SG11201910134SA - Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof - Google Patents

Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof

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Publication number
SG11201910134SA
SG11201910134SA SG11201910134SA SG11201910134SA SG 11201910134S A SG11201910134S A SG 11201910134SA SG 11201910134S A SG11201910134S A SG 11201910134SA SG 11201910134S A SG11201910134S A SG 11201910134SA
Authority
SG
Singapore
Prior art keywords
international
new jersey
antibodies
kenilworth
rule
Prior art date
Application number
Inventor
Soumendu Bhattacharya
Arnab De
Chakravarthy Nachu Narasimhan
Manoj Sharma
Xiaoyu Yang
Rubi Burlage
Jason Cheung
Original Assignee
Merck Sharp & Dohme
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 Merck Sharp & Dohme filed Critical Merck Sharp & Dohme
Publication of SG11201910134SA publication Critical patent/SG11201910134SA/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [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
    • C07K16/2818—Immunoglobulins [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 CD28 or CD152
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 08 November 2018 (08.11.2018) WIPO I PCT Iiiimmomiolollmonolooloionmilmilonomom (10) International Publication Number WO 2018/204343 Al (51) International Patent Classification: A61K 39/395 (2006.01) C07K 16/30 (2006.01) CO7K 16/28 (2006.01) (21) International Application Number: PCT/US2018/030420 (22) International Filing Date: 01 May 2018 (01.05.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/500,268 02 May 2017 (02.05.2017) US (71) Applicant: MERCK SHARP & DOHME CORP. [US/US]; 126 East Lincoln Avenue, Rahway, New Jersey 07065-0907 (US). (72) Inventors; and (71) Applicants (for US only): BHATTACHARYA, Soumen- du [US/US]; 2000 Galloping Hill Road, Kenilworth, New Jersey 07033 (US). DE, Arnab [IN/US]; 2000 Gallop- ing Hill Road, Kenilworth, New Jersey 07033 (US). NARASIMHAN, Chakravarthy Nachu [US/US]; 2000 Galloping Hill Road, Kenilworth, New Jersey 07033 (US). SHARMA, Manoj, K. [US/US]; 7 Fraser St., Littleton, Massachusetts 01460 (US). YANG, Xiaoyu [US/US]; 2000 Galloping Hill Road, Kenilworth, New Jersey 07033 (US). (74) Common Representative: MERCK SHARP & DOHME CORP.; 126 East Lincoln Avenue, Rahway, New Jersey 07065-0907 (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, JO, 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, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). (54) Title: STABLE FORMULATIONS OF ANTI-CTLA4 ANTIBODIES ALONE AND IN COMBINATION WITH PRO- = GRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF Formulation Al: UV A350 0.300 a. =3 0.200 —*-5C —M-25C --k-40C 5 0.100 0.000 O 00 O C 6 10 Time (weeks) FIG.1 A (57) : The invention relates to stable formulations comprising antibodies or antigen binding fragments thereof that bind to cytotoxic T lymphocyte associated antigen 4 (CTLA4), optionally further containing an anti-human programmed death receptor 1 (PD-1) antibody or antigen binding fragment thereof. Also provided are methods of treating various cancers and chronic infections with the formulations of the invention. [Continued on next page] WO 2018/204343 Al MIDEDIMOMOIDEIRDERIHIMINIMIIMIERVOIMIE Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(11)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: — with international search report (Art. 21(3)) with sequence listing part of description (Rule 5.2(a))
SG11201910134S 2017-05-02 2018-05-01 Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof SG11201910134SA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762500268P 2017-05-02 2017-05-02
PCT/US2018/030420 WO2018204343A1 (en) 2017-05-02 2018-05-01 Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof

Publications (1)

Publication Number Publication Date
SG11201910134SA true SG11201910134SA (en) 2019-11-28

Family

ID=64016829

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201910134S SG11201910134SA (en) 2017-05-02 2018-05-01 Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof

Country Status (16)

