOCLONAL ANTIBODIES AGAINST GROWTH AND DIFFERENTIATION FACTOR 15 (GDF-15), AND USES THEREOF FOR THE THERAPEUTIC TREATMENT OF CANCER CACHESIS AND CANCER | |
| MX2020008736A (en) | FORMULATIONS OF B7-H4 ANTIBODIES. | |
| EP4114861A4 (en) | Chimeric antigen receptors and related methods and compositions for the treatment of cancer | |
| CA3260415A1 (en) | Methods for treating complement-mediated diseases | |
| IL272194A (en) | Multispecific antibodies for use in treating diseases | |
| EP4217355A4 (en) | Agents for the treatment of diseases by inhibition of foxo1 | |
| EP4291568A4 (en) | Process for the purification of monoclonal antibodies | |
| HK40114941A (en) | Multispecific antibodies for treating cd47-associated diseases | |
| EP4048678A4 (en) | Compounds and compositions for the treatment of parasitic diseases | |
| EP4058063A4 (en) | Methods for treating diseases | |
| HK40097516A (en) | Humanized anti-liv1 antibodies for the treatment of cancer | |
| HK40098219A (en) | Humanized anti-liv1 antibodies for the treatment of cancer | |
| HK40083652A (en) | Multispecific antibodies for use in treating diseases | |
| HK40066949A (en) | Method for preventing or treating cholesterol-related diseases by using anti-pcsk9 antibody | |
| CA3270474A1 (en) | Anti-bssl antibodies for the treatment of cancer | |
| CA3263021A1 (en) | Methods for treating polysorbate-containing protein formulations | |
| HK40103804A (en) | Anti-survivin antibodies for treatment of autoimmune diseases | |
| HK40091622A (en) | Bispecific antibodies for use in treatment of nlrc4-gof inflammasomapathy | |
| HK40097084A (en) | Multispecific antibodies for the treatment of cancer | |
| HK40117713A (en) | Compound useful for treating diseases such as cancer |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
|
| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE |
|
| 17P | Request for examination filed |
Effective date: 20230307 |
|
| AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
| DAV | Request for validation of the european patent (deleted) | ||
| DAX | Request for extension of the european patent (deleted) | ||
| A4 | Supplementary search report drawn up and despatched |
Effective date: 20250224 |
|
| RIC1 | Information provided on ipc code assigned before grant |
Ipc: A61P 29/00 20060101ALI20250218BHEP Ipc: A61P 19/02 20060101ALI20250218BHEP Ipc: A61K 47/18 20170101ALI20250218BHEP Ipc: A61K 9/08 20060101ALI20250218BHEP Ipc: A61K 39/395 20060101AFI20250218BHEP |