DK2916866T3 - Formulering til bispecifikke t-celle-engangers (bites) - Google Patents

Formulering til bispecifikke t-celle-engangers (bites) Download PDF

Info

Publication number
DK2916866T3
DK2916866T3 DK13786255.3T DK13786255T DK2916866T3 DK 2916866 T3 DK2916866 T3 DK 2916866T3 DK 13786255 T DK13786255 T DK 13786255T DK 2916866 T3 DK2916866 T3 DK 2916866T3
Authority
DK
Denmark
Prior art keywords
psma
ser
composition
gly
thr
Prior art date
Application number
DK13786255.3T
Other languages
English (en)
Inventor
Carsten Olbrich
Thomas Bunte
Jörg Peters
Thomas Trill
Jonas Winter
Original Assignee
Bayer Pharma AG
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 Bayer Pharma AG filed Critical Bayer Pharma AG
Application granted granted Critical
Publication of DK2916866T3 publication Critical patent/DK2916866T3/da

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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • 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
    • C07K16/2809Immunoglobulins [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 the T-cell receptor (TcR)-CD3 complex
    • 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
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3069Reproductive system, e.g. ovaria, uterus, testes, prostate
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Microbiology (AREA)
  • Reproductive Health (AREA)
  • Pregnancy & Childbirth (AREA)
  • Cell Biology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Mycology (AREA)
  • Zoology (AREA)
  • Urology & Nephrology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Oil, Petroleum & Natural Gas (AREA)

Claims (12)

1. Flydende farmaceutisk sammensætning, der omfatter et polypeptid, TRIS og phosphat, hvor polypeptidet omfatter aminosyresekvensen ifølge SEQ ID NO: 8, kendetegnet ved, at sammensætningen indeholder polypeptidet i en koncentration fra 0,5 yg/mL til 3,0 mg/ml, at sammensætningen indeholder 100 mM TRIS og 50 mM phosphat, at sammensætningens pH-værdi ligger mellem 5,0 og 7,5, at sammensætningen indeholder 0,04 % (m/v) polysorbat 80 og at sammensætningen endvidere indeholder et lyobeskyttende stof.
2. Sammensætning ifølge krav 1, kendetegnet ved, at sammensætningen indeholder 2 - 10 % (m/v) af et lyobeskyttende stof.
3. Sammensætning ifølge krav 2, kendetegnet ved, at det lyobeskyttende stof er trehalose eller trehalosedihydrat.
4. Sammensætning ifølge et hvilket som helst foregående krav, kendetegnet ved, at sammensætningen indeholder polypeptidet i en koncentration på 2 mg/ml.
5. Faststofblanding, der kan fremstilles ved frysetørring af en flydende sammensætning ifølge et hvilket som helst foregående krav.
6. Flydende farmaceutisk sammensætning, kendetegnet ved, at sammensætningen rekonstitueres ved opløsning af en frysetørret faststofblanding ifølge krav 5 i et egnet flydende medium.
7. Sammensætning ifølge et hvilket som helst foregående krav, kendetegnet ved, at polypeptidets biotilgængelighed efter subkutan indgivelse af sammensætningen er >60 %.
8. Sammensætning ifølge et hvilket som helst foregående krav til anvendelse i en terapeutisk fremgangsmåde.
9. Sammensætning ifølge et hvilket som helst foregående krav til anvendelse i en terapeutisk fremgangsmåde, hvor fremgangsmåden omfatter parenteral indgivelse af sammensætningen.
10. Sammensætning ifølge et hvilket som helst foregående krav til anvendelse i en fremgangsmåde til terapeutisk behandling af hyperproliferative prostatasygdomme.
11. Sammensætning ifølge et hvilket som helst foregående krav til anvendelse i en fremgangsmåde til terapeutisk behandling af hyperproliferative prostatasygdomme, hvor fremgangsmåden omfatter subkutan indgivelse af sammensætningen.
12. Injektionssprøjte, der indeholder en sammensætning ifølge et hvilket som helst foregående krav.
DK13786255.3T 2012-11-06 2013-11-05 Formulering til bispecifikke t-celle-engangers (bites) DK2916866T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP12191493 2012-11-06
PCT/EP2013/073024 WO2014072277A1 (de) 2012-11-06 2013-11-05 Formulierung für bispecific t-cell-engangers (bites)