Country Link
US (1) US20200262922A1 (en)
EP (1) EP3618866A4 (en)
JP (2) JP2020518598A (en)
KR (1) KR102624564B1 (en)
CN (1) CN110678199A (en)
AU (1) AU2018263837A1 (en)
BR (1) BR112019022695A2 (en)
CA (1) CA3060695A1 (en)
CL (1) CL2019003143A1 (en)
CO (1) CO2019012143A2 (en)
EA (1) EA201992526A1 (en)
MA (1) MA50501A (en)
MX (1) MX2019013034A (en)
SG (1) SG11201910134SA (en)
TN (1) TN2019000294A1 (en)
WO (1) WO2018204343A1 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI2170959T1 (en) 2007-06-18 2014-04-30 Merck Sharp & Dohme B.V. Antibodies to human programmed death receptor pd-1
ES2963226T3 (en) 2016-12-07 2024-03-26 Agenus Inc ANTI-CTLA-4 antibodies and methods of their use
JOP20190260A1 (en) 2017-05-02 2019-10-31 Merck Sharp & Dohme Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof
US11845798B2 (en) 2017-05-02 2023-12-19 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
BR112020015915A8 (en) * 2018-02-13 2023-01-31 Merck Sharp & Dohme USES OF AN ANTI-PD-1 ANTIBODY AND AN ANTI-CTLA4 ANTIBODY OR ANTIGEN-BINDING FRAGMENTS THEREOF, AS WELL AS A KIT FOR TREATMENT OF A PATIENT WITH CANCER
WO2020097141A1 (en) * 2018-11-07 2020-05-14 Merck Sharp & Dohme Corp. Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof
WO2021061504A1 (en) * 2019-09-23 2021-04-01 Merck Sharp & Dohme Corp. Methods and compositions comprising an anti-ctla4 monoclonal antibody with reduced host cell proteins and increased polysorbate-80 stability
WO2021178657A1 (en) * 2020-03-05 2021-09-10 Merck Sharp & Dohme Corp. Methods for treating cancer using a combination of a pd-1 antagonist, a ctla4 antagonist, and lenvatinib or a pharmaceutically acceptable salt thereof
MX2022016218A (en) * 2020-07-08 2023-03-31 Regeneron Pharma Stabilized formulations containing anti-ctla-4 antibodies.
KR20230107250A (en) * 2020-11-10 2023-07-14 사노피 CEACAM5 antibody-drug conjugate formulation
WO2022165001A1 (en) 2021-01-29 2022-08-04 Merck Sharp & Dohme Llc Compositions of programmed death receptor 1 (pd-1) antibodies and methods of obtaining the compositions thereof
WO2023211868A1 (en) * 2022-04-29 2023-11-02 Merck Sharp & Dohme Llc Stable formulations of anti-ilt4 antibodies or antigen-binding fragments thererof in combination with anti-pd-1 antibodies and methods of use thereof
WO2024025989A1 (en) * 2022-07-28 2024-02-01 Merck Sharp & Dohme Llc Pharmaceutical compositions of programmed death receptor 1 (pd-1) antibodies and rhuph20 or variants or fragments thereof
WO2024025986A1 (en) * 2022-07-28 2024-02-01 Merck Sharp & Dohme Llc Pharmaceutical compositions of programmed death receptor 1 (pd-1) antibodies and ph20 variants or fragments thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1865986B1 (en) * 2005-03-08 2016-02-17 Pfizer Products Inc. Anti-ctla-4 antibody compositions
RU2406760C3 (en) * 2005-05-09 2017-11-28 Оно Фармасьютикал Ко., Лтд. HUMAN MONOCLONAL ANTIBODIES TO PROGRAMMABLE DEATH 1 PROTECTION (PD-1) AND METHODS OF CANCER TREATMENT USING ANTI-PD-1-ANTI-BODY, INDEPENDENTLY OR IN COMBINATION WITH OTHER IMMUNETURAH AND I And I And I And I, In The Combine, I And I Do Not Allocate To Them, Combined With Other Overarching
AU2010263058A1 (en) * 2009-06-18 2012-01-12 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
CN105296433B (en) * 2014-08-01 2018-02-09 中山康方生物医药有限公司 A kind of CTLA4 antibody, its medical composition and its use
CN113577264A (en) * 2015-04-17 2021-11-02 百时美施贵宝公司 Compositions comprising a combination of an anti-PD-1 antibody and an additional antibody
US9995753B2 (en) * 2015-09-25 2018-06-12 Merck Sharp & Dohme Corp. Anti-pembrolizumab antibodies

Also Published As

Publication number Publication date
EP3618866A4 (en) 2021-07-14
EP3618866A1 (en) 2020-03-11
CO2019012143A2 (en) 2020-01-17
KR102624564B1 (en) 2024-01-12
CL2019003143A1 (en) 2020-03-20
MX2019013034A (en) 2020-02-05
JP2020518598A (en) 2020-06-25
EA201992526A1 (en) 2020-03-13
JP2023109942A (en) 2023-08-08
TN2019000294A1 (en) 2021-05-07
MA50501A (en) 2020-09-09
CN110678199A (en) 2020-01-10
US20200262922A1 (en) 2020-08-20
CA3060695A1 (en) 2018-11-08
AU2018263837A1 (en) 2019-12-05
KR20190142393A (en) 2019-12-26
BR112019022695A2 (en) 2020-05-26
WO2018204343A1 (en) 2018-11-08

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