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| EXAMINATION | - CHO S -F, "AMG 701, a half-life extended anti-BCMA BiTE , potently induces T cell-redirected lysis of human multiple myeloma cells and can be combined with IMiDs to overcome the immunosuppressive bone marrow microenvironment", CLINICAL LYMPHOMA, MYELOMA AND LEUKEMIA - 17TH INTERNATIONAL MYELOMA WORKSHOP 20191001 ELSEVIER INC. NLD, (20191001), vol. 19, no. 10, Supplement, ISSN 2152-2650, pages e54 CONF 20190912 to 20190915 Boston MA - 17th Inte | - |
| OPPOSITION | - Anonymous, "A Study of TNB-383B in Subjects With Relapsed or Refractory Multiple Myeloma - Full Text View - ClinicalTrials.gov", (20190501), URL: https://clinicaltrials.gov/ct2/show/NCT03933735, (20210706), XP055821787 | - |
| OPPOSITION | - Anonymous, "A Study of WVT078 in Patients With Multiple Myeloma (MM)", ClinicalTrials.gov, NCT04123418, (20240315), pages 1 - 9, XP093270720 | - |
| OPPOSITION | - Anonymous, "A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma ", Clinical Trials, (20171013), pages 1 - 17, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT03287908?tab=history&a=2%2523version-content-panel, XP093241190 | - |
| OPPOSITION | - Anonymous, "Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispeci^c Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)", ClinicalTrials.gov, NCT03145181, (20240814), pages 1 - 12, XP093270710 | - |
| OPPOSITION | - Anonymous, "First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)", ClinicalTrials.gov, NCT04083534, (20230710), pages 1 - 10, XP093270716 | - |
| OPPOSITION | - Anonymous, "Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers", Pharmacology and Toxicology, (20050701), pages 1 - 30, XP093270514 | - |
| OPPOSITION | - Anonymous, "Immunoglobulin, anti-(human tumor necrosis factor receptor superfamily protein TNFRSF17) (human monoclonal bra-hwzv 1 single-chain variable fragment VH1-(GGGGS)3-VL1) fusion protein with peptide linker (GGGGS) fusion protein with immunoglobulin anti-(human CD3 antigen ε-chain) (human monoclonal bra-hwzv 1 single-chain variable fragment VH2-(GGGGS)3-VL2) fusion protein with fusion protein with peptide linker (GGGG) fusion protein with immunoglobulin G1 (human γ1-chain C-region C-terminal fragment) fusion protein with peptide linker (GGGGS)6 fusion protein with immunoglobulin G1 (human γ1-chain C-region C-terminal fragment)", Registry, (20181130), Database accession no. 2250292-39-6, XP093270474 | - |
| OPPOSITION | - Anonymous, "Immunoglobulin, anti-(human tumor necrosis factor receptor superfamily protein TNFRSF17) (human monoclonal bra-kan 1 single-chain variable fragment VH1-(GGGGS)3-VL1) fusion protein with peptide linker (GGGGS) fusion protein with immunoglobulin anti-(human CD3 antigen ε-chain) (human monoclonal bra-kan 1 single-chain variable fragment VH2-(GGGGS)3-VL2) fusion protein with hexahistidine tag", CAS Registry, (20181206), Database accession no. 2251756-52-0, XP093270519 | - |
| OPPOSITION | - Anonymous, "PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma", Clinicaltrials, NCT03269136, (20240223), pages 1 - 10, XP093270706 | - |
| OPPOSITION | - Anonymous, "Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma (LINKER-MM1)", ClinicalTrials.gov, NCT03761108, (20240829), pages 1 - 10, XP093270714 | - |
| OPPOSITION | - Anonymous, "Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma", Clinical Trials, (20180330), pages 1 - 12, Clinical Trials, URL: https://www.clinicaltrials.gov/study/NCT03486067?tab=history&a=1#versioncontent-panel, XP093241111 | - |
| OPPOSITION | - Anonymous, "Vital and Health Statistics", Anthropometric Reference Data for Children and Adults: United States, 2015-2018 Analytical and Epidemiological Studies, (20210101), pages 1 - 5, XP093270700 | - |
