HRP20200102T1 - Formulacije protutijela anti-pdl1 - Google Patents
Formulacije protutijela anti-pdl1 Download PDFInfo
- Publication number
- HRP20200102T1 HRP20200102T1 HRP20200102TT HRP20200102T HRP20200102T1 HR P20200102 T1 HRP20200102 T1 HR P20200102T1 HR P20200102T T HRP20200102T T HR P20200102TT HR P20200102 T HRP20200102 T HR P20200102T HR P20200102 T1 HRP20200102 T1 HR P20200102T1
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- Croatia
- Prior art keywords
- formulation
- formulation according
- monoclonal antibody
- concentration
- polysorbate
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims 33
- 238000009472 formulation Methods 0.000 title claims 32
- 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 claims 6
- 229930006000 Sucrose Natural products 0.000 claims 6
- 239000005720 sucrose Substances 0.000 claims 6
- 229920000136 polysorbate Polymers 0.000 claims 5
- 229950008882 polysorbate Drugs 0.000 claims 5
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 4
- 125000003275 alpha amino acid group Chemical group 0.000 claims 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 4
- 229910001092 metal group alloy Inorganic materials 0.000 claims 4
- 229920001213 Polysorbate 20 Polymers 0.000 claims 3
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 3
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 3
- 229940068977 polysorbate 20 Drugs 0.000 claims 3
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 2
- 230000004071 biological effect Effects 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 239000011521 glass Substances 0.000 claims 2
- 229910000856 hastalloy Inorganic materials 0.000 claims 2
- 238000001990 intravenous administration Methods 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 235000017281 sodium acetate Nutrition 0.000 claims 2
- 239000001632 sodium acetate Substances 0.000 claims 2
- 239000010935 stainless steel Substances 0.000 claims 2
- 229910001220 stainless steel Inorganic materials 0.000 claims 2
- 102000008096 B7-H1 Antigen Human genes 0.000 claims 1
- 108010074708 B7-H1 Antigen Proteins 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- 238000006467 substitution reaction Methods 0.000 claims 1
Classifications
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- 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
- A61K47/26—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
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- 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
- 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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2827—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against B7 molecules, e.g. CD80, CD86
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Mycology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Genetics & Genomics (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (20)
1. Stabilna vodena farmaceutska formulacija, naznačena time, da formulacija sadrži monoklonsko protutijelo anti-PDL1 u koncentraciji od 40 mg/ml do 125 mg/ml, histidin acetat ili natrijev acetat u koncentraciji od 15 mM do 25 mM, saharozu u koncentraciji od 60 mM do 240 mM, polisorbat u koncentraciji od 0,005 % (m/v) do 0,06 % (m/v) i pH vrijednost od 5,0 do 6,3, pri čemu navedeno monoklonsko protutijelo sadrži varijabilno područje lakog lanca koje sadrži aminokiselinsku sekvencu identifikacijskog broja sekvence SEQ ID NO: 7 i varijabilno područje teškog lanca koje sadrži aminokiselinsku sekvencu identifikacijskog broja sekvence SEQ ID NO: 32; te je pritom navedeno monoklonsko protutijelo humanizirano IgG1 protutijelo.
2. Formulacija prema patentnom zahtjevu 1, naznačena time, da navedeno monoklonsko protutijelo u formulaciji iznosi od 40 mg/ml do 80 mg/ml, od 54 mg/ml do 66 mg/ml, od 60 mg/ml do 125 mg/ml, 60 mg/ml ili 125 mg/ml.
3. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 2, naznačena time, da je navedeni histidin acetat ili natrijev acetat u koncentraciji od 17 mM do 22 mM ili 20 mM.
4. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, da je navedena saharoza prisutna u formulaciji u količini od 60 mM do 180 mM ili 120 mM.
5. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 4, naznačena time, da pH vrijednost formulacije iznosi od 5,5 do 6,1, 5,5 ili 5,8.
6. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time, da navedeni polisorbat u formulaciji je polisorbat 20.
7. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 6, naznačena time, da se navedeni polisorbat u formulaciji nalazi od 0,02 % do 0,04 %.
8. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 7, naznačena time, da navedeno monoklonsko protutijelo u formulaciji iznosi 60 mg/ml, da saharoza u formulaciji iznosi 120 mM te da je pH vrijednost 5,8;
navedeno monoklonsko protutijelo u formulaciji iznosi 125 mg/ml, saharoza u formulaciji iznosi 240 mM, a pH vrijednost je 5,5;
navedeno monoklonsko protutijelo je u količini od 60 mg/ml, navedeni histidin acetat je u koncentraciji od 20 mM, navedena saharoza je u koncentraciji od 120 mM, i navedeni polisorbat je polisorbat 20 u koncentraciji od 0,04 % (m/v), dok navedena formulacija ima pH vrijednost od 5,8; ili
navedeno monoklonsko protutijelo je u količini od 125 mg/ml, navedeni histidin acetat je u koncentraciji od 20 mM, navedena saharoza je u koncentraciji od 240 mM, i navedeni polisorbat je polisorbat 20 u koncentraciji od 0,02 %, a navedena formulacija ima pH vrijednost od 5,5.
9. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 8, naznačena time, da navedeno monoklonsko protutijelo nije podvrgnuto prethodnoj liofilizaciji.
10. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 9, naznačena time, da navedeno monoklonsko protutijelo sadrži: laki lanac koji sadrži aminokiselinsku sekvencu identifikacijskog broja sekvence SEQ ID NO: 9 i teški lanac koji sadrži aminokiselinsku sekvencu identifikacijskog broja sekvence SEQ ID NO: 10.
11. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 10, naznačena time, da je navedeno monoklonsko protutijelo pohranjeno u staklenu bočicu ili spremnik od metalne legure, pri čemu je metalna legura prema potrebi nehrđajući čelik 316L ili hastelloy.
12. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time, da je formulacija stabilna na temperaturi od 2-8 °C najmanje 6 mjeseci, najmanje 12 mjeseci, najmanje 18 mjeseci ili najmanje 24 mjeseca.
13. Formulacija prema patentnom zahtjevu 12, naznačena time, da protutijelo u formulaciji zadržava najmanje 80 % svoje biološke aktivnosti nakon skladištenja.
14. Formulacija prema patentnom zahtjevu 13, naznačena time, da je biološka aktivnost izmjerena vezanjem protutijela na PD-L1.
15. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 14, naznačena time, da je sterilna.
16. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 15 naznačena time, da je pogodna za primjenu na subjektu, opcionalno za intravenozno (IV) davanje.
17. Proizvod, naznačen time, da sadrži spremnik ispunjen stabilnom vodenom farmaceutskom formulacijom prema bilo kojem od patentnih zahtjeva 1 do 16.
18. Proizvod prema patentnom zahtjevu 17, naznačen time, da je spremnik staklena bočica ili spremnik od metalne legure, pri čemu je metalna legura prema potrebi nehrđajući čelik 316L ili hastelloy.
19. Sastav, naznačen time, da je za uporabu u postupku liječenja bolesti ili poremećaja kod subjekta, pri čemu on sadrži učinkovitu količinu formulacije prema bilo kojem od patentnih zahtjeva 1 do 16, gdje se bolest ili poremećaj odabire iz skupine koju čine infekcije, rak i upalne bolesti.
20. Formulacija prema bilo kojem od patentnih zahtjeva 1 do 16, naznačena time, da monoklonsko protutijelo sadrži supstituciju N297A ili D265A/N297A u konstantnom području, a ostatak je numeriran prema EU indeksu kao u Kabat-definiciji.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361883953P | 2013-09-27 | 2013-09-27 | |
PCT/US2014/057821 WO2015048520A1 (en) | 2013-09-27 | 2014-09-26 | Anti-pdl1 antibody formulations |
EP14784169.6A EP3049441B1 (en) | 2013-09-27 | 2014-09-26 | Anti-pdl1 antibody formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20200102T1 true HRP20200102T1 (hr) | 2020-04-03 |
Family
ID=51703416
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20200102TT HRP20200102T1 (hr) | 2013-09-27 | 2020-01-21 | Formulacije protutijela anti-pdl1 |
Country Status (33)
Country | Link |
---|---|
US (3) | US10875922B2 (hr) |
EP (3) | EP3626742A1 (hr) |
JP (3) | JP6942465B2 (hr) |
KR (1) | KR102331663B1 (hr) |
CN (1) | CN105793288B (hr) |
AR (1) | AR097791A1 (hr) |
AU (3) | AU2014324703C1 (hr) |
BR (1) | BR112016006397B1 (hr) |
CA (1) | CA2925310C (hr) |
CL (1) | CL2016000680A1 (hr) |
CR (1) | CR20160141A (hr) |
DK (1) | DK3049441T3 (hr) |
EA (2) | EA201991715A1 (hr) |
ES (1) | ES2768614T3 (hr) |
HK (1) | HK1222867A1 (hr) |
HR (1) | HRP20200102T1 (hr) |
HU (1) | HUE047194T2 (hr) |
IL (3) | IL244712B (hr) |
LT (1) | LT3049441T (hr) |
MA (1) | MA38960A1 (hr) |
MX (3) | MX2016003939A (hr) |
MY (1) | MY175472A (hr) |
NZ (1) | NZ719036A (hr) |
PE (1) | PE20160541A1 (hr) |
PH (2) | PH12016500566A1 (hr) |
PL (1) | PL3049441T3 (hr) |
PT (1) | PT3049441T (hr) |
RS (1) | RS59880B1 (hr) |
SG (2) | SG11201602283UA (hr) |
SI (1) | SI3049441T1 (hr) |
TW (2) | TWI714022B (hr) |
UA (1) | UA122478C2 (hr) |
WO (1) | WO2015048520A1 (hr) |
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US9427477B2 (en) | 2011-05-09 | 2016-08-30 | Mayo Foundation For Medical Education And Research | Cancer treatments |
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US10570204B2 (en) | 2013-09-26 | 2020-02-25 | The Medical College Of Wisconsin, Inc. | Methods for treating hematologic cancers |
SG11201602283UA (en) | 2013-09-27 | 2016-04-28 | Genentech Inc | Anti-pdl1 antibody formulations |
TWI680138B (zh) | 2014-01-23 | 2019-12-21 | 美商再生元醫藥公司 | 抗pd-l1之人類抗體 |
TWI681969B (zh) | 2014-01-23 | 2020-01-11 | 美商再生元醫藥公司 | 針對pd-1的人類抗體 |
JOP20200094A1 (ar) | 2014-01-24 | 2017-06-16 | Dana Farber Cancer Inst Inc | جزيئات جسم مضاد لـ pd-1 واستخداماتها |
JOP20200096A1 (ar) | 2014-01-31 | 2017-06-16 | Children’S Medical Center Corp | جزيئات جسم مضاد لـ tim-3 واستخداماتها |
CN113134095A (zh) | 2014-06-16 | 2021-07-20 | 梅约医学教育与研究基金会 | 治疗骨髓瘤 |
EP3925622A1 (en) | 2014-09-13 | 2021-12-22 | Novartis AG | Combination therapies |
US9446148B2 (en) | 2014-10-06 | 2016-09-20 | Mayo Foundation For Medical Education And Research | Carrier-antibody compositions and methods of making and using the same |
EP4245376A3 (en) | 2014-10-14 | 2023-12-13 | Novartis AG | Antibody molecules to pd-l1 and uses thereof |
BR112017019559B1 (pt) | 2015-03-13 | 2020-08-04 | Cytomx Therapeutics, Inc | Anticorpos anti-pdl1, anticorpos anti-pdl1 ativáveis, e métodos de uso destes |
WO2016191397A1 (en) * | 2015-05-22 | 2016-12-01 | Td2 Inc. | Benzamide and active compound compositions and methods of use |
EA201890790A1 (ru) | 2015-09-29 | 2018-10-31 | Селджин Корпорейшн | Связывающие pd-1 белки и способы их применения |
US10947598B2 (en) | 2015-09-29 | 2021-03-16 | Inserm (Institut National De La Sante Et De La Recherche Medicale) | Methods for determining the metabolic status of lymphomas |
TW201713360A (en) | 2015-10-06 | 2017-04-16 | Mayo Foundation | Methods of treating cancer using compositions of antibodies and carrier proteins |
BR112018009064A8 (pt) | 2015-11-17 | 2019-02-26 | Jiangsu Hengrui Medicine Co | anticorpo de pd-l1, fragmento de ligação ao antígeno do mesmo e aplicação médica do mesmo |
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US11571469B2 (en) | 2016-01-07 | 2023-02-07 | Mayo Foundation For Medical Education And Research | Methods of treating cancer with interferon wherein the cancer cells are HLA negative or have reduced HLA expression |
CA3006529A1 (en) | 2016-01-08 | 2017-07-13 | F. Hoffmann-La Roche Ag | Methods of treating cea-positive cancers using pd-1 axis binding antagonists and anti-cea/anti-cd3 bispecific antibodies |
EP3413874A4 (en) | 2016-02-12 | 2020-01-22 | Mayo Foundation for Medical Education and Research | HEMATOLOGICAL CANCER TREATMENTS |
EP4112641A1 (en) * | 2016-03-15 | 2023-01-04 | Chugai Seiyaku Kabushiki Kaisha | Methods of treating cancers using pd-1 axis binding antagonists and anti-gpc3 antibodies |
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2016
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2019
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2020
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2022
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2023
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