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1. WO2022000046 - HIGH CONCENTRATION FORMULATION OF FACTOR XII ANTIGEN BINDING PROTEINS

Publication Number WO/2022/000046
Publication Date 06.01.2022
International Application No. PCT/AU2021/050714
International Filing Date 05.07.2021
IPC
A61K 39/395 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
A61P 7/02 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
7Drugs for disorders of the blood or the extracellular fluid
02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
C07K 16/36 2006.1
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
18against material from animals or humans
36against blood coagulation factors
A61K 47/18 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
16containing nitrogen
18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
A61K 47/22 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
A61K 9/08 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
CPC
A61K 2039/505
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
505comprising antibodies
A61K 2039/54
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
54characterised by the route of administration
A61K 2039/545
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
545characterised by the dose, timing or administration schedule
A61P 7/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
7Drugs for disorders of the blood or the extracellular fluid
02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
C07K 16/36
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
18against material from animals or humans
36against blood coagulation factors
C07K 2317/56
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
2317Immunoglobulins specific features
50characterized by immunoglobulin fragments
56variable (Fv) region, i.e. VH and/or VL
Applicants
  • CSL INNOVATION PTY LTD [AU]/[AU]
Inventors
  • JOHNSTON, Michael
  • GOODALL, Dianna Grace
  • EDWARDS, Nathan Aaron
Agents
  • FB RICE PTY LTD
Priority Data
20184004.803.07.2020EP
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) HIGH CONCENTRATION FORMULATION OF FACTOR XII ANTIGEN BINDING PROTEINS
(FR) FORMULATION À HAUTE CONCENTRATION DE PROTÉINES DE LIAISON À L'ANTIGÈNE DU FACTEUR XII
Abstract
(EN) The present application is directed to a liquid formulation comprising at least 100mg/ml of a protein comprising an antigen binding domain that binds to FXII (and/or an activated form thereof), an organic buffer, a non-ionic surfactant and an amino acid stabilizer, wherein the pH of the formulation is 5.0-6.5 and the viscosity is less than 30 mPa*s at 20°C. Exemplary formulations comprise the specific Factor XII antibody 3F7, in formulation with a histidine buffer, a polysorbate 80 surfactant and the amino acid stabilizers arginine and proline.
(FR) La présente demande est relative à une formulation liquide comprenant au moins 100 mg/ml d'une protéine comprenant un domaine de liaison à l'antigène qui se lie à FXII (et/ou à une forme activée de ce dernier), un tampon organique, un tensioactif non ionique et un acide aminé stabilisateur, le pH de la formulation étant compris entre 5,0 et 6,5 et la viscosité étant inférieure à 30 mPa*s à 20 °C. Des formulations données à titre d'exemple comprennent l'anticorps anti-facteur XII spécifique 3F7, dans une formulation avec un tampon histidine, un tensioactif polysorbate 80 et les acides aminés stabilisateurs arginine et proline.
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