| OPPOSITION | - D07: Epitope mapping data für AMG701 | - |
| OPPOSITION | - D08a: SEQUENCE COMPARISON OF AMG701 AND SEQ ID NO:661 OF THE OPPOSED PATENT | - |
| OPPOSITION | - D08b: SEQUENCE COMPARISON OF AMG701 AND AMG420 | - |
| OPPOSITION | - D08c: ANNOTATED SEQUENCE OF AMG701 (=SEQ ID NO:661 OF THE OPPOSED PATENT) | - |
| OPPOSITION | - D08d: SEQUENCE COMPARISON OF AMG701 AND SEQ ID NO:700 OF THE OPPOSED PATENT | - |
| OPPOSITION | - D13a: TECLISTAMAB (INN 10928) | - |
| OPPOSITION | - D13b: LINVOSELTAMAB (INN 12104) | - |
| OPPOSITION | - D13d: ALNUCTAMAB (INN 11457) | - |
| OPPOSITION | - D13e: TABLE OF DENOMINATIONS OF BCMA X CD3 BISPECIFIC ANTIBODY CONSTRUCTS IN CLINICAL DEVELOPMENT AT THE APPLICATION DATE (INTERNAL NAMES, INNS AND PRODUCT NAMES) | - |
| OPPOSITION | - D14: FDA LABEL OF TECVAYLI® (TECLISTAMAB) OF OCTOBER 2022 | - |
| OPPOSITION | - D24a: EP 19207293 (PRIORITY DOCUMENT OF D24) | - |
| OPPOSITION | - D29: AMGEN INC WEBCAST INVESTOR MEETING AT ASH 2018 - FINAL © 2018 BY CQ-ROLL CALL, INC. ALL RIGHTS RESERVED. PRESENTATION PROVIDED BY FACTIVA INC. | - |
| OPPOSITION | - D34: TABLE EXTRACTED FROM THE OPPOSED PATENT PROVIDING DESIGNATIONS FOR SEQUENCES SEQ ID NO: 1 TO 715 | - |
| OPPOSITION | - D57: EudraCT Number: 2018-003188-78 | - |
| OPPOSITION | - D61: World Health Organization table of weight-for-age for boys aged 5 to 10 years (https://cdn.who.int/media/docs/default-source/child-growth/growth-reference-5-19-years/weightfor-age-(5-10-years)/sft-wfa-boys-z-5-10years.pdf?sfvrsn=dbc4f49d_4) | - |
| OPPOSITION | - D68: Proprietors’ submission of 23rd August 2021 in contentious proceedings against EP 2 780 375 | - |
| OPPOSITION | - D71: Proprietors’ response to notice of opposition on EP 3 411 402 B1 | - |
| OPPOSITION | - D73: Proprietors’ submissions under Rule 116 EPC in EPO opposition proceedings relating to the Proprietors’ now-revoked EP 2 780 375 | - |
| OPPOSITION | - D74: Proprietors’ response to Appeal in proceedings relating to EP 2 155 783 | - |
| OPPOSITION | - Einsele Hermann et al, "The anti-BCMA Bispecific T-cell Engager (BITE®) Molecule AMG 420 Induced MRD-Negative Complete Responses in R/R Multiple Myeloma in a FIH study", 17th International Myeloma Workshop, (20190901), pages e18 - e19, XP093241668 | - |
| OPPOSITION | - Helwick Caroline, "Bispecific Antibodies: Successes and Challenges", The ASCO Post, (20200410), pages 1 - 5, The ASCO Post, URL: https://ascopost.com/issues/april-10-2020/bispecific-antibodies-successes-and-challenges/, XP093241687 | - |
| OPPOSITION | - Janeway C.A, Travers P, Walport M, "The T-cell receptor complex is made up of antigen-recognition proteins and invariant signaling proteins", Immunobiology: The Immune System in Health and Disease. 5th edition, (20010101), page 1, XP093270491 | - |
| OPPOSITION | - Konterman Roland E., "Bispecific Antibodies: Developments and Current Perspectives", Bispecific Antibodies, Berlin, Heidelberg , Springer Berlin Heidelberg , (20110101), pages 1 - 136, ISBN 978-3-642-20910-9, XP093270543 | - |
| OPPOSITION | - Lederman Lynne, "Anti-BCMA BiTE AMG 701 Shows Preclinical Promise in Multiple Myeloma", onclive, (20190916), pages 1 - 3, onclive, URL: https://www.onclive.com/view/antibcma-bite-amg-701-shows-preclinical-promise-in-multiple-myeloma, XP093241557 | - |
| OPPOSITION | - S13c: ELRANATAMAB (INN 11838) | - |
| OPPOSITION | - Taylor Nick Paul, "Amgen takes BiTEs out of pipeline, dropping BCMA, PSMA assets in light of data and competition", Fierce Biotec, (20220805), pages 1 - 1, Fierce Biotec, URL: https://www.fiercebiotech.com/biotech/amgen-takes-bites-out-pipeline-dropping-bcma-and-psma-assets-light-data-and-competition, XP093241696 | - |
