HRP20211125T1 - Konjugati protutijelo-lijek koji se temelje na eribulinu i postupci uporabe - Google Patents
Konjugati protutijelo-lijek koji se temelje na eribulinu i postupci uporabe Download PDFInfo
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- HRP20211125T1 HRP20211125T1 HRP20211125TT HRP20211125T HRP20211125T1 HR P20211125 T1 HRP20211125 T1 HR P20211125T1 HR P20211125T T HRP20211125T T HR P20211125TT HR P20211125 T HRP20211125 T HR P20211125T HR P20211125 T1 HRP20211125 T1 HR P20211125T1
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- drug conjugate
- cancer
- amino acid
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- 239000000611 antibody drug conjugate Substances 0.000 title claims 15
- 229940049595 antibody-drug conjugate Drugs 0.000 title claims 15
- UFNVPOGXISZXJD-XJPMSQCNSA-N eribulin Chemical compound C([C@H]1CC[C@@H]2O[C@@H]3[C@H]4O[C@H]5C[C@](O[C@H]4[C@H]2O1)(O[C@@H]53)CC[C@@H]1O[C@H](C(C1)=C)CC1)C(=O)C[C@@H]2[C@@H](OC)[C@@H](C[C@H](O)CN)O[C@H]2C[C@@H]2C(=C)[C@H](C)C[C@H]1O2 UFNVPOGXISZXJD-XJPMSQCNSA-N 0.000 title claims 4
- 229960003649 eribulin Drugs 0.000 title claims 4
- 238000000034 method Methods 0.000 title claims 4
- 125000003275 alpha amino acid group Chemical group 0.000 claims 12
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 8
- 239000000427 antigen Substances 0.000 claims 6
- 102000036639 antigens Human genes 0.000 claims 6
- 108091007433 antigens Proteins 0.000 claims 6
- 239000012634 fragment Substances 0.000 claims 6
- 206010028980 Neoplasm Diseases 0.000 claims 4
- 206010033128 Ovarian cancer Diseases 0.000 claims 4
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 4
- 206010014733 Endometrial cancer Diseases 0.000 claims 3
- 206010014759 Endometrial neoplasm Diseases 0.000 claims 3
- 239000012472 biological sample Substances 0.000 claims 3
- 201000011510 cancer Diseases 0.000 claims 3
- NFGXHKASABOEEW-UHFFFAOYSA-N 1-methylethyl 11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate Chemical compound COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims 2
- 206010009944 Colon cancer Diseases 0.000 claims 2
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 2
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 2
- 208000003721 Triple Negative Breast Neoplasms Diseases 0.000 claims 2
- 230000003432 anti-folate effect Effects 0.000 claims 2
- 229940127074 antifolate Drugs 0.000 claims 2
- 208000002458 carcinoid tumor Diseases 0.000 claims 2
- 239000004052 folic acid antagonist Substances 0.000 claims 2
- 206010017758 gastric cancer Diseases 0.000 claims 2
- 210000004072 lung Anatomy 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 208000002154 non-small cell lung carcinoma Diseases 0.000 claims 2
- 201000008968 osteosarcoma Diseases 0.000 claims 2
- 102000005962 receptors Human genes 0.000 claims 2
- 108020003175 receptors Proteins 0.000 claims 2
- 201000011549 stomach cancer Diseases 0.000 claims 2
- 208000022679 triple-negative breast carcinoma Diseases 0.000 claims 2
- 208000029729 tumor suppressor gene on chromosome 11 Diseases 0.000 claims 2
- 102000010451 Folate receptor alpha Human genes 0.000 claims 1
- 108050001931 Folate receptor alpha Proteins 0.000 claims 1
- 238000001574 biopsy Methods 0.000 claims 1
- 230000021615 conjugation Effects 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 210000004696 endometrium Anatomy 0.000 claims 1
- 201000003866 lung sarcoma Diseases 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
-
- 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
- A61K47/62—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 a protein, peptide or polyamino acid
- A61K47/65—Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
-
- 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
- A61K47/68031—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being an auristatin
-
- 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
- A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
-
- 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
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- 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
- A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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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
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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
- C07K16/30—Immunoglobulins [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
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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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
- C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
-
- 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
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/77—Internalization into the cell
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- 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
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- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
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- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Cell Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (13)
1. Konjugat protutijelo-lijek formule (I):
Ab-(L-D)p (I)
naznačen time što
(i) Ab je internalizirajući anti-folatni receptor alfa protutijela ili njegov internalizirajući ulomak koji veže antigen koji sadrži tri regije za određivanje komplementarnosti teškog lanca (HCDR) koje sadrže aminokiselinske sekvence SEQ ID NO:2 (HCDR1), SEQ ID NO:3 (HCDR2), i SEQ ID NO:4 (HCDR3); i tri regije za određivanje komplementarnosti lakog lanca (LCDR) koje sadrže aminokiselinske sekvence SEQ ID NO:7 (LCDR1), SEQ ID NO:8 (LCDR2), i SEQ ID NO:9 (LCDR3), kako je definirano Kabat sustavom numeriranja; ili tri regije za određivanje komplementarnosti teškog lanca (HCDR) koje sadrže aminokiselinske sekvence SEQ ID NO:13 (HCDR1), SEQ ID NO:14 (HCDR2), i SEQ ID NO:15 (HCDR3); i tri regije za određivanje komplementarnosti lakog lanca (LCDR) koje sadrže aminokiselinske sekvence SEQ ID NO:16 (LCDR1), SEQ ID NO:17 (LCDR2), i SEQ ID NO:18 (LCDR3), kako je definirano IMGT sustavom numeriranja;
(ii) D je eribulin;
(iii) L je poveznica koja se može cijepati koja sadrži Mal-(PEG)2-Val-Cit-pAB; i
(iv) p je cijeli broj od 1 do 8.
2. Konjugat protutijelo-lijek prema patentnom zahtjevu 1, naznačen time što protutijelo ili ulomak koji veže antigen sadrži varijabilnu regiju teškog lanca koja sadrži aminokiselinsku sekvencu SEQ ID NO:23, i varijabilnu regiju lakog lanca koja sadrži aminokiselinsku sekvencu SEQ ID NO:24.
3. Konjugat protutijelo-lijek prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time što je p cijeli broj od 3 do 4.
4. Konjugat protutijelo-lijek prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time što protutijelo ili ulomak koji veže antigen sadrži konstantnu domenu humanog IgG1 teškog lanca i konstantnu domenu humanog Ig kapa lakog lanca.
5. Pripravak koji sadrži više kopija konjugata protutijelo-lijek prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time što je prosječni p konjugata protutijelo-lijek u pripravku od oko 3,2 do oko 3,8 ili od oko 3,6 do oko 4,4.
6. Konjugat protutijelo-lijek prema bilo kojem od patentnih zahtjeva 1 do 4 ili pripravak prema zahtjevu 5 naznačen time što je za uporabu u liječenju karcinoma koji eksprimira folatni receptor alfa.
7. Konjugat protutijelo-lijek za uporabu prema patentnom zahtjevu 6, naznačen time što rak je rak želuca, serozni rak jajnika, rak jajnika svijetlih stanica, rak pluća ne-malih stanica, kolorektalni karcinom, trostruko negativni rak dojke, rak endometrija, serozni karcinom endometrija, karcinoid pluća ili osteosarkom.
8. Farmaceutski pripravak naznačen time što sadrži konjugat protutijelo-lijek prema bilo kojem od patentnih zahtjeva 1 do 4 ili pripravak prema zahtjevu 5, te farmaceutski prihvatljiv nosač.
9. Postupak za proizvodnju konjugata protutijelo-lijek prema bilo kojem od patentnih zahtjeva 1 do 4 ili pripravka prema patentnom zahtjevu 5, naznačen time što obuhvaća reakciju protutijela ili ulomka koji veže antigen s poveznicom koja se može cijepati pridruženu na eribulin pod uvjetima koji dopuštaju konjugaciju.
