US 2025/0049912 A1Published application

Multicistronic Vaccine and Methods for Producing and Using the Same

AssigneeOcugen, Inc.

InventorsArun Kumar Upadhyay, Farokh Jal Dotiwala, Dinesh Kumar Singh, Ilayaraja Muthuramu

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Abstract

The present disclosure provides multicistronic vaccines and method for producing and using the same in preventing infection or transmission, or reducing severity of disease caused by influenza and/or SARS-Cov-2 virus in a subject. Multicistronic vaccines of the disclosure can be administered via intramuscular, intranasal, or inhalation route. In one particular embodiments, the disclosure provides a recombinant adenovirus comprising at least two different extraneous oligonucleotides that are capable of stimulating an immune response in a subject. Each of the oligonucleotide independently comprises an oligonucleotide that encodes either influenza or SARS-Cov-2 virus antigens.

Claims20

Dependent claims

A recombinant adenovirus adapted for use in preventing infection or transmission, or reducing severity of disease caused by influenza and/or SARS-Cov-2 virus in a subject, said recombinant adenovirus comprising an oligonucleotide that encodes an immune response stimulating antigen in the subject, wherein said recombinant adenovirus comprises at least two different oligonucleotides, wherein each of said oligonucleotide is selected from the group consisting of:

(i) an oligonucleotide that encodes a hemagglutinin of influenza A virus or an immunogenic portion, variant, mutant, or fragment thereof;
(ii) an oligonucleotide that encodes a neuraminidase of influenza A virus or an immunogenic portion, variant, mutant, or fragment thereof;
(iii) an oligonucleotide that encodes a hemagglutinin of a first influenza B virus or an immunogenic portion, variant, mutant, or fragment thereof;
(iv) an oligonucleotide that encodes a hemagglutinin of a second influenza B virus or an immunogenic portion, variant, mutant, or fragment thereof, wherein said second influenza B virus is a different strain compared to said first influenza B virus;
(v) an oligonucleotide that encodes a spike(S) protein or an immunogenic portion, variant, mutant, or fragment thereof of a first SARS-COV-2 virus;
and
(vi) an oligonucleotide that encodes an S protein or an immunogenic portion, variant, mutant, or fragment thereof of a second SARS-COV-2 virus, wherein said second SARS-COV-2 virus is a different strain compared to said first SARS-COV-2 virus;
and wherein an adenovirus of said recombinant adenovirus is selected from the group consisting of:
(i) a first, second, or third-generation human adenovirus 5;
(ii) a rare-serotype adenovirus;
(iii) a nonhuman adenovirus;
and
(iv) a combination thereof.

10 more elements

A plasmid comprising a genome of an adenovirus, wherein said genome of the adenovirus has been modified such that said genome comprises a transgene that is operatively linked to expression control sequences which direct transcription, translation, and/or expression in a host cell, and wherein said transgene comprises at least two different oligonucleotides, wherein each of said oligonucleotide is independently selected from the group consisting of:

(i) an oligonucleotide that encodes a hemagglutinin of influenza A virus or an immunogenic portion, variant, mutant, or fragment thereof;
(ii) an oligonucleotide that encodes a neuraminidase of influenza A virus or an immunogenic portion, variant, mutant, or fragment thereof;
(iii) an oligonucleotide that encodes a hemagglutinin of a first influenza B virus or an immunogenic portion, variant, mutant, or fragment thereof;
(iv) an oligonucleotide that encodes a hemagglutinin of a second influenza B virus or an immunogenic portion, variant, mutant, or fragment thereof, wherein said second influenza B virus is a different strain than said first influenza B virus;
(v) an oligonucleotide that encodes a spike protein (S-protein) or an immunogenic portion, variant, mutant, or fragment thereof of a first SARS-COV-2 virus;
and
(vi) an oligonucleotide that encodes an S-protein or an immunogenic portion, variant, mutant, or fragment thereof of a second SARS-COV-2 virus, wherein said second SARS-COV-2 virus is a different strain than said first SARS-COV-2 virus.

4 more elements

A method for reducing or preventing an incidence of or reducing a severity of influenza virus infection, SARS-COV-2 virus infection, or a combination thereof in a subject, said method comprising administering a therapeutically effective amount of a polycistronic vaccine to the subject, wherein said polycistronic vaccine comprises a recombinant adenovirus (rAd) vector or a pharmaceutical composition comprising said rAd vector, wherein said rAd vector comprises a genome of an adenovirus that has been modified such that said genome comprises (i) a first extraneous oligonucleotide encoding at least one immune response stimulating antigen of an influenza virus and (ii) a second extraneous oligonucleotide encoding at least one immune response stimulating antigen of a SARS-COV-2 virus.

Dependencies are inferred from the claim text.

Facts

Application: 18/586,220Filed 23 Feb 2024
Priority: 23 Feb 2023
Published: 13 Feb 2025
Term ends: Not estimatedThe source records don’t support an estimate.

Classification19 codes

A61K 39/295
Viral antigens: polyvalent viral antigens ; Mixtures of viral and bacterial antigens
C07K 14/005
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof: from viruses
A61K 39/12
Medicinal preparations containing antigens or antibodies: viral antigens
A61K 39/145
Viral antigens: orthomyxoviridae, e.g. influenza virus

Family

Application63/447,734Us provisional application · filed 23 Feb 2023
US 2025/0049912 A1This patent

From the US filing history. Foreign family members aren’t listed.

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