SG11201804857WA - Anti-tl1a/anti-tnf-alpha bispecific antigen binding proteins and uses thereof - Google Patents

Anti-tl1a/anti-tnf-alpha bispecific antigen binding proteins and uses thereof

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Publication number
SG11201804857WA
SG11201804857WA SG11201804857WA SG11201804857WA SG11201804857WA SG 11201804857W A SG11201804857W A SG 11201804857WA SG 11201804857W A SG11201804857W A SG 11201804857WA SG 11201804857W A SG11201804857W A SG 11201804857WA SG 11201804857W A SG11201804857W A SG 11201804857WA
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Singapore
Prior art keywords
tl1a
california
antigen binding
international
binding proteins
Prior art date
Application number
SG11201804857WA
Inventor
Hailing Hsu
Gunasekaran Kannan
Kenneth W Walker
Michelle Hortter
Edward J Belouski
Original Assignee
Amgen Inc
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
Priority claimed from PCT/US2016/052006 external-priority patent/WO2017049004A1/en
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of SG11201804857WA publication Critical patent/SG11201804857WA/en

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • C07K16/468Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
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    • 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
    • C07K16/2875Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • 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
    • C07K16/2878Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • 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)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/66Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a swap of domains, e.g. CH3-CH2, VH-CL or VL-CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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    • C07ORGANIC CHEMISTRY
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    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
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    • C07ORGANIC CHEMISTRY
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    • C07K2319/00Fusion polypeptide
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
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    • C07K2319/00Fusion polypeptide
    • C07K2319/90Fusion polypeptide containing a motif for post-translational modification
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    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/10Processes for the isolation, preparation or purification of DNA or RNA
    • C12N15/1034Isolating an individual clone by screening libraries
    • C12N15/1058Directional evolution of libraries, e.g. evolution of libraries is achieved by mutagenesis and screening or selection of mixed population of organisms

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
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  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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  • Endocrinology (AREA)
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  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

v) (v3) 3S5! (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2017/106383 A4 22 June 2017 (22.06.2017) WIPO I PCT (51) International Patent Classification: C07K 16/24 (2006.01) (21) International Application Number: PCT/US2016/066722 (22) International Filing Date: 14 December 2016 (14.12.2016) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/268,432 16 December 2015 (16.12.2015) US 62/333,063 6 May 2016 (06.05.2016) US PCT/US2016/052006 15 September 2016 (15.09.2016) US (71) Applicant: AMGEN INC. [US/US]; One Amgen Center Drive, Thousand Oaks, California 91320-1799 (US). (72) Inventors: HSU, Hailing; 7264 Littler Court, Moorpark, California 93021 (US). KANNAN, Gunasekaran; 151 Crestview Circle, Daly City, California 94015 (US). WALKER, Kenneth W.; 175 Mesa Avenue, Newbury Park, California 91320 (US). HORTTER, Michelle; 455 Mariposa Drive, Camarillo, California 93012 (US). BE- LOUSKI, Edward J.; 761 Camino Las Conchas, Thou- sand Oaks, California 91360 (US). (74) Agents: GAUL, Timothy J. et al.; Amgen Inc., One Am- gen Center Drive, Thousand Oaks, California 91320-1799 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.1700) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: with international search report (Art. 21(3)) [Continued on next page] — (54) Title: ANTI-TL1A/ANTI-TNF-ALPHA BISPECIFIC ANTIGEN BINDING PROTEINS AND USES THEREOF 1111111111111101110101011111010111110 010110111111011111111011111111111011111111 (v4) K392D :356K K4090 399K K3700 357K W O 20 17 / 106383 A4 HC1 SISaK HC1 039K & • .6.3K HC1 48K & S .61 . HC1 SifLi HC2 S183E HC2 039E & S183E HC2 G44E & S183E HC2 S183E LC1 S176E LC1 0.38E & S176E LC1 GlOOE & S176E LC1 S176E LC2 S176K LC2 038K & S: 76K LC2 i100K & S .76K LC2 S176k Fig_ 1 (57) : The present invention concerns antigen binding proteins that bind TL1A, including bispecific antigen binding pro- teins (e.g., antibodies) to TL1A and TNF-a. Such bispecific antibodies can be in a tetrameric immunoglobulin format, in which one heavy chain-light chain pair of the antibody is directed to TL1A and the other to TNF-a. The bispecific antigen binding proteins may also be comprised in an IgG-scFv fusion, in which a conventional tetrameric antibody directed to one antigen is fused to a pair of single chain Fv units directed to the other. The bispecific antigen binding protein may also be comprised in an IgG-Fab fusion, in which a Fab molecule that binds to one antigen is fused to each heavy chain of a conventional tetrameric antibody directed to the other antigen. The invention further relates to uses of the anti-TL1A binding proteins and anti-TL1A/anti-TNF-alpha antigen binding proteins, and pharmaceutical formulations thereof. WO 2017/106383 A4 MIDEDIMOMOIDEIRMEMOMM1110110MMOMEION with amended claims (Art. 190)) Date of publication of the amended claims: 8 September 2017 with sequence listing part of description (Rule 5.2(a))
SG11201804857WA 2015-12-16 2016-12-14 Anti-tl1a/anti-tnf-alpha bispecific antigen binding proteins and uses thereof SG11201804857WA (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562268432P 2015-12-16 2015-12-16
US201662333063P 2016-05-06 2016-05-06
PCT/US2016/052006 WO2017049004A1 (en) 2015-09-15 2016-09-15 Tetravalent bispecific and tetraspecific antigen binding proteins and uses thereof
PCT/US2016/066722 WO2017106383A1 (en) 2015-12-16 2016-12-14 Anti-tl1a/anti-tnf-alpha bispecific antigen binding proteins and uses thereof

Publications (1)

Publication Number Publication Date
SG11201804857WA true SG11201804857WA (en) 2018-07-30

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EP (1) EP3390444A1 (en)
JP (1) JP7263007B2 (en)
KR (1) KR20180099723A (en)
CN (1) CN109311971A (en)
AU (2) AU2016370659B2 (en)
BR (1) BR112018012096A2 (en)
CA (1) CA3008267A1 (en)
CL (3) CL2018001596A1 (en)
CO (1) CO2018007355A2 (en)
CR (1) CR20180365A (en)
EA (1) EA201891322A1 (en)
IL (1) IL259847A (en)
JO (1) JO3816B1 (en)
MA (1) MA44060A (en)
MX (1) MX2018007424A (en)
PH (1) PH12018501284A1 (en)
SG (2) SG10201912002YA (en)
TN (1) TN2019000275A1 (en)
TW (1) TWI799368B (en)
UA (1) UA124305C2 (en)
UY (1) UY37027A (en)
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