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Pharmaceutical formulations for inducing specific immunity against SARS-COV-2

A pharmaceutical preparation, a specific technology, applied in the fields of immunology, virology, and biotechnology, which can solve problems such as ineffectiveness of vaccines

Pending Publication Date: 2022-07-08
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] A great disadvantage of this solution is related to the fact that the vaccine may not be effective in some populations due to pre-existing immunity against human adenovirus type 5

Method used

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  • Pharmaceutical formulations for inducing specific immunity against SARS-COV-2
  • Pharmaceutical formulations for inducing specific immunity against SARS-COV-2
  • Pharmaceutical formulations for inducing specific immunity against SARS-COV-2

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0256] Preparation of expression vectors containing the genome of recombinant human adenovirus serotype 26.

[0257] In the first stage, the design of the plasmid construct pAd26-Ends was proposed. It carries two regions of homology to the genome of recombinant human adenovirus serotype 26 (two homology arms) and an ampicillin resistance gene. One of the homology arms is the start of the genome of recombinant human adenovirus serotype 26 (from the left inverted terminal repeat to the E1 region) and the viral genome sequence containing the pIX protein). The other homology arm contains the nucleotide sequence located after the ORF3 E4 region until the end of the genome. The synthesis of the pAd26-Ends construct was carried out by the Moscow company "Eurogen" ZAO (Moscow company "Eurogen" ZAO).

[0258] Human adenovirus serotype 26 DNA isolated from virions was mixed with pAd26-Ends. The plasmid pAd26-dlE1 carrying the genome of human adenovirus serotype 26 with the deleted E1...

example 2

[0271] An immunobiological preparation in the form of an expression vector was produced based on the genome of recombinant human adenovirus serotype 26, in which the E1 and E3 regions were deleted and the ORF6-Ad26 region was replaced by ORF6-Ad5, in which the group selected from SEQ ID NO: 1, SEQ ID NO: 1, SEQ ID NO: 1 was integrated. : 2. The expression cassette of SEQ ID NO: 3.

[0272] At this stage, the expression vector obtained in Example 1 was purified using anion exchange and size exclusion chromatography. The final suspension contains adenoviral particles in a buffered solution for liquid formulations of pharmaceutical formulations or in buffered solutions for lyophilized (lyophilized) formulations of pharmaceutical formulations.

[0273] Therefore, the following immunobiologics were generated based on the genome of recombinant human adenovirus serotype 26, in which the E1 and E3 regions were deleted and the ORF6-Ad26 region was replaced by ORF6-Ad5:

[0274] 1. An ...

example 3

[0282] Preparation of expression vectors containing the genome of recombinant simian adenovirus serotype 25.

[0283] In the first stage, the design of the plasmid construct pSim25-Ends was proposed. It carries two regions of genome homology to the simian adenovirus serotype 25 (two homology arms). One of the homology arms is the start of the genome of simian adenovirus serotype 25 (from the left inverted terminal repeat to the E1 region) and the sequence from the end of the E1 region to the pIVa2 protein. The other homology arm contains sequences at the end of the adenoviral genome, including the right inverted terminal repeat. The synthesis of the pSim25-Ends construct was carried out by the Moscow company "Eurogen" ZAO.

[0284] The DNA of simian adenovirus serotype 25 isolated from virions was mixed with pSim25-Ends. Through the process of homologous recombination between pSim25-Ends and viral DNA, plasmid pSim25-dlE1 was obtained, which carries the genome of simian ade...

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Abstract

The present invention relates to biotechnology. The claimed agents can be used for the prevention of SARS-CoV-2. A pharmaceutical formulation is created which contains a component (1) comprising an agent in the genomic form of a recombinant human adenovirus serotype (26) in which an expression cassette selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3 is placed, and which further contains a component (2) comprising an agent in the genomic form of a recombinant human adenovirus serotype (5) in which an expression cassette selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3 is placed. Furthermore, a pharmaceutical formulation is created which contains a component 1 comprising an agent in the genomic form of a recombinant human adenovirus serotype (26) in which an expression cassette selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3 is placed, and which further contains a component (2) comprising an agent in the genomic form of a recombinant simian adenovirus serotype (25) in which an expression cassette selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3 is placed, wherein an expression cassette selected from SEQ ID NO: 4, SEQ ID NO: 2 and SEQ ID NO: 3 is placed. Furthermore, a pharmaceutical formulation is created which contains component 1 comprising an agent in the genomic form of a recombinant simian adenovirus serotype (25) in which an expression cassette selected from the group consisting of SEQ ID NO: 4, SEQ ID NO: 2, SEQ ID NO: 3 is placed, and which further contains component (2) comprising an agent in the genomic form of a recombinant human adenovirus serotype (5) in which an expression cassette selected from the group consisting of SEQ ID NO: 4, SEQ ID NO: 2, SEQ ID NO: 3 is placed, wherein an expression cassette selected from SEQ ID NO: 1, SEQ ID NO: 2 and SEQ ID NO: 3 is placed.

Description

technical field [0001] The present invention relates to biotechnology, immunology and virology. The claimed agent can be used to prevent disease caused by the severe acute respiratory syndrome virus SARS-CoV-2. Background technique [0002] At the end of 2019, an outbreak of atypical pneumonia of unknown etiology broke out in Wuhan, the capital of Hubei Province (People's Republic of China). Studies conducted by researchers have shown that the outbreak is caused by a single-stranded RNA virus belonging to the family Coronaviridae, lineage B betacoronavirus (beta-CoVB). On February 11, 2020, the World Health Organization officially named the new virus SARS-CoV-2 and the disease it causes COVID-19 (“Coronavirus Disease 2019”). [0003] Within a few months, SARS-CoV-2 had spread around the world and became an epidemic affecting more than 200 countries. As of August 1, 2020, the number of cases exceeded 17,500,000 and the number of deaths was 683,000. [0004] Coronaviruses ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/215
CPCA61K39/215A61P31/14C12N7/00C12N15/86A61K39/12A61K2039/53C07K14/005C12N2710/10343C12N2770/20022C12N2770/20034A61K9/08A61K9/19A61K47/02A61K47/18A61K47/183A61K47/26C12N2710/10045A61K2039/575A61K47/10C12N2710/10371
Inventor O·V·祖布科娃T·A·奥扎罗夫斯凯亚I·V·多尔日科娃O·波波娃D·V·谢布利亚科夫D·M·格鲁索娃A·S·扎鲁拉耶娃A·I·图赫瓦图林N·M·图赫瓦图丽娜D·N·谢尔比宁I·B·埃斯马甘贝托夫E·A·托卡尔斯卡亚A·G·博季科夫A·S·埃罗克索瓦F·M·伊扎伊瓦A·S·赛米欣S·V·鲍里塞维奇B·S·纳罗季茨基D·Y·洛古诺夫A·L·金斯堡
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