HRP20221298T1 - Anti-ror2 protutijela, fragmenti protutijela, njihovi imunokonjugati i njihove uporabe - Google Patents

Anti-ror2 protutijela, fragmenti protutijela, njihovi imunokonjugati i njihove uporabe Download PDF

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Publication number
HRP20221298T1
HRP20221298T1 HRP20221298TT HRP20221298T HRP20221298T1 HR P20221298 T1 HRP20221298 T1 HR P20221298T1 HR P20221298T T HRP20221298T T HR P20221298TT HR P20221298 T HRP20221298 T HR P20221298T HR P20221298 T1 HRP20221298 T1 HR P20221298T1
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Croatia
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seq
antibody
variable region
antibody fragment
chain variable
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HRP20221298TT
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English (en)
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Jay M. Short
Hwai Wen Chang
Gerhard Frey
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Bioatla, Inc.
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Publication of HRP20221298T1 publication Critical patent/HRP20221298T1/hr

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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/07—Tetrapeptides
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • 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
    • C07K2317/20—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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/705—Assays involving receptors, cell surface antigens or cell surface determinants
    • G01N2333/70503—Immunoglobulin superfamily, e.g. VCAMs, PECAM, LFA-3

Claims (12)

1. Anti-Ror2 protutijelo ili fragment protutijela koji se specifično veže na Ror2 protein s omjerom afiniteta vezanja na Ror2 protein na vrijednosti pH u tumorskom mikrookruženju u usporedbi s različitim pH koji se javlja u mikrookruženju bez tumora od najmanje 1,5:1, pri čemu pH vrijednost u mikrookruženju tumora se kreće se od pH 5,8 do 6,8, i pH za mikorookruženje bez tumora se kreće od pH vrijednosti 7,0 do 7,6; i a) varijabilna regija teškog lanca (VH) uključuje sekvencu aminokiseline odabranu između SEK ID BR: 18-22 i varijabilna regija lakog lanca (VL) uključuje sekvencu aminokiseline odabranu između SEK ID BR: 13-16; ili b) varijabilna regija teškog lanca (VH) uključuje sekvencu aminokiseline odabranu između SEK ID BR: 23 -26, i varijabilna regija lakog lanca (VL) uključuje sekvencu aminokiseline odabranu između SEK ID BR: 17 i 27.
2. Anti-Ror2 protutijelo ili fragment protutijela sukladno patentnom zahtjevu 1, pri čemu varijabilna regija teškog lanca (VH) uključuje sekvencu aminokiseline: odabranu između SEK ID BR: 18, SEK ID BR: 20, SEK ID BR: 21, i SEK ID BR: 22, varijabilna regija lakog lanca (VL) uključuje sekvencu aminokiseline odabranu između SEK ID BR: 13, SEK ID BR: 14, SEK ID BR: 15, i SEK ID BR: 16.
3. Anti-Ror2 protutijelo ili fragment protutijela sukladno patentnom zahtjevu 1, pri čemu varijabilna regija teškog lanca (VH) uključuje sekvencu aminokiseline: odabranu između SEK ID BR: 20, SEK ID BR: 21, i SEK ID BR: 22, i varijabilna regija lakog lanca (VL) uključuje sekvencu aminokiseline odabranu između SEK ID BR: 15 i SEK ID BR: 16.
4. Anti-Ror2 protutijelo ili fragment protutijela sukladno patentnom zahtjevu 1, pri čemu je protutijelo ili fragment protutijela izabrano iz sljedećih protutijela ili fragmenata protutijela: a) protutijelo ili fragment protutijela uključuje varijabilna regija teškog lanca (VH) iz SEK ID BR: 20, varijabilna regija lakog lanca (VL) iz SEK ID BR: 15; b) protutijelo ili fragment protutijela uključuje varijabilna regija teškog lanca (VH) iz SEK ID BR: 21, varijabilna regija lakog lanca (VL) iz SEK ID BR: 16; protutijelo ili fragment protutijela uključuje varijabilna regija teškog lanca (VH) iz SEK ID BR: 22, varijabilna regija lakog lanca (VL) iz SEK ID BR: 16.
5. Anti-Ror2 protutijelo ili fragment protutijela sukladno patentnom zahtjevu 1, pri čemu varijabilna regija teškog lanca (VH) uključuje sekvencu aminokiseline: odabranu između SEK ID BR: 21, i SEK ID BR: 22, varijabilna regija lakog lanca (VL) uključuje SEK ID BR: 16.
6. Protutijelo ili fragment protutijela sukladno bilo kojem od patentnih zahtjeva 1-5, pri čemu protutijelo ili fragment protutijela ima odnos afiniteta vezivanja na Ror2 protein pri pH vrijednosti za mikrookruženje tumora na afinitet vezivanja na Ror2 protein pri različitim pH vrijednostima u mikrookruženju bez tumora od najmanje 2:1, najmanje 3:1, najmanje 4:1, najmanje 5:1, najmanje 6:1, najmanje 7:1, najmanje 8:1, najmanje 9:1, najmanje 10:1, najmanje 20:1, najmanje 30:1, najmanje 50:1, najmanje 70:1, ili najmanje 100:1.
7. Imunokonjugat uključuje protutijelo ili fragment protutijela sukladno bilo kojem od patentnih zahtjeva 1-6.
8. Imunokonjugat sukladno patentnom zahtjevu 7, pri čemu taj imunokonjugat uključuje najmanje jedno sredstvo odabrano između kemoterapijskog agensa, radioaktivnog atoma, citostatičkog agensa i citotoksičnog agensa.
9. Imunokonjugat sukladno patentnom zahtjevu 8, uključuje najmanje dva navedena sredstva.
10. Imunokonjugat sukladno bilo kojem od patentnih zahtjeva 8-9, pri čemu su protutijelo ili fragment protutijela i najmanje jedno sredstvo kovalentno vezani na linker molekul.
11. Imunokonjugat sukladno bilo kojem od patentnih zahtjeva 8-10, pri čemu se najmanje jedno sredstvo izabire između maitansinoida, auristatina, dolastatina, kaliheamicina, pirolobenzodiazepina, i antraciklina.
12. Farmaceutski pripravak koji uključuje: protutijelo ili fragment protutijela sukladno bilo kojem od patentnih zahtjeva 1-6, ili imunokonjugat sukladno bilo kojem od patentnih zahtjeva 7-11; i farmaceutski prihvatljiv nosač.
HRP20221298TT 2016-05-13 2017-05-12 Anti-ror2 protutijela, fragmenti protutijela, njihovi imunokonjugati i njihove uporabe HRP20221298T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201662335719P 2016-05-13 2016-05-13
US201762447218P 2017-01-17 2017-01-17
PCT/US2017/032357 WO2017197234A1 (en) 2016-05-13 2017-05-12 Anti-ror2 antibodies, antibody fragments, their immunoconjugates and uses thereof
EP17796915.1A EP3455261B1 (en) 2016-05-13 2017-05-12 Anti-ror2 antibodies, antibody fragments, their immunoconjugates and uses thereof

