HRP20231282T1 - Stabilna formulacija antitijela - Google Patents

Stabilna formulacija antitijela Download PDF

Info

Publication number
HRP20231282T1
HRP20231282T1 HRP20231282TT HRP20231282T HRP20231282T1 HR P20231282 T1 HRP20231282 T1 HR P20231282T1 HR P20231282T T HRP20231282T T HR P20231282TT HR P20231282 T HRP20231282 T HR P20231282T HR P20231282 T1 HRP20231282 T1 HR P20231282T1
Authority
HR
Croatia
Prior art keywords
antibody
pharmaceutical formulation
formulation according
concentration
histidine
Prior art date
Application number
HRP20231282TT
Other languages
English (en)
Inventor
Qingyan HU
Dingjiang Liu
Original Assignee
Regeneron Pharmaceuticals, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Regeneron Pharmaceuticals, Inc. filed Critical Regeneron Pharmaceuticals, Inc.
Publication of HRP20231282T1 publication Critical patent/HRP20231282T1/hr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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 CD28 or CD152
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Claims (17)

1. Stabilna tekuća farmaceutska formulacija koja sadrži: (a) antitijelo koje se specifično veže za humani programirane smrti tipa 1 (PD-1), pri čemu antitijelo sadrži tri regije koje određuju komplementarnost teškog lanca (CDR) (HCDR1, HCDR2 i HCDR3) sadržane u varijabilnoj regiji teškog lanca (HCVR) i tri CDR lakog lanca (LCDR1, LCDR2 i LCDR3) sadržane u varijabilnoj regiji lakog lanca (LCVR), pri čemu HCDR1 sadrži SEQ ID NO: 3, HCDR2 sadrži SEQ ID NO: 4, HCDR3 sadrži SEQ ID NO: 5, LCDR1 sadrži SEQ ID NO: 6, LCDR2 sadrži SEQ ID NO: 7 i LCDR3 sadrži SEQ ID NO: 8; (b) pufer koji sadrži histidin; (c) organsko otapalo koje sadrži polisorbat; (d) saharozu kao stabilizator; i (e) prolin kao modifikator viskoznosti; pri čemu je pH stabilne tekuće farmaceutske formulacije 6,0 ± 0,3.
2. Farmaceutska formulacija prema patentnom zahtjevu 1, gdje je koncentracija antitijela: (a) od 5 mg/mL ± 0,75 mg/mL do 250 mg/mL ± 37,5 mg/mL; (b) 25 mg/mL ± 3,75 mg/mL; (c) 50 mg/mL ± 7,5 mg/mL; (d) 150 mg/mL ± 22,5 mg/mL; ili (e) 175 mg/mL ± 26,25 mg/mL.
3. Farmaceutska formulacija prema patentnom zahtjevu 1 ili 2, gdje je koncentracija histidinskog pufera od 5 mM ± 1 mM do 20 mM ± 4 mM, opcionalno gdje: (a) koncentracija histidinskog pufera je 10 mM ± 2 mM; i/ili (b) histidinski pufer se priprema od L-histidina i L-histidin monohidrokloridnog monohidrata, dalje opcionalno pri čemu se histidinski pufer priprema od 4,8 mM ± 0,96 mM L-histidina i 5,2 mM ± 1,04 mM L-histidin monohidrokloridnog monohidrata.
4. Farmaceutska formulacija prema bilo kojem od patentnih zahtjeva 1-3, gdje je koncentracija polisorbata od 0,01% ± 0,005% do 0,5% ± 0,25% w/v, opcionalno gdje: (a) koncentracija polisorbata je 0,1% ± 0,05% w/v ili 0,2% ± 0,1% w/v; i/ili (b) polisorbat je polisorbat 80.
5. Farmaceutska formulacija prema bilo kojem od patentnih zahtjeva 1-4, gdje je koncentracija saharoze od 1% ± 0,2% do 20% ± 4% w/v, opcionalno gdje je koncentracija saharoze od 1% ± 0,2% do 10% ± 2 % w/v, kao što je 5% ± 1% w/v.
6. Farmaceutska formulacija prema patentnom zahtjevu 5, gdje je koncentracija saharoze 5% ± 1% w/v, a koncentracija prolina je od 1% ± 0,2% do 5% ± 1% w/v, kao što je 1,5% ± 0,3% w/v.
7. Farmaceutska formulacija prema patentnom zahtjevu 1, koja sadrži: (a) 5 mg/mL ± 0,75 mg/mL do 250 mg/mL ± 37,5 mg/mL antitijela, (b) 10 mM ± 2 mM histidinskog pufera, (c) 0,2% ± 0,1% w/v polisorbata, (d) 5% ± 1% w/v saharoze, i (e) 1,5% ± 0,3% w/v prolina; pri pH 6,0 ± 0,3; opcionalno, gdje je koncentracija antitijela: (i) 175 mg/mL ± 26,25 mg/mL antitijela; (ii) 150 mg/mL ± 22,5 mg/mL antitijela; (iii) 50 mg/mL ± 7,5 mg/mL antitijela; ili (iv) 25 mg/mL ± 3,75 mg/mL antitijela.
8. Farmaceutska formulacija prema patentnom zahtjevu 1, koja sadrži: (a) 5 mg/mL ± 0,75 mg/mL do 250 mg/mL ± 37,5 mg/mL antitijela, (b) 0,74 mg/mL L-histidina, (c) 1,1 mg/mL L-histidin monohidrokloridnog monohidrata, (d) 2 mg/mL polisorbata, (e) 50 mg/mL saharoze, i (f) 15 mg/mL prolina; pri pH 6,0 ± 0,3; opcionalno, gdje je koncentracija antitijela: (i) 175 mg/mL ± 26,25 mg/mL antitijela; (ii) 150 mg/mL ± 22,5 mg/mL antitijela; (iii) 50 mg/mL ± 7,5 mg/mL antitijela; ili (iv) 25 mg/mL ± 3,75 mg/mL antitijela.
9. Farmaceutska formulacija prema bilo kojem od patentnih zahtjeva 1-8, gdje: (a) najmanje 90% antitijela ima nativnu konformaciju nakon 28 dana na 45°C; i/ili (b) najmanje 35% antitijela je glavna varijanta naboja antitijela nakon 28 dana na 45°C; i/ili (c) najmanje 94% antitijela ima nativnu konformaciju nakon tri mjeseca na 25°C; i/ili (d) najmanje 44% antitijela je glavna varijanta naboja antitijela nakon tri mjeseca na 25°C; i/ili (e) najmanje 96% antitijela ima nativnu konformaciju nakon 12 mjeseci na 5°C; i/ili (f) najmanje 45% antitijela glavna varijanta naboja antitijela nakon 12 mjeseci na 5°C; i/ili (g) najmanje 96% antitijela ima nativnu konformaciju nakon 12 mjeseci na -20°C, -30°C i/ili -80°C; i/ili (h) najmanje 40% antitijela je glavna varijanta naboja antitijela nakon 12 mjeseci na -20°C, -30°C i/ili -80°C.
10. Farmaceutska formulacija prema bilo kojem od patentnih zahtjeva 1-9, pri čemu antitijelo sadrži HCVR iz SEQ ID NO: 1 i LCVR iz SEQ ID NO: 2.
11. Farmaceutska formulacija prema patentnom zahtjevu 10, gdje je koncentracija antitijela: (i) 175 mg/mL ± 26,25 mg/mL antitijela; (ii) 150 mg/mL ± 22,5 mg/mL antitijela; (iii) 50 mg/mL ± 7,5 mg/mL antitijela; ili (iv) 25 mg/mL ± 3,75 mg/mL antitijela.
12. Farmaceutska formulacija prema patentnom zahtjevu 11, gdje: (a) ≥ 90% antitijela ima molekulsku težinu od 143 kDa ± 1 kDa; i/ili (b) farmaceutska formulacija ima viskoznost manju od 20 mPa-s na 25°C, opcionalno manju od 15 mPa-s na 25°C.
13. Farmaceutska formulacija prema bilo kojem od patentnih zahtjeva 1 - 12, pri čemu antitijelo sadrži teški i laki lanac, gdje: (a) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 9; (b) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 11; (c) laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 10; (d) antitijelo sadrži teški /laki lanac koji sadrži aminokiselinske sekvence SEQ ID NO: 9/10; ili (e) antitijelo sadrži teški lanac/laki lanac koji sadrži aminokiselinske sekvence SEQ ID NO: 11/10.
14. Farmaceutska formulacija prema bilo kojem od patentnih zahtjeva 1-13, pri čemu je formulacija pogodna za podkožno ili intravenozno davanje.
15. Farmaceutska formulacija prema bilo kojem od patentnih zahtjeva 1-14, pri čemu se navedena formulacija nalazi u kontejneru, opcionalno pri čemu: (a) kontejner je bočica; (b) kontejner je bočica, a bočica je prozirna bočica od stakla Tipa 1 od 10 mL; (c) kontejner je šprica; (d) kontejner je šprica, a šprica je od stakla s niskim sadržajem volframa; (e) kontejner je prethodno napunjena šprica; ili (f) kontejner je autoinjektor.
16. Komplet koji sadrži farmaceutsku formulaciju prema bilo kojem od patentnih zahtjeva 1-14, kontejner i uputstva, opcionalno gdje: (a) kontejner je staklena bočica; (b) kontejner je prethodno napunjena šprica; ili (c) kontejner je autoinjektor.
17. Farmaceutska formulacija prema patentnom zahtjevu 1, koja sadrži: (a) 50 mg/mL ± 7,5 mg/mL antitijela, (b) 0,74 mg/mL L-histidina, (c) 1,1 mg/mL L-histidin monohidrokloridnog monohidrata, (d) 2 mg/mL polisorbata 80, (e) 50 mg/mL saharoze, i (f) 15 mg/mL prolina; u vodi, pri pH 6,0 ± 0,3.
HRP20231282TT 2017-04-06 2018-03-23 Stabilna formulacija antitijela HRP20231282T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762482270P 2017-04-06 2017-04-06
PCT/US2018/024032 WO2018187057A1 (en) 2017-04-06 2018-03-23 Stable antibody formulation
EP18719338.8A EP3606504B1 (en) 2017-04-06 2018-03-23 Stable antibody formulation

Publications (1)

Publication Number Publication Date
HRP20231282T1 true HRP20231282T1 (hr) 2024-02-02

Family

ID=62028099

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20231282TT HRP20231282T1 (hr) 2017-04-06 2018-03-23 Stabilna formulacija antitijela

Country Status (29)

Country Link
US (2) US11603407B2 (hr)
EP (2) EP4249512A3 (hr)
JP (1) JP7229171B2 (hr)
KR (1) KR102667484B1 (hr)
CN (1) CN110709062B (hr)
AR (1) AR111455A1 (hr)
AU (1) AU2018247501A1 (hr)
BR (1) BR112019020246A2 (hr)
CA (1) CA3059087A1 (hr)
CL (1) CL2019002828A1 (hr)
CO (1) CO2019011021A2 (hr)
DK (1) DK3606504T5 (hr)
EA (1) EA201992377A1 (hr)
ES (1) ES2955062T3 (hr)
FI (1) FI3606504T3 (hr)
HR (1) HRP20231282T1 (hr)
HU (1) HUE063509T2 (hr)
IL (1) IL269499B1 (hr)
LT (1) LT3606504T (hr)
MA (1) MA49043B1 (hr)
MX (1) MX2019011207A (hr)
PH (1) PH12019502123A1 (hr)
PL (1) PL3606504T3 (hr)
PT (1) PT3606504T (hr)
RS (1) RS64680B1 (hr)
SG (2) SG11201908540PA (hr)
SI (1) SI3606504T1 (hr)
TW (1) TWI795396B (hr)
WO (1) WO2018187057A1 (hr)

Families Citing this family (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
FI3394103T3 (fi) 2015-12-22 2023-08-30 Regeneron Pharma Anti-PD-1-vasta-aineiden ja bispesifisten anti-CD20-/anti-CD3-vasta-aineiden yhdistelmä syövän hoitoon
KR102628557B1 (ko) 2017-02-21 2024-01-29 리제너론 파아마슈티컬스, 인크. 폐암의 치료를 위한 항-pd-1 항체
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
WO2020097141A1 (en) 2018-11-07 2020-05-14 Merck Sharp & Dohme Corp. Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof
EP3880186B1 (en) 2018-11-14 2024-04-03 Regeneron Pharmaceuticals, Inc. Intralesional administration of pd-1 inhibitors for treating skin cancer
US11634485B2 (en) 2019-02-18 2023-04-25 Eli Lilly And Company Therapeutic antibody formulation
JP2022521800A (ja) 2019-02-28 2022-04-12 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 皮膚がんを治療するためのpd-1阻害剤の投与
CA3129963A1 (en) 2019-03-06 2020-09-10 Regeneron Pharmaceuticals, Inc. Il-4/il-13 pathway inhibitors for enhanced efficacy in treating cancer
US20200369760A1 (en) * 2019-05-24 2020-11-26 Regeneron Pharmaceuticals, Inc. Stabilized formulations containing anti-angptl3 antibodies
KR20220113355A (ko) * 2019-10-02 2022-08-12 알라맵 테라퓨틱스, 인크. 항-코넥신 항체 제제
BR112022008164A2 (pt) * 2019-11-04 2022-07-12 Inovio Pharmaceuticals Inc Terapia de combinação para tratar câncer cerebral
WO2021096278A1 (ko) * 2019-11-15 2021-05-20 삼성바이오에피스 주식회사 항체 의약품용 액상 조성물
WO2021123202A1 (en) 2019-12-20 2021-06-24 Formycon Ag Formulations of anti-pd1 antibodies
KR20210097882A (ko) * 2020-01-30 2021-08-10 삼성바이오에피스 주식회사 안정한 항-pd-1 항체 약제학적 제제
WO2021187897A1 (ko) * 2020-03-18 2021-09-23 (주)지아이이노베이션 Il-2 단백질 및 cd80 단백질을 포함하는 융합단백질 제제
CA3168738A1 (en) 2020-05-26 2021-12-02 Matthew G. Fury Methods of treating cervical cancer by administering a pd-1 inhibitor
CA3180463A1 (en) * 2020-06-19 2021-12-23 Ping Hu Stable formulation for recombinant anti-pd-1 monoclonal antibody
KR20230042744A (ko) * 2020-07-31 2023-03-29 알라맵 테라퓨틱스, 인크. 항-코넥신 항체 제제
BR112023002843A2 (pt) * 2020-08-18 2023-03-14 Omeros Corp Anticorpo isolado ou fragmento de ligação a antígeno do mesmo, molécula de ácido nucleico, vetor de clonagem ou cassete de expressão, célula, métodos para gerar um anticorpo isolado ou fragmento de ligação a antígeno do mesmo, para determinar a presença ou quantidade de fator d maduro e de pró-fator d em uma amostra de teste, para avaliar o grau de ativação do caminho alternativo de complemento (apc) em uma amostra de teste, para monitorar a eficácia de tratamento com um anticorpo inibidor de lectina serina protease 3 de ligação a manana ou fragmento de ligação a antígeno do mesmo e para tratar um sujeito mamífero sofrendo de ou em risco de desenvolver uma doença ou distúrbio do caminho alternativo, composição, substrato para o uso em um imunoensaio, kit para detectar a presença ou quantidade de fator d maduro em uma amostra de teste, composição farmacêutica, e, artigo de fabricação
EP4204592A1 (en) 2020-08-26 2023-07-05 Regeneron Pharmaceuticals, Inc. Methods of treating cancer by administering a pd-1 inhibitor
AU2021337650A1 (en) 2020-09-03 2023-05-04 Regeneron Pharmaceuticals, Inc. Methods of treating cancer pain by administering a pd-1 inhibitor
AR123585A1 (es) 2020-09-24 2022-12-21 Merck Sharp & Dohme Formulaciones estables de anticuerpos programados del receptor de muerte 1 (pd-1) y variantes de hialuronidasa y fragmentos de las mismas y métodos de uso de las mismas
AU2022219955A1 (en) 2021-02-11 2023-09-21 Regeneron Pharmaceuticals, Inc. Methods of treating cancer by administering a neoadjuvant pd-1 inhibitor
AU2022227549A1 (en) 2021-02-23 2023-09-21 Regeneron Pharmaceuticals, Inc. Methods of treating lung cancer by administering a pd-1 inhibitor
MX2023011007A (es) 2021-03-23 2023-12-07 Regeneron Pharma Metodos para tratar el cancer en pacientes inmunosuprimidos o inmunocomprometidos mediante la administracion de un inhibidor de pd-1.
WO2022268887A1 (en) 2021-06-23 2022-12-29 Formycon Ag Formulations of anti-pd1 antibodies
WO2023198116A1 (en) * 2022-04-14 2023-10-19 Beigene Switzerland Gmbh Stable high concentration arginine formulations containing pd-1 antibody and methods of use thereof
TW202342098A (zh) * 2022-04-14 2023-11-01 瑞士商百濟神州瑞士有限責任公司 含有pd-1抗體的穩定高濃度氯化鈉配製物及其使用方法
WO2024133625A1 (en) 2022-12-21 2024-06-27 Formycon Ag Formulations of anti-pd1 antibodies
WO2024171082A1 (en) 2023-02-16 2024-08-22 Sun Pharmaceutical Industries Limited Stable protein compositions of anti-pd1 antibody

Family Cites Families (101)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JPH07291996A (ja) 1994-03-01 1995-11-07 Yuu Honshiyo ヒトにおけるプログラムされた細胞死に関連したポリペプチド、それをコードするdna、そのdnaからなるベクター、そのベクターで形質転換された宿主細胞、そのポリペプチドの抗体、およびそのポリペプチドまたはその抗体を含有する薬学的組成物
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
GB9809951D0 (en) 1998-05-08 1998-07-08 Univ Cambridge Tech Binding molecules
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
US7087411B2 (en) 1999-06-08 2006-08-08 Regeneron Pharmaceuticals, Inc. Fusion protein capable of binding VEGF
EP1210428B1 (en) 1999-08-23 2015-03-18 Dana-Farber Cancer Institute, Inc. Pd-1, a receptor for b7-4, and uses therefor
HUP0202882A2 (en) 1999-08-23 2002-12-28 Dana Farber Cancer Inst Inc Novel b7-4 molecules and uses therefor
EP1234031B2 (en) 1999-11-30 2021-11-24 Mayo Foundation For Medical Education And Research B7-h1, a novel immunoregulatory molecule
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
EP1297135B1 (en) 2000-06-28 2013-01-09 Genetics Institute, LLC Pd-l2 molecules: novel pd-1 ligands and uses therefor
US6596541B2 (en) 2000-10-31 2003-07-22 Regeneron Pharmaceuticals, Inc. Methods of modifying eukaryotic cells
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
AR036993A1 (es) 2001-04-02 2004-10-20 Wyeth Corp Uso de agentes que modulan la interaccion entre pd-1 y sus ligandos en la submodulacion de respuestas inmunologicas
US7794710B2 (en) 2001-04-20 2010-09-14 Mayo Foundation For Medical Education And Research Methods of enhancing T cell responsiveness
JP4488740B2 (ja) 2001-11-13 2010-06-23 ダナ−ファーバー キャンサー インスティテュート,インコーポレイテッド 免疫細胞活性化を調節する作用剤およびその使用方法
AU2003281200A1 (en) 2002-07-03 2004-01-23 Tasuku Honjo Immunopotentiating compositions
JP2004104681A (ja) 2002-09-12 2004-04-02 Renesas Technology Corp 入力バッファ回路
US20040101920A1 (en) 2002-11-01 2004-05-27 Czeslaw Radziejewski Modification assisted profiling (MAP) methodology
CA2508660C (en) 2002-12-23 2013-08-20 Wyeth Antibodies against pd-1 and uses therefor
EP2270051B1 (en) 2003-01-23 2019-05-15 Ono Pharmaceutical Co., Ltd. Antibody specific for human PD-1 and CD3
WO2005092925A2 (en) 2004-03-24 2005-10-06 Xencor, Inc. Immunoglobulin variants outside the fc region
RU2368622C2 (ru) 2004-04-13 2009-09-27 Ф.Хоффманн-Ля Рош Аг Антитела к р-селектину
JP5848861B2 (ja) 2004-04-20 2016-01-27 ジェンマブ エー/エスGenmab A/S Cd20に対するヒトモノクローナル抗体
WO2006033386A1 (ja) 2004-09-22 2006-03-30 Kirin Beer Kabushiki Kaisha 安定化されたヒトIgG4抗体
US8257740B1 (en) 2011-08-15 2012-09-04 Gp Medical, Inc. Pharmaceutical composition of nanoparticles
NZ563193A (en) 2005-05-09 2010-05-28 Ono Pharmaceutical Co Human monoclonal antibodies to programmed death 1(PD-1) and methods for treating cancer using anti-PD-1 antibodies alone or in combination with other immunotherapeutics
US8246995B2 (en) 2005-05-10 2012-08-21 The Board Of Trustees Of The Leland Stanford Junior University Hydrophobic nanotubes and nanoparticles as transporters for the delivery of drugs into cells
EP1899379B1 (en) 2005-06-20 2018-04-11 E. R. Squibb & Sons, L.L.C. Cd19 antibodies and their uses
SI1907424T1 (sl) 2005-07-01 2015-12-31 E. R. Squibb & Sons, L.L.C. Humana monoklonska protitelesa proti programiranem smrtnem ligandu 1 (PD-L1)
CN104072614B (zh) 2005-07-08 2017-04-26 生物基因Ma公司 抗-αvβ6 抗体及其用途
EP1820513A1 (en) 2006-02-15 2007-08-22 Trion Pharma Gmbh Destruction of tumor cells expressing low to medium levels of tumor associated target antigens by trifunctional bispecific antibodies
EP1997887B1 (en) 2006-03-03 2013-09-04 Ono Pharmaceutical Co., Ltd. Multimer of extracellular domain of cell surface functional molecule
MY159787A (en) 2006-06-02 2017-01-31 Regeneron Pharma High affinity antibodies to human il-6 receptor
ES2437327T3 (es) 2007-06-18 2014-01-10 Merck Sharp & Dohme B.V. Anticuerpos para el receptor PD-1 humano de muerte programada
US20090028857A1 (en) 2007-07-23 2009-01-29 Cell Genesys, Inc. Pd-1 antibodies in combination with a cytokine-secreting cell and methods of use thereof
US9243052B2 (en) 2007-08-17 2016-01-26 Daniel Olive Method for treating and diagnosing hematologic malignancies
AR070315A1 (es) * 2008-02-07 2010-03-31 Merck & Co Inc Anticuerpos 1b20 antagonistas de pcsk9
JP2011512332A (ja) 2008-02-11 2011-04-21 キュアー テック リミテッド 腫瘍治療のためのモノクローナル抗体
EP2262837A4 (en) 2008-03-12 2011-04-06 Merck Sharp & Dohme PD-1 BINDING PROTEINS
AU2009288730B2 (en) 2008-08-25 2013-06-20 Amplimmune, Inc. Compositions of PD-1 antagonists and methods of use
US8927697B2 (en) 2008-09-12 2015-01-06 Isis Innovation Limited PD-1 specific antibodies and uses thereof
EP2342228B1 (en) 2008-09-12 2017-09-06 Oxford University Innovation Limited Pd-1 specific antibodies and uses thereof
SI2342226T1 (sl) 2008-09-26 2016-11-30 Dana-Farber Cancer Institute Inc. Humana protitelesa proti PD-1, PD-L1 in PD-L2 in njihove uporabe
KR101050829B1 (ko) 2008-10-02 2011-07-20 서울대학교산학협력단 항 pd-1 항체 또는 항 pd-l1 항체를 포함하는 항암제
CN114835812A (zh) 2008-12-09 2022-08-02 霍夫曼-拉罗奇有限公司 抗-pd-l1抗体及它们用于增强t细胞功能的用途
EP2393835B1 (en) 2009-02-09 2017-04-05 Université d'Aix-Marseille Pd-1 antibodies and pd-l1 antibodies and uses thereof
MX342623B (es) 2009-06-26 2016-10-06 Regeneron Pharma Anticuerpos biespecificos facilmente aislados con formato de inmunoglobulina original.
CN104826106B (zh) 2009-09-30 2019-01-11 斯隆凯特林防癌纪念中心 用于治疗癌症的组合免疫疗法
CA2992770A1 (en) 2009-11-24 2011-06-03 Medimmune Limited Targeted binding agents against b7-h1
JP2013512251A (ja) 2009-11-24 2013-04-11 アンプリミューン、インコーポレーテッド Pd−l1/pd−l2の同時阻害
NZ719253A (en) 2010-02-08 2022-08-26 Regeneron Pharma Common light chain mouse
EP2545078A1 (en) 2010-03-11 2013-01-16 UCB Pharma, S.A. Pd-1 antibody
TW201134488A (en) 2010-03-11 2011-10-16 Ucb Pharma Sa PD-1 antibodies
CN107090029B (zh) 2010-11-11 2021-07-13 港大科桥有限公司 可溶性 pd-1变体、融合构建体及其用途
HUE039209T2 (hu) * 2011-03-31 2018-12-28 Merck Sharp & Dohme Antitestek stabil formulációi emberi programozott halálreceptor PD-1 ellen és ezzel kapcsolatos kezelések
CA2832556A1 (en) * 2011-04-07 2012-10-11 Glaxosmithkline Llc Formulations with reduced viscosity
RS57324B1 (sr) 2011-04-20 2018-08-31 Medimmune Llc Antitela i drugi molekuli koji vezuju b7-h1 i pd-1
EP2734551B1 (en) 2011-07-24 2018-01-10 Cure Tech Ltd. Variants of humanized immunomodulatory monoclonal antibodies
BR112014002353B1 (pt) 2011-08-01 2022-09-27 Genentech, Inc Usos de antagonistas de ligação do eixo pd-1 e inibidores de mek, composições farmacêuticas, e kit
EP3578203A1 (en) 2011-10-28 2019-12-11 Integritybio Inc. Protein formulations containing amino acids
EA036814B9 (ru) 2011-11-28 2021-12-27 Мерк Патент Гмбх Антитело против pd-l1 (варианты), композиция, содержащая это антитело, и их применение
GB201120527D0 (en) 2011-11-29 2012-01-11 Ucl Business Plc Method
WO2013112986A1 (en) 2012-01-27 2013-08-01 Gliknik Inc. Fusion proteins comprising igg2 hinge domains
EP3511343A1 (en) 2012-05-04 2019-07-17 Dana Farber Cancer Institute, Inc. Affinity matured anti-ccr4 humanized monoclonal antibodies and methods of use
WO2013169693A1 (en) 2012-05-09 2013-11-14 Bristol-Myers Squibb Company Methods of treating cancer using an il-21 polypeptide and an anti-pd-1 antibody
US20130303250A1 (en) 2012-05-11 2013-11-14 Ryan Moore Method of Playing a Card Game
SG11201407190TA (en) 2012-05-15 2014-12-30 Bristol Myers Squibb Co Cancer immunotherapy by disrupting pd-1/pd-l1 signaling
JP6312659B2 (ja) 2012-05-31 2018-04-18 ジェネンテック, インコーポレイテッド Pd−1系結合アンタゴニスト及びvegfアンタゴニストを用いた癌の治療方法
JOP20200236A1 (ar) 2012-09-21 2017-06-16 Regeneron Pharma الأجسام المضادة لمضاد cd3 وجزيئات ربط الأنتيجين ثنائية التحديد التي تربط cd3 وcd20 واستخداماتها
EA038920B1 (ru) 2012-10-02 2021-11-10 Бристол-Майерс Сквибб Компани Комбинация антител к kir и антител к pd-1 для лечения злокачественной опухоли
US10034939B2 (en) 2012-10-26 2018-07-31 The University Of Chicago Synergistic combination of immunologic inhibitors for the treatment of cancer
TWI635098B (zh) 2013-02-01 2018-09-11 再生元醫藥公司 含嵌合恆定區之抗體
MX2015010880A (es) 2013-02-22 2015-12-03 Curevac Gmbh Combinacion de vacunacion e inhibicion de la trayectoria pd-1.
WO2014159562A1 (en) 2013-03-14 2014-10-02 Bristol-Myers Squibb Company Combination of dr5 agonist and anti-pd-1 antagonist and methods of use
SG10201701380TA (en) 2013-03-15 2017-04-27 Genentech Inc Biomarkers and methods of treating pd-1 and pd-l1 related conditions
TWI679019B (zh) 2013-04-29 2019-12-11 法商賽諾菲公司 抗il-4/抗il-13之雙特異性抗體調配物
CN105339389B (zh) 2013-05-02 2021-04-27 安奈普泰斯生物有限公司 针对程序性死亡-1(pd-1)的抗体
WO2014194293A1 (en) 2013-05-30 2014-12-04 Amplimmune, Inc. Improved methods for the selection of patients for pd-1 or b7-h4 targeted therapies, and combination therapies thereof
WO2014209804A1 (en) 2013-06-24 2014-12-31 Biomed Valley Discoveries, Inc. Bispecific antibodies
KR20220042248A (ko) 2013-07-16 2022-04-04 제넨테크, 인크. Pd-1 축 결합 길항제 및 tigit 억제제를 사용한 암을 치료하는 방법
WO2015016718A1 (en) 2013-08-02 2015-02-05 Bionovion Holding B.V. Combining cd27 agonists and immune checkpoint inhibition for immune stimulation
AR097306A1 (es) 2013-08-20 2016-03-02 Merck Sharp & Dohme Modulación de la inmunidad tumoral
AU2014309199B2 (en) 2013-08-20 2018-04-19 Merck Sharp & Dohme Llc Treating cancer with a combination of a PD-1 antagonist and dinaciclib
ES2728578T3 (es) 2013-09-20 2019-10-25 Bristol Myers Squibb Co Combinación de anticuerpos anti-LAG-3 y anticuerpos anti-PD-1 para tratar tumores
EP3757130A1 (en) 2013-09-26 2020-12-30 Costim Pharmaceuticals Inc. Methods for treating hematologic cancers
CA2925310C (en) 2013-09-27 2022-12-06 Genentech, Inc. Anti-pdl1 antibody formulations
KR101712245B1 (ko) 2013-11-29 2017-03-06 아레스 트레이딩 에스.에이. TNFR 및 면역글로블린 Fc 영역을 포함하는 융합 단백질을 포함하는 액상 제제
WO2015095392A1 (en) 2013-12-17 2015-06-25 Genentech, Inc. Anti-cd3 antibodies and methods of use
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
TWI754319B (zh) 2014-03-19 2022-02-01 美商再生元醫藥公司 用於腫瘤治療之方法及抗體組成物
US10092645B2 (en) 2014-06-17 2018-10-09 Medimmune Limited Methods of treatment with antagonists against PD-1 and PD-L1 in combination with radiation therapy
TWI693232B (zh) 2014-06-26 2020-05-11 美商宏觀基因股份有限公司 與pd-1和lag-3具有免疫反應性的共價結合的雙抗體和其使用方法
EP4245376A3 (en) 2014-10-14 2023-12-13 Novartis AG Antibody molecules to pd-l1 and uses thereof
EP3268392A2 (en) 2015-03-13 2018-01-17 CytomX Therapeutics, Inc. Anti-pdl1 antibodies, activatable anti-pdl1 antibodies, and methods of use thereof
ES2813580T3 (es) 2015-04-17 2021-03-24 Bristol Myers Squibb Co Composiciones que comprenden una combinación de ipilimumab y nivolumab
FI3394103T3 (fi) 2015-12-22 2023-08-30 Regeneron Pharma Anti-PD-1-vasta-aineiden ja bispesifisten anti-CD20-/anti-CD3-vasta-aineiden yhdistelmä syövän hoitoon

Also Published As

Publication number Publication date
PH12019502123A1 (en) 2020-06-29
PT3606504T (pt) 2023-09-04
US20190040137A1 (en) 2019-02-07
CN110709062B (zh) 2024-03-08
MX2019011207A (es) 2019-12-11
JP7229171B2 (ja) 2023-02-27
SG10202111008QA (en) 2021-11-29
MA49043A (fr) 2020-02-12
EP3606504B1 (en) 2023-07-19
IL269499B1 (en) 2024-08-01
JP2020516608A (ja) 2020-06-11
BR112019020246A2 (pt) 2020-05-12
FI3606504T3 (fi) 2023-08-23
CN110709062A (zh) 2020-01-17
SI3606504T1 (sl) 2023-10-30
HUE063509T2 (hu) 2024-01-28
ES2955062T3 (es) 2023-11-28
US11603407B2 (en) 2023-03-14
WO2018187057A1 (en) 2018-10-11
SG11201908540PA (en) 2019-10-30
EA201992377A1 (ru) 2020-02-17
AR111455A1 (es) 2019-07-17
MA49043B1 (fr) 2023-11-30
RS64680B1 (sr) 2023-11-30
IL269499A (en) 2019-11-28
TW201900210A (zh) 2019-01-01
TWI795396B (zh) 2023-03-11
US20230183348A1 (en) 2023-06-15
LT3606504T (lt) 2023-09-11
KR20190134743A (ko) 2019-12-04
KR102667484B1 (ko) 2024-05-22
CO2019011021A2 (es) 2020-01-17
PL3606504T3 (pl) 2024-01-08
EP3606504A1 (en) 2020-02-12
AU2018247501A1 (en) 2019-10-31
DK3606504T3 (en) 2023-09-04
DK3606504T5 (da) 2024-09-02
EP4249512A2 (en) 2023-09-27
CA3059087A1 (en) 2018-10-11
EP4249512A3 (en) 2023-11-22
CL2019002828A1 (es) 2019-12-27

Similar Documents

Publication Publication Date Title
HRP20231282T1 (hr) Stabilna formulacija antitijela
US11926670B2 (en) Stabilized formulations containing anti-interleukin-4 receptor (IL-4R) antibodies
JP6456470B2 (ja) 抗pcsk9抗体を含む安定化製剤
ES2688070T3 (es) Forrmulaciones estabilizadas que contienen anticuerpos anti-receptor de la interleucina 6 (IL-6R)
CA3028238C (en) Stable liquid pharmaceutical preparation
KR20130079486A (ko) 항―ngf 항체를 함유하는 안정화된 제형
RU2014142990A (ru) Стабильные препараты связывающего средства на основе igg4
RU2019102943A (ru) Составы на основе антитела
EP2854849A1 (en) Stabilized formulations containing anti-dll4 antibodies
TWI498121B (zh) 含有抗-介白素-4受體(il-4r)抗體之安定化配製物
JPWO2020191270A5 (hr)
OA20777A (en) Stable antibody formulation.
EA042167B1 (ru) Стабилизированные композиции, содержащие антитела к рецептору интерлейкина-4 (il-4r)
EA047546B1 (ru) Стабилизированные составы, содержащие антитела анти-pcsk9
OA16466A (en) Stabilized formulations containing antiinterleukin-6 receptor (IL-6R) antibodies.