SG11201805048SA - Bispecific anti-cd20/anti-cd3 antibodies to treat acute lymphoblastic leukemia - Google Patents

Bispecific anti-cd20/anti-cd3 antibodies to treat acute lymphoblastic leukemia

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Publication number
SG11201805048SA
SG11201805048SA SG11201805048SA SG11201805048SA SG11201805048SA SG 11201805048S A SG11201805048S A SG 11201805048SA SG 11201805048S A SG11201805048S A SG 11201805048SA SG 11201805048S A SG11201805048S A SG 11201805048SA SG 11201805048S A SG11201805048S A SG 11201805048SA
Authority
SG
Singapore
Prior art keywords
international
data
lymphoblastic leukemia
acute lymphoblastic
pct
Prior art date
Application number
SG11201805048SA
Inventor
Carrie Brownstein
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of SG11201805048SA publication Critical patent/SG11201805048SA/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • C07K16/30Immunoglobulins [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
    • 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
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • 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
    • C07K16/2803Immunoglobulins [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
    • 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
    • C07K16/2803Immunoglobulins [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
    • C07K16/2809Immunoglobulins [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 against the T-cell receptor (TcR)-CD3 complex
    • 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
    • C07K16/2887Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • C07K16/30Immunoglobulins [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
    • C07K16/3061Blood cells
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K19/00Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/53Hinge
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

5 0 5 10 50 n W O 20 171127 / 6 2 Al (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 2017/112762 Al 29 June 2017 (29.06.2017) WIPO I PCT 1111111111111101110111111111110101111101110111011101011111111011111111111110111111 Treatment in NSG mice with established Raji tumors Tum or Vo lume mm ( 3) 150 (51) International Patent Classification: C07K 16/28 (2006.01) A61K 39/00 (2006.01) A61P 35/00 (2006.01) (21) International Application Number: PCT/US2016/068003 (22) International Filing Date: 21 December 2016 (21.12.2016) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/270,749 22 December 2015 (22.12.2015) US 62/306,031 9 March 2016 (09.03.2016) US (71) Applicant: REGENERON PHARMACEUTICALS, INC. [US/US]; 777 Old Saw Mill River Road, Tarrytown, New York 10591-6707 (US). (72) Inventor: BROWNSTEIN, Carrie; c/o Regeneron Phar- maceuticals, Inc., 777 Old Saw Mill River Road, Tarry- town, New York 10591-6707 (US). (74) Agents: TERMES, Lance, A. et al.; Schwabe, Williamson & Wyatt, 1211 SW 5th Avenue, Suite 1900, Portland, OR 97204 (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, [Continued on next page] (54) Title: BISPECIFIC ANTI-CD20/ANTI-CD3 ANTIBODIES TO TREAT ACUTE LYMPHOBLASTIC LEUKEMIA (57) : The present invention provides methods for treating, reducing the severity, or inhibiting the growth of acute lymphoblastic leukemia. The methods of the present invention comprise administer- ing to a subject in need thereof a thera- 1000 peutically effective amount of a bispecific antibody that specifically binds to CD20 and CD3. Days Post Treatment Control-Vehicle -NI- Control Ab 6 - 0.4 m gAcg ; 2x/week -le- Ab 1 -OA mg/kg ; 2x/week -- Rituximab -8 mg/kg; 5xlweek -4- C D19xCD3 BiTE - 0.5 mgkg; 5x/week compared to vehicle commit 41.;;;- competed to Ab 6 control; @ - compared to rin.Lximab; ns - not significant Data represents the composite data from n=4-6 mice per grow. Data are expressed as mean (SEM) and were analysed using analysis of variance (ANOVA) and post hoc tests to probe significant effects (Tukey's for two-way ANOVA). Two mice in the CD19 BITE group, and one mouse from the Ab 1 gimp was excluded from this composite graph due to early death in order to analyze data by two-way ANOVA. Figure 1 WO 2017/112762 Al 1#11101M011111 1111111101011111301011010111111111101111111011110111111 SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, Published: GW, KM, ML, MR, NE, SN, TD, TG). with international search report (Art. 21(3)) Declarations under Rule 4.17: with sequence listing part of description (Rule 5.2(a)) — as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii))
SG11201805048SA 2015-12-22 2016-12-21 Bispecific anti-cd20/anti-cd3 antibodies to treat acute lymphoblastic leukemia SG11201805048SA (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562270749P 2015-12-22 2015-12-22
US201662306031P 2016-03-09 2016-03-09
PCT/US2016/068003 WO2017112762A1 (en) 2015-12-22 2016-12-21 Bispecific anti-cd20/anti-cd3 antibodies to treat acute lymphoblastic leukemia

Publications (1)

Publication Number Publication Date
SG11201805048SA true SG11201805048SA (en) 2018-07-30

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Application Number Title Priority Date Filing Date
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Country Status (14)

Country Link
US (1) US20170174781A1 (en)
EP (1) EP3394102A1 (en)
JP (1) JP2019503363A (en)
KR (1) KR20180087401A (en)
CN (1) CN108602889A (en)
AU (1) AU2016378573A1 (en)
BR (1) BR112018012929A2 (en)
CA (1) CA3009322A1 (en)
EA (1) EA201891495A1 (en)
IL (1) IL260000A (en)
MA (1) MA44145A (en)
MX (1) MX2018007756A (en)
SG (1) SG11201805048SA (en)
WO (1) WO2017112762A1 (en)

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TWI701042B (en) 2014-03-19 2020-08-11 美商再生元醫藥公司 Methods and antibody compositions for tumor treatment
MX2017006312A (en) 2014-11-17 2017-08-21 Regeneron Pharma Methods for tumor treatment using cd3xcd20 bispecific antibody.
AU2017312785A1 (en) 2016-08-16 2019-01-24 Regeneron Pharmaceuticals, Inc. Methods for quantitating individual antibodies from a mixture
JP7102401B2 (en) 2016-10-25 2022-07-19 リジェネロン・ファーマシューティカルズ・インコーポレイテッド Methods and systems for chromatographic data analysis
SG11202012405WA (en) * 2018-06-14 2021-01-28 Bioatla Inc Multi-specific antibody constructs
TW202005694A (en) 2018-07-02 2020-02-01 美商里珍納龍藥品有限公司 Systems and methods for preparing a polypeptide from a mixture
US11157011B2 (en) * 2018-07-30 2021-10-26 Fedex Corporate Services, Inc. Enhanced systems, apparatus, and methods for improved automated and autonomous operation of logistics ground support equipment
MA53495A (en) * 2018-08-31 2021-12-08 Regeneron Pharma DOSING STRATEGY TO MITIGATE CYTOKINE RELEASE SYNDROME FOR CD3/C20 BISPECIFIC ANTIBODIES
SG11202103628PA (en) 2018-10-31 2021-05-28 Regeneron Pharma Method and system of identifying and quantifying a protein
US11249089B2 (en) 2018-12-12 2022-02-15 Regeneron Pharmaceuticals, Inc. System and method of analysis of a protein using liquid chromatography-mass spectrometry
WO2020232165A1 (en) * 2019-05-14 2020-11-19 Qlb Biotherapeutics Bispecific anti-cd3 x cd20 antibodies and uses thereof
CN110563849B (en) * 2019-08-09 2022-09-09 安徽瀚海博兴生物技术有限公司 anti-VEGF-anti-PD 1 bispecific antibody
CN110498857B (en) * 2019-08-09 2022-09-09 安徽瀚海博兴生物技术有限公司 anti-VEGF-anti-PD 1 bispecific antibody
MX2021014863A (en) 2019-12-06 2022-09-28 Regeneron Pharma Anti-vegf protein compositions and methods for producing the same.
TW202135860A (en) * 2019-12-10 2021-10-01 美商再生元醫藥公司 Stabilized formulations containing anti-cd20 x anti-cd3 bispecific antibodies
JP2023527926A (en) * 2020-06-04 2023-06-30 バイオインベント インターナショナル アーべー Improved antibody tolerance associated with intravenous administration
CN112062855A (en) * 2020-08-26 2020-12-11 康诺亚生物医药科技(成都)有限公司 Development and application of medicinal therapeutic agent containing adapter
CN114524878A (en) 2020-11-23 2022-05-24 康诺亚生物医药科技(成都)有限公司 Bispecific antibody and application thereof
AR127271A1 (en) * 2021-10-09 2024-01-03 Hutchmed Ltd BISPECIFIC ANTIBODIES THAT BIND SPECIFICALLY TO CD47 AND CD20, AND USES THEREOF

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US9382327B2 (en) * 2006-10-10 2016-07-05 Vaccinex, Inc. Anti-CD20 antibodies and methods of use
PL2344539T3 (en) * 2008-11-07 2015-07-31 Amgen Res Munich Gmbh Treatment of pediatric acute lymphoblastic leukemia
TWI701042B (en) * 2014-03-19 2020-08-11 美商再生元醫藥公司 Methods and antibody compositions for tumor treatment

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US20170174781A1 (en) 2017-06-22
EA201891495A1 (en) 2018-11-30
EP3394102A1 (en) 2018-10-31
BR112018012929A2 (en) 2018-12-11
KR20180087401A (en) 2018-08-01
IL260000A (en) 2018-07-31
WO2017112762A1 (en) 2017-06-29
MA44145A (en) 2018-10-31
CA3009322A1 (en) 2017-06-29
AU2016378573A1 (en) 2018-07-19
MX2018007756A (en) 2018-08-09
CN108602889A (en) 2018-09-28
JP2019503363A (en) 2019-02-07

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