CA3161118A1 - Pharmaceutical formulations and dosage regimens for factor xi/xia antibodies - Google Patents

Pharmaceutical formulations and dosage regimens for factor xi/xia antibodies Download PDF

Info

Publication number
CA3161118A1
CA3161118A1 CA3161118A CA3161118A CA3161118A1 CA 3161118 A1 CA3161118 A1 CA 3161118A1 CA 3161118 A CA3161118 A CA 3161118A CA 3161118 A CA3161118 A CA 3161118A CA 3161118 A1 CA3161118 A1 CA 3161118A1
Authority
CA
Canada
Prior art keywords
seq
antibody
chain variable
variable region
drug delivery
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
CA3161118A
Other languages
English (en)
French (fr)
Inventor
Debra A. FREEDHOLM
Daniel M. BLOOMFIELD
Royston J. GLASSPOOL
Jonathan E. Freeman
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.)
Anthos Therapeutics Inc
Original Assignee
Anthos Therapeutics 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 Anthos Therapeutics Inc filed Critical Anthos Therapeutics Inc
Publication of CA3161118A1 publication Critical patent/CA3161118A1/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
    • 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
    • A61K47/22—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • 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
    • C07K16/36—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • 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
    • 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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CA3161118A 2019-12-20 2020-12-18 Pharmaceutical formulations and dosage regimens for factor xi/xia antibodies Pending CA3161118A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962951887P 2019-12-20 2019-12-20
US62/951,887 2019-12-20
PCT/US2020/066151 WO2021127525A1 (en) 2019-12-20 2020-12-18 Pharmaceutical formulations and dosage regimens for factor xi/xia antibodies

Publications (1)

Publication Number Publication Date
CA3161118A1 true CA3161118A1 (en) 2021-06-24

Family

ID=76478578

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3161118A Pending CA3161118A1 (en) 2019-12-20 2020-12-18 Pharmaceutical formulations and dosage regimens for factor xi/xia antibodies

Country Status (9)

Country Link
US (1) US20230071973A1 (https=)
EP (1) EP4076511A4 (https=)
JP (2) JP2023507795A (https=)
KR (1) KR20220119090A (https=)
CN (1) CN115003325A (https=)
BR (1) BR112022012064A2 (https=)
CA (1) CA3161118A1 (https=)
IL (1) IL293367A (https=)
WO (1) WO2021127525A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024540435A (ja) * 2021-11-18 2024-10-31 アントス セラピューティクス， インコーポレイテッド 第ＸＩ／ＸＩａ因子抗体の投薬レジメン
TW202333789A (zh) * 2022-01-05 2023-09-01 大陸商上海邁晉生物醫藥科技有限公司 一種包含抗ＦＸＩ／ＦＸＩａ抗體的醫藥組成物及其用途
DE102022116219A1 (de) * 2022-06-29 2024-01-04 St. Jude Medical, Cardiology Division, Inc. Kandidatenscreening für eine Zieltherapie

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8476239B2 (en) * 2005-12-20 2013-07-02 Bristol-Myers Squibb Company Stable protein formulations
US20100129379A1 (en) * 2006-09-25 2010-05-27 John Carpenter Stabilized antibody formulations and uses thereof
CN106038481A (zh) * 2007-06-28 2016-10-26 锡德克斯药物公司 皮质类固醇水溶液的鼻部和眼部给药
LT2953969T (lt) * 2013-02-08 2019-12-10 Novartis Ag Anti-il-17a antikūnai ir jų panaudojimas autoimuninių ir uždegiminių ligų gydymui
UY36751A (es) * 2015-06-26 2017-01-31 Novartis Ag Anticuerpos de factor xi y métodos de uso
MX2018002166A (es) * 2015-08-20 2018-09-12 Abbvie Stemcentrx Llc Conjugados anticuerpo anti-dll3-farmaco y metodos de uso.
IL267519B2 (en) * 2016-12-23 2025-04-01 Novartis Ag Factor XI/XIA for use in the prevention, treatment, management, or reduction of the risk of stroke or thromboembolism in a patient with end-stage renal disease
AU2017383232B2 (en) * 2016-12-23 2024-09-12 Novartis Ag Factor XI antibodies and methods of use
US20190367636A1 (en) * 2017-01-19 2019-12-05 Bayer Pharma Aktiengesellschaft Novel stable formulation for fxia antibodies
JOP20190260A1 (ar) * 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
EP3713965A1 (en) * 2017-11-22 2020-09-30 Novartis AG Reversal binding agents for anti-factor xi/xia antibodies and uses thereof
JP2024540435A (ja) * 2021-11-18 2024-10-31 アントス セラピューティクス， インコーポレイテッド 第ＸＩ／ＸＩａ因子抗体の投薬レジメン

Also Published As

Publication number Publication date
KR20220119090A (ko) 2022-08-26
BR112022012064A2 (pt) 2022-08-30
JP2023507795A (ja) 2023-02-27
EP4076511A4 (en) 2024-02-14
WO2021127525A1 (en) 2021-06-24
EP4076511A1 (en) 2022-10-26
IL293367A (en) 2022-07-01
JP2026048712A (ja) 2026-03-17
CN115003325A (zh) 2022-09-02
US20230071973A1 (en) 2023-03-09

Similar Documents

Publication Publication Date Title
JP7277649B2 (ja) 高濃度抗ｃ５抗体製剤
TW202104270A (zh) 包含抗ｃｄ４７／ｐｄ－ｌ１雙特異性抗體的製劑及其製備方法和用途
JP2026048712A (ja) 第ＸＩ／ＸＩａ因子抗体の医薬製剤および投薬レジメン
KR20180094028A (ko) 혈장 칼리크레인 저해제 및 유전성 혈관부종 발작을 치료하기 위한 이의 용도
US20240294669A1 (en) Dosing regimens of factor xi/xia antibodies
CN110960490A (zh) 一种抗egfr抗体偶联药物组合物及其用途
JP2024528724A (ja) 抗ｐｄ－１抗体医薬組成物及びその使用
WO2019020069A1 (zh) 一种sost抗体药物组合物及其用途
JP2023113883A (ja) 小児患者のための生物薬剤組成物及び方法
TW202214297A (zh) 用於治療疼痛之結合TGF-α及表皮調節素(EPIREGULIN)之抗體
WO2018223958A1 (zh) 一种含c-Met抗体药物偶联物的药物组合物及其用途
EP4543434A2 (en) Combination therapies with an anti-factor xi/factor xia antibody
TW202434633A (zh) 治療甲狀腺眼疾之方法
CN118302196A (zh) 因子XI/XIa抗体的给药方案
HK40096185A (zh) 生物医药组合物
EA045920B1 (ru) Ингибиторы калликреина плазмы и их применение для лечения обострения наследственного ангионевротического отека

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220920

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 4TH ANNIV.) - STANDARD

Year of fee payment: 4

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: 20241213

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: 20241213

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: 20250409

R00 Party data change recorded

Free format text: ST27 STATUS EVENT CODE: A-2-2-R10-R00-R116 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPOINTMENT OF AGENT REQUEST

Effective date: 20250625

Free format text: ST27 STATUS EVENT CODE: A-2-2-R10-R00-R119 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REVOCATION OF AGENT REQUEST

Effective date: 20250625

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: 20250702

T11 Administrative time limit extension requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-T10-T11-T100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXTENSION OF TIME FOR TAKING ACTION REQUEST RECEIVED

Effective date: 20250806

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: 20251009

R17 Change to representative recorded

Free format text: ST27 STATUS EVENT CODE: A-2-2-R10-R17-R117 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPOINTMENT OF AGENT REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20251117

Free format text: ST27 STATUS EVENT CODE: A-2-2-R10-R17-R121 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REVOCATION OF AGENT REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20251117

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20251117

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 5TH ANNIV.) - STANDARD

Year of fee payment: 5

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: 20251118

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: 20251118

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: 20251118

T13 Administrative time limit extension granted

Free format text: ST27 STATUS EVENT CODE: A-2-2-T10-T13-T101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXTENSION OF TIME FOR TAKING ACTION REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20251125

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: 20251125