10. Postupak određivanja hoće li pacijent reagirati na liječenje konjugatom protutijelo-lijek prema bilo kojem od patentnih zahtjeva 1 do 4 ili pripravkom prema zahtjevu 5, naznačen time što obuhvaća osiguravanje biološkog uzorka od pacijenta i dovođenje u kontakt biološkog uzorka s konjugatom protutijelo-lijek prema bilo kojem od patentnih zahtjeva 1 do 4 ili pripravkom prema zahtjevu 5.
11. Postupak prema patentnom zahtjevu 10, naznačen time što je biološki uzorak biopsija tumora raka želuca, seroznog karcinoma jajnika, raka jajnika svijetlih stanica, raka pluća ne-malih stanica, kolorektalnog karcinoma, trostruko negativnog raka dojke, raka endometrija, karcinoma endometrija, karcinoida pluća ili osteosarkoma.
12. Pripravak koji sadrži više kopija konjugata protutijelo-lijek formule (I):
Ab-(L-D)p (I)
naznačen time što
(i) Ab je internalizirajući anti-folatni receptor alfa protutijela ili njegov internalizirajući ulomak koji veže antigen koji sadrži tri regije za određivanje komplementarnosti teškog lanca (HCDR) koje sadrže aminokiselinske sekvence SEQ ID NO:2 (HCDR1), SEQ ID NO:3 (HCDR2), i SEQ ID NO:4 (HCDR3); i tri regije za određivanje komplementarnosti lakog lanca (LCDR) koje sadrže aminokiselinske sekvence SEQ ID NO:7 (LCDR1), SEQ ID NO:8 (LCDR2), i SEQ ID NO:9 (LCDR3), kako je definirano Kabat sustavom numeriranja; ili tri regije za određivanje komplementarnosti teškog lanca (HCDR) koje sadrže aminokiselinske sekvence SEQ ID NO:13 (HCDR1), SEQ ID NO:14 (HCDR2), i SEQ ID NO:15 (HCDR3); i tri regije za određivanje komplementarnosti lakog lanca (LCDR) koje sadrže aminokiselinske sekvence SEQ ID NO:16 (LCDR1), SEQ ID NO:17 (LCDR2), i SEQ ID NO:18 (LCDR3), kako je definirano IMGT sustavom numeriranja;
(ii) D je eribulin;
(iii) L je je poveznica koja se može cijepati koja sadrži Mal-(PEG)2-Val-Cit-pAB; i
(iv) p je prosječni broj -L-D ostataka po Ab, pri čemu prosječni p konjugata protutijelo-lijek u pripravku iznosi od oko 3,6 do oko 4,4.
13. Pripravak prema patentnom zahtjevu 12, naznačen time što protutijelo ili ulomak koji veže antigen sadrži varijabilnu regiju teškog lanca koja sadrži aminokiselinsku sekvencu SEQ ID NO:23, i varijabilnu regiju lakog lanca koja sadrži aminokiselinsku sekvencu SEQ ID NO:24.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662302562P | 2016-03-02 | 2016-03-02 | |
PCT/US2017/020529 WO2017151979A1 (en) | 2016-03-02 | 2017-03-02 | Eribulin-based antibody-drug conjugates and methods of use |
EP17711475.8A EP3423105B1 (en) | 2016-03-02 | 2017-03-02 | Eribulin-based antibody-drug conjugates and methods of use |
Publications (1)
Publication Number | Publication Date |
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HRP20211125T1 true HRP20211125T1 (hr) | 2021-10-15 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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HRP20211125TT HRP20211125T1 (hr) | 2016-03-02 | 2021-07-14 | Konjugati protutijelo-lijek koji se temelje na eribulinu i postupci uporabe |
Country Status (34)
Country | Link |
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US (4) | US10548986B2 (hr) |
EP (2) | EP3824909A1 (hr) |
JP (5) | JP6599019B2 (hr) |
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