EP3548088A4 - Therapy for metastatic urothelial cancer with the antibody-drug conjugate, sacituzumab govitecan (immu-132) - Google Patents

Therapy for metastatic urothelial cancer with the antibody-drug conjugate, sacituzumab govitecan (immu-132) Download PDF

Info

Publication number
EP3548088A4
EP3548088A4 EP17876335.5A EP17876335A EP3548088A4 EP 3548088 A4 EP3548088 A4 EP 3548088A4 EP 17876335 A EP17876335 A EP 17876335A EP 3548088 A4 EP3548088 A4 EP 3548088A4
Authority
EP
European Patent Office
Prior art keywords
immu
antibody
therapy
drug conjugate
urothelial cancer
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP17876335.5A
Other languages
German (de)
French (fr)
Other versions
EP3548088A1 (en
Inventor
Serengulam V. Govindan
David M. Goldenberg
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Immunomedics Inc
Original Assignee
Immunomedics 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
Application filed by Immunomedics Inc filed Critical Immunomedics Inc
Publication of EP3548088A1 publication Critical patent/EP3548088A1/en
Publication of EP3548088A4 publication Critical patent/EP3548088A4/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A61K47/6861—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell the tumour determinant being from kidney or bladder cancer cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
EP17876335.5A 2016-12-01 2017-11-22 Therapy for metastatic urothelial cancer with the antibody-drug conjugate, sacituzumab govitecan (immu-132) Pending EP3548088A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662428655P 2016-12-01 2016-12-01
PCT/US2017/062976 WO2018102212A1 (en) 2016-12-01 2017-11-22 Therapy for metastatic urothelial cancer with the antibody-drug conjugate, sacituzumab govitecan (immu-132)

Publications (2)

Publication Number Publication Date
EP3548088A1 EP3548088A1 (en) 2019-10-09
EP3548088A4 true EP3548088A4 (en) 2020-07-22

Family

ID=62242742

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17876335.5A Pending EP3548088A4 (en) 2016-12-01 2017-11-22 Therapy for metastatic urothelial cancer with the antibody-drug conjugate, sacituzumab govitecan (immu-132)

Country Status (5)

Country Link
EP (1) EP3548088A4 (en)
CN (1) CN110248680A (en)
CA (1) CA3044096A1 (en)
RU (1) RU2757395C2 (en)
WO (1) WO2018102212A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3139180A1 (en) * 2019-03-27 2020-10-01 Daiichi Sankyo Company, Limited Combination of antibody-pyrrolobenzodiazepine derivative conjugate and parp inhibitor
AU2022290855A1 (en) * 2021-06-11 2023-12-07 Gilead Sciences, Inc. Combination mcl-1 inhibitors with anti-body drug conjugates

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160193357A1 (en) * 2012-12-13 2016-07-07 Immunomedics, Inc. Dosages of Immunoconjugates of Antibodies and SN-38 for Improved Efficacy and Decreased Toxicity
US20160296633A1 (en) * 2013-07-23 2016-10-13 Immunomedics, Inc. Combining anti-hla-dr or anti-trop-2 antibodies with microtubule inhibitors, parp inhibitors, bruton kinase inhibitors or phosphoinositide 3-kinase inhibitors significantly improves therapeutic outcome in cancer

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW200731990A (en) * 2005-12-16 2007-09-01 Sonus Pharma Inc Lipophilic anticancer drug compounds, compositions, and related methods
WO2014092804A1 (en) * 2012-12-13 2014-06-19 Immunomedics, Inc. Dosages of immunoconjugates of antibodies and sn-38 for improved efficacy and decreased toxicity
ES2819573T3 (en) * 2012-12-13 2021-04-16 Immunomedics Inc Method for Producing Antibody-SN-38 Immunoconjugates with a CL2A Linker
US9931417B2 (en) * 2012-12-13 2018-04-03 Immunomedics, Inc. Antibody-SN-38 immunoconjugates with a CL2A linker
EP3024460B1 (en) * 2013-07-23 2020-07-22 Immunomedics, Inc. Method for producing antibody-sn-38 immunoconjugates with a cl2a linker

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160193357A1 (en) * 2012-12-13 2016-07-07 Immunomedics, Inc. Dosages of Immunoconjugates of Antibodies and SN-38 for Improved Efficacy and Decreased Toxicity
US20160296633A1 (en) * 2013-07-23 2016-10-13 Immunomedics, Inc. Combining anti-hla-dr or anti-trop-2 antibodies with microtubule inhibitors, parp inhibitors, bruton kinase inhibitors or phosphoinositide 3-kinase inhibitors significantly improves therapeutic outcome in cancer

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BISHOY FALTAS ET AL: "Sacituzumab Govitecan, a Novel Antibody-Drug Conjugate, in Patients With Metastatic Platinum-Resistant Urothelial Carcinoma", CLINICAL GENITOURINARY CANCER, vol. 14, no. 1, 1 February 2016 (2016-02-01), US, pages e75 - e79, XP055490362, ISSN: 1558-7673, DOI: 10.1016/j.clgc.2015.10.002 *
See also references of WO2018102212A1 *

Also Published As

Publication number Publication date
RU2019119320A (en) 2021-01-12
RU2019119320A3 (en) 2021-01-12
WO2018102212A1 (en) 2018-06-07
EP3548088A1 (en) 2019-10-09
RU2757395C2 (en) 2021-10-14
CN110248680A (en) 2019-09-17
CA3044096A1 (en) 2018-06-07

Similar Documents

Publication Publication Date Title
EP3565638B8 (en) Bicycle conjugate for treating cancer
EP3473270A4 (en) Antibody-drug conjugate
EP3488001A4 (en) Treating cancer
IL279133A (en) Tumor microenvironment-activated drug-binder conjugates, and uses related thereto
ZA201905902B (en) 2-heteroaryl-3-oxo-2,3-dihydropyridazine-4-carboxamides for the treatment of cancer
EP3651772A4 (en) Combination cancer therapy
HK1255412A1 (en) Axl-specific antibody-drug conjugates for cancer treatment
AU2017260425B2 (en) Combination therapy for cancer treatment
WO2015168019A3 (en) Anti-ptk7 antibody-drug conjugates
EP3157560A4 (en) Her2 antibody-drug conjugates
EP3713585A4 (en) Msc-expressed immunomodulators in combination with car-t for cancer therapy
IL287644A (en) Cytarabine conjugates for cancer therapy
EP3413927A4 (en) Cancer therapy
EP3474854A4 (en) Cancer treatment combinations
EP3380495A4 (en) Peptide compounds and peptide conjugates for the treatment of cancer through receptor-mediated chemotherapy
EP3733175A4 (en) Cancer therapeutic
EP3413906A4 (en) Cancer treatment combination compositions, methods and uses
EP3256115A4 (en) Combination cancer therapy
EP3439651A4 (en) Improvements in cancer treatment
EP3576746A4 (en) Cancer therapeutic
EP3548088A4 (en) Therapy for metastatic urothelial cancer with the antibody-drug conjugate, sacituzumab govitecan (immu-132)
EP3538098A4 (en) Antibody-drug conjugates
EP3582810A4 (en) ß-1,6-GLUCAN THERAPEUTIC ANTIBODY CONJUGATES
EP3532638A4 (en) Targeting microrna-101-3p in cancer therapy
EP3407909A4 (en) Cancer treatment

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20190701

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 40008065

Country of ref document: HK

A4 Supplementary search report drawn up and despatched

Effective date: 20200624

RIC1 Information provided on ipc code assigned before grant

Ipc: A61P 35/04 20060101ALI20200618BHEP

Ipc: A61K 47/68 20170101ALI20200618BHEP

Ipc: A61K 31/4745 20060101AFI20200618BHEP

Ipc: A61K 45/06 20060101ALI20200618BHEP

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

17Q First examination report despatched

Effective date: 20210630

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS