ME02485B - Bispecifično jednolančano protutijelo psmaxcd3 s međuvrsnom specifičnošću - Google Patents

Bispecifično jednolančano protutijelo psmaxcd3 s međuvrsnom specifičnošću

Info

Publication number
ME02485B
ME02485B MEP-2016-156A MEP15616A ME02485B ME 02485 B ME02485 B ME 02485B ME P15616 A MEP15616 A ME P15616A ME 02485 B ME02485 B ME 02485B
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ME
Montenegro
Prior art keywords
cdr
seq
chain antibody
bispecific single
antibody molecule
Prior art date
Application number
MEP-2016-156A
Other languages
English (en)
French (fr)
Inventor
Doris Rau
Evelyne Schaller
Susanne Hausmann
Petra Fluhr
Carola Steiger
Peter Kufer
Tobias Raum
Roman Kischel
Ralf LUTTERBÜSE
Patrick Hoffmann
Susanne Mangold
Matthias Klinger
Original Assignee
Amgen Res Munich Gmbh
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.)
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Publication date
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Application filed by Amgen Res Munich Gmbh filed Critical Amgen Res Munich Gmbh
Publication of ME02485B publication Critical patent/ME02485B/me

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Classifications

    • 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
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3069—Reproductive system, e.g. ovaria, uterus, testes, prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • C07K2317/30—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
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Reproductive Health (AREA)
  • Cell Biology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Urology & Nephrology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (18)

