Immunogenic compositions

Patent metadata

Field	Value
Publication number	US-2024181038-A1
Application number	US-202218283632-A
Country	US
Kind code	A1
Filing date	Mar 25, 2022
Priority date	Mar 26, 2021
Publication date	Jun 6, 2024
Grant date	—

Abstract

The present invention relates to a carrier-formulated mRNA comprising at least one coding sequence encoding an influenza HA stem polypeptide, and to related aspects.

First claim

1 - 94 . (canceled)

95 . A carrier-formulated mRNA comprising at least one coding sequence encoding an influenza HA stem polypeptide.

96 . The carrier-formulated mRNA according to claim 95 , wherein the carrier is a lipid nanoparticle (LNP).

97 . The carrier-formulated mRNA according to claim 96 , wherein the LNP comprise a PEG-modified lipid, a non-cationic lipid, a sterol, and a non-ionisable cationic lipid.

98 . The carrier-formulated mRNA according to claim 96 , wherein the LNP comprise a PEG-modified lipid, a non-cationic lipid, a sterol, and an ionisable cationic lipid.

99 . The carrier-formulated mRNA according to claim 95 , wherein the mRNA comprises at least one additional coding sequence which encodes a protein nanoparticle, and wherein the protein nanoparticle is ferritin.

100 . The carrier-formulated mRNA according to claim 99 , wherein the ferritin is insect ferritin.

101 . The carrier-formulated mRNA according to claim 95 , wherein the influenza HA stem polypeptide is derived from influenza A Group 1, or influenza A Group 2.

102 . The carrier-formulated mRNA according to claim 101 , wherein influenza A Group 1 comprises:
(i) subtype H1, H2, H5, H6, H8, H9, H11, H12, H13, H16, H17 or H18; or (ii) subtype H1.

103 . The carrier-formulated mRNA according to claim 101 , wherein influenza A Group 2 comprises:
(i) subtype H3, H4, H7, H10, H14 or H15; (ii) H3 or H10; or (iii) H10.

104 . The carrier-formulated mRNA according to claim 95 , wherein the influenza HA stem polypeptide is 130 to 400 residues in length, 160 to 300 in length, 180 to 250 in length, or 190 to 220 in length.

105 . The carrier-formulated mRNA according to claim 95 , comprising two or more coding sequences each encoding an influenza HA stem polypeptide, wherein the coding sequences are encoded on the same mRNA molecule.

106 . The carrier-formulated mRNA according to claim 105 , wherein the two or more coding sequences encode different influenza HA stem polypeptides.

107 . The carrier-formulated mRNA according to claim 105 , wherein the two or more coding sequences that encode influenza HA stem polypeptides are derived from influenza A Group 1 and/or influenza A Group 2.

108 . The carrier-formulated mRNA according to claim 106 , wherein the two or more coding sequences that encode influenza HA stem polypeptides are derived from influenza A Group 1 and/or influenza A Group 2.

109 . The carrier-formulated mRNA according to claim 107 , wherein at least one of the two or more coding sequence that encodes an influenza HA stem polypeptide derived from influenza A Group 1 and influenza A Group 2.

110 . The carrier-formulated mRNA according to claim 109 , wherein influenza A Group 1 comprises:
(i) subtype H1, H2, H5, H6, H8, H9, H11, H12, H13, H16, H17 and/or H18; or (ii) subtype H1.

111 . The carrier-formulated mRNA according to claim 109 , wherein influenza A Group 2 comprises:
(i) subtype H3, H4, H7, H10, H14 and/or H15; (ii) H3 or H10; or (iii) H10.

112 . The carrier-formulated mRNA according to claim 109 , wherein at least one of said two or more coding sequence that encodes an influenza HA stem polypeptide derived influenza A subtype H1 and at least one of said two or more coding sequence that encodes an influenza HA stem polypeptide derived from influenza A subtype H10.

113 . The carrier-formulated mRNA according to claim 95 , wherein the mRNA comprises at least one chemical modification selected from pseudouridine, N1-methylpseudouridine, N1-ethylpseudouridine, 2-thiouridine, 4′-thiouridine, 5-methylcytosine, 5-methyluridine, 2-thio-1-methyl-1-deaza-pseudouridine, 2-thio-1-methyl-pseudouridine, 2-thio-5-aza-uridine, 2-thio-dihydropseudouridine, 2-thio-dihydrouridine, 2-thio-pseudouridine, 4-methoxy-2-thio-pseudouridine, 4-methoxy-pseudouridine, 4-thio-1-methyl-pseudouridine, 4-thio-pseudouridine, 5-aza-uridine, dihydropseudouridine, 5-methoxyuridine and 2′-O-methyl uridine.

114 . The carrier-formulated mRNA, according to claim 95 , wherein the mRNA is self-replicating.

115 . An immunogenic composition comprising the carrier-formulated mRNA according to claim 95 , wherein the composition comprises at least one pharmaceutically acceptable carrier.

116 . A vaccine comprising the mRNA of claim 95 and/or the immunogenic composition of claim 15 .

117 . A kit or kit of parts comprising the RNA of claim 95 , and/or the composition of claim 115 , and/or the vaccine of claim 116 .

118 . A method of treating or preventing a disorder, wherein the method comprises applying or administering to a subject in need thereof the carrier-formulated mRNA of claim 95 , the composition of claim 115 , the vaccine of claim 116 , or the kit or kit of parts of claim 117 .

119 . A method of eliciting an immune response, wherein the method comprises applying or administering to a subject in need thereof the carrier-formulated mRNA of claim 95 , the composition of claim 115 , the vaccine of claim 116 , or the kit or kit of parts of claim 117 .

Assignees

• Glaxosmithkline Biologicals Sa
• Us Secretary Department Of Health And Human Services

Inventors

• Vassilev Ventzislav Bojidarov
• Mallett Corey
• Rouxel Ronan
• Blais Normand
• Kanekiyo Masaru
• Graham Barney S

Classifications

• A61K39/145 Primary

  Orthomyxoviridae, e.g. influenza virus · CPC title

• A61K39/385

  Haptens or antigens, bound to carriers · CPC title

• A61P31/16 Primary

  for influenza or rhinoviruses · CPC title

• C07K14/005

  from viruses · CPC title

• A61K2039/53

  DNA (RNA) vaccination · CPC title