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WO2025071366A1 - Formulation liquide à tamponnage spontané d'un anticorps anti-il-23 - Google Patents

Formulation liquide à tamponnage spontané d'un anticorps anti-il-23 Download PDF

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Publication number
WO2025071366A1
WO2025071366A1 PCT/KR2024/014798 KR2024014798W WO2025071366A1 WO 2025071366 A1 WO2025071366 A1 WO 2025071366A1 KR 2024014798 W KR2024014798 W KR 2024014798W WO 2025071366 A1 WO2025071366 A1 WO 2025071366A1
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Prior art keywords
liquid formulation
formulation according
concentration
antibody
histidine
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English (en)
Korean (ko)
Inventor
오인영
정소윤
정우진
박지은
황지영
김인애
이현주
장성근
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Samsung Bioepis Co Ltd
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Samsung Bioepis Co Ltd
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Publication of WO2025071366A1 publication Critical patent/WO2025071366A1/fr
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    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Definitions

  • Self-buffering liquid formulations of anti-IL-23 antibodies, devices comprising same, and uses thereof for treating IL-23 associated conditions are provided.
  • Antibody drugs have a large molecular weight compared to general protein drugs, and their secondary/higher order structures are complex, which can cause physicochemical instability. For this reason, antibody drugs require the development of an optimal formulation that guarantees quality and stability throughout the entire process from manufacturing, storage, and administration to patients. Protein instability can be caused by various external factors such as temperature, light, and chemical factors, which can lead to decreased activity, decreased efficacy, or immunogenicity when administered to the human body. Therefore, it is important to improve the instability of such antibody drugs and maintain optimal quality until they are administered to patients. To achieve optimal quality, methods such as changing the buffer solution, evaluating the optimal pH, and adding stabilizers are used. Since the material properties of each antibody protein are different, and the optimal combination of buffer solution, pH, and stabilizer may be different, a formulation suitable for the target substance is required to solve this problem.
  • guselkumab an IL-23 inhibitor
  • guselkumab is a liquid formulation consisting of 100 mg/mL anti-IL-23 IgG, 11 mM histidine, 7.9% (w/v) sucrose, and 0.05% (w/v) polysorbate 80, and is manufactured and sold under the trade name Tremfya ® .
  • various conditions such as the type and concentration of each component, such as adding buffers, stabilizers, and surfactants, or applying a specific pH , are being reviewed and applied, as in the Tremfya ® product composition.
  • buffers are prone to self-decomposition under stress conditions, which may affect the stability of antibody drugs.
  • phosphoric acid may not maintain pH in a freezing environment, which may affect the stability of antibodies.
  • the present disclosure relates to a self-buffering liquid formulation of an anti-IL-23 antibody, such as guselkumab.
  • the present disclosure provides a liquid formulation of an anti-IL-23 antibody, such as guselkumab, which has a buffering capacity without containing a buffer, unlike the existing commercialized formulation, Tremfya ® , which contains a histidine buffer.
  • One aspect is to provide a liquid formulation comprising an anti-IL-23 antibody and not comprising a buffer.
  • Another aspect is to provide a device comprising the liquid formulation.
  • Another aspect provides a method of treating an IL-23 associated condition, comprising administering the liquid formulation to a subject in need thereof.
  • Another aspect provides use of the liquid formulation in the manufacture of a medicament for treating an IL-23 associated condition.
  • One aspect provides a self-buffering liquid formulation of an anti-IL-23 antibody, specifically:
  • antibody as used herein may be interpreted to mean a full-length antibody or an antigen-binding fragment thereof.
  • the antibody includes a monoclonal antibody, a polyclonal antibody, a humanized antibody, a human antibody, and a chimeric antibody.
  • an antigen-binding fragment means a fragment comprising an antigen-binding site of an antibody.
  • an antigen-binding fragment includes, but is not limited to, a Fab fragment, a F(ab') 2 fragment, an Fc fragment, or a scFv fragment.
  • the antibody may be an anti-IL-23 antibody.
  • the anti-IL-23 antibody may refer to any antibody that specifically binds to interleukin-23 (IL-23).
  • IL-23 has a heterodimer structure in which the IL-23p19 subunit and the IL-12p40 subunit are S-S bonded.
  • the IL-23 heterodimer binds to a receptor complex, and specifically, the p19 subunit binds to IL-23R, and the p40 subunit binds to IL-12RB1.
  • the above anti-IL-23 antibody may be an anti-IL-23p19 antibody.
  • the above anti-IL-23p19 antibody may mean any antibody that specifically binds to the p19 subunit of IL-23.
  • the above anti-IL-23 antibody may be guselkumab (CAS No. 1350289-85-8). Therefore, the liquid formulation may be a stable liquid formulation of guselkumab.
  • Guselkumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that binds to the p19 subunit of IL-23.
  • Guselkumab is sold under the trade name Tremfya ® .
  • Tremfya ® is a drug approved by the Food and Drug Administration (FDA) for the treatment of plaque psoriasis, and is also used to treat palmoplantar pustulosis, psoriatic arthritis, and recently, ulcerative colitis.
  • FDA Food and Drug Administration
  • the sequence of guselkumab is known, and can be produced by general methods known in the art. More detailed information about guselkumab can be easily obtained by those skilled in the art from known databases.
  • guselkumab herein may also be interpreted to mean guselkumab having a modified amino acid sequence (deletion, insertion, and/or substitution) and/or a modified glycosylation characteristic, as long as it does not affect the polypeptide function.
  • the anti-IL-23 antibody has a buffering function for pH in an aqueous solution.
  • the concentration of the anti-IL-23 antibody may be a concentration suitable for providing a buffering function to the liquid formulation.
  • the anti-IL-23 antibody may be included in the liquid formulation in a therapeutically effective amount.