| OPPOSITION | - Yuraszeck T, S Kasichayanula1 And Je Benjamin, "Translation and Clinical Development of Bispecific T-cell Engaging Antibodies forCancer Treatment", Clinical Pharmacology & Therapeutics, (20170501), vol. 101, no. 5, pages 634 - 645, XP055866812 | - |
| OPPOSITION | - Rajshekhar Chakraborty; Navneet S. Majhail, "Treatment and disease‐related complications in multiple myeloma: Implications for survivorship", AMERICAN JOURNAL OF HEMATOLOGY, NEW YORK, NY, US, US , (20200313), vol. 95, no. 6, doi:10.1002/ajh.25764, ISSN 0361-8609, pages 672 - 690, XP071632805 | |
| OPPOSITION | - Ravi Gayathri, Costa Luciano J., "Bispecific T‐cell engagers for treatment of multiple myeloma", AMERICAN JOURNAL OF HEMATOLOGY, NEW YORK, NY, US, US , (20230301), vol. 98, no. S2, doi:10.1002/ajh.26628, ISSN 0361-8609, pages S13 - S21, XP093241227 | |
| OPPOSITION | - Lu Zheng, Rüdiger Kaspera, Yoichi Naritomi, Tianli Wang, "Dose Finding in Single Dose Studies by Allometric Scaling", Drug Discovery and Evaluation: Methods in Clinical Pharmacology, Springer International Publishing AG , (20180101), pages 1 - 11, doi:10.1007/978-3-319-56637-5_3-1, XP093241656 | |
| OPPOSITION | - Bittner Beate, Richter Wolfgang, Schmidt Johannes, "Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities", BIODRUGS, Adis International Ltd., NZ, NZ , (20181001), vol. 32, no. 5, doi:10.1007/s40259-018-0295-0, ISSN 1173-8804, pages 425 - 440, XP055884493 | |
| OPPOSITION | - Xiaoying Chen et al, "Fusion protein linkers: Property, design and functionality", Advanced Drug Delivery Reviews, Elsevier, (20120901), doi:10.1016/j.addr.2012.09.039, ISSN 0169409X, XP055062583 | |
| OPPOSITION | - Seckinger Anja et al, "Target Expression, Generation, Preclinical Activity, and Pharmacokinetics of the BCMA-T Cell Bispecific Antibody EM801 for Multiple Myeloma Treatment", CANCER CELL, CELL PRESS, US, US , (20170302), vol. 31, no. 3, doi:10.1016/j.ccell.2017.02.002, ISSN 1535-6108, pages 396 - 410, XP029953443 | |
| OPPOSITION | - Crusoe Edvan De et al, "Multiple Myeloma: A Rare Case in an 8-Year-Old Child", Clinical Lymphoma Myeloma and Leukemia, Elsevier, NL, NL , (20150101), vol. 15, no. 1, doi:10.1016/j.clml.2014.08.004, ISSN 2152-2650, pages e31 - e33, XP093241699 | |
| OPPOSITION | - Cho S -FLin L et al, "AMG701, a half-life extended anti-BCMA BiTE®, potently induces T cell-redirected lysis of human multiple myeloma cells and can be combined with IMiDs to overcome the immunosuppressive bone marrow microenvironment", Clinical Lymphoma Myeloma and Leukemia, Elsevier, NL, NL , (20191001), vol. 19, no. 10, Supplement, doi:10.1016/j.clml.2019.09.082, ISSN 2152-2650, page e54, XP009519992 | |
| OPPOSITION | - Muller, P.Y. et al, "The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies", Current Opinion in Biotechnology, LONDON, GB, GB , (20091201), vol. 20, no. 6, doi:10.1016/j.copbio.2009.10.013, ISSN 0958-1669, pages 722 - 729, XP026778884 | |
| OPPOSITION | - Steffen Dickopf, Georges Guy J., Brinkmann Ulrich, "Format and geometries matter: Structure-based design defines the functionality of bispecific antibodies", COMPUTATIONAL AND STRUCTURAL BIOTECHNOLOGY JOURNAL, Research Network of Computational and Structural Biotechnology, Sweden, Sweden , (20200514), vol. 18, doi:10.1016/j.csbj.2020.05.006, ISSN 2001-0370, pages 1221 - 1227, XP055740966 | |
| OPPOSITION | - Spiess Christoph; Zhai Qianting; Carter Paul J., "Alternative molecular formats and therapeutic applications for bispecific antibodies", Molecular Immunology, PERGAMON, GB, GB , (20150127), vol. 67, no. 2, doi:10.1016/j.molimm.2015.01.003, ISSN 0161-5890, pages 95 - 106, XP029246892 | |
| OPPOSITION | - Saber Haleh et al, "An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection", REGULATORY TOXICOLOGY AND PHARMACOLOGY, ACADEMIC PRESS,NEW YORK, NY,, US, US , (19000101), vol. 90, doi:10.1016/j.yrtph.2017.09.001, ISSN 0273-2300, pages 144 - 152, XP085227685 | |
