CO2022009089A2 - Formulaciones de anticuerpos anti-cd38 para administración subcutánea - Google Patents
Formulaciones de anticuerpos anti-cd38 para administración subcutáneaInfo
- Publication number
- CO2022009089A2 CO2022009089A2 CONC2022/0009089A CO2022009089A CO2022009089A2 CO 2022009089 A2 CO2022009089 A2 CO 2022009089A2 CO 2022009089 A CO2022009089 A CO 2022009089A CO 2022009089 A2 CO2022009089 A2 CO 2022009089A2
- Authority
- CO
- Colombia
- Prior art keywords
- antibody
- subcutaneous administration
- formulations
- antibody formulations
- viscosity
- Prior art date
Links
Classifications
-
- 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
- C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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
-
- 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)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pain & Pain Management (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Transplantation (AREA)
- Rheumatology (AREA)
- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962944082P | 2019-12-05 | 2019-12-05 | |
| PCT/US2020/063452 WO2021113739A1 (en) | 2019-12-05 | 2020-12-04 | Formulations of anti-cd38 antibodies for subcutaneous administration |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO2022009089A2 true CO2022009089A2 (es) | 2022-07-08 |
Family
ID=74130308
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CONC2022/0009089A CO2022009089A2 (es) | 2019-12-05 | 2022-06-29 | Formulaciones de anticuerpos anti-cd38 para administración subcutánea |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US20210188996A1 (https=) |
| EP (1) | EP4069743A1 (https=) |
| JP (2) | JP7670713B2 (https=) |
| KR (1) | KR20220159947A (https=) |
| CN (1) | CN115698064A (https=) |
| AU (1) | AU2020397170A1 (https=) |
| BR (1) | BR112022010905A2 (https=) |
| CA (1) | CA3160502A1 (https=) |
| CO (1) | CO2022009089A2 (https=) |
| IL (1) | IL293563A (https=) |
| MX (1) | MX2022006882A (https=) |
| TW (1) | TW202133879A (https=) |
| WO (1) | WO2021113739A1 (https=) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20210030411A (ko) * | 2018-07-10 | 2021-03-17 | 사노피 | Cd38 및 tgf-베타를 표적으로 하는 암에 대한 병용 요법 |
| US11655302B2 (en) | 2019-06-10 | 2023-05-23 | Sanofi | Anti-CD38 antibodies and formulations |
| MX2022010012A (es) * | 2020-02-13 | 2022-09-07 | Amgen Inc | Formulaciones de anticuerpos anti-tslp humanos y métodos de tratamiento de una enfermedad inflamatoria. |
| WO2023212526A1 (en) * | 2022-04-26 | 2023-11-02 | Keystone Bio, Inc. | Formulation for antigen-binding molecules that bind to porphyromonas gingivalis |
| WO2024023843A1 (en) * | 2022-07-26 | 2024-02-01 | Dr. Reddy’S Laboratories Limited | A pharmaceutical formulation of a therapeuticantibody and preparations thereof |
| WO2025240486A1 (en) * | 2024-05-14 | 2025-11-20 | Enable Injections, Inc. | Device and method for subcutaneous administration of anti-cd38 antibodies |
| WO2026046348A1 (zh) * | 2024-08-30 | 2026-03-05 | 杭州九源基因生物医药股份有限公司 | 抗cd38抗体的稳定药物制剂及其用途 |
Family Cites Families (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5449345A (en) | 1989-03-17 | 1995-09-12 | Merit Medical Systems, Inc. | Detachable and reusable digital control unit for monitoring balloon catheter data in a syringe inflation system |
| US5064413A (en) | 1989-11-09 | 1991-11-12 | Bioject, Inc. | Needleless hypodermic injection device |
| US5722956A (en) | 1995-08-24 | 1998-03-03 | The General Hospital Corporation | Multi-dose syringe driver |
| US6645177B1 (en) | 1999-02-09 | 2003-11-11 | Alaris Medical Systems, Inc. | Directly engaged syringe driver system |
| US6428509B1 (en) | 1999-07-29 | 2002-08-06 | Alaris Medical Systems, Inc. | Syringe plunger driver system and method |
| US7195610B1 (en) | 2001-09-17 | 2007-03-27 | Cardinal Health 303, Inc. | Pneumatic syringe driver |
| US7150724B2 (en) | 2002-06-05 | 2006-12-19 | Cardinal Health 303, Inc. | Syringe plunger driver system |
| JP5225069B2 (ja) | 2005-03-23 | 2013-07-03 | ゲンマブ エー/エス | 多発性骨髄腫の治療のためのcd38に対する抗体 |
| US7867197B2 (en) | 2006-03-29 | 2011-01-11 | The General Hospital Corporation | Single-dose syringe driver |
| EP1914242A1 (en) | 2006-10-19 | 2008-04-23 | Sanofi-Aventis | Novel anti-CD38 antibodies for the treatment of cancer |
| EP2191843A1 (en) | 2008-11-28 | 2010-06-02 | Sanofi-Aventis | Antitumor combinations containing antibodies recognizing specifically CD38 and cyclophosphamide |
| EP2191842A1 (en) | 2008-11-28 | 2010-06-02 | Sanofi-Aventis | Antitumor combinations containing antibodies recognizing specifically CD38 and cytarabine |
| EP2191840A1 (en) | 2008-11-28 | 2010-06-02 | Sanofi-Aventis | Antitumor combinations containing antibodies recognizing specifically CD38 and melphalan |
| EP2191841A1 (en) | 2008-11-28 | 2010-06-02 | Sanofi-Aventis | Antitumor combinations containing antibodies recognizing specifically CD38 and vincristine |
| UA112170C2 (uk) | 2010-12-10 | 2016-08-10 | Санофі | Протипухлинна комбінація, що містить антитіло, яке специфічно розпізнає cd38, і бортезоміб |
| UA118255C2 (uk) | 2012-12-07 | 2018-12-26 | Санофі | Композиція, яка містить антитіло до cd38 і леналідомід |
| SG10201913777XA (en) | 2013-03-13 | 2020-03-30 | Sanofi Sa | Compositions comprising anti-cd38 antibodies and carfilzomib |
| US20150118251A1 (en) | 2013-10-31 | 2015-04-30 | Sanofi | Specific anti-cd38 antibodies for treating human cancers |
| WO2016109822A1 (en) * | 2014-12-31 | 2016-07-07 | Novelmed Therapeutics, Inc. | Formulation of aglycosylated therapeutic antibodies |
| CA3004152C (en) * | 2015-11-03 | 2024-04-16 | Janssen Biotech, Inc. | Subcutaneous formulations of anti-cd38 antibodies and their uses |
| MA45674A (fr) * | 2016-07-15 | 2019-05-22 | Takeda Pharmaceuticals Co | Méthodes et matériaux permettant d'évaluer une réponse à des traitements de déplétion de plasmoblastes et de plasmocytes |
| US10646569B2 (en) * | 2017-05-16 | 2020-05-12 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| KR20250117714A (ko) * | 2018-03-28 | 2025-08-05 | 다케다 야쿠힌 고교 가부시키가이샤 | 항-cd38 항체의 피하 투약 |
| JP7712206B2 (ja) * | 2019-01-28 | 2025-07-23 | サノフィ-アベンティス・ユー・エス・エルエルシー | 多発性骨髄腫の処置方法 |
| BR112021021099A2 (pt) * | 2019-04-23 | 2021-12-14 | Sanofi Sa | Formulações de anticorpos estáveis, de baixa viscosidade, e usos das mesmas |
-
2020
- 2020-12-04 IL IL293563A patent/IL293563A/en unknown
- 2020-12-04 BR BR112022010905A patent/BR112022010905A2/pt unknown
- 2020-12-04 MX MX2022006882A patent/MX2022006882A/es unknown
- 2020-12-04 JP JP2022533413A patent/JP7670713B2/ja active Active
- 2020-12-04 EP EP20838318.2A patent/EP4069743A1/en active Pending
- 2020-12-04 US US17/112,768 patent/US20210188996A1/en active Pending
- 2020-12-04 KR KR1020227022845A patent/KR20220159947A/ko active Pending
- 2020-12-04 AU AU2020397170A patent/AU2020397170A1/en active Pending
- 2020-12-04 WO PCT/US2020/063452 patent/WO2021113739A1/en not_active Ceased
- 2020-12-04 CA CA3160502A patent/CA3160502A1/en active Pending
- 2020-12-04 CN CN202080094829.6A patent/CN115698064A/zh active Pending
- 2020-12-04 TW TW109142916A patent/TW202133879A/zh unknown
-
2022
- 2022-06-29 CO CONC2022/0009089A patent/CO2022009089A2/es unknown
-
2025
- 2025-04-16 JP JP2025067240A patent/JP2025156294A/ja active Pending
- 2025-10-21 US US19/364,297 patent/US20260042861A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| IL293563A (en) | 2022-08-01 |
| AU2020397170A1 (en) | 2022-07-21 |
| CN115698064A (zh) | 2023-02-03 |
| JP2023505217A (ja) | 2023-02-08 |
| BR112022010905A2 (pt) | 2022-09-06 |
| TW202133879A (zh) | 2021-09-16 |
| JP7670713B2 (ja) | 2025-04-30 |
| EP4069743A1 (en) | 2022-10-12 |
| KR20220159947A (ko) | 2022-12-05 |
| US20260042861A1 (en) | 2026-02-12 |
| CA3160502A1 (en) | 2021-06-10 |
| WO2021113739A1 (en) | 2021-06-10 |
| JP2025156294A (ja) | 2025-10-14 |
| MX2022006882A (es) | 2022-11-08 |
| US20210188996A1 (en) | 2021-06-24 |
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