Dosing Regimen For Anti-Bcma Agents - EP4058148

The patent EP4058148 was granted to Amgen on Mar 13, 2024. The application was originally filed on May 8, 2020 under application number EP20729951A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP4058148

AMGEN
Application Number
EP20729951A
Filing Date
May 8, 2020
Status
Granted And Under Opposition
Feb 9, 2024
Grant Date
Mar 13, 2024
External Links
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Patent Summary

Patent Family

Patent Family

Patent Oppositions (3)

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ABBVIEDec 13, 2024KONIG SZYNKA TILMANN VON RENESSE PATENTANWALTE PARTNERSCHAFT MBB DUSSELDORFADMISSIBLE
REGENERON PHARMACEUTICALSAug 2, 2024CARPMAELS & RANSFORDADMISSIBLE
STRAWMANMar 15, 2024RCF PROTECTING INNOVATIONADMISSIBLE

Patent Citations (62) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

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Non-Patent Literature (NPL) Citations (80) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
OPPOSITION- 32c-Annotated sequence of AMG701 (=SEQ ID NO.661 of the Opposed Patent)-
OPPOSITION- Anonymous, "A Study of WVT078 in Patients With Multiple Myeloma (MM)", Clinical Trials, (20191009), pages 1 - 9, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT04123418?tab=history&a=1#versioncontent-panel, (2024112024), XP093241147-
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, (20170915), pages 1 - 12, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT03287908?tab=history&a=1#versionconte%20D12%20nt-panel, (20240910), XP093241102-
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OPPOSITION- Anonymous, "CAS Registry AMG-420 / Pacanalotamab ", REGISTRY , (20181206), Database accession no. 2251756-52-0, URL: STN, XP093241547-
OPPOSITION- Anonymous, "CAS Registry: AM G-701", REGISTRY , (20181130), Database accession no. 2250292-39-6 , URL: STN, XP093241202-
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OPPOSITION- Anonymous , Fda, "Blincyto (blinatumomab)", FDA, (20140101), pages 1 - 51, XP093241646-
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OPPOSITION- D24- EP 19 208 417.6, priority application to the Opposed Patent-
OPPOSITION- D31-Epitope mapping data fur AMG701-
OPPOSITION- D32a-Sequence comparison of AMG701 and SEQ ID NO:661 of the Opposed Patent-
OPPOSITION- D32b-Sequence comparison of AMG701 and AMG420-
OPPOSITION- D32d-Sequence comparison of AMG701 and SEQ ID NO:700 of the Opposed Patent-
OPPOSITION- D34- Janeway et al., Garland Sci, 2001, figure 6.8 of antigen receptor sturcture and signaling pathways Immunobiology: The immune system in health and disease-
OPPOSITION- D36a-Teclistamab (INN 10928)-
OPPOSITION- D36b - Linvoseltamab (INN 12104)-
OPPOSITION- D36c - Elranatamab (INN 11838)-
OPPOSITION- D36d - Alnuctamab (INN 11457)-
OPPOSITION- D36e - Table of denominations of BCMA x CD3 bispecifc antibody constructs in clinical development at the priority date (internal names, INNs and product names-
OPPOSITION- D48- Amgen Inc Webcast Investor Meeting at ASH 2018 - Final © 2018 by CQ-Roll Call, Inc. All rights reserved. Presentation Provided by Factiva InC-
OPPOSITION- D4a- EP 19207293 (priority document of D4)-
OPPOSITION- D56-able extracted from the priority document (P1) of the Opposed Patent providing designations for sequences SEO ID NO: 1 to 71-
OPPOSITION- D59-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-
OPPOSITION- D65-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-
OPPOSITION- D73-EudraCT Number: 2018-003188-78-
OPPOSITION- D77-World Health Organization table of weight-for-age for boys aged 5 to 10-
