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1. WO2021143572 - PREPARATION METHOD FOR PEGYLATED BIOMOLECULES HAVING CONTROLLABLE BINDING SITES

Publication Number WO/2021/143572
Publication Date 22.07.2021
International Application No. PCT/CN2021/070264
International Filing Date 05.01.2021
IPC
C07K 14/55 2006.1
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
14Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
435from animals; from humans
52Cytokines; Lymphokines; Interferons
54Interleukins (IL)
55IL-2
C07K 1/107 2006.1
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
1General processes for the preparation of peptides
107by chemical modification of precursor peptides
A61K 38/20 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
19Cytokines; Lymphokines; Interferons
20Interleukins
A61K 47/60 2017.1
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
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
51the non-active ingredient being a modifying agent
56the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
59obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
60the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61P 31/04 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
31Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
04Antibacterial agents
A61P 31/12 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
31Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
12Antivirals
CPC
A61K 38/20
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
19Cytokines; Lymphokines; Interferons
20Interleukins [IL]
A61K 47/60
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
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
51the non-active ingredient being a modifying agent
56the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
59obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
60the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61P 31/04
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
31Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
04Antibacterial agents
A61P 31/12
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
31Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
12Antivirals
A61P 35/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
A61P 37/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
37Drugs for immunological or allergic disorders
02Immunomodulators
Applicants
  • 天津键凯科技有限公司 JENKEM TECHNOLOGY CO., LTD. (TIANJIN) [CN]/[CN]
Inventors
  • 王庆彬 WANG, Qingbin
  • 齐杰 QI, Jie
  • 李玉 LI, Yu
Agents
  • 北京领科知识产权代理事务所(特殊普通合伙) BEIJING LINKTEC IP LAW FIRM (SPECIAL GENERAL PARTNERSHIP)
Priority Data
202010043172.215.01.2020CN
Publication Language Chinese (ZH)
Filing Language Chinese (ZH)
Designated States
Title
(EN) PREPARATION METHOD FOR PEGYLATED BIOMOLECULES HAVING CONTROLLABLE BINDING SITES
(FR) PROCÉDÉ DE PRÉPARATION DE BIOMOLÉCULES PEGYLÉES AYANT DES SITES DE LIAISON POUVANT ÊTRE CONTRÔLÉS
(ZH) 一种制备结合位点可控的PEG化生物分子的方法
Abstract
(EN)
Disclosed is a preparation method for PEGylated biomolecules having controllable binding sites, comprising the following steps: (1) PEGylating biomolecules; (2) binding a barrier to at least one binding site in the PEGylated biomolecules;(3) separating the PEGylated biomolecules that are not bound to the barrier; and (4) separating the PEGylated biomolecules bound to the barrier. Also disclosed is a preparation method for PEGylated IL-2 having a controllable binding site, comprising the following steps: (1) performing PEGylation to couple PEG and IL-2; (2) binding PEGylated IL-2 to an IL-2α receptor; (3) separating the PEGylated IL-2 that does not bind to the IL-2α receptor; and (4) separating the PEGylated IL-2 bound to the IL-2α receptor. By controlling the binding site of IL-2, only 1 or 2 PEGs are added during the PEGylation process.
(FR)
La présente invention concerne un procédé de préparation de biomolécules pegylées ayant des sites de liaison pouvant être contrôlés, comprenant les étapes suivantes : (1) la pégylation des biomolécules ; (2) la liaison d'une barrière à au moins un site de liaison dans les biomolécules pegylées ; (3) la séparation des biomolécules pegylées qui ne sont pas liées à la barrière ; et (4) la séparation des biomolécules pegylées liées à la barrière. L'invention concerne également un procédé de préparation d'IL-2 pegylée ayant un site de liaison pouvant être contrôlé, comprenant les étapes suivantes : (1) la réalisation de la pégylation pour coupler le PEG et l'IL-2 ; (2) la liaison de l'IL-2 pegylée à un récepteur IL-2α ; (3) la séparation de l'IL-2 pegylée qui ne se lie pas au récepteur IL-2α ; et (4) la séparation de l'IL-2 pegylée liée au récepteur IL-2α. En contrôlant le site de liaison de l'IL-2, seuls 1 ou 2 PEG sont ajoutés pendant le procédé de pégylation.
(ZH)
公开了一种制备结合位点可控的PEG化生物分子的方法,包括如下步骤:(1)PEG化生物分子;(2)阻隔物与PEG化生物分子中至少一个结合位点结合;(3)分离未与阻隔物结合的PEG化生物分子;(4)将阻隔物与之结合的PEG化生物分子分离。还公开了一种制备结合位点可控的PEG化IL-2的方法,包括如下步骤:(1)PEG化,PEG与IL-2偶联;(2)PEG化IL-2与IL-2α受体结合;(3)分离未与IL-2α受体结合的PEG化IL-2;(4)将IL-2α受体与之结合的PEG化IL-2分离。通过对IL-2的结合位点进行调控,PEG化过程中只添加1或2个PEG。
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