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US (3) US11254742B2 (hr)
EP (2) EP4122958A1 (hr)
JP (3) JP7051715B2 (hr)
KR (2) KR20180137517A (hr)
CN (3) CN109311987A (hr)
AU (2) AU2017263568B2 (hr)
CA (1) CA3023979A1 (hr)
DK (1) DK3455261T3 (hr)
ES (1) ES2930255T3 (hr)
HR (1) HRP20221298T1 (hr)
HU (1) HUE060072T2 (hr)
IL (2) IL262404B2 (hr)
LT (1) LT3455261T (hr)
MX (2) MX2018013306A (hr)
PL (1) PL3455261T3 (hr)
PT (1) PT3455261T (hr)
RS (1) RS63698B1 (hr)
SG (1) SG11201808882QA (hr)
SI (1) SI3455261T1 (hr)
TW (2) TW202208441A (hr)
WO (1) WO2017197234A1 (hr)

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CN111378039B (zh) * 2018-12-29 2021-08-24 深圳大学 治疗恶性肿瘤的抗体及其应用
CN111378040B (zh) * 2018-12-29 2021-08-10 深圳大学 检测多种恶性肿瘤细胞的抗体及其应用
WO2020143506A1 (zh) * 2019-01-08 2020-07-16 深圳大学 检测多种恶性肿瘤细胞的抗体及其应用
MX2022005949A (es) * 2019-11-18 2022-08-02 Univ California Anticuerpos anti-ror-2 y metodos de uso.
TW202342537A (zh) * 2022-02-25 2023-11-01 美商拜奧亞特拉公司 使用條件性活性抗ror2抗體-藥物結合物之癌症治療

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