OPPOSITION- D78-Table of body surface area in children from the National Institute for Health and Care Excellence website-
OPPOSITION- D79a-Regeneron Archived Presentations-
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OPPOSITION- D85-Proprietors’ response to Appeal in proceedings relating to EP 2 155 783-
OPPOSITION- D8a- US 62/865381 (priority document of D8)-
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OPPOSITION- Saber Haleh; Del Valle Pedro; Ricks Tiffany K.; Leighton John K., "An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection", Regulatory toxicology and pharmacology, US , (19000101), vol. 90, doi:10.1016/j.yrtph.2017.09.001, ISSN 0273-2300, pages 144 - 152, XP085227685
OPPOSITION- Usmani Saad Z, Garfall Alfred L, Van De Donk Niels W C J, Nahi Hareth, San-Miguel Jesus F, Oriol Albert, Rosinol Laura, Chari Ajai, Bhutani Manisha, Karlin Lionel, Benboubker Lotfi, Pei Lixia, Verona Raluca, Girgis Suzette, Stephenson Tara, Elsayed Yusri, Infante Jeffrey, Goldberg Jenna D, Banerjee Arnob, Mateos María-Victoria, Krishnan Amrita, "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, AMSTERDAM, NL , (20210801), vol. 398, no. 10301, doi:10.1016/S0140-6736(21)01338-6, ISSN 0140-6736, pages 665 - 674, XP055951020
OPPOSITION- Raab Marc S., Cohen Yael C., Schjesvold Fredrik, Aardalen Kimberly, Oka Adwait, Spencer Andrew, Wermke Martin, Souza Anita D., Kaufman Jonathan L., Cafro Anna Maria, Ocio Enrique M., Doki Noriko, Henson Kristin, Trabucco Gina, Carrion Ana, Bender Florent C., Juif Pierre-Eric, Fessehatsion Adonai, Fan Liqiong, Stonehouse Jeffrey P., Blankenship John W., Granda Brian, De Vita Serena, Lu Haihui, "Preclinical discovery and initial clinical data of WVT078, a BCMA × CD3 bispecific antibody", Blood Cancer Journal, London, (20230601), vol. 37, no. 6, doi:10.1038/s41375-023-01883-3, ISSN 0887-6924, pages 1349 - 1360, XP093241080
OPPOSITION- Bahlis Nizar J., Costello Caitlin L., Raje Noopur S., Levy Moshe Y., Dholaria Bhagirathbhai, Solh Melhem, Tomasson Michael H., Damore Michael A., Jiang Sibo, Basu Cynthia, Skoura Athanasia, Chan Edward M., Trudel Suzanne, Jakubowiak Andrzej, Gasparetto Cristina, Chu Michael P., Dalovisio Andrew, Sebag Michael, Lesokhin Alexander M., "Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial", Nature Medicine, 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, (20190703), vol. 19, no. 7, doi:10.1080/14712598.2019.1604672, ISSN 1471-2598, pages 707 - 720, XP093123106
OPPOSITION- Tai Yu-Tzu, Anderson Kenneth C, "B cell maturation antigen (BCMA)-based immunotherapy for multiple myeloma", Expert Opinion on Biological Therapy (Author manuscript), (20191101), vol. 19, no. 11, doi:10.1080/14712598.2019.1641196, ISSN 1471-2598, pages 1 - 27, XP093241161
OPPOSITION- Ball Kathryn, Dovedi Simon J, Vajjah Pavan, Phipps Alex, "Strategies for clinical dose optimization of T cell-engaging therapies in oncology", mAbs, 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- Tai Yu-Tzu; Mayes Patrick A; Acharya Chirag; Zhong Mike Y; Cea Michele; Cagnetta Antonia; Craigen Jenny; Yates John; Gliddon Louise; Fieles William; Hoang Bao; Tunstead James; Christie Amanda L; Kung Andrew L; Richardson Paul; Munshi Nikhil C; Anderson Kenneth C, "Novel anti-B-cell maturation antigen antibody-drug conjugate (GSK2857916) selectively induces killing of multiple myeloma", Blood, US , (20140515), vol. 123, no. 20, doi:10.1182/blood-2013-10-535088, ISSN 0006-4971, pages 3128 - 3138, XP009505860
OPPOSITION- Topp Max S; Duell Johannes; Zugmaier Gerhard; Attal Michel; Moreau Philippe; Langer Christian; Kroenke Jan; Facon Thierry; Einsele Hermann; Munzert Gerd, "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, US , (20181129), vol. 132, no. Suppl. 1, doi:10.1182/blood-2018-99-109769, ISSN 0006-4971, pages 1 - 5, XP009519963
OPPOSITION- Lesokhin Alexander M.; Raje Noopur; Gasparetto Cristina J; Walker Justine; Krupka Heike I.; Joh Tenshang; Taylor Carrie T.; Jakubowiak Andrzej, "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, US , (20181129), vol. 132, doi:10.1182/blood-2018-99-110427, ISSN 0006-4971, page 3229, XP086591928
OPPOSITION- Costa Luciano J.; Wong Sandy W.; Bermudez Arancha; de la Rubia Javier; Mateos Maria-Victoria; Ocio Enrique M.; Rodriguez-Otero Paula; San-Miguel Jesus; Li Shaoyi; Sarmiento Rafael; Lardelli Pilar; Gaudy Allison; Boss Isaac; Kelly Lisa M.; Burgess Michael R.; Hege Kristen; Bensinger William I., "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, US , (20191113), vol. 134, doi:10.1182/blood-2019-122895, ISSN 0006-4971, pages 1 - 5, XP086665034
OPPOSITION- Cooper Dennis; Madduri Deepu; Lentzsch Suzanne; Jagannath Sundar; Li Jingjin; Boyapati Anita; Adriaens Lieve; Chokshi Dhruti; Zhu Min; Lowy Israel; Weinreich David M.; Yancopoulos George D.; Sharma Manish; Karasarides Maria; Sternberg David, "Safety and Preliminary Clinical Activity of REGN5458, an Anti-Bcma x Anti-CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma", Blood, US , (20191113), vol. 134, doi:10.1182/blood-2019-126818, ISSN 0006-4971, pages 1 - 4, XP086663599
OPPOSITION- Harrison Simon J, Minnema Monique C., Lee Hans C., Spencer Andrew, Kapoor Prashant, Madduri Deepu, Larsen Jeremy, Ailawadhi Sikander, Kaufman Jonathan L., Raab Marc S., Hari Parameswaran, Iida Shinsuke, Vij Ravi, Davies Faith E., Lesley Robin, Upreti Vijay V., Yang Zhao, Sharma Anjali, Minella Alex, Lentzsch Suzanne, "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, American Society of Hematology, US , (20201105), vol. 136, no. Supplement 1, doi:10.1182/blood-2020-134063, ISSN 0006-4971, pages 28 - 29, XP055893178
OPPOSITION- Goldstein Rebecca L., Goyos Ana, Li Chi-Ming, Deegen Petra, Bogner Pamela, Sternjak Alexander, Thomas Oliver, Klinger Matthias, Wahl Joachim, Friedrich Matthias, Rattel Benno, Lamas Edwin, Min Xiaoshan, Sudom Athena, Farshbaf Mozhgan, Coxon Angela, Balazs Mercedesz, Arvedson Tara, "AMG 701 induces cytotoxicity of multiple myeloma cells and depletes plasma cells in cynomolgus monkeys", Blood Advances, (20200908), vol. 4, no. 17, doi:10.1182/bloodadvances.2020002565, ISSN 2473-9529, pages 4180 - 4194, XP093241204
OPPOSITION- Bumma Naresh, Richter Joshua, Jagannath Sundar, Lee Hans C., Hoffman James E., Suvannasankha Attaya, Zonder Jeffrey A., Shah Mansi R., Lentzsch Suzanne, Baz Rachid, Maly Joseph J., Namburi Swathi, Pianko Matthew J., Ye Jing Christine, Wu Ka Lung, Silbermann Rebecca, Min Chang-Ki, Vekemans Marie-Christiane, Munder Markus, Byun Ja Min, Martínez-Lopez Joaquín, Cassady Kaniel, Deveaux Michelle, Chokshi Dhruti, Boyapati Anita, Hazra Anasuya, Yancopoulos George D., Sirulnik L. Andres, Rodriguez Lorenc Karen, Kroog Glenn S., Houvras Yariv, Dhodapkar Madhav V., "Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma", Journal of Clinical Oncology, (20240801), vol. 42, no. 22, doi:10.1200/JCO.24.01008, ISSN 0732-183X, pages 2702 - 2712, XP093241519
OPPOSITION- Eckhert Erik, Hewitt Rhonda, Liedtke Michaela, "B-cell maturation antigen directed monoclonal antibody therapies for multiple myeloma", Immunotherapy, UK, (20190501), vol. 11, no. 9, doi:10.2217/imt-2018-0199, ISSN 1750-743X, pages 801 - 811, XP009527380
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