  • the concentration of the anti-IL-23 antibody is about 1 mg/ml to about 300 mg/ml, about 1 mg/ml to about 250 mg/ml, about 1 mg/ml to about 200 mg/ml, about 1 mg/ml to about 175 mg/ml, about 1 mg/ml to about 150 mg/ml, about 1 mg/ml to about 125 mg/ml, about 1 mg/ml to about 100 mg/ml, about 1 mg/ml to about 75 mg/ml, about 1 mg/ml to about 50 mg/ml, about 1 mg/ml to about 30 mg/ml, about 1 mg/ml to about 20 mg/ml, about 1 mg/ml to about 10 mg/ml, about 2 mg/ml to about 300 mg/ml, about 2 mg/ml to about 250 mg/ml, about 2 mg/ml to about 200 mg/ml, about 2 mg/ml to about 175 mg/ml, about 2 mg/ml to about 150 mg/ml, about 2
  • the concentration of the anti-IL-23 antibody can be about 5 mg/ml, about 10 mg/ml, about 25 mg/ml, about 50 mg/ml, about 75 mg/ml, about 100 mg/ml, about 125 mg/ml, about 150 mg/ml, about 175 mg/ml, about 200 mg/ml, about 250 mg/ml, or about 300 mg/ml.
  • the concentration of the anti-IL-23 antibody may be about 100 mg/ml.
  • the liquid formulation according to one aspect does not contain a buffer (free of buffer). Therefore, the liquid formulation may be a buffer-free formulation, a bufferless formulation, or a self-buffering formulation. Although the liquid formulation is a buffer-free formulation, it has a buffering capacity, and therefore may have stability equivalent to or greater than that of a Tremfya ® formulation containing a buffer.
  • buffering is the resistance of a composition to a change in pH under the addition of an acid or base. Therefore, “buffering capacity” can be defined as the ability of a composition to resist a change in pH.
  • buffering capacity ( ⁇ ) is generally expressed as the amount of a strong acid or strong base required to change the pH of a composition by a given amount. Buffering capacity ( ⁇ ) is a unitless number, and the higher the value, the greater the buffering capacity. Methods for evaluating or measuring buffering capacity are known in the art.
  • component A' or 'substantially free of A' may be interpreted to include cases where component A is not present at all, or where component A is present in trace amounts that do not substantially affect the properties of the formulation, or where it is present in undetectable amounts.
  • the phrase "does not contain a buffer” may be interpreted to mean that no buffering component is present in the formulation, or that the formulation contains such an amount that it cannot function as the intended buffering component in the formulation.
  • self-buffering may be understood to mean that the buffering capacity of the antibody formulation is substantially or completely provided by the antibody itself.
  • the liquid formulation may be a self-buffering formulation. Accordingly, the liquid formulation may be substantially free of buffering agents other than the anti-IL-23 antibody (e.g., guselkumab).
  • the liquid formulation may have a buffering capacity in the range of pH 4.0 to pH 8.3.
  • the liquid formulation may have a buffering capacity in the range of pH 4.0 to pH 5.8, for example, when an acid (e.g., HCl) is added.
  • the liquid formulation may have a buffering capacity in the range of pH 5.8 to pH 8.3, for example, when a base (e.g., NaOH) is added.
  • the liquid formulation may have a buffering capacity of at least about 70%, at least about 71%, at least about 72%, at least about 73%, at least about 74%, at least about 75%, at least about 76%, at least about 77%, at least about 78%, at least about 79%, at least about 80%, at least about 81%, or at least about 82% of the buffering capacity of the liquid formulation comprising the histidine buffer.
  • the liquid formulation can have a buffering capacity of, for example, at least about 70%, at least about 75%, at least about 80%, at least about 81%, or at least about 82% of the buffering capacity of the liquid formulation comprising the histidine buffer in the range of pH 4.0 to 5.8 when an acid (e.g., HCl) is added.
  • the liquid formulation can have a buffering capacity ( ⁇ ) of at least 0.003, at least 0.004, at least 0.005, at least 0.006, at least 0.007, at least 0.0071, at least 0.0072, or at least 0.00722 in the range of pH 4.0 to 5.8.
  • the liquid formulation may have a buffering capacity of at least about 70%, or at least about 71%, of the buffering capacity of the liquid formulation comprising the histidine buffer in the range of pH 5.8 to 8.3, for example, when a base (e.g., NaOH) is added.
  • the liquid formulation may have a buffering capacity ( ⁇ ) of at least 0.002, at least 0.003, at least 0.0035, at least 0.0036, at least 0.0037, at least 0.0038, or at least 0.0039 in the range of pH 5.8 to 8.3.
  • the histidine buffer may comprise at least one selected from histidine, a salt thereof, and a hydrate thereof.
  • the histidine buffer may comprise histidine, histidine monohydrochloride monohydrate, or a combination thereof.
  • the histidine buffer may comprise a combination of histidine and histidine monohydrochloride monohydrate.
  • the concentration of the histidine buffer may be about 10.9 mM to about 11 mM.
  • the liquid formulation can have a buffering capacity that is at least about 80% as high or equivalent to a Tremfya ® formulation comprising about 11 mM (e.g., 10.9 mM) histidine buffer (e.g., 4.0 mM histidine + 6.9 mM L-histidine monohydrochloride monohydrate) without including a buffer.
  • the liquid formulation can have a buffering capacity that is at least about 80% as high or equivalent to a Tremfya ® formulation comprising about 11 mM (e.g., 10.9 mM) histidine buffer (e.g., 4.0 mM histidine + 6.9 mM L-histidine monohydrochloride monohydrate) without including a buffer.
  • the above liquid formulation has a buffering capacity even without containing a buffer, and thus may have superior stability compared to formulations containing a buffer such as Tremfya ® .
  • the liquid formulation does not contain, or substantially does not contain, a buffer.
  • the buffer may contain one or more selected from acetate, histidine, phosphate, citrate, succinate, malate, tartarate, carbonate, salts thereof, and hydrates thereof.
  • salt may be a pharmaceutically acceptable salt.
  • the salt may include an inorganic acid salt, an organic acid salt, a metal salt, and the like of the compound.
  • the inorganic acid salt may be a hydrochloride, a bromate, a phosphate, a sulfate, or a disulfate.
  • the organic acid salt may be a formate, an acetate, a propionate, a lactate, an oxalate, a tartrate, a malate, a maleate, a citrate, a fumarate, a besylate, a camsylate, an edisyl salt, a trichloroacetic acid, a trifluoroacetate, a benzoate, a gluconate, a methanesulfonate, a glycolate, a succinate, a 4-toluenesulfonate, a galacturonate, an emboxide, a glutamate, an ethanesulfonate, a benzenesulfonate, a p-toluenesulfonate, or an aspartate.
  • the metal salt may be a calcium salt, a sodium salt, a magnesium salt, a strontium salt, or a potassium salt.
  • hydrate refers to a substance that contains water molecules within its molecule.
  • the hydrate may be a monohydrate, a dihydrate, or a trihydrate.
  • a hydrate of histidine may include histidine monohydrochloride monohydrate.
  • the buffer may include one or more selected from histidine, a salt thereof, and a hydrate thereof. Accordingly, the liquid formulation may not include any of histidine, a salt thereof, and a hydrate thereof as the buffer.
  • the buffering agent may comprise histidine, histidine monohydrochloride monohydrate, or a combination thereof. Accordingly, the liquid formulation may comprise neither histidine nor histidine monohydrochloride monohydrate as the buffering agent.
  • the pH of the liquid formulation may be from about 4.0 to about 8.3.
  • the pH of the formulation can be any range or any value selected from about 4.0 to about 8.3.
  • the pH can be from about 4.0 to about 8.3, from about 4.0 to about 8.0, from about 4.0 to about 7.5, from about 4.0 to about 7.2, from about 4.0 to about 7.0, from about 4.0 to about 6.9, from about 4.0 to about 6.8, from about 4.0 to about 6.7, from about 4.0 to about 6.6, from about 4.0 to about 6.5, from about 4.0 to about 6.4, from about 4.0 to about 6.3, from about 4.0 to about 6.2, from about 4.0 to about 6.1, from about 4.0 to about 6.0, from about 4.0 to about 5.9, from about 4.0 to about 5.8, from about 4.0 to about 5.7, from about 4.0 to about 5.6, from about 4.0 to about 5.5, about 4.0 to about 5.2, about 4.0 to about 5.0, about 4.0 to about 4.7, about 4.0 to about 4.5, about 4.5 to about 8.3, about 4.5 to about 8.0,
  • the pH of the liquid formulation can be about 4.0, about 4.5, about 5.0, about 5.5, about 5.8, about 5.9, about 6.0, about 6.1, about 6.2, about 6.3, about 6.4, about 6.5, about 6.6, about 6.7, about 6.8, about 6.9, about 7.0, about 7.1, about 7.2, about 7.3, about 7.4, about 7.5, about 7.6, about 7.7, about 7.8, about 7.9, or about 8.0.
  • the pH of the liquid formulation can be any range or any value selected from the range of about 5.5 to about 6.5, or from about 5.8 to about 6.0.
  • Liquid formulations according to the invention may additionally contain a stabilizer.
  • the liquid formulation may be a liquid formulation comprising an anti-IL-23 antibody and a stabilizer, and not comprising a buffer.
  • stabilizer refers to a substance added to prevent changes in state or chemical changes when preserving a substance.
  • the above stabilizer can be used without limitation in its type as long as it is applicable to biopharmaceuticals.
  • the above stabilizer may include at least one selected from sugar, sugar alcohol, amino acid, metal salt, salts thereof, and hydrates thereof.
  • the sugar may be a monosaccharide, a disaccharide, an oligosaccharide, or a polysaccharide.
  • the sugar may include at least one selected from trehalose, sucrose, galactose, mannose, maltose, lactose, fructose, and glucose.
  • the above sugar alcohol is a general term for polyols having two or more hydroxy groups, which are made into alcohol groups by reducing an aldehyde group or a ketone group of a sugar.
  • the sugar alcohol may include at least one selected from mannitol, sorbitol, xylitol, arabitol, erythritol, lactitol, maltitol, and inositol.
  • the sugar alcohol includes an anhydride or hydrate of the sugar alcohol.
  • trehalose may include not only trehalose but also trehalose dihydrate.
  • the above amino acids may include one or more selected from glycine, alanine, valine, leucine, isoleucine, proline, phenylalanine, tyrosine, tryptophan, serine, threonine, cysteine, methionine, asparagine, glutamine, lysine, arginine, aspartic acid, and glutamic acid.
  • the above metal salt may include at least one selected from NaCl, KCl, NaF, KBr, NaBr, Na 2 SO 4 , NaSCN, CaCl 2 , MgCl 2 , and K 2 SO 4 .
  • the concentration of the sugar can be freely adjusted within a range that maintains the stability of the antibody, and can vary individually depending on each specific sugar type.
  • the concentration of the sugar can be any range or any value selected from about 0.1% (w/v) to about 20.0% (w/v).
  • the concentration of the sugar may be from about 0.1% (w/v) to about 20.0% (w/v), from about 0.1% (w/v) to about 15.0% (w/v), from about 0.1% (w/v) to about 12.0% (w/v), from about 0.1% (w/v) to about 10.0% (w/v), from about 0.1% (w/v) to about 8.0% (w/v), from about 0.1% (w/v) to about 5.0% (w/v), from about 1.0% (w/v) to about 20.0% (w/v), from about 1.0% (w/v) to about 15.0% (w/v), from about 1.0% (w/v) to about 12.0% (w/v), from about 1.0% (w/v) to about 10.0% (w/v), about 1.0% (w/v) to about 8.0% (w/v), about 1.0% (w/v) to about 5.0% (w/v), about 2.0% (w/v) to about 20.0% (w/v), about 2.0% (w/v) to about 15.0% (
  • the concentration of the sugar alcohol can be freely adjusted within a range that maintains the stability of the antibody, and can vary individually depending on each specific sugar alcohol type.
  • the concentration of the sugar alcohol can be any range or any value selected from about 0.1% (w/v) to about 20.0% (w/v).
  • the concentration of the sugar alcohol may be from about 0.1% (w/v) to about 20.0% (w/v), from about 0.1% (w/v) to about 15.0% (w/v), from about 0.1% (w/v) to about 12.0% (w/v), from about 0.1% (w/v) to about 10.0% (w/v), from about 0.1% (w/v) to about 8.0% (w/v), from about 0.1% (w/v) to about 5.0% (w/v), from about 1.0% (w/v) to about 20.0% (w/v), from about 1.0% (w/v) to about 15.0% (w/v), from about 1.0% (w/v) to about 12.0% (w/v), from about 1.0% (w/v) to about 10.0% (w/v), about 1.0% (w/v) to about 8.0% (w/v), about 1.0% (w/v) to about 5.0% (w/v), about 2.0% (w/v) to about 20.0% (w/v), about 2.0% (w/v) to about 20.
  • the concentration of the above amino acid can be freely adjusted within a range that maintains the stability of the antibody, and can vary individually depending on each specific amino acid type.
  • the concentration of the above amino acid can be any range or any value selected from about 1 mM to about 400 mM.
  • the concentration of the amino acid can be about 1 mM to about 400 mM, about 1 mM to about 300 mM, about 1 mM to about 200 mM, about 1 mM to about 100 mM, about 10 mM to about 400 mM, about 10 mM to about 300 mM, about 10 mM to about 200 mM, about 10 mM to about 100 mM, about 20 mM to about 400 mM, about 20 mM to about 300 mM, about 20 mM to about 200 mM, about 20 mM to about 150 mM, about 20 mM to about 100 mM, about 20 mM to about 50 mM, about 20 mM to about 40 mM, about 20 mM to about 30 mM, about 30 mM to about 400 mM, about 30 mM to about 300 mM, about 30 mM to about 200 mM, about 30 mM to about 150 mM, about 30 mM,
  • the concentration of the metal salt can be freely controlled within a range that maintains the stability of the antibody, and can vary individually depending on the type of each specific metal salt.
  • the concentration of the metal salt can be any range or any value selected from about 1 mM to about 400 mM.
  • the concentration of the metal salt may be about 1 mM to about 400 mM, about 1 mM to about 300 mM, about 1 mM to about 200 mM, about 1 mM to about 100 mM, about 1 mM to about 50 mM, about 10 mM to about 400 mM, about 10 mM to about 300 mM, about 10 mM to about 200 mM, about 10 mM to about 100 mM, about 20 mM to about 400 mM, about 20 mM to about 300 mM, about 20 mM to about 200 mM, about 20 mM to about 150 mM, about 20 mM to about 100 mM, about 50 mM to about 400 mM, about 50 mM to about 300 mM, about 50 mM to about 200 mM, about 50 mM to about 150 mM, about 50 mM to About 100 mM, about 80 mM to about 400 mM, about 80 mM,
  • the stabilizer can include one or more selected from sucrose, trehalose, sorbitol, mannitol, arginine, lysine, methionine, glycine, and NaCl. In another embodiment, the stabilizer can include one or more selected from trehalose, sorbitol, mannitol, arginine, lysine, methionine, glycine, and NaCl.
  • the stabilizer can include one or more selected from sorbitol, mannitol, arginine, lysine, methionine, and NaCl. In another embodiment, the stabilizer can include one or more selected from sorbitol, mannitol, arginine, lysine, methionine, and NaCl.
  • the stabilizer may comprise sucrose.
  • the concentration of the sucrose is about 0.1% (w/v) to about 20.0% (w/v), about 1.0% (w/v) to about 20.0% (w/v), about 1.0% (w/v) to about 15.0% (w/v), about 1.0% (w/v) to about 12.0% (w/v), about 1.0% (w/v) to about 10.0% (w/v), about 5.0% (w/v) to about 20.0% (w/v), about 5.0% (w/v) to about 15.0% (w/v), about 5.0% (w/v) to about 12.0% (w/v), about 5.0% (w/v) to about 10.0% (w/v), about 7.0% (w/v) to 9.0% (w/v), or about 7.9% (w/v).
  • the stabilizer may comprise trehalose.
  • the concentration of the trehalose is about 0.1% (w/v) to about 20.0% (w/v), about 1.0% (w/v) to about 20.0% (w/v), about 1.0% (w/v) to about 15.0% (w/v), about 1.0% (w/v) to about 12.0% (w/v), about 1.0% (w/v) to about 10.0% (w/v), about 5.0% (w/v) to about 20.0% (w/v), about 5.0% (w/v) to about 15.0% (w/v), about 5.0% (w/v) to about 12.0% (w/v), about 5.0% (w/v) to about 10.0% (w/v), about 8.0% (w/v) to about 20.0% (w/v), about 8.0% (w/v) to about 15.0% (w/v), about 8.0% (w/v) to about 14.0% (w/v), about 8.0% (w/v) to about 13.0% (w/v), about 8.0% (w/w/
  • the stabilizer may comprise sorbitol.