1. Molekula bispecifičnog jednolančanog protutijela, naznačena time što sadrži prvu vežuću domenu koja se specifično veže na epitop u lancu CD3ε kod čovjeka i Callithrix jacchus, Saguinus oedipus ili Saimiri sciureus, gdje je navedeni epitop dio aminokiselinskogi slijeda iz skupine koju čine SEQ ID NO. 2, 4, 6 ili 8, i u najmanju ruku sadrži aminokiselinski slijed Gln-Asp-Gly-Asn-Glu, te drugu vežuću domenu koja se veže na membranski antigen specifičan za prostatu (PSMA).
2. Molekula bispecifičnog jednolančanog protutijela u skladu s patentnim zahtjevom 1, naznačena time što prva vežuća domena sadrži područje VL, koje sadrži CDR-L1, CDR-L2 i CDR-L3, koje se bira između: (a) CDR-L1, kao što je opisan u SEQ ID NO. 27, CDR-L2, kao što je opisan u SEQ ID NO. 28 i CDR-L3, kao što je opisan u SEQ ID NO. 29; (b) CDR-L1, kao što je opisan u SEQ ID NO. 117, CDR-L2, kao što je opisan u SEQ ID NO. 118 i CDR-L3, kao što je opisan u SEQ ID NO. 119; i (c) CDR-L1, kao što je opisan u SEQ ID NO. 153, CDR-L2, kao što je opisan u SEQ ID NO. 154 i CDR-L3, kao što je opisan u SEQ ID NO. 155.
3. Molekula bispecifičnog jednolančanog protutijela u skladu s patentnim zahtjevom 1 ili 2, naznačena time što prva vežuća domena sadrži područje VH, koje sadrži CDR-H1, CDR-H2 i CDR-H3, koje se bira između: (a) CDR-H1, kao što je opisan u SEQ ID NO. 12, CDR-H2, kao što je opisan u SEQ ID NO. 13 i CDR-H3, kao što je opisan u SEQ ID NO. 14; (b) CDR-H1, kao što je opisan u SEQ ID NO. 30, CDR-H2, kao što je opisan u SEQ ID NO. 31 i CDR-H3, kao što je opisan u SEQ ID NO. 32; (c) CDR-H1, kao što je opisan u SEQ ID NO. 48, CDR-H2, kao što je opisan u SEQ ID NO. 49 i CDR-H3, kao što je opisan u SEQ ID NO. 50; (d) CDR-H1, kao što je opisan u SEQ ID NO. 66, CDR-H2, kao što je opisan u SEQ ID NO. 67 i CDR-H3, kao što je opisan u SEQ ID NO. 68; (e) CDR-H1, kao što je opisan u SEQ ID NO. 84, CDR-H2, kao što je opisan u SEQ ID NO. 85 i CDR-H3, kao što je opisan u SEQ ID NO. 86; (f) CDR-H1, kao što je opisan u SEQ ID NO. 102, CDR-H2, kao što je opisan u SEQ ID NO. 103 i CDR-H3, kao što je opisan u SEQ ID NO. 104; (g) CDR-H1, kao što je opisan u SEQ ID NO. 120, CDR-H2 kao što je opisan u SEQ ID NO. 121 i CDR-H3kao što je opisan u SEQ ID NO. 122; (h) CDR-H1, kao što je opisan u SEQ ID NO. 138, CDR-H2, kao što je opisan u SEQ ID NO. 139 i CDR-H3, kao što je opisan u SEQ ID NO. 140; (i) CDR-H1, kao što je opisan u SEQ ID NO. 156, CDR-H2, kao što je opisan u SEQ ID NO. 157 i CDR-H3, kao što je opisan u SEQ ID NO. 158; i (j) CDR-H1, kao što je opisan u SEQ ID NO. 174, CDR-H2, kao što je opisan u SEQ ID NO. 175 i CDR-H3, kao što je opisan u SEQ ID NO. 176.
4. Molekula bispecifičnog jednolančanog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time što se druga vežuća domena može vezati na ljudski PSMA i/ili na neljudski primatski PSMA.
5. Molekula bispecifičnog jednolančanog protutijela u skladu s patentnim zahtjevom 4, naznačena time što molekula bispecifičnog jednolančanog protutijela uključuje skupinu sljedećih sljedova poput CDR H1, CDR H2, CDR H3, CDR L1, CDR L2 i CDR L3 u drugoj vežućoj domeni koju se bira između: a) CDR H1-3 sa SEQ ID NO: 394-396 i CDR L1-3 sa SEQ ID NO: 389-391; b) CDR H1-3 sa SEQ ID NO: 408-410 i CDR L1-3 sa SEQ ID NO: 403-405; c) CDR H1-3 sa SEQ ID NO: 422-424 i CDR L1-3 sa SEQ ID NO: 417-419; d) CDR H1-3 sa SEQ ID NO: 436-438 i CDR L1-3 sa SEQ ID NO: 431-433; e) CDR H1-3 sa SEQ ID NO: 445-447 i CDR L1-3 sa SEQ ID NO: 450-452; f) CDR H1-3 sa SEQ ID NO: 464-466 i CDR L1-3 sa SEQ ID NO: 459-461; g) CDR H1-3 sa SEQ ID NO: 478-480 i CDR L1-3 sa SEQ ID NO: 473-475; h) CDR H1-3 sa SEQ ID NO: 492-494 i CDR L1-3 sa SEQ ID NO: 487-489; i) CDR