AU2021236340A1 - A combination therapy with nirogacestat and a BCMA-directed therapy and uses thereof - Google Patents

A combination therapy with nirogacestat and a BCMA-directed therapy and uses thereof Download PDF

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Publication number
AU2021236340A1
AU2021236340A1 AU2021236340A AU2021236340A AU2021236340A1 AU 2021236340 A1 AU2021236340 A1 AU 2021236340A1 AU 2021236340 A AU2021236340 A AU 2021236340A AU 2021236340 A AU2021236340 A AU 2021236340A AU 2021236340 A1 AU2021236340 A1 AU 2021236340A1
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Prior art keywords
subject
bcma
nirogacestat
dihydrobromide
therapy
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Pending
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AU2021236340A
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English (en)
Inventor
Badreddin EDRIS
Todd Webster SHEARER
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SpringWorks Therapeutics Inc
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SpringWorks Therapeutics Inc
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Publication of AU2021236340A1 publication Critical patent/AU2021236340A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/417Imidazole-alkylamines, e.g. histamine, phentolamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/0005Vertebrate antigens
    • A61K39/0011Cancer antigens
    • A61K39/001102Receptors, cell surface antigens or cell surface determinants
    • A61K39/001116Receptors for cytokines
    • A61K39/001117Receptors for tumor necrosis factors [TNF], e.g. lymphotoxin receptor [LTR] or CD30
    • 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
    • A61K40/00Cellular immunotherapy
    • A61K40/10Cellular immunotherapy characterised by the cell type used
    • A61K40/11T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00Cellular immunotherapy
    • A61K40/30Cellular immunotherapy characterised by the recombinant expression of specific molecules in the cells of the immune system
    • A61K40/31Chimeric antigen receptors [CAR]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00Cellular immunotherapy
    • A61K40/40Cellular immunotherapy characterised by antigens that are targeted or presented by cells of the immune system
    • A61K40/41Vertebrate antigens
    • A61K40/42Cancer antigens
    • A61K40/4202Receptors, cell surface antigens or cell surface determinants
    • A61K40/4214Receptors for cytokines
    • A61K40/4215Receptors for tumor necrosis factors [TNF], e.g. lymphotoxin receptor [LTR], CD30
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/80Vaccine for a specifically defined cancer
    • A61K2039/804Blood cells [leukemia, lymphoma]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/46Indexing codes associated with cellular immunotherapy of group A61K40/00 characterised by the cancer treated
    • A61K2239/48Blood cells, e.g. leukemia or lymphoma
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Oncology (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Biotechnology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Virology (AREA)
  • Zoology (AREA)
AU2021236340A 2020-03-13 2021-03-12 A combination therapy with nirogacestat and a BCMA-directed therapy and uses thereof Pending AU2021236340A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062989372P 2020-03-13 2020-03-13
US62/989,372 2020-03-13
PCT/US2021/022177 WO2021183934A1 (en) 2020-03-13 2021-03-12 A combination therapy with nirogacestat and a bcma-directed therapy and uses thereof

Publications (1)

Publication Number Publication Date
AU2021236340A1 true AU2021236340A1 (en) 2022-09-29

Family

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AU2021236340A Pending AU2021236340A1 (en) 2020-03-13 2021-03-12 A combination therapy with nirogacestat and a BCMA-directed therapy and uses thereof

Country Status (16)

Country Link
US (1) US20230121547A1 (enExample)
EP (1) EP4132515A1 (enExample)
JP (2) JP7781764B2 (enExample)
KR (1) KR20230009873A (enExample)
CN (1) CN115916188A (enExample)
AR (1) AR121566A1 (enExample)
AU (1) AU2021236340A1 (enExample)
BR (1) BR112022018251A2 (enExample)
CA (1) CA3171267A1 (enExample)
CL (1) CL2022002479A1 (enExample)
CO (1) CO2022014388A2 (enExample)
IL (1) IL296075A (enExample)
MX (1) MX2022011258A (enExample)
PE (1) PE20230614A1 (enExample)
TW (1) TW202200132A (enExample)
WO (1) WO2021183934A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024530795A (ja) 2021-09-01 2024-08-23 スプリングワークス、セラピューティクス、インコーポレイテッド ニロガセスタットの合成
WO2023064872A1 (en) * 2021-10-14 2023-04-20 Precision Biosciences, Inc. Combinations of anti-bcma car t cells and gamma secretase inhibitors
CN118338900A (zh) * 2021-11-05 2024-07-12 斯普林渥克斯治疗有限公司 含尼罗加司他的组合物和治疗
CN118302412A (zh) * 2021-11-23 2024-07-05 梯瓦制药国际有限责任公司 Nirogacestat盐的固态形式
US11951096B2 (en) 2022-05-20 2024-04-09 Springworks Therapeutics, Inc. Treatments with nirogacestat
US12138246B2 (en) 2022-05-20 2024-11-12 Springworks Therapeutics, Inc. Treatments with nirogacestat
US12036207B2 (en) 2022-05-20 2024-07-16 Springworks Therapeutics, Inc. Treatments with nirogacestat
US20230372301A1 (en) * 2022-05-20 2023-11-23 Springworks Therapeutics, Inc. Treatments with nirogacestat
AU2024231546A1 (en) * 2023-03-09 2025-10-02 Crystal Pharmaceutical (Suzhou) Co., Ltd. Crystal form of nirogacestat dihydrobromide, and preparation method therefor and use thereof

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10149855B2 (en) * 2014-02-05 2018-12-11 The Trustees Of Columbia University In The City Of New York Gamma-secretase inhibition reduce APOC3 levels and plasma triglycerides
CN108025001A (zh) * 2015-07-24 2018-05-11 安可初克公司 用于治疗免疫系统功能障碍的γ分泌酶调节剂
WO2018151836A1 (en) * 2017-02-17 2018-08-23 Fred Hutchinson Cancer Research Center Combination therapies for treatment of bcma-related cancers and autoimmune disorders
EP3615068A1 (en) * 2017-04-28 2020-03-04 Novartis AG Bcma-targeting agent, and combination therapy with a gamma secretase inhibitor
WO2018201056A1 (en) * 2017-04-28 2018-11-01 Novartis Ag Cells expressing a bcma-targeting chimeric antigen receptor, and combination therapy with a gamma secretase inhibitor
JP7050813B2 (ja) * 2017-05-05 2022-04-08 華為技術有限公司 支援データ送信方法、デバイス、およびシステム
SG11202003427XA (en) * 2017-11-06 2020-05-28 Juno Therapeutics Inc Combination of a cell therapy and a gamma secretase inhibitor
WO2019094626A1 (en) * 2017-11-08 2019-05-16 Fred Hutchinson Cancer Research Center Bispecific antibody compositions and related methods for improved pretargeted radioimunotherapies
WO2019143818A1 (en) * 2018-01-17 2019-07-25 Mingsight Pharmaceuticals, Inc. Combination therapy for the treatment of cancer
CN112203661A (zh) * 2018-05-24 2021-01-08 艾雅拉制药公司 包含双氟烷基-1,4-苯并二氮杂*酮化合物与免疫治疗剂的组合物和其使用方法
JP7398396B2 (ja) * 2018-06-01 2023-12-14 ノバルティス アーゲー Bcmaに対する結合分子及びその使用
CN113924318B (zh) * 2019-04-10 2025-06-20 葛兰素史密斯克莱知识产权发展有限公司 具有抗BCMA抗体和gamma分泌酶抑制剂的联合疗法
JP7608435B2 (ja) * 2019-08-09 2025-01-06 ファイザー・インク (s)-2-(((s)-6,8-ジフルオロ-1,2,3,4-テトラヒドロナフタレン-2-イル)アミノ)-n-(1-(2-メチル-1-(ネオペンチルアミノ)プロパン-2-イル)-1h-イミダゾール-4-イル)ペンタンアミドの固体状態形態およびその使用

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Publication number Publication date
KR20230009873A (ko) 2023-01-17
MX2022011258A (es) 2023-01-11
JP2025168430A (ja) 2025-11-07
PE20230614A1 (es) 2023-04-14
CA3171267A1 (en) 2021-09-16
TW202200132A (zh) 2022-01-01
US20230121547A1 (en) 2023-04-20
CN115916188A (zh) 2023-04-04
CL2022002479A1 (es) 2023-08-18
WO2021183934A1 (en) 2021-09-16
IL296075A (en) 2022-11-01
EP4132515A1 (en) 2023-02-15
BR112022018251A2 (pt) 2022-11-08
JP2023517243A (ja) 2023-04-24
AR121566A1 (es) 2022-06-15
JP7781764B2 (ja) 2025-12-08
CO2022014388A2 (es) 2023-02-16

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