  • the concentration of the sorbitol is about 0.1% (w/v) to about 20.0% (w/v), about 1.0% (w/v) to about 20.0% (w/v), about 1.0% (w/v) to about 15.0% (w/v), about 1.0% (w/v) to about 12.0% (w/v), about 1.0% (w/v) to about 10.0% (w/v), about 1.0% (w/v) to about 8.0% (w/v), about 1.0% (w/v) to about 5.0% (w/v), about 2.0% (w/v) to about 20.0% (w/v), about 2.0% (w/v) to about 15.0% (w/v), about 2.0% (w/v) to about 12.0% (w/v), about 2.0% (w/v) to about 10.0% (w/v), about 2.0% (w/v) to about 8.0% (w/v), about 2.0% (w/v) to about 5.0% (w/v), about 3.0% (w/v
  • the stabilizer may comprise mannitol.
  • the concentration of the above mannitol is about 0.1% (w/v) to about 20.0% (w/v), about 1.0% (w/v) to about 20.0% (w/v), about 1.0% (w/v) to about 15.0% (w/v), about 1.0% (w/v) to about 12.0% (w/v), about 1.0% (w/v) to about 10.0% (w/v), about 1.0% (w/v) to about 8.0% (w/v), about 1.0% (w/v) to about 5.0% (w/v), about 2.0% (w/v) to about 20.0% (w/v), about 2.0% (w/v) to about 15.0% (w/v), about 2.0% (w/v) to about 12.0% (w/v), about 2.0% (w/v) to about 10.0% (w/v), about 2.0% (w/v) to about 8.0% (w/v), about 2.0% (w/v) to about 5.0% (w/v), about 3.0% (w/
  • the stabilizer may comprise arginine.
  • the concentration of said arginine is about 1 mM to about 400 mM, about 10 mM to about 400 mM, about 20 mM to about 400 mM, about 50 mM to about 400 mM, about 50 mM to about 300 mM, about 50 mM to about 200 mM, about 50 mM to about 150 mM, about 80 mM to about 400 mM, about 80 mM to about 300 mM, about 80 mM to about 200 mM, about 80 mM to about 150 mM, about 100 mM to about 400 mM, about 100 mM to about 300 mM, about 100 mM to about 200 mM, about 100 mM to about 180 mM, about 100 mM to about 150 mM, about 120 mM to about 400 mM, about 120 mM to about 300 mM, about 120 mM to about 200 mM, about 120 mM
  • the stabilizer may comprise lysine.
  • the concentration of the lysine is about 1 mM to about 400 mM, about 10 mM to about 400 mM, about 20 mM to about 400 mM, about 50 mM to about 400 mM, about 50 mM to about 300 mM, about 50 mM to about 200 mM, about 50 mM to about 150 mM, about 80 mM to about 400 mM, about 80 mM to about 300 mM, about 80 mM to about 200 mM, about 80 mM to about 150 mM, about 100 mM to about 400 mM, about 100 mM to about 300 mM, about 100 mM to about 200 mM, about 100 mM to about 180 mM, about 100 mM to about 150 mM, about 120 mM to about 400 mM, about 120 mM to about 300 mM, about 120 mM to about 200 mM, about 120 mM
  • the stabilizer may comprise methionine.
  • the concentration of the methionine is about 1 mM to about 400 mM, about 1 mM to about 300 mM, about 1 mM to about 200 mM, about 1 mM to about 100 mM, about 1 mM to about 80 mM, about 1 mM to about 60 mM, about 1 mM to about 50 mM, about 1 mM to about 30 mM, about 10 mM to about 400 mM, about 20 mM to about 400 mM, about 20 mM to about 300 mM, about 20 mM to about 200 mM, about 20 mM to about 100 mM, about 20 mM to about 80 mM, about 20 mM to about 60 mM, about 20 mM to about 50 mM, about 20 mM to about 30 mM, about 30 mM to about 400 mM, about 30 mM to about 300 mM, about 30 About
  • the stabilizer may comprise glycine.
  • the concentration of said glycine is about 1 mM to about 400 mM, about 10 mM to about 400 mM, about 50 mM to about 400 mM, about 100 mM to about 400 mM, about 100 mM to about 300 mM, about 100 mM to about 280 mM, about 100 mM to about 250 mM, about 150 mM to about 400 mM, about 150 mM to about 300 mM, about 150 mM to about 250 mM, about 200 mM to about 400 mM, about 200 mM to about 350 mM, about 200 mM to about 300 mM, about 200 mM to about 250 mM, about 220 mM to about 400 mM, about 220 mM to about 350 mM, about 220 mM to about 300 mM, or about It can be from 220 mM to about 280 mM.
  • the stabilizer may comprise NaCl.
  • the concentration of the NaCl is about 1 mM to about 400 mM, about 10 mM to about 400 mM, about 20 mM to about 400 mM, about 50 mM to about 400 mM, about 50 mM to about 300 mM, about 50 mM to about 200 mM, about 50 mM to about 150 mM, about 80 mM to about 400 mM, about 80 mM to about 300 mM, about 80 mM to about 200 mM, about 80 mM to about 150 mM, about 100 mM to about 400 mM, about 100 mM to about 300 mM, about 100 mM to about 200 mM, about 100 mM to about 180 mM, about 100 mM to about 150 mM, about 120 mM to about 400 mM, about 120 mM to about 300 mM, about 120 mM to about 200 mM, about 120 mM, about
  • Liquid formulations according to the aspect may additionally contain a surfactant.
  • the liquid formulation may be a liquid formulation comprising an anti-IL-23 antibody and a surfactant, and not comprising a buffer.
  • the above liquid formulation may be a liquid formulation comprising an anti-IL-23 antibody; a stabilizer; and a surfactant, and not comprising a buffer.
  • the above surfactant can be selected from any pharmaceutically acceptable surfactants capable of evenly dispersing a protein (e.g., antibody) in a liquid formulation medium.
  • the above surfactant may be a nonionic surfactant.
  • the surfactant may be at least one selected from the group consisting of polysorbate, poloxamer, sorbitan esters of other fatty acids, polyethylene-polypropylene glycol, polyoxyethylene compounds, and sodium dodecyl sulphate (SDS).
