AU2021207470A1 - Formulations for protein therapeutics - Google Patents

Formulations for protein therapeutics Download PDF

Info

Publication number
AU2021207470A1
AU2021207470A1 AU2021207470A AU2021207470A AU2021207470A1 AU 2021207470 A1 AU2021207470 A1 AU 2021207470A1 AU 2021207470 A AU2021207470 A AU 2021207470A AU 2021207470 A AU2021207470 A AU 2021207470A AU 2021207470 A1 AU2021207470 A1 AU 2021207470A1
Authority
AU
Australia
Prior art keywords
composition
seq
binding domain
administered
day
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
Application number
AU2021207470A
Other languages
English (en)
Inventor
David BIENVENUE
Jonathan Clapper
Catherine J. Mcmahan
Scott STROMATT
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Aptevo Research and Development LLC
Original Assignee
Aptevo Research and Development LLC
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 Aptevo Research and Development LLC filed Critical Aptevo Research and Development LLC
Publication of AU2021207470A1 publication Critical patent/AU2021207470A1/en
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional 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
    • 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
    • A61K47/26—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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • C07K16/2803—Immunoglobulins [IG], 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
    • C07K16/2809—Immunoglobulins [IG], 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
    • 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
    • C07K16/2866—Immunoglobulins [IG], 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
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • 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
    • C07K2317/524—CH2 domain
    • 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
    • C07K2317/53—Hinge
    • 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
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • 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
    • C07K2317/71—Decreased effector function due to an Fc-modification
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
AU2021207470A 2020-01-13 2021-01-13 Formulations for protein therapeutics Pending AU2021207470A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202062960562P 2020-01-13 2020-01-13
US62/960,562 2020-01-13
US202063121633P 2020-12-04 2020-12-04
US63/121,633 2020-12-04
PCT/US2021/013294 WO2021146328A1 (en) 2020-01-13 2021-01-13 Formulations for protein therapeutics

Publications (1)

Publication Number Publication Date
AU2021207470A1 true AU2021207470A1 (en) 2022-07-07

Family

ID=74592744

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021207470A Pending AU2021207470A1 (en) 2020-01-13 2021-01-13 Formulations for protein therapeutics

Country Status (11)

Country Link
US (1) US20230303720A1 (https=)
EP (1) EP4090367A1 (https=)
JP (2) JP2023512454A (https=)
KR (1) KR20220127843A (https=)
CN (1) CN115279406A (https=)
AU (1) AU2021207470A1 (https=)
BR (1) BR112022013725A2 (https=)
CA (1) CA3164385A1 (https=)
IL (1) IL294458A (https=)
MX (1) MX2022008654A (https=)
WO (1) WO2021146328A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109952112B (zh) 2016-09-21 2024-09-06 阿帕特夫研究和发展有限公司 Cd123结合蛋白和相关的组合物和方法
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
WO2020232247A1 (en) 2019-05-14 2020-11-19 Provention Bio, Inc. Methods and compositions for preventing type 1 diabetes
IL298999A (en) 2020-06-11 2023-02-01 Provention Bio Inc Methods and compositions for the prevention of type 1 diabetes
JP2024520444A (ja) 2021-05-24 2024-05-24 プロヴェンション・バイオ・インコーポレイテッド １型糖尿病を治療するための方法

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5283173A (en) 1990-01-24 1994-02-01 The Research Foundation Of State University Of New York System to detect protein-protein interactions
GB9518220D0 (en) 1995-09-06 1995-11-08 Medical Res Council Checkpoint gene
US6440418B1 (en) 1995-11-07 2002-08-27 Idec Pharmaceuticals Corporation Methods of treating autoimmune diseases with gp39-specific antibodies
US6660843B1 (en) 1998-10-23 2003-12-09 Amgen Inc. Modified peptides as therapeutic agents
JP2008501621A (ja) 2003-05-31 2008-01-24 マイクロメット アクツィエン ゲゼルシャフト Ｂ細胞関連疾患を処置するための二重特異性抗ｃｄ３、抗ｃｄ１９抗体構築物を含む薬学的組成物
DK1629011T3 (da) 2003-05-31 2010-05-03 Micromet Ag Humane anti-humane-DC3-bindingsmolekyler
MXPA06004035A (es) 2003-10-16 2006-08-31 Micromet Ag Aglutinantes cd3 de-inmunizados multi-especificos.
US7393662B2 (en) 2004-09-03 2008-07-01 Centocor, Inc. Human EPO mimetic hinge core mimetibodies, compositions, methods and uses
NZ573646A (en) 2006-06-12 2012-04-27 Wyeth Llc Single-chain multivalent binding proteins with effector function
TW200831129A (en) * 2006-10-06 2008-08-01 Amgen Inc Stable formulations
MX2009010611A (es) 2007-04-03 2010-03-26 Micromet Ag Enlazadores biespecificos, especificos para especies.
JP2011526792A (ja) 2008-07-02 2011-10-20 エマージェント プロダクト デベロップメント シアトル， エルエルシー ＴＮＦ−αアンタゴニスト多重標的結合性タンパク質
US20110293619A1 (en) 2008-10-01 2011-12-01 Micromet Ag CROSS-SPECIES-SPECIFIC PSMAxCD3 BISPECIFIC SINGLE CHAIN ANTIBODY
NO2344540T3 (https=) 2008-10-02 2018-04-28
US20130129723A1 (en) 2009-12-29 2013-05-23 Emergent Product Development Seattle, Llc Heterodimer Binding Proteins and Uses Thereof
CA2785907A1 (en) 2009-12-29 2011-07-28 Emergent Product Development Seattle, Llc Ron binding constructs and methods of use thereof
TWI653333B (zh) 2010-04-01 2019-03-11 安進研究（慕尼黑）有限責任公司 跨物種專一性之ＰＳＭＡｘＣＤ３雙專一性單鏈抗體
AU2011286024B2 (en) 2010-08-02 2014-08-07 Macrogenics, Inc. Covalent diabodies and uses thereof
KR102060389B1 (ko) 2011-05-21 2019-12-31 마크로제닉스, 인크. 사람 및 비-사람 cd3에 결합할 수 있는 cd3-결합 분자
JP6509724B2 (ja) 2012-04-20 2019-05-08 アプティーボ リサーチ アンド デベロップメント エルエルシー Ｃｄ３結合ポリペプチド
WO2016094873A2 (en) 2014-12-12 2016-06-16 Emergent Product Development Seattle, Llc Receptor tyrosine kinase-like orphan receptor 1 binding proteins and related compositions and methods
CN114181309B (zh) 2015-05-21 2024-07-30 鳄鱼生物科学公司 新型多肽
WO2017053469A2 (en) * 2015-09-21 2017-03-30 Aptevo Research And Development Llc Cd3 binding polypeptides
CN109952112B (zh) * 2016-09-21 2024-09-06 阿帕特夫研究和发展有限公司 Cd123结合蛋白和相关的组合物和方法
WO2019050521A1 (en) * 2017-09-07 2019-03-14 Macrogenics, Inc. DOSAGE SCHEMES OF BISPECIFIC DIACORPS CD123 X CD3 IN THE TREATMENT OF HEMATOLOGICAL MALIGNANCIES

Also Published As

Publication number Publication date
CA3164385A1 (en) 2021-07-22
US20230303720A1 (en) 2023-09-28
EP4090367A1 (en) 2022-11-23
MX2022008654A (es) 2022-08-18
JP2026021465A (ja) 2026-02-10
IL294458A (en) 2022-09-01
KR20220127843A (ko) 2022-09-20
JP2023512454A (ja) 2023-03-27
CN115279406A (zh) 2022-11-01
WO2021146328A1 (en) 2021-07-22
BR112022013725A2 (pt) 2022-10-11

Similar Documents

Publication Publication Date Title
US12448423B2 (en) Targeted heterodimeric Fc fusion proteins containing NKG2D antigen binding domains
US11524991B2 (en) PD-1 targeted heterodimeric fusion proteins containing IL-15/IL-15Ra Fc-fusion proteins and PD-1 antigen binding domains and uses thereof
US12441798B2 (en) CD123 binding proteins and related compositions and methods
JP7661446B2 (ja) 多重特異性結合タンパク質およびその使用方法
JP6524087B2 (ja) Ｃｄ１２３及びｃｄ３に結合できる二重特異性１価ダイアボディ、並びにその使用
US20230303720A1 (en) Formulations for protein therapeutics
JP2021520829A (ja) ＩＬ−１５／ＩＬ−１５ＲＡ Ｆｃ融合タンパク質およびＴＩＭ−３抗原結合ドメインを含む、ＴＩＭ−３標的化ヘテロ二量体融合タンパク質
JP2021521779A (ja) ＩＬ−１５／ＩＬ−１５ＲＡ Ｆｃ融合タンパク質およびＬＡＧ−３抗原結合ドメインを含む、ＬＡＧ−３を標的とするヘテロ二量体融合タンパク質
JP7707306B2 (ja) 抗ｃｄ２０／抗ｃｄ３二重特異性抗体による治療のための投薬
WO2022150791A2 (en) Compositions and methods related to il2 receptor binding
US20240262920A1 (en) Dosing regimens for protein therapeutics
JP2026062861A (ja) 治療的タンパク質の薬物送達システム構成要素への吸着を防ぐ方法および組成物
HK40050240A (en) Pd-1 targeted il-15/il-15ralpha fc fusion proteins and uses in combination therapies thereof