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1. WO2022253191 - TLR7 AGONIST CONJUGATED PEPTIDE-BASED NOVEL CORONAVIRUS NANOEMULSION VACCINE AND PREPARATION THEREOF

Publication Number WO/2022/253191
Publication Date 08.12.2022
International Application No. PCT/CN2022/096041
International Filing Date 30.05.2022
IPC
C07K 14/165 2006.1
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
14Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
005from viruses
08RNA viruses
165Coronaviridae, e.g. avian infectious bronchitis virus
A61K 39/215 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
12Viral antigens
215Coronaviridae, e.g. avian infectious bronchitis virus
A61K 39/39 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
39characterised by the immunostimulating additives, e.g. chemical adjuvants
A61K 47/55 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
54the modifying agent being an organic compound
55the modifying agent being also a pharmacologically or therapeutically active agent, i.e. the entire conjugate being a codrug, i.e. a dimer, oligomer or polymer of pharmacologically or therapeutically active compounds
A61K 47/65 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
62the modifying agent being a protein, peptide or polyamino acid
65Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
A61K 9/10 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
CPC
A61K 31/52
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495having six-membered rings with two ; or more; nitrogen atoms as the only ring heteroatoms, e.g. piperazine ; or tetrazines
505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
519ortho- or peri-condensed with heterocyclic rings
52Purines, e.g. adenine
A61K 39/215
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
12Viral antigens
215Coronaviridae, e.g. avian infectious bronchitis virus
A61K 39/385
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
385Haptens or antigens, bound to carriers
A61K 39/39
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
39characterised by the immunostimulating additives, e.g. chemical adjuvants
A61K 47/55
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
54the modifying agent being an organic compound
55the modifying agent being also a pharmacologically or therapeutically active agent, i.e. the entire conjugate being a codrug, i.e. a dimer, oligomer or polymer of pharmacologically or therapeutically active compounds
A61K 47/65
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
62the modifying agent being a protein, peptide or polyamino acid
65Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
Applicants
  • 中国科学院上海药物研究所 SHANGHAI INSTITUTE OF MATERIA MEDICA, CHINESE ACADEMY OF SCIENCES [CN]/[CN]
  • 深圳大学 SHENZHEN UNIVERSITY [CN]/[CN]
Inventors
  • 张馨欣 ZHANG, Xinxin
  • 宫丽崑 GONG, Likun
  • 任进 REN, Jin
  • 靳广毅 JIN, Guangyi
  • 黄蔚 HUANG, Wei
  • 甘勇 GAN, Yong
  • 孙建华 SUN, Jianhua
  • 刘婷婷 LIU, Tingting
  • 龙益如 LONG, Yiru
  • 缪云秋 MIAO, Yunqiu
  • 秦秋平 QIN, Qiuping
  • 唐峰 TANG, Feng
  • 余盼 YU, Pan
  • 郭琳苗 GUO, Linmiao
Agents
  • 上海一平知识产权代理有限公司 XU&PARTNERS, LLC.
Priority Data
202110596120.230.05.2021CN
Publication Language Chinese (zh)
Filing Language Chinese (ZH)
Designated States
Title
(EN) TLR7 AGONIST CONJUGATED PEPTIDE-BASED NOVEL CORONAVIRUS NANOEMULSION VACCINE AND PREPARATION THEREOF
(FR) VACCIN SOUS FORME DE NANOÉMULSION CONTRE LE NOUVEAU CORONAVIRUS À BASE D'UN PEPTIDE CONJUGUÉ AGONISTE DE TLR7 ET SA PRÉPARATION
(ZH) 一种基于TLR7激动剂偶联肽的新型冠状病毒纳米乳疫苗及其制备
Abstract
(EN) The present invention relates to a novel coronavirus vaccine using a TLR7 agonist conjugated peptide as an antigen and an emulsion as an adjuvant. An antigen polypeptide of the conjugated peptide is a polypeptide derived from an S protein of SARS-CoV-2, and the adjuvant is an oil-in-water nanoemulsion containing squalene. The conjugated peptide nanoemulsion vaccine preparation of the present invention is thermally stable, and can induce a high level of protective humoral immune response in a cynomolgus monkey, and the neutralizing antibody titer of antiserum after immunization of cynomolgus monkey is high, such that invasion of wild-type strain and mutant novel coronavirus can be blocked. The vaccine of the present invention has a nearly complete protection effect on the upper and lower respiratory tracts of the cynomolgus monkey in a cynomolgus monkey SARS-CoV-2 challenge test. The nanoemulsion vaccine of the present invention is fast and convenient to prepare, and can realize large-scale production in a short term for coping with the novel coronavirus outbreak.
(FR) La présente invention concerne un vaccin contre le nouveau coronavirus utilisant un peptide conjugué agoniste de TLR7 en tant qu'antigène et une émulsion en tant qu'adjuvant. Un polypeptide antigénique du peptide conjugué est un polypeptide dérivé d'une protéine S du SARS-CoV-2, et l'adjuvant est une nanoémulsion huile dans l'eau contenant du squalène. La préparation vaccinale sous forme de nanoémulsion à base de peptide conjugué de la présente invention est thermiquement stable et peut induire un niveau élevé de réponse immunitaire humorale protectrice chez un singe cynomolgus, et le titre d'anticorps neutralisants d'antisérum après l'immunisation du singe cynomolgus est élevé de sorte que l'invasion de la souche de type sauvage et du nouveau coronavirus mutant peut être bloquée. Le vaccin de la présente invention a un effet de protection presque complet sur les voies respiratoires supérieures et inférieures du singe cynomolgus lors d'un test de provocation du SARS-CoV -2 chez le singe cynomolgus. Le vaccin sous forme de nanoémulsion de la présente invention est rapide et pratique à préparer, et peut permettre une production à grande échelle à court terme pour faire face à l'épidémie du nouveau coronavirus.
(ZH) 本发明涉及一种以TLR7激动剂偶联肽为抗原,乳剂为佐剂的新型冠状病毒疫苗。其中,所述偶联肽的抗原多肽是衍生自冠状病毒SARS-CoV-2的S蛋白的多肽,所述佐剂为含有角鲨烯的水包油型纳米乳剂。本发明的偶联肽纳米乳疫苗制剂具有热稳定性,在食蟹猴中可以引发高水平的保护性体液免疫反应,食蟹猴免疫后抗血清的中和抗体滴度高,可阻断野毒株和突变株新型冠状病毒入侵。在食蟹猴SARS-CoV-2攻毒试验中,本发明的疫苗对食蟹猴上下呼吸道均具有接近完全的保护作用。本发明的纳米乳疫苗制备快速简便,可在短期内实现规模生产用于应对新型冠状病毒突发疫情。
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