JPWO2021163438A5 - - Google Patents
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- JPWO2021163438A5 JPWO2021163438A5 JP2022548783A JP2022548783A JPWO2021163438A5 JP WO2021163438 A5 JPWO2021163438 A5 JP WO2021163438A5 JP 2022548783 A JP2022548783 A JP 2022548783A JP 2022548783 A JP2022548783 A JP 2022548783A JP WO2021163438 A5 JPWO2021163438 A5 JP WO2021163438A5
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- 125000003275 alpha amino acid group Chemical group 0.000 claims 62
- 102000004169 proteins and genes Human genes 0.000 claims 47
- 108090000623 proteins and genes Proteins 0.000 claims 47
- 239000002105 nanoparticle Substances 0.000 claims 26
- 229920001184 polypeptide Polymers 0.000 claims 23
- 102000004196 processed proteins & peptides Human genes 0.000 claims 23
- 108090000765 processed proteins & peptides Proteins 0.000 claims 23
- 108020004707 nucleic acids Proteins 0.000 claims 17
- 102000039446 nucleic acids Human genes 0.000 claims 17
- 150000007523 nucleic acids Chemical class 0.000 claims 17
- 239000000203 mixture Substances 0.000 claims 10
- 241001678559 COVID-19 virus Species 0.000 claims 8
- 239000013604 expression vector Substances 0.000 claims 8
- 239000008194 pharmaceutical composition Substances 0.000 claims 8
- 229960005486 vaccine Drugs 0.000 claims 8
- 230000035772 mutation Effects 0.000 claims 7
- 108020004999 messenger RNA Proteins 0.000 claims 5
- 102220214846 rs1060503566 Human genes 0.000 claims 5
- 102220599406 Spindlin-1_N501Y_mutation Human genes 0.000 claims 4
- 102200018026 c.469G>A Human genes 0.000 claims 4
- 230000028993 immune response Effects 0.000 claims 4
- 102200128238 rs201124247 Human genes 0.000 claims 4
- 102200115309 rs267607160 Human genes 0.000 claims 4
- 241000701161 unidentified adenovirus Species 0.000 claims 4
- 229940126580 vector vaccine Drugs 0.000 claims 4
- 102220590628 Spindlin-1_L18F_mutation Human genes 0.000 claims 3
- 239000000427 antigen Substances 0.000 claims 3
- 102000036639 antigens Human genes 0.000 claims 3
- 108091007433 antigens Proteins 0.000 claims 3
- 102220472614 Endothelin-1_K90T_mutation Human genes 0.000 claims 2
- 102220590324 Spindlin-1_D80A_mutation Human genes 0.000 claims 2
- 102220599656 Spindlin-1_E484K_mutation Human genes 0.000 claims 2
- 102220590604 Spindlin-1_K417N_mutation Human genes 0.000 claims 2
- 102220590625 Spindlin-1_P26S_mutation Human genes 0.000 claims 2
- 102220590630 Spindlin-1_T20N_mutation Human genes 0.000 claims 2