  • the above polysorbate may include polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, and polysorbate 85.
  • the above poloxamer may include a PEO-PPO-PEO copolymer (PEO is poly(ethylene oxide) and PPO is poly(propylene oxide)).
  • PEO poly(ethylene oxide)
  • PPO poly(propylene oxide)
  • sorbitan esters of other fatty acids may mean sorbitan esters of other fatty acids than polysorbates, and may include, for example, sorbitan polyethoxylates.
  • the above polyoxyethylene compound may include polyoxyethylene-stearate, polyoxyethylene alkyl ether (alkyl: C1-C30), polyoxyethylene monoryl ether, alkylphenyl polyoxyethylene copolymer (alkyl: C1-C30), and the like.
  • the surfactant may include one or more selected from polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, and polysorbate 85.
  • the surfactant may include polysorbate 20, polysorbate 80, or a combination thereof.
  • the surfactant may comprise polysorbate 80.
  • the concentration of the surfactant can be any range or value selected from about 0.01% (w/v) to about 0.9% (w/v).
  • the concentration of the surfactant may be from about 0.01% (w/v) to about 0.9% (w/v), from about 0.01% (w/v) to about 0.5% (w/v), from about 0.01% (w/v) to about 0.1% (w/v), from about 0.01% (w/v) to about 0.08% (w/v), from about 0.01% (w/v) to about 0.06% (w/v), from about 0.03% (w/v) to about 0.9% (w/v), from about 0.03% (w/v) to about 0.5% (w/v), from about 0.03% (w/v) to about 0.1% (w/v), from about 0.03% (w/v) to about 0.08% (w/v), from about 0.03% (w/v) to about 0.07% (w/v), about 0.03% (w/v) to about 0.06% (w
  • the concentration of the surfactant may be about 0.05% (w/v).
  • Liquid formulations may additionally contain a diluent.
  • the above diluent may be an aqueous carrier.
  • the aqueous carrier may be a pharmaceutically acceptable carrier that is safe and non-toxic when administered to humans, such as water, saline solution, Ringer's solution, dextrose, or a mixture thereof.
  • the diluent may be water.
  • the water may be water in a standard state.
  • the liquid formulation may be an aqueous liquid formulation.
  • standard state is a reference that specifies the temperature and pressure used to describe a solution having a particular composition, and can mean, for example, a temperature of 25 ⁇ C ⁇ 2 ⁇ C and a pressure of 1 atmosphere.
  • Those skilled in the art will recognize that liquid formulations equivalent to those disclosed herein can be produced at other temperatures and pressures. Whether such liquid formulations are equivalent to those disclosed herein can be determined under standard state conditions.
  • the liquid formulation according to one aspect may be a biosimilar of Tremfya ® . Accordingly, the liquid formulation according to one aspect has a stability level equivalent to or greater than that of Tremfya ® .
  • biosimilar is also called “biogeneric” and refers to a copy of an original biopharmaceutical. Since biopharmaceuticals are not synthesized chemical products but are produced through cells, they cannot be exactly the same as the original drug. Therefore, a copy of a biopharmaceutical is called a biosimilar because it is similar, but not identical, to the original drug.
  • Stability means that the antibody (e.g., guselkumab) contained in the formulation substantially retains its physical stability, chemical stability and/or biological activity before, during, and after administration, further manufacturing processes, storage or preservation. Physical stability, chemical stability and/or biological activity can be assessed by methods commonly known in the art.
  • Liquid formulations according to one aspect may have self-buffering ability even without containing a buffer. Therefore, they may have superior stability compared to commercially available formulations such as Tremfya ® containing a buffer.
  • liquid formulation means a formulation in liquid form.
  • the liquid formulation according to one aspect is a self-buffering liquid formulation of anti-IL-23 antibody.
  • the liquid formulation can have a buffering capacity equivalent to Tremfya ® without containing a buffer, and thus can have excellent stability.
  • Liquid formulations according to the aspect of the work may be selected from the following items:
  • a liquid formulation containing an anti-IL-23 antibody e.g., guselkumab
  • an anti-IL-23 antibody e.g., guselkumab
  • a liquid formulation containing an anti-IL-23 antibody e.g., guselkumab
  • an anti-IL-23 antibody e.g., guselkumab
  • a liquid formulation comprising an anti-IL-23 antibody (e.g., guselkumab) and not comprising histidine, a salt thereof, a hydrate thereof, or a combination thereof as a buffer;
  • an anti-IL-23 antibody e.g., guselkumab
  • Anti-IL-23 antibodies e.g., guselkumab
  • a liquid formulation comprising, and not containing histidine, histidine monohydrochloride monohydrate, or a combination thereof as a buffering agent;
  • the concentration of the anti-IL-23 antibody is about 1 mg/ml to about 250 mg/ml, about 5 mg/ml to about 250 mg/ml, about 5 mg/ml to about 200 mg/ml, about 5 mg/ml to about 150 mg/ml, about 5 mg/ml to about 100 mg/ml, about 10 mg/ml to about 250 mg/ml, about 10 mg/ml to about 200 mg/ml, about 10 mg/ml to about 150 mg/ml, about 10 mg/ml to about 100 mg/ml, about 75 mg/ml to about 250 mg/ml, about 75 mg/ml to about 200 mg/ml, about 75 mg/ml to about 150 mg/ml, about 75 mg/ml to about 120 mg/ml, about A liquid formulation having from about 50 mg/ml to about 250 mg/ml, from about 50 mg/ml to about 150 mg/ml, from about 90 mg/ml to about 110 mg/ml, from about
  • a liquid formulation which is a self-buffering formulation in any one of items 1 to 5;
  • a liquid formulation further comprising a stabilizer according to any one of items 1 to 9;
  • a liquid formulation comprising at least one stabilizer selected from sugar, sugar alcohol, amino acid, metal salt, salt thereof, and hydrate thereof;
  • a liquid formulation comprising the stabilizer including sucrose
  • a liquid formulation further comprising a surfactant in any one of items 1 to 17;
  • a liquid formulation according to item 18, wherein the surfactant comprises polysorbate 80;
  • a liquid formulation further comprising a diluent in any one of items 1 to 22;
  • a liquid formulation which is an award-winning liquid formulation in any one of items 1 to 24;
  • a liquid formulation comprising guselkumab in an amount of about 50 mg/ml to about 250 mg/ml; a stabilizer; and a surfactant comprising about 0.01% (w/v) to about 0.9% (w/v) of polysorbate 80; and wherein the liquid formulation does not comprise a buffering agent such as histidine, a salt thereof, a hydrate thereof, or a combination thereof;
  • a liquid formulation comprising guselkumab in an amount of about 90 mg/ml to about 110 mg/ml; a stabilizer; and a surfactant comprising about 0.03% (w/v) to about 0.07% (w/v) of polysorbate 80; and wherein the liquid formulation does not comprise a buffering agent such as histidine, a salt thereof, a hydrate thereof, or a combination thereof;
  • Another aspect provides a device comprising a liquid formulation according to the above aspect.
  • the device is primarily intended for parenteral administration (e.g., subcutaneous, intramuscular, intravenous, intraperitoneal, intracerebrospinal, intraarticular, intrasynovial, and/or intrathecal administration).
  • parenteral administration e.g., subcutaneous, intramuscular, intravenous, intraperitoneal, intracerebrospinal, intraarticular, intrasynovial, and/or intrathecal administration.
  • the device may be accompanied by instructions for administration.
  • the device may comprise the liquid formulation in a container selected from a syringe, a pre-filled syringe, an autoinjector, a bottle, a vial, and a tube.
  • the liquid formulation may be contained in a prefilled syringe.
  • the prefilled syringe may be a single-dose prefilled syringe.
  • Another aspect provides a method of treating an IL-23 associated condition, comprising administering to a subject in need thereof a liquid formulation according to one aspect of the invention.
  • the liquid formulation may be in a form contained in a device.
  • Another aspect provides the use of a liquid formulation according to the above aspect in the manufacture of a medicament for treating an IL-23 associated condition.
  • the method of treating the IL-23 associated condition may further comprise, prior to the administering step, a step of identifying a subject in need of administration of an anti-IL-23 antibody (e.g., guselkumab).
  • an anti-IL-23 antibody e.g., guselkumab
  • the subject may be a subject in need of administration of a liquid formulation containing the anti-IL-23 antibody (e.g., guselkumab).
  • a liquid formulation containing the anti-IL-23 antibody e.g., guselkumab
  • the subject in need of administration of the liquid formulation containing the anti-IL-23 antibody may be a subject having a disease or disorder that can be significantly treated (e.g., elimination, reduction, alleviation, or improvement of symptoms, etc.) by administration of the anti-IL-23 antibody.
  • the subject may be selected from mammals, including humans.
  • the above liquid formulation can be administered in a pharmaceutically effective amount.
  • the IL-23 associated condition may include any condition or disease that can be treated by administration of an anti-IL-23 antibody.
  • the IL-23 associated condition that can be treated by administration of an anti-IL-23 antibody may include any indication currently approved or that may be approved in the future for an anti-IL-23 antibody (e.g., guselkumab).
  • the above IL-23 associated condition may be any one selected from psoriasis, psoriatic arthritis, palmoplantar pustulosis, Crohn's disease (CD), inflammatory bowel disease (IBD), multiple sclerosis (MS), ulcerative colitis (UC), and ankylosing spondylitis.
  • the above psoriasis may be plaque psoriasis.
  • the above plaque psoriasis may be moderate to severe plaque psoriasis.
  • the above psoriatic arthritis may be active psoriatic arthritis (PsA).
  • PsA active psoriatic arthritis
  • the above ulcerative colitis can be moderately to severely active ulcerative colitis.
  • Liquid formulations according to the aspect may be administered by parenteral route.
  • the parenteral route may include subcutaneous administration, intravenous administration, etc.
  • Parenteral administration may be by bolus injection or continuous infusion.
  • the liquid formulation may be for subcutaneous injection.
  • the above liquid formulation may be formulated into a formulation suitable for the above administration route.
  • the above liquid formulation may be formulated into an injection, an injectable ready-to-use form, etc., but is not limited thereto.
  • the liquid formulation may be formulated to contain the entire amount or a pharmaceutically effective amount of the anti-IL-23 antibody (e.g., guselkumab) in a single formulation, or may be formulated to contain two or more (e.g., two, three, four, five, six, seven, eight, nine, or ten) formulations.
  • the liquid formulation may be contained in a single-dose form of the device.
  • the above liquid formulation may be administered to the body in one dose, such that the entire amount of the anti-IL-23 antibody (e.g., guselkumab) contained in the formulation is administered to the body at one time (e.g., within 1 minute, within 30 seconds, within 20 seconds, or within 10 seconds); or may be administered to the body gradually over a period of, but not limited to, 5 minutes or more, 10 minutes or more, 30 minutes or more, 60 minutes or more, 90 minutes or more, 120 minutes or more, 150 minutes or more, 180 minutes or more, 210 minutes or more, or 240 minutes or more.
  • the anti-IL-23 antibody e.g., guselkumab
  • the administration target of the above liquid formulation can be selected from mammals including primates (e.g., humans, etc.), rodents (e.g., mice, rats, guinea pigs, hamsters, rabbits, etc.), cats, dogs, pigs, cows, horses, etc.
  • mammals including primates (e.g., humans, etc.), rodents (e.g., mice, rats, guinea pigs, hamsters, rabbits, etc.), cats, dogs, pigs, cows, horses, etc.
