CA3072913A1 - Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome - Google Patents

Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome Download PDF

Info

Publication number
CA3072913A1
CA3072913A1 CA3072913A CA3072913A CA3072913A1 CA 3072913 A1 CA3072913 A1 CA 3072913A1 CA 3072913 A CA3072913 A CA 3072913A CA 3072913 A CA3072913 A CA 3072913A CA 3072913 A1 CA3072913 A1 CA 3072913A1
Authority
CA
Canada
Prior art keywords
masp
antibody
formulation
formulations
viscosity
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
CA3072913A
Other languages
English (en)
French (fr)
Inventor
Gregory A. Demopulos
Kenneth M. Ferguson
William Joseph Lambert
John Steven Whitaker
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.)
Omeros Corp
Original Assignee
Omeros Medical Systems 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 Omeros Medical Systems Inc filed Critical Omeros Medical Systems Inc
Publication of CA3072913A1 publication Critical patent/CA3072913A1/en
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CA3072913A 2017-08-25 2018-08-21 Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome Pending CA3072913A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762550328P 2017-08-25 2017-08-25
US62/550,328 2017-08-25
PCT/US2018/047255 WO2019040453A1 (en) 2017-08-25 2018-08-21 HIGHLY CONCENTRATED MASP-2 INHIBITOR ANTIBODY FORMULATIONS WITH LOW VISCOSITY, KITS AND METHODS FOR TREATING SUBJECTS SUFFERING FROM ATYPICAL HEMOLYTIC SYNDROME

Publications (1)

Publication Number Publication Date
CA3072913A1 true CA3072913A1 (en) 2019-02-28

Family

ID=65436837

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3072913A Pending CA3072913A1 (en) 2017-08-25 2018-08-21 Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome

Country Status (15)

Country Link
US (2) US20190062455A1 (enExample)
EP (1) EP3672994A4 (enExample)
JP (1) JP2020531523A (enExample)
KR (1) KR20200037863A (enExample)
CN (1) CN111278863A (enExample)
AU (1) AU2018322032B2 (enExample)
BR (1) BR112020003632A2 (enExample)
CA (1) CA3072913A1 (enExample)
CL (1) CL2020000397A1 (enExample)
IL (1) IL272673B2 (enExample)
MA (1) MA49960A (enExample)
MX (1) MX2020002077A (enExample)
RU (1) RU2020111574A (enExample)
TW (1) TW201925224A (enExample)
WO (1) WO2019040453A1 (enExample)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114641270A (zh) * 2019-11-15 2022-06-17 豪夫迈·罗氏有限公司 防止水性蛋白质溶液中可见颗粒的形成
TW202135860A (zh) * 2019-12-10 2021-10-01 美商再生元醫藥公司 含有抗cd20x抗cd3雙特異性抗體之穩定調配物
IL300245A (en) * 2020-07-31 2023-03-01 Alamab Therapeutics Inc Anti-connexin antibody formulations
EP4489782A4 (en) * 2022-03-10 2026-03-25 Omeros Corp MASP-2 and MASP-3 inhibitors, and associated compositions and methods for the treatment of sickle cell disease

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UY34054A (es) * 2011-05-02 2012-11-30 Millennium Pharm Inc FORMULACIÓN PARA ANTICUERPO ANTI-a(alfa)4B(Beta)7
HUE049154T2 (hu) * 2011-05-04 2020-09-28 Omeros Corp Készítmények a MASP-2-függõ komplement-aktiválás gátlására
PT2861246T (pt) * 2012-06-18 2021-04-05 Univ Leicester Composições e métodos para inibir masp-1 e/ou masp-2 e/ou masp-3 para o tratamento de várias doenças e perturbações
RS61351B1 (sr) * 2013-10-17 2021-02-26 Omeros Corp Postupci za lečenje stanja udruženih sa aktivacijom komplementa zavisnom od masp-2
US20160168237A1 (en) * 2014-12-12 2016-06-16 Alexion Pharmaceuticals, Inc. Method for treating a complement mediated disorder caused by an infectious agent in a patient
CN117398458A (zh) * 2015-11-09 2024-01-16 奥默罗斯公司 用于治疗与masp-2依赖性补体活化相关的病况的方法
JOP20170170B1 (ar) * 2016-08-31 2022-09-15 Omeros Corp صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق

Also Published As

Publication number Publication date
AU2018322032B2 (en) 2025-04-17
IL272673B2 (en) 2024-10-01
KR20200037863A (ko) 2020-04-09
RU2020111574A3 (enExample) 2021-11-17
MA49960A (fr) 2021-06-02
IL272673B1 (en) 2024-06-01
CL2020000397A1 (es) 2020-07-10
RU2020111574A (ru) 2021-09-27
JP2020531523A (ja) 2020-11-05
AU2018322032A1 (en) 2020-03-12
MX2020002077A (es) 2020-03-24
US20240247078A1 (en) 2024-07-25
BR112020003632A2 (pt) 2020-10-27
US20190062455A1 (en) 2019-02-28
WO2019040453A1 (en) 2019-02-28
CN111278863A (zh) 2020-06-12
TW201925224A (zh) 2019-07-01
IL272673A (en) 2020-03-31
EP3672994A4 (en) 2021-06-02
EP3672994A1 (en) 2020-07-01

Similar Documents

Publication Publication Date Title
US20230226178A1 (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
US20240247078A1 (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome
HK40117196A (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
HK40093811A (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
HK40009867A (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
HK40009867B (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods
OA19221A (en) Highly concentrated low viscosity MASP-2 inhibitory antibody formulations, kits, and methods
HK40031101A (en) Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods of treating subjects suffering from atypical hemolytic syndrome
EA043928B1 (ru) Высококонцентрированные низковязкие препараты ингибирующего masp-2 антитела, наборы и способы
BR112019003479B1 (pt) Formulação farmacêutica, recipiente vedado, dispositivo de administração subcutânea, kit, forma de dosagem unitária farmacêutica, e, uso de uma formulação

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20230809

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 6TH ANNIV.) - STANDARD

Year of fee payment: 6

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20240816

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20240816

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20240816

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20240830

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - RESPONSE TO EXAMINER'S REQUISITION

Effective date: 20241211

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20250206

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20250606

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20250606

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20250716

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 7TH ANNIV.) - STANDARD

Year of fee payment: 7

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250815

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250815

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - RESPONSE TO EXAMINER'S REQUISITION

Effective date: 20251112

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20260115

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20260115

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20260115