| OPPOSITION | - Usmani Saad Z. et al, "Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20210801), vol. 398, no. 10301, doi:10.1016/S0140-6736(21)01338-6, pages 665 - 674, XP055951020 | |
| OPPOSITION | - Raab Marc S. et al, "Preclinical discovery and initial clinical data of WVT078, a BCMA × CD3 bispecific antibody", Blood Cancer Journal, Nature Publishing Group UK, London, London, (20230601), vol. 37, no. 6, doi:10.1038/s41375-023-01883-3, ISSN 0887-6924, pages 1349 - 1360, XP093241080 | |
| OPPOSITION | - Bahlis Nizar J. et al, "Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial", Nature Medicine(Author manuscript ), Nature Publishing Group US, New York, New York, (20231001), vol. 29, no. 10, doi:10.1038/s41591-023-02589-w, ISSN 1078-8956, pages 2570 - 2576, XP093241076 | |
| OPPOSITION | - Foster Laahn H., Lum Lawrence G., "Treatment of hematological malignancies with T cell redirected bispecific antibodies: current status and future needs", EXPERT OPINION ON BIOLOGICAL THERAPY, Informa Healthcare, (20190703), vol. 19, no. 7, doi:10.1080/14712598.2019.1604672, ISSN 1471-2598, pages 707 - 720, XP093123106 | |
| OPPOSITION | - Yu-Tzu Tai, Kenneth C Anderson, "B cell maturation antigen (BCMA)-based immunotherapy for multiple myeloma", EXPERT OPINION ON BIOLOGICAL THERAPY, Informa Healthcare, (20191102), vol. 19, no. 11, doi:10.1080/14712598.2019.1641196, ISSN 1471-2598, pages 1143 - 1156, XP055686682 | |
| OPPOSITION | - Ball Kathryn, Dovedi Simon J, Vajjah Pavan, Phipps Alex, "Strategies for clinical dose optimization of T cell-engaging therapies in oncology", mAbs, Landes Bioscience, US, US , (20231231), vol. 15, no. 1, doi:10.1080/19420862.2023.2181016, ISSN 1942-0862, pages 1 - 18, XP093241178 | |
| OPPOSITION | - Clynes Raphael A, Desjarlais John R, "Annual Review of Medicine Redirected T Cell Cytotoxicity in Cancer Therapy ", Annu. Rev. Med, (20181031), vol. 70, doi:10.1146/annurev-med-062617-, pages 437 - 50, XP093051050 | |
| OPPOSITION | - Goyos Ana, Li Chi-Ming, Deegen Petra, Bogner Pamela, Thomas Oliver, Wahl Joachim, Goldstein Rebecca, Friedrich Maththias, Coxon Angela, Balazs Mercedesz, Arvedson Tara, "Abstract LB-299: Cynomolgus monkey plasma cell gene signature to quantify the in vivo activity of a half-life extended anti-BCMA BiTE® for the treatment of multiple myeloma", Cancer research, University of Chicago Press, (20180701), vol. 78, no. 13_Supplement, doi:10.1158/1538-7445.AM2018-LB-299, ISSN 0008-5472, pages 1 - 2, XP093270539 | |
| OPPOSITION | - Tai Yu-Tzu et al, "Novel anti-B-cell maturation antigen antibody-drug conjugate (GSK2857916) selectively induces killing of multiple myeloma", Blood, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20140515), vol. 123, no. 20, doi:10.1182/blood-2013-10-535088, ISSN 0006-4971, pages 3128 - 3138, XP009505860 | |
| OPPOSITION | - Ravandi Farhad et al, "A Phase 1 First-in-Human Study of AMG 330, an Anti-CD33 Bispecific T-Cell Engager (BiTE (R)) Antibody Construct, in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)", Blood, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20181129), vol. 132, no. Suppl. 1, doi:10.1182/blood-2018-99-109762, ISSN 0006-4971, page 25, XP009516802 | |
| OPPOSITION | - Topp Max S et al, "Treatment with AMG 420, an Anti-B-CellMaturationAntigen (BCMA) Bispecific T-Cell Engager (BiTE (R)) Antibody Construct, Induces Minimal Residual Disease (MRD) Negative Complete Responses in Relapsed and/or Refractory (R/R) Multiple Myeloma (MM) Patients: Results of a First-in-Human (FIH) Phase I Dose Escalation Study", Blood, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20181129), vol. 132, no. Suppl. 1, doi:10.1182/blood-2018-99-109769, ISSN 0006-4971, page 1010, XP009519963 | |