  • the pharmaceutically effective amount of the liquid formulation or the anti-IL-23 antibody (e.g., guselkumab) included therein may refer to an amount or dosage that can exhibit a desired pharmacological effect, such as elimination, alleviation, relief, or improvement of symptoms.
  • the pharmaceutically effective amount may vary depending on factors such as the formulation method, administration method, patient's age, weight, sex, pathological condition (severity of condition), food, administration time, administration interval, administration route, excretion rate, response sensitivity, previous therapy, clinical history, and the like.
  • the dosage may be adjusted at the discretion of the physician in charge.
  • the pharmaceutically effective amount may be administered at once or administered in two or more divided doses.
  • the liquid formulation can be administered once every 4 to 8 weeks over a period of 4 weeks or more at a dosage such that the anti-IL-23 antibody (e.g., guselkumab) is about 250 mg or less, about 200 mg, about 150 mg, about 100 mg, about 50 mg, about 25 mg, about 10 mg, or about 5 mg.
  • the anti-IL-23 antibody e.g., guselkumab
  • the above liquid formulation can be prepared as a general bulk formulation, and the components of the liquid formulation can be adjusted to a higher concentration than that required for administration and used after being suitably diluted before administration.
  • the liquid formulation of anti-IL-23 antibody according to one aspect can have excellent stability because it has self-buffering ability even without containing a buffer. Therefore, the liquid formulation can be usefully used as a medicament for treating IL-23-related conditions.
  • Figure 1 is a graph showing the results of evaluating the buffering capacity of the formulation according to the antibody concentration and the presence or absence of a buffer under acid (HCl) conditions.
  • Figure 2 is a graph showing the results of evaluating the buffering capacity of the formulation according to the antibody concentration and the presence or absence of a buffer under basic (NaOH) conditions.
  • Tremfya ® is a liquid formulation containing 100 mg/mL guselkumab, 11 mM histidine, 7.9% (w/v) sucrose, 0.05% (w/v) polysorbate 80, pH 5.8.
  • aqueous liquid formulation having the composition shown in Table 1 below was prepared using guselkumab (CAS No. 1350289-85-8) as an anti-IL-23 antibody.
  • * 4 is a formulation having the same antibody concentration, buffer, pH, stabilizer, and surfactant conditions as Tremfya ® .
  • the buffer capacity of the formulation manufactured in the above manufacturing example was evaluated.
  • the buffering capacity was evaluated by gradually adding a specific concentration of HCl or NaOH to the manufactured formulation, measuring the pH, and calculating the mole number of acid or base required for a pH change of 1 based on the derived results.
  • Table 2 shows the results of evaluating the buffering capacity of the formulation according to antibody concentration and the presence or absence of buffer.
  • Buffer capacity ( ⁇ ) Formulation No. Buffer Antibody concentration pH range 3.5-5.6 4.0-5.8 5.5-8.3 5.8-8.3 1 Buffer free 0 mg/mL 0.00014 N/A 0.00004 N/A 2 100 mg/mL N/A 0.00722 N/A 0.00390 3 11 mM histidine 0 mg/mL N/A 0.00224 N/A 0.00271 4 100 mg/mL N/A 0.00901 N/A 0.00556 5 150 mg/mL N/A 0.01478 N/A 0.00801 6 200 mg/mL N/A 0.02027 N/A 0.00939
  • Figure 1 is a graph showing the results of evaluating the buffering capacity of the formulation according to the antibody concentration and the presence or absence of a buffer under acid (HCl) conditions.
  • Figure 2 is a graph showing the results of evaluating the buffering capacity of the formulation according to the antibody concentration and the presence or absence of a buffer under basic (NaOH) conditions.
  • the buffer-free liquid formulation containing guselkumab had self-buffering ability.
  • formulations No. 2 and No. 4 manufactured in the above manufacturing examples were exposed to temperature stress conditions of 40°C or 25°C for 4 weeks, and then the pH and the degree of change therein ( ⁇ pH) over the storage time were confirmed.
  • the No. 2 and No. 4 formulations manufactured in the above manufacturing examples were subjected to freeze-thaw stress under 5 cycles of -70°C ⁇ 10°C freezing-thawing, and the pH and the degree of change ( ⁇ pH) before and after the 5 cycles were confirmed.
  • stirring stress was applied to formulations No. 2 and No. 4 manufactured in the above manufacturing examples under the condition of stirring at 400 rpm for 72 hours, and then the pH before and after stirring and the degree of change therein ( ⁇ pH) were confirmed.
  • Example 1 showed a buffering capacity of 70-80% of Formulation No. 4, the degree of change in pH under stress in Example 2 was shown to be similar to that of the Tremfya® formulation, which means that a buffering capacity of 70-80% is sufficient to maintain pH.

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Abstract

La présente invention concerne : une formulation liquide contenant un anticorps anti-IL-23 et ne contenant pas d'agent tampon ; un dispositif la contenant ; et son utilisation pour le traitement d'états liés à l'IL-23. La formulation liquide a une fonction de tamponnage spontané et ne contient pas d'agent tampon, et présente ainsi une excellente stabilité, et peut ainsi être utilisée utilement en tant que médicament pour le traitement d'états liés à l'IL-23.
PCT/KR2024/014798 2023-09-27 2024-09-27 Formulation liquide à tamponnage spontané d'un anticorps anti-il-23 Pending WO2025071366A1 (fr)

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KR20080031684A (ko) * 2005-06-14 2008-04-10 암젠 인코포레이티드 자가 - 완충성 단백질 제형
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US20210363234A1 (en) * 2020-05-21 2021-11-25 Janssen Biotech, Inc. Method of Treating Inflammatory Bowel Disease with a Combination Therapy of Antibodies to IL-23 and TNF Alpha

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