H1-3 sa SEQ ID NO: 506-508 i CDR L1-3 sa SEQ ID NO: 501-503; j) CDR H1-3 sa SEQ ID NO: 520-522 i CDR L1-3 sa SEQ ID NO: 515-517; k) CDR H1-3 sa SEQ ID NO: 534-536 i CDR L1-3 sa SEQ ID NO: 529-531; l) CDR H1-3 sa SEQ ID NO: 548-550 i CDR L1-3 sa SEQ ID NO: 543-545; m) CDR H1-3 sa SEQ ID NO: 562-564 i CDR L1-3 sa SEQ ID NO: 557-559; n) CDR H1-3 sa SEQ ID NO: 576-578 i CDR L1-3 sa SEQ ID NO: 571-573; o) CDR H1-3 sa SEQ ID NO: 590-592 i CDR L1-3 sa SEQ ID NO: 585-587; p) CDR H1-3 sa SEQ ID NO: 604-606 i CDR L1-3 sa SEQ ID NO: 599-601; q) CDR H1-3 sa SEQ ID NO: 618-620 i CDR L1-3 sa SEQ ID NO: 613-615; r) CDR H1-3 sa SEQ ID NO: 632-634 i CDR L1-3 sa SEQ ID NO: 627-629; s) CDR H1-3 sa SEQ ID NO: 646-648 i CDR L1-3 sa SEQ ID NO: 641-643; t) CDR H1-3 sa SEQ ID NO: 660-662 i CDR L1-3 sa SEQ ID NO: 655-657; u) CDR H1-3 sa SEQ ID NO: 674-676 i CDR L1-3 sa SEQ ID NO: 669-671; v) CDR H1-3 sa SEQ ID NO: 688-690 i CDR L1-3 sa SEQ ID NO: 683-685; w) CDR H1-3 sa SEQ ID NO: 702-704 i CDR L1-3 sa SEQ ID NO: 697-699; x) CDR H1-3 sa SEQ ID NO: 716-718 i CDR L1-3 sa SEQ ID NO: 711-713; y) CDR H1-3 sa SEQ ID NO: 729-731 i CDR L1-3 sa SEQ ID NO: 724-726; z) CDR H1-3 sa SEQ ID NO: 788-790 i CDR L1-3 sa SEQ ID NO: 793-795; aa) CDR H1-3 sa SEQ ID NO: 806-808 i CDR L1-3 sa SEQ ID NO: 811-813; ab) CDR H1-3 sa SEQ ID NO: 852-854 i CDR L1-3 sa SEQ ID NO: 857-859; ac) CDR H1-3 sa SEQ ID NO: 838-840 i CDR L1-3 sa SEQ ID NO: 843-845; ad) CDR H1-3 sa SEQ ID NO: 824-826 i CDR L1-3 sa SEQ ID NO: 829-831; ae) CDR H1-3 sa SEQ ID NO: 774-776 i CDR L1-3 sa SEQ ID NO: 779-781; af) CDR H1-3 sa SEQ ID NO: 688-690 i CDR L1-3 sa SEQ ID NO: 683-685; ag) CDR H1-3 sa SEQ ID NO: 870-872 i CDR L1-3 sa SEQ ID NO: 875-877; ah) CDR H1-3 sa SEQ ID NO: 888-890 i CDR L1-3 sa SEQ ID NO: 893-895; ai) CDR H1-3 sa SEQ ID NO: 924-926 i CDR L1-3 sa SEQ ID NO: 929-931; aj) CDR H1-3 sa SEQ ID NO: 1019-1021 i CDR L1-3 sa SEQ ID NO: 1025-1027; ak) CDR H1-3 sa SEQ ID NO: 1006-1008 i CDR L1-3 sa SEQ ID NO: 1011-1013; al) CDR H1-3 sa SEQ ID NO: 906-908 i CDR L1-3 sa SEQ ID NO: 911-913; am) CDR H1-3 sa SEQ ID NO: 992-994 i CDR L1-3 sa SEQ ID NO: 997-999; an) CDR H1-3 sa SEQ ID NO: 942-944 i CDR L1-3 sa SEQ ID NO: 947-949; ao) CDR H1-3 sa SEQ ID NO: 960-962 i CDR L1-3 sa SEQ ID NO: 965-967; i ap) CDR H1-3 sa SEQ ID NO: 978-980 i CDR L1-3 sa SEQ ID NO: 983-985.
6. Molekula bispecifičnog jednolančanog protutijela u skladu s patentnim zahtjevom 5, naznačena time što vežuće domene idu redoslijedom VH PSMA-VL PSMA-VH CD3-VL CD3 ili VL PSMA-VH PSMA-VH CD3-VL CD3.
7. Molekula bispecifičnog jednolančanog protutijela u skladu s patentnim zahtjevom 6, naznačena time što molekula bispecifičnog jednolančanog protutijela ima slijed koji se bira između: (a) aminokiselinskog slijeda kao što je opisan u bilo kojem od SEQ ID NO: 399, 413, 427, 441, 455, 469, 483, 497, 511, 525, 539, 553, 567, 581, 595, 609, 623, 637, 651, 665, 679, 693, 707, 721, 734, 799, 817, 863, 849, 835, 785, 899, 935, 1017, 1031, 917, 1003, 953, 971 ili 989; (b) aminokiselinskog slijeda kojeg kodira nukleinskokiselinski slijed kao što je opisan u bilo kojem od SEQ ID NO: 400, 414, 428, 442, 456, 470, 484,498, 512, 526, 540, 554, 568, 582, 596, 610, 624, 638, 652, 666, 680, 694, 708, 736 735, 800, 818, 864, 850, 836, 786, 882, 900, 936, 1018, 1032, 918, 1004, 954, 972, 990, 804, 822, 868, 886, 904, 940, 922, 958 ili 976; i (c) aminokiselinskog slijeda koji je najmanje 90% identičan, poželjnije najmanje 95% identičan, a najpoželjnije najmanje 96% identičan aminokiselinskom slijedu iz (a) ili (b).
8. Nukleinskokiselinski slijed, naznačen time što kodira molekulu bispecifičnog jednolančanog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 7.
9. Vektor, naznačen time što sadrži nukleinskokiselinski slijed u skladu s patentnim zahtjevom 8.
10. Stanica domaćin, naznačena time što je transformirana ili transficirana vektorom u skladu s bilo kojim od patentnih zahtjeva 6 do 9.
11. Postupak proizvodnje molekule bispecifičnog jednolančanog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što se navedeni postupak sastoji u uzgoju stanice domaćina u skladu s patentnim zahtjevom 10 u uvjetima koji omogućuju eksprimiranje molekule bispecifičnog jednolančanog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 7 i prikupljanju proizvedenog polipeptida iz kulture.
12. Farmaceutski pripravak, naznače time što sadrži molekulu bispecifičnog jednolančanog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 7, ili proizvedenu postupkom u skladu s patentnim zahtjevom 11.
13. Molekula bispecifičnog jednolančanog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 7, ili proizvedena postupkom u skladu s patentnim zahtjevom 11, naznačena time što je namijenjena upotrebi u sprječavanju, liječenju ili ublažavanju raka.
14. Molekula bispecifičnog jednolančanog protutijela u skladu s patentnim zahtjevom 13, naznačena time što je navedeni rak čvrsti tumor, po mogućnosti karcinom ili rak prostate.
15. Komplet, naznačen time što sadrži molekulu bispecifičnog jednolančanog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 7, molekula nukleinske kiseline u skladu s patentnim zahtjevom 8, vektor u skladu s patentnim zahtjevom 9, ili stanicu domaćina u skladu s patentnim zahtjevom 10.
16. Molekula bispecifičnog jednolančanog protutijela u skladu s patentnim zahtjevom 1, naznačena time što se navedena prva vežuća domena veže na N-terminalni CD3ε polipeptidni fragment in vitro i na nativnu CD3ε podjedinicu CD3 kompleksa na T-stanicama in vivo s istim afinitetom vezanja.
17. Molekula bispecifičnog jednolančanog protutijela u skladu s patentnim zahtjevom 1, naznačena time što je navedeni epitop dio aminokiselinskog slijeda koji se sastoji od 26, 25, 24, 23, 22, 21 ,20, 19, 18, 17, 16, 15, 14, 13, 12, 11 , 10, 9, 8, 7, 6 ili 5 aminokiselina.
18. Molekula bispecifičnog jednolančanog protutijela u skladu s patentnim zahtjevom 1, naznačena time što je homogenost molekule bispecifičnog jednolančanog protutijela najmanje 90%, 95% ili 98%.
MEP-2016-156A 2008-10-01 2009-10-01 Bispecifično jednolančano protutijelo psmaxcd3 s međuvrsnom specifičnošću ME02485B (me)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10185708P 2008-10-01 2008-10-01
PCT/EP2009/062793 WO2010037836A2 (en) 2008-10-01 2009-10-01 Cross-species-specific psmaxcd3 bispecific single chain antibody
EP09783664.7A EP2356153B1 (en) 2008-10-01 2009-10-01 Cross-species-specific psmaxcd3 bispecific single chain antibody

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ME02485B true ME02485B (me) 2017-02-20

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US (6) US20110293619A1 (me)
EP (3) EP2356153B1 (me)
JP (4) JP6126782B2 (me)
KR (1) KR101820535B1 (me)
CN (1) CN102171248B (me)
AU (1) AU2009299792B2 (me)
BR (1) BRPI0919841A2 (me)
CA (1) CA2738565C (me)
CY (1) CY1118303T1 (me)
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ES (1) ES2588155T3 (me)
HR (1) HRP20160684T1 (me)
HU (1) HUE030090T2 (me)
IL (1) IL212099A (me)
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MX (1) MX2011003502A (me)
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PL (1) PL2356153T3 (me)
PT (1) PT2356153T (me)
RS (1) RS54900B1 (me)
RU (1) RU2559531C2 (me)
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SM (1) SMT201600256B (me)
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