| OPPOSITION | - Lesokhin Alexander M. et al, "A Phase I, Open-Label Study to Evaluate the Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity of PF-06863135, a B-Cell Maturation Antigen/CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Advanced Multiple Myeloma", Blood, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20181129), vol. 132, doi:10.1182/blood-2018-99-110427, ISSN 0006-4971, page 3229, XP086591928 | |
| OPPOSITION | - Costa Luciano J. et al, "First Clinical Study of the B-Cell Maturation Antigen (BCMA) 2+1 T Cell Engager (TCE) CC-93269 in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Interim Results of a Phase 1 Multicenter Trial", Blood, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20191113), vol. 134, doi:10.1182/blood-2019-122895, ISSN 0006-4971, page 143, XP086665034 | |
| OPPOSITION | - Harrison Simon J. et al, "A Phase 1 First in Human (FIH) Study of AMG 701, an Anti-B-Cell Maturation Antigen (BCMA) Half-Life Extended (HLE) BiTE® (bispecific T-cell engager) Molecule, in Relapsed/Refractory (RR) Multiple Myeloma (MM)", Blood, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20201105), vol. 136, no. Supplement 1, doi:10.1182/blood-2020-134063, ISSN 0006-4971, pages 28 - 29, XP055893178 | |
| OPPOSITION | - Goldstein Rebecca L. et al, "AMG 701 induces cytotoxicity of multiple myeloma cells and depletes plasma cells in cynomolgus monkeys", Blood Advances, American Society of Hematology, (20200908), vol. 4, no. 17, doi:10.1182/bloodadvances.2020002565, ISSN 2473-9529, pages 4180 - 4194, XP093241204 | |
| OPPOSITION | - Topp M S. et al, "8007: Evaluation of AMG 420, an anti-BCMA bispecific T-cell engager (BiTE) immunotherapy, in R/R multiple myeloma (MM) patients: Updated results of a first-in-human (FIH) phase i dose escalation study", Journal of Clinical Oncology, Grune & Stratton, (20190520), vol. 37, no. Supplement 15, doi:10.1200/JCO.2019.37.15_suppl.8007, ISSN 1527-7755, page 8007, XP009519965 | |
| OPPOSITION | - Bumma Naresh et al, "Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma", Journal of Clinical Oncology, (20240801), vol. 42, no. 22, doi:10.1200/JCO.24.01008, pages 2702 - 2712, XP093241519 | |
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| OPPOSITION | - Caraccio Chiara et al, "Bispecific Antibodies for Multiple Myeloma: A Review of Targets, Drugs, Clinical Trials, and Future Directions", Frontiers in Immunology, Frontiers Media, Lausanne, CH, Lausanne, CH , (20200424), vol. 11, doi:10.3389/fimmu.2020.00501, ISSN 1664-3224, XP055860851 | |
| OPPOSITION | - Strohl William R, Naso, M, "Bispecific T-Cell Redirection versus Chimeric Antigen Receptor (CAR)-T Cells as Approaches to Kill Cancer Cells", Antibodies, (20190703), vol. 8, no. 3, doi:10.3390/antib8030041, pages 1 - 68, XP055935197 | |
| OPPOSITION | - Dalla Palma Benedetta et al, "Monoclonal and Bispecific Anti-BCMA Antibodies in Multiple Myeloma", Journal of Clinical Medicine, Multidisciplinary Digital Publishing Institute (MDPI), CH, CH , (20200101), vol. 9, no. 9, doi:10.3390/jcm9093022, ISSN 2077-0383, pages 1 - 11, XP093241528 | |
| OPPOSITION | - Trabolsi Asaad et al, "T Cell-Activating Bispecific Antibodies in Cancer Therapy", Journal of Immunology, Williams & Wilkins Co., (20190801), vol. 203, no. 3, doi:10.4049/jimmunol.1900496, ISSN 0022-1767, pages 585 - 592, XP055812112 | |
| OPPOSITION | - Anroopb Nair, Shery Jacob, "A simple practice guide for dose conversion between animals and human", Journal of Basic and Clinical Pharmacy, India, India , (20160501), vol. 7, no. 2, doi:10.4103/0976-0105.177703, ISSN 0976-0105, page 27, XP055407475 | |
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