- 102220510809 Toll-like receptor 3_P681H_mutation Human genes 0.000 claims 2
- 230000037430 deletion Effects 0.000 claims 2
- 238000012217 deletion Methods 0.000 claims 2
- 230000002163 immunogen Effects 0.000 claims 2
- 208000015181 infectious disease Diseases 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 102200144284 rs235768 Human genes 0.000 claims 2
- 102220075059 rs529697285 Human genes 0.000 claims 2
- 102220033185 rs62646881 Human genes 0.000 claims 2
- 102220058675 rs786203529 Human genes 0.000 claims 2
- 102220579649 ATP-dependent RNA helicase A_K417N_mutation Human genes 0.000 claims 1
- 208000025721 COVID-19 Diseases 0.000 claims 1
- 208000035473 Communicable disease Diseases 0.000 claims 1
- 241000494545 Cordyline virus 2 Species 0.000 claims 1
- 102220543270 Eukaryotic peptide chain release factor GTP-binding subunit ERF3A_Y453F_mutation Human genes 0.000 claims 1
- 241000315672 SARS coronavirus Species 0.000 claims 1
- 208000037847 SARS-CoV-2-infection Diseases 0.000 claims 1
- 201000003176 Severe Acute Respiratory Syndrome Diseases 0.000 claims 1
- 101000629318 Severe acute respiratory syndrome coronavirus 2 Spike glycoprotein Proteins 0.000 claims 1
- 102220599612 Spindlin-1_A701V_mutation Human genes 0.000 claims 1
- 102220599673 Spindlin-1_H655Y_mutation Human genes 0.000 claims 1
- 102220599422 Spindlin-1_L452R_mutation Human genes 0.000 claims 1
- 241000700605 Viruses Species 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 claims 1
- 230000000712 assembly Effects 0.000 claims 1
- 238000000429 assembly Methods 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000003472 neutralizing effect Effects 0.000 claims 1
- 102000005962 receptors Human genes 0.000 claims 1
- 108020003175 receptors Proteins 0.000 claims 1
- 230000000241 respiratory effect Effects 0.000 claims 1
- 230000004044 response Effects 0.000 claims 1
- 102200059660 rs104894317 Human genes 0.000 claims 1
- 102200056390 rs12204826 Human genes 0.000 claims 1
- 102220277108 rs1553412687 Human genes 0.000 claims 1
- 102220237612 rs1554688023 Human genes 0.000 claims 1
- 102220053106 rs199537178 Human genes 0.000 claims 1
- 102220045931 rs587782500 Human genes 0.000 claims 1
- 102220114694 rs763810935 Human genes 0.000 claims 1
- 102220029076 rs78775072 Human genes 0.000 claims 1
- 239000013638 trimer Substances 0.000 claims 1
- 230000009385 viral infection Effects 0.000 claims 1
Claims (17)