Publications (1)

Publication Number Publication Date
DK2916866T3 true DK2916866T3 (da) 2018-07-23

Family

ID=47143702

Family Applications (1)

Application Number Title Priority Date Filing Date
DK13786255.3T DK2916866T3 (da) 2012-11-06 2013-11-05 Formulering til bispecifikke t-celle-engangers (bites)

Country Status (27)

Country Link
US (1) US11052128B2 (da)
EP (1) EP2916866B1 (da)
JP (1) JP6321667B2 (da)
KR (1) KR20150082328A (da)
CN (1) CN104780940B (da)
AR (1) AR093365A1 (da)
AU (2) AU2013343638B2 (da)
CA (1) CA2890166C (da)
CY (1) CY1120391T1 (da)
DK (1) DK2916866T3 (da)
ES (1) ES2676468T3 (da)
HK (1) HK1211215A1 (da)
HR (1) HRP20181021T1 (da)
HU (1) HUE038151T2 (da)
IL (1) IL238615A0 (da)
LT (1) LT2916866T (da)
MX (1) MX367034B (da)
NZ (1) NZ707895A (da)
PL (1) PL2916866T3 (da)
PT (1) PT2916866T (da)
RS (1) RS57394B1 (da)
RU (1) RU2679124C2 (da)
SG (1) SG11201502730SA (da)
SI (1) SI2916866T1 (da)
TR (1) TR201809507T4 (da)
TW (1) TWI615158B (da)
WO (1) WO2014072277A1 (da)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016019969A1 (en) 2014-08-08 2016-02-11 Ludwig-Maximilians-Universität München Subcutaneously administered bispecific antibodies for use in the treatment of cancer
SG11202102995PA (en) * 2018-10-01 2021-04-29 Amgen Inc Methods for reducing aggregation of bispecific antibodies
EP3897720A4 (en) * 2018-12-19 2022-12-07 City of Hope BAFF-R BISPECIFIC T-CELL ENGAGER ANTIBODY
BR112022007776A2 (pt) * 2019-10-25 2022-07-05 Amgen Inc Composições e métodos para minimizar a perda de proteína em baixas concentrações de proteína
CN115968867B (zh) * 2023-03-21 2023-07-14 天津外泌体科技有限公司 外泌体冻干保护剂和外泌体冻干制剂的制备方法

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6171586B1 (en) * 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
EP1767225A1 (en) 2005-09-21 2007-03-28 Insense Limited Method for stabilisation of a protein solution by addition of hydroxyl radical quenchers and its sterilisation by ionising radiation
GB0626021D0 (en) 2006-12-29 2007-02-07 Insense Ltd The stabilisation of proteins
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
RS53008B2 (sr) 2007-04-03 2022-12-30 Amgen Res Munich Gmbh Interspecijski specifičan cd3-epsilon vezujući domen
MX2009010611A (es) 2007-04-03 2010-03-26 Micromet Ag Enlazadores biespecificos, especificos para especies.
JP5490714B2 (ja) * 2007-11-28 2014-05-14 メディミューン,エルエルシー タンパク質製剤
AR070316A1 (es) * 2008-02-07 2010-03-31 Merck & Co Inc Antagonistas de pcsk9 (proproteina subtilisina-kexina tipo 9)
US7681537B2 (en) * 2008-08-17 2010-03-23 Cummins Intellectual Properties, Inc. Gas extractor for an engine coolant system
EP2352763B2 (en) * 2008-10-01 2022-09-21 Amgen Research (Munich) GmbH Bispecific single chain antibodies with specificity for high molecular weight target antigens
CA2738565C (en) * 2008-10-01 2023-10-10 Micromet Ag Cross-species-specific psmaxcd3 bispecific single chain antibody
CN102695499A (zh) 2009-06-18 2012-09-26 惠氏有限责任公司 小模块免疫药物的冻干制剂
RU2548772C2 (ru) 2009-11-20 2015-04-20 Биокон Лимитед Составы антитела
EP2568960B1 (en) * 2010-05-10 2018-06-06 Intas Pharmaceuticals Ltd. Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
EP2686014A1 (en) * 2011-03-16 2014-01-22 Sanofi Uses of a dual v region antibody-like protein
JP5917682B2 (ja) * 2011-04-22 2016-05-18 ワイス・エルエルシー 変異体クロストリジウム・ディフィシル毒素に関する組成物およびその方法

Also Published As

Publication number Publication date
EP2916866B1 (de) 2018-04-04
CA2890166A1 (en) 2014-05-15
JP6321667B2 (ja) 2018-05-09
MX2015005700A (es) 2015-08-20
CN104780940A (zh) 2015-07-15
US11052128B2 (en) 2021-07-06
SG11201502730SA (en) 2015-05-28
SI2916866T1 (en) 2018-08-31
JP2015536938A (ja) 2015-12-24
TWI615158B (zh) 2018-02-21
RU2679124C2 (ru) 2019-02-06
AU2013343638A1 (en) 2015-05-28
NZ707895A (en) 2019-07-26
PT2916866T (pt) 2018-07-10
HUE038151T2 (hu) 2018-10-29
CY1120391T1 (el) 2019-07-10
KR20150082328A (ko) 2015-07-15
RU2015121574A (ru) 2016-12-27
AR093365A1 (es) 2015-06-03
WO2014072277A1 (de) 2014-05-15
IL238615A0 (en) 2015-06-30
CA2890166C (en) 2023-08-15
AU2018214096A1 (en) 2018-08-30
HK1211215A1 (en) 2016-05-20
RS57394B1 (sr) 2018-09-28
TW201438764A (zh) 2014-10-16
EP2916866A1 (de) 2015-09-16
ES2676468T3 (es) 2018-07-19
CN104780940B (zh) 2017-11-07
HRP20181021T1 (hr) 2018-08-24
US20150335706A1 (en) 2015-11-26
TR201809507T4 (tr) 2018-07-23
MX367034B (es) 2019-08-02
LT2916866T (lt) 2018-07-25
AU2013343638B2 (en) 2018-08-30
PL2916866T3 (pl) 2018-10-31

Similar Documents

Publication Publication Date Title
AU2018214096A1 (en) Formulation for bispecific T-cell engagers (BITES)
KR102272568B1 (ko) 안정화 항체 조성물
JP7407118B2 (ja) 低pH医薬抗体製剤
CA2781467C (en) Formulations of antibody
US20210147570A1 (en) Anticancer combination therapy with cd73 antagonist antibody and pd-1/pd-l1 axis antagonist antibody
JP7503056B6 (ja) 抗lag3抗体および抗pd-1抗体の共-製剤
JP7503056B2 (ja) 抗lag3抗体および抗pd-1抗体の共-製剤
KR20090104017A (ko) A베타 항체 비경구 제제
KR20210062027A (ko) Csf-1r 항체 제제
CA3095986A1 (en) Axl-specific antibodies for cancer treatment
CA3156812A1 (en) Anti-connexin antibody formulations
KR20220013343A (ko) 안과용 액상 조성물
KR20220147061A (ko) 항-pd1 항체 프롤골리맙의 수성 약학 조성물 및 이의 용도
JP2022523290A (ja) 製剤
RU2806320C2 (ru) Водная фармацевтическая композиция антитела к pd-1 пролголимаба и ее применение
RU2791857C2 (ru) Фармацевтическая композиция пембролизумаба и ее применение
CN116763917A (zh) 一种稳定的抗人il15/pd-l1双功能融合蛋白制剂
OA21466A (en) Pharmaceutical composition of pembrolizumab and use thereof