SG11201906853QA - Anti-rsv monoclonal antibody formulation - Google Patents

Anti-rsv monoclonal antibody formulation

Info

Publication number
SG11201906853QA
SG11201906853QA SG11201906853QA SG11201906853QA SG11201906853QA SG 11201906853Q A SG11201906853Q A SG 11201906853QA SG 11201906853Q A SG11201906853Q A SG 11201906853QA SG 11201906853Q A SG11201906853Q A SG 11201906853QA SG 11201906853Q A SG11201906853Q A SG 11201906853QA
Authority
SG
Singapore
Prior art keywords
international
monoclonal antibody
formulation
pct
present
Prior art date
Application number
SG11201906853QA
Inventor
Brian Lobo
Deborah Goldberg
Original Assignee
Medimmune Ltd
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 Medimmune Ltd filed Critical Medimmune Ltd
Publication of SG11201906853QA publication Critical patent/SG11201906853QA/en

Links

Classifications

    • 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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61K39/42Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1002Coronaviridae
    • C07K16/1003Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2 or Covid-19]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1027Paramyxoviridae, e.g. respiratory syncytial virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/522CH1 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

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

Abstract

1596X+99.62 — D 0.40C El 25C © 5C 1 3 4 97.5 0 2 TIME (MONTHS) = -0.0211X+99.638 Y = -0.5254+99.373 100 99.5 >_ 99 m • 98.5 O _ 98 W O 20 18/ 1607 22 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 07 September 2018 (07.09.2018) WIP0 I PCT Iiiimmomitiaonolomomioolimommom oimIE (10) International Publication Number WO 2018/160722 Al (51) International Patent Classification: C07K 16/08 (2006.01) A61K 39/395 (2006.01) C07K 16/10 (2006.01) A61P 31/12 (2006.01) A61K 38/16 (2006.01) A61P 31/14 (2006.01) A61K 39/42 (2006.01) (21) International Application Number: PCT/US2018/020264 (22) International Filing Date: 28 February 2018 (28.02.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/465,379 01 March 2017 (01.03.2017) US (71) Applicant: MEDIMMUNE LIMITED [GB/GB]; Mil- stein Building, Granta Park, Cambridge CB21 6GH (GB). (72) Inventors; and (71) Applicants: LOBO, Brian [US/US]; Medlmmune, LLC, One MedImmune Way, Gaithersburg, MD 20878 (US). GOLDBERG, Deborah [US/US]; 6219 Sutton Court, Elkridge, MD 21075 (US). (74) Agent: JOHNSON, Nancy, A.; Mueting, Raasch & Gebhardt, P.A., P.O. Box 581336, Minneapolis, MN 55458-1336 (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: ANTI-RSV MONOCLONAL ANTIBODY FORMULATION MEDI8897 REPRESENTATIVE DRUG PRODUCT STABILITY Fig. 3 (57) : The present invention provides a formulation comprising: (i) an anti-RSV monoclonal antibody; and (ii) an ionic ex- cipient; wherein the monoclonal antibody is present at a concentration of about 50mg/m1 or greater and the ionic excipient is present at a concentration of between 50 and 150 mM and the formulation has a pH of about 5.5 to about 7.5. [Continued on next page] WO 2018/160722 Al D ill Published: with international search report (Art. 21(3)) before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) with sequence listing part of description (Rule 5.2(a))
SG11201906853QA 2017-03-01 2018-02-28 Anti-rsv monoclonal antibody formulation SG11201906853QA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762465379P 2017-03-01 2017-03-01
PCT/US2018/020264 WO2018160722A1 (en) 2017-03-01 2018-02-28 Anti-rsv monoclonal antibody formulation

Publications (1)

Publication Number Publication Date
SG11201906853QA true SG11201906853QA (en) 2019-09-27

Family

ID=61903153

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201906853QA SG11201906853QA (en) 2017-03-01 2018-02-28 Anti-rsv monoclonal antibody formulation

Country Status (23)

Country Link
US (4) US10774133B2 (en)
EP (1) EP3589648A4 (en)
JP (2) JP7046088B2 (en)
KR (2) KR102668158B1 (en)
CN (3) CN116059343A (en)
AR (1) AR111083A1 (en)
AU (2) AU2018227502B2 (en)
BR (1) BR112019017755A2 (en)
CA (1) CA3051864A1 (en)
CL (1) CL2019002478A1 (en)
CO (1) CO2019009034A2 (en)
CR (1) CR20190400A (en)
EA (1) EA201991701A1 (en)
EC (1) ECSP19062769A (en)
GB (1) GB2564175B (en)
IL (2) IL312499A (en)
MX (1) MX2019010408A (en)
PH (1) PH12019501979A1 (en)
SG (1) SG11201906853QA (en)
TW (2) TW202228779A (en)
UA (1) UA128450C2 (en)
WO (1) WO2018160722A1 (en)
ZA (1) ZA202006797B (en)

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EP3589318A1 (en) * 2017-03-01 2020-01-08 MedImmune Limited Formulations of monoclonal antibodies
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
BR112019022873A8 (en) 2017-05-02 2023-04-11 Merck Sharp & Dohme FORMULATION, AND, INJECTION VESSEL OR DEVICE.
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TW202228779A (en) 2017-03-01 2022-08-01 英商梅迪繆思有限公司 Anti-rsv monoclonal antibody formulation

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Publication number Publication date
GB201802974D0 (en) 2018-04-11
CR20190400A (en) 2019-12-03
KR20220020420A (en) 2022-02-18
CN110418803B (en) 2024-01-19
IL268202A (en) 2019-09-26
US10774133B2 (en) 2020-09-15
KR102668158B1 (en) 2024-05-23
NZ755790A (en) 2024-04-26
CN116059343A (en) 2023-05-05
IL312499A (en) 2024-07-01
US20200339667A1 (en) 2020-10-29
CN110418803A (en) 2019-11-05
EP3589648A1 (en) 2020-01-08
JP7446356B2 (en) 2024-03-08
IL268202B1 (en) 2024-06-01
EA201991701A1 (en) 2020-03-04
GB2564175A (en) 2019-01-09
US20210317191A1 (en) 2021-10-14
US20230399383A1 (en) 2023-12-14
JP7046088B2 (en) 2022-04-01
CO2019009034A2 (en) 2019-08-30
ECSP19062769A (en) 2019-09-30
KR20190125318A (en) 2019-11-06
CA3051864A1 (en) 2018-09-07
US11286294B2 (en) 2022-03-29
ZA202006797B (en) 2023-03-29
CN117982637A (en) 2024-05-07
BR112019017755A2 (en) 2020-04-07
US11667698B2 (en) 2023-06-06
PH12019501979A1 (en) 2020-06-29
TW202228779A (en) 2022-08-01
IL268202B2 (en) 2024-10-01
US20180251526A1 (en) 2018-09-06
AU2022263564A1 (en) 2022-12-15
TWI761453B (en) 2022-04-21
EP3589648A4 (en) 2020-12-23
WO2018160722A1 (en) 2018-09-07
JP2022095697A (en) 2022-06-28
GB2564175B (en) 2021-12-08
TW201840334A (en) 2018-11-16
MX2019010408A (en) 2019-12-19
KR102359181B1 (en) 2022-02-08
AU2018227502A1 (en) 2019-08-15
AR111083A1 (en) 2019-05-29
AU2018227502B2 (en) 2022-08-11
CL2019002478A1 (en) 2020-01-24
JP2020509031A (en) 2020-03-26
UA128450C2 (en) 2024-07-17

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