（ｂ）配列番号１～８、又は
（ｃ）配列番号１～４、又は
（ｄ）配列番号５～８、又は
（ｅ）配列番号１及び５、又は
（ｆ）配列番号１、又は
（ｇ）配列番号５
からなる群から選択されるアミノ酸配列を含む、請求項１に記載のポリペプチド。 (a) SEQ ID NOs: 1-12 and 142-151 , or
(b) SEQ ID NOs: 1 to 8, or
(c) SEQ ID NO: 1 to 4, or
(d) SEQ ID NOs: 5 to 8, or
(e) SEQ ID NOs: 1 and 5, or
(f) SEQ ID NO: 1, or
(g) Sequence number 5
2. The polypeptide of claim 1, comprising an amino acid sequence selected from the group consisting of.
（ＩＩ）（ａ） 複数の第１の集合体であって、各第１の集合体は複数の同一の第１のタンパク質を含む、複数の第１の集合体と、
（ｂ） 複数の第２の集合体であって、各第２の集合体は複数の第２のタンパク質を含む、複数の第２の集合体と、を含むナノ粒子であって、
前記第１のタンパク質の前記アミノ酸配列は、前記第２のタンパク質の前記配列とは異なり、
前記複数の第１の集合体は、前記複数の第２の集合体と非共有結合的に相互作用して、前記ナノ粒子を形成し、
前記ナノ粒子は、その表面上に、前記少なくとも１つの第２のタンパク質に存在するＳＡＲＳ－ＣｏＶ－２抗原又はそのバリアント若しくはホモログの免疫原性部分を提示し、任意選択で、
前記第２のタンパク質が、配列番号８５～１２４又は１８５～１９３からなる群から選択されるアミノ酸配列と少なくとも９５％、少なくとも９６％、少なくとも９７％、少なくとも９８％、少なくとも９９％、又は少なくとも１００％同一であるアミノ酸配列を含み、少なくとも１つの第２のタンパク質のＸ１は、ＳＡＲＳ－ＣｏＶ－２抗原又はそのバリアント若しくはホモログの免疫原性部分を含み、Ｘ２は存在しないか、又はアミノ酸リンカーであり、括弧内の残基は任意選択であり、任意選択で、
前記第２のタンパク質が、配列番号８５～８８からなる群から選択されるアミノ酸配列を含む、又は、
前記第２のタンパク質が、配列番号８５～８６からなる群から選択されるアミノ酸配列を含む、又は、
前記第２のタンパク質が、配列番号８５のアミノ酸配列を含む、ナノ粒子。 (I) Nanoparticles comprising a plurality of polypeptides according to any one of claims 1 to 2 , or
(II) (a) a plurality of first aggregates, each first aggregate comprising a plurality of identical first proteins;
(b) a nanoparticle comprising a plurality of second aggregates, each second aggregate comprising a plurality of second proteins;
The amino acid sequence of the first protein is different from the sequence of the second protein,
the plurality of first aggregates non-covalently interacting with the plurality of second aggregates to form the nanoparticles;
Said nanoparticle displays on its surface an immunogenic portion of the SARS-CoV-2 antigen or a variant or homolog thereof present on said at least one second protein , and optionally,
the second protein has at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or at least 100% an amino acid sequence selected from the group consisting of SEQ ID NOs: 85-124 or 185-193. X1 of the at least one second protein comprises an immunogenic portion of the SARS-CoV-2 antigen or a variant or homolog thereof, and X2 is absent or is an amino acid linker, and Residues in parentheses are optional;
the second protein comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 85-88, or
the second protein comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 85-86, or
A nanoparticle , wherein the second protein comprises the amino acid sequence of SEQ ID NO: 85.
（ＩＩ）前記第２のタンパク質の少なくとも２０％、３０％、４０％、５０％、６０％、７０％、８０％、９０％、又は１００％のＸ１が、配列番号１２５～１３７からなる群から選択されるアミノ酸配列と少なくとも７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％、又は１００％同一性を有するアミノ酸配列を含む、
（ＩＩＩ）前記第２のタンパク質の少なくとも２０％、３０％、４０％、５０％、６０％、７０％、８０％、９０％、又は１００％のＸ１が、配列番号１２５のアミノ酸配列と少なくとも７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％、又は１００％同一性を有するアミノ酸配列を含み、任意選択で、
（ａ） 前記第２のタンパク質の少なくとも２０％、３０％、４０％、５０％、６０％、７０％、８０％、９０％、又は１００％のＸ１が、Ｋ９０Ｎ、Ｋ９０Ｔ、Ｇ１１９Ｓ、Ｙ１２６Ｆ、Ｔ１５１Ｉ、Ｅ１５７Ｋ、Ｅ１５７Ａ、Ｓ１６７Ｐ、Ｎ１７４Ｙ、及びＬ１２５Ｒからなる群から選択される配列番号１２５に対して、１、２、３、４、５、６、７、又は８つの位置全てにおいて変異を含み、以下の自然に発生する変異又は変異の組合わせ、
Ｎ１７４Ｙ（ＵＫバリアント）；
Ｋ９０Ｎ／Ｅ１５７Ｋ／Ｎ１７４Ｙ（南アフリカバリアント）；
Ｋ９０Ｎ又はＴ／Ｅ１５７Ｋ／Ｎ１７４Ｙ（ブラジルバリアント）；又は
Ｌ１２５Ｒ（ＬＡバリアント）、のうちの１つを含む変異を含むが、これらに限定されず、
（ｂ） 前記第２のタンパク質の少なくとも２０％、３０％、４０％、５０％、６０％、７０％、８０％、９０％、又は１００％におけるＸ１が、Ｌ１８Ｆ、Ｔ２０Ｎ、Ｐ２６Ｓ、残基６９～７０の欠失、Ｄ８０Ａ、Ｄ１３８Ｙ、Ｒ１９０Ｓ、Ｄ２１５Ｇ、Ｋ４１７Ｎ、Ｋ４１７Ｔ、Ｇ４４６Ｓ、Ｌ４５２Ｒ、Ｙ４５３Ｆ、Ｔ４７８Ｉ、Ｅ４８４Ｋ、Ｓ４９４Ｐ、Ｎ５０１Ｙ、Ａ５７０Ｄ、Ｄ６１４Ｇ、Ｈ６５５Ｙ、Ｐ６８１Ｈ、Ａ７０１Ｖ、Ｔ７１６Ｌからなる群から選択される配列番号１３０に対して、１、２、３、４、５、６、７、又は８つの位置全てにおいて変異を含み、以下の天然に存在する変異又は変異の組合わせ、
場合により、１、２、３、４、又は５個の、残基６９～７０の１つ又は両方の欠失、Ａ５７０Ｄ、Ｄ６１４Ｇ、Ｐ６８１Ｈ、及び／又はＴ７１６Ｌを更に含むＮ５０１Ｙ（ＵＫバリアント）；
Ｌ１８Ｆ、Ｄ８０Ａ、Ｄ２１５Ｇ、Ｄ６１４Ｇ、及び／又はＡ７０１Ｖの１、２、３、４、又は５個を任意に更に含むＫ４１７Ｎ／Ｅ４８４Ｋ／Ｎ５０１Ｙ（南アフリカバリアント）；
Ｌ１８Ｆ、Ｔ２０Ｎ、Ｐ２６Ｓ、Ｄ１３８Ｙ、Ｒ１９０Ｓ、Ｄ６１４Ｇ、及び／又はＨ６５５Ｙの１、２、３、４、又は５個を任意に更に含む、Ｋ４１７Ｎ又はＴ／Ｅ４８４Ｋ／Ｎ５０１Ｙ（ブラジル変異体）；又は
Ｌ４５２Ｒ（ＬＡバリアント）のうちの１つを含む変異を含むが、これらに限定されない、又は、
前記第２のタンパク質の少なくとも２０％、３０％、４０％、５０％、６０％、７０％、８０％、９０％、又は１００％のＸ１が、Ｋ９０Ｎ、Ｋ９０Ｔ、Ｅ１５７Ｋ、及びＮ１７４Ｙからなる群から選択される、配列番号１２５に対する、１、２、３、又は４つ全ての変異を含む、
（ＩＶ）前記第２のタンパク質の少なくとも２０％、３０％、４０％、５０％、６０％、７０％、８０％、９０％、又は１００％のＸ１が、配列番号１２５のアミノ酸配列を含む、又は、
（Ｖ）前記第２のタンパク質の１００％におけるＸ１が配列番号１２５のアミノ酸配列を含み、全ての第２のタンパク質が同一である、請求項３に記載のナノ粒子。 (I) at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of X1 of the second protein is derived from SARS-CoV-2; (S) For protein extracellular domain (ECD) amino acid sequence, S1 subunit amino acid sequence, S2 subunit amino acid sequence, S1 receptor binding domain (RBD) amino acid sequence, and/or N-terminal domain (NTD) amino acid sequence , at least 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% amino acid sequence identity. or a variant or homologue thereof ,
(II) at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of X1 of the second protein is from the group consisting of SEQ ID NOs: 125-137; At least 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identical to the selected amino acid sequence containing an amino acid sequence with a
(III) At least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of X1 of the second protein has an amino acid sequence of SEQ ID NO: 125 and at least 75 %, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% , 99%, or 100% identity. , optionally,
(a) at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of X1 of the second protein is K90N, K90T, G119S, Y126F, T151I , E157K, E157A, S167P, N174Y, and L125R with mutations at all 1, 2, 3, 4, 5, 6, 7, or 8 positions, and naturally occurring mutations or combinations of mutations;
N174Y (UK variant);
K90N/E157K/N174Y (South African variant);
K90N or T/E157K/N174Y (Brazil variant); or L125R (LA variant);
(b) X1 in at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of the second protein is L18F, T20N, P26S, residue 69 ~70 deletions, selected from the group consisting of D80A, D138Y, R190S, D215G, K417N, K417T, G446S, L452R, Y453F, T478I, E484K, S494P, N501Y, A570D, D614G, H655Y, P681H, A701V, T716L be done 1, 2, 3, 4, 5, 6, 7, or all 8 positions relative to SEQ ID NO: 130, the following naturally occurring mutations or combinations of mutations:
N501Y (UK variant) optionally further comprising 1, 2, 3, 4, or 5 deletions of one or both of residues 69-70, A570D, D614G, P681H, and/or T716L;
K417N/E484K/N501Y (South African variant) optionally further comprising 1, 2, 3, 4, or 5 of L18F, D80A, D215G, D614G, and/or A701V;
K417N or T/E484K/N501Y (Brazil variant), optionally further comprising 1, 2, 3, 4, or 5 of L18F, T20N, P26S, D138Y, R190S, D614G, and/or H655Y; or L452R ( including, but not limited to, mutations comprising one of the following:
At least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of X1 of the second protein is from the group consisting of K90N, K90T, E157K, and N174Y. 1, 2, 3, or all 4 mutations relative to SEQ ID NO: 125 , selected
(IV) at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of X1 of the second protein comprises the amino acid sequence of SEQ ID NO: 125; Or
4. The nanoparticle of claim 3 , wherein (V) X1 in 100% of the second proteins comprises the amino acid sequence of SEQ ID NO: 125, and all second proteins are identical.
前記複数の第２の集合体が、請求項１～２のいずれか一項に記載のポリペプチドのアミノ酸配列を含む合計で２、３、４、５、６、７、８、又はそれを超えるポリペプチドを含み、任意選択で、
全ての第２の集合体が、請求項１～２のいずれか一項に記載のポリペプチドのアミノ酸配列を含む少なくとも１つの第２のタンパク質を含み、任意選択で、
全ての第２のタンパク質が、請求項１～２のいずれか一項に記載のポリペプチドのアミノ酸配列を含む、請求項３～４のいずれか一項に記載のナノ粒子。 said plurality of second populations comprises a total of 2, 3, 4, 5, 6, 7, 8, or more different SARS-CoV-2 antigens, and/or
The plurality of second aggregates comprises a total of 2, 3, 4, 5, 6, 7, 8, or more amino acid sequences of the polypeptide according to any one of claims 1 to 2 . comprising a polypeptide, optionally;
Every second population comprises at least one second protein comprising the amino acid sequence of a polypeptide according to any one of claims 1-2 , optionally comprising:
Nanoparticles according to any one of claims 3 to 4 , wherein all the second proteins contain the amino acid sequence of the polypeptide according to any one of claims 1 to 2 .
（ＩＩ）前記第１のタンパク質が、配列番号１５２～１５９からなる群から選択されるアミノ酸配列と少なくとも８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％、又は１００％同一であるアミノ酸配列を含む、請求項３～５のいずれか一項に記載のナノ粒子。 (I) the first protein has at least 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94% of the amino acid sequence selected from the group consisting of SEQ ID NOs: 152-159; Contains 95%, 96%, 97%, 98%, 99%, or 100% identical amino acid sequences, where the residues in parentheses are optional, may be present, or are part of any of the foregoing residues. or all may be absent, or
(II) the first protein has at least 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96% of the amino acid sequence selected from the group consisting of SEQ ID NOs: 152-159; Nanoparticles according to any one of claims 3 to 5 , comprising amino acid sequences that are 97%, 98%, 99% or 100% identical.
前記少なくとも１つの第２の集合体が、配列番号８５～８８からなる群から選択されるアミノ酸配列を含む少なくとも１つの第２のタンパク質を含み、任意選択で、
全ての第２の集合体が、配列番号８５～８８からなる群から選択されるアミノ酸配列を含む少なくとも１つの第２のタンパク質を含む、又は、
全ての第２のタンパク質が、配列番号８５～８８からなる群から選択されるアミノ酸配列を含む、請求項３～６のいずれか一項に記載のナノ粒子。 The first protein comprises the amino acid sequence of SEQ ID NO: 155, preferably
said at least one second assembly comprises at least one second protein comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 85-88, optionally;
all second assemblies comprise at least one second protein comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 85-88, or
Nanoparticles according to any one of claims 3 to 6 , wherein all second proteins comprise an amino acid sequence selected from the group consisting of SEQ ID NOs: 85-88.
（ｂ） 全ての第２のタンパク質が、配列番号８５のアミノ酸配列を含み、前記第２のタンパク質の少なくとも２０％、３０％、４０％、５０％、６０％、７０％、８０％、９０％、又は１００％のＸ１が、配列番号１２５のアミノ酸配列に対して、７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％、又は１００％アミノ酸配列同一性のアミノ酸配列を含む、又は、
（ＩＩ）（ａ） 前記第１のタンパク質が、配列番号１５５のアミノ酸配列を含み、
（ｂ） 全ての第２のタンパク質が、配列番号８５のアミノ酸配列を含み、前記第２のタンパク質の少なくとも５０％、６０％、７０％、８０％、９０％、又は１００％のＸ１が、配列番号１２５のアミノ酸配列に対して、７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％、又は１００％アミノ酸配列同一性のアミノ酸配列を含む、又は、
（ＩＩＩ）（ａ） 前記第１のタンパク質が、配列番号１５５のアミノ酸配列を含み、
（ｂ） 全ての第２のタンパク質が、配列番号１～８からなる群から選択されるアミノ酸配列を含む、又は、
（ＩＶ）（ａ） 前記第１のタンパク質が、配列番号１５５のアミノ酸配列を含み、
（ｂ） 全ての第２のタンパク質が、配列番号１又は５のアミノ酸配列を含む、請求項３～８のいずれか一項に記載のナノ粒子。 (I) ( a) the first protein comprises the amino acid sequence of SEQ ID NO: 155;
(b) all of the second proteins comprise the amino acid sequence of SEQ ID NO: 85, and at least 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% of said second proteins; , or 100% X1 is 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97% with respect to the amino acid sequence of SEQ ID NO: 125 , comprising an amino acid sequence of 98%, 99%, or 100% amino acid sequence identity, or
(II) (a) the first protein includes the amino acid sequence of SEQ ID NO: 155;
(b) all of the second proteins comprise the amino acid sequence of SEQ ID NO: 85, and at least 50%, 60%, 70%, 80%, 90%, or 100% of the second proteins have the sequence For the amino acid sequence number 125, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100 % amino acid sequence identity, or
(III) (a) the first protein includes the amino acid sequence of SEQ ID NO: 155;
(b) all of the second proteins comprise an amino acid sequence selected from the group consisting of SEQ ID NOs: 1 to 8, or
(IV) (a) the first protein includes the amino acid sequence of SEQ ID NO: 155;
(b) Nanoparticles according to any one of claims 3 to 8 , wherein all the second proteins comprise the amino acid sequence of SEQ ID NO: 1 or 5.
任意選択で、前記核酸分子がｍＲＮＡを含む、核酸分子。 A nucleic acid molecule encoding a polypeptide according to any one of claims 1 to 2 , preferably encoding an amino acid sequence of SEQ ID NO: 1 to 12 ,
Optionally, the nucleic acid molecule comprises mRNA .
（ａ） 請求項１～１３のいずれか一項に記載の、ポリペプチド、ナノ粒子、組成物、核酸、発現ベクター、及び／又は細胞と、
（ｂ） 薬学的に許容される担体と、を含み、任意選択で、
前記医薬組成物が、請求項９に記載の複数のナノ粒子を含み、任意選択で、アジュバントを更に含む、医薬組成物。 A pharmaceutical composition comprising:
(a) a polypeptide, nanoparticle, composition, nucleic acid, expression vector, and/or cell according to any one of claims 1 to 13 ;
(b) a pharmaceutically acceptable carrier, optionally;
10. A pharmaceutical composition comprising a plurality of nanoparticles according to claim 9 and optionally further comprising an adjuvant .
任意選択で、前記ワクチンが、請求項９に記載の複数のナノ粒子を含む、ワクチン。 A vaccine comprising a polypeptide, nanoparticle, composition, nucleic acid and/or composition according to any one of claims 1 to 14 ,
Optionally, the vaccine comprises a plurality of nanoparticles according to claim 9 .
任意選択で、前記方法が、請求項９に記載の複数のナノ粒子、請求項９に記載の複数のナノ粒子を含む医薬組成物、又は請求項９に記載の複数のナノ粒子を含むワクチンを前記対象に投与することを含み、
任意選択で、前記対象がＳＡＲＳ－ＣｏＶ－２に感染しておらず、前記投与が、前記対象におけるＳＡＲＳ－ＣｏＶ－２感染症の発症を制限する、前記対象におけるＳＡＲＳ－ＣｏＶ－２に対する免疫応答を誘発し、
任意選択で、前記投与が、第１の用量及び第２の用量を投与することを含み、前記第２の用量が、前記第１の用量が投与される約２週間～約１２週間、又は約４週間～約１２週間投与され、
好ましくは、前記投与が、
（ａ） ＤＮＡ、ｍＲＮＡ、又はアデノウイルスベクターワクチンのプライム用量を前記対象に投与することであって、前記ＤＮＡ、ｍＲＮＡ、又はアデノウイルスベクターワクチンは、配列番号１２５～１３７のアミノ酸配列と、少なくとも７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％、又は１００％アミノ酸配列同一性を有するアミノ酸配列をコードする、前記対象に投与することと、
（ｂ） ポリペプチド、ナノ粒子、組成物、核酸、医薬組成物、又はワクチンのブースト用量を前記対象に投与することと、を含む、又は、
前記投与が、
（ａ） ポリペプチド、ナノ粒子、組成物、核酸、医薬組成物、又はワクチンのプライム用量を前記対象に投与することと、
（ｂ） ＤＮＡ、ｍＲＮＡ、又はアデノウイルスベクターワクチンのブースト用量を前記対象に投与することであって、前記ＤＮＡ、ｍＲＮＡ、又はアデノウイルスベクターワクチンは、配列番号１２５～１３７のアミノ酸配列と、少なくとも７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％、又は１００％アミノ酸配列同一性を有するアミノ酸配列をコードする、前記対象に投与することと、を含み、
任意選択で、前記免疫応答が、ＳＡＲＳ－ＣｏＶ－２に対する中和抗体の生成を含み、
任意選択で、前記免疫応答が、少なくとも１ｘ１０5の平均幾何力価を有するＳＡＲＳ－ＣｏＶ－２スパイクタンパク質抗体特異的応答の生成を含む、又は、
前記対象が、ＳＡＲＳ－ＣｏＶ－２を含むがこれに限定されない重症急性呼吸器（ＳＡＲＳ）ウイルスに感染しており、前記投与が、前記対象のＳＡＲＳウイルス感染を治療する、前記対象のＳＡＲＳウイルスに対する免疫応答を誘発する、請求項１又は２に記載のポリペプチド、請求項３～９のいずれか一項に記載のナノ粒子、請求項１０に記載の組成物、請求項１１に記載の核酸分子、請求項１４に記載の医薬組成物、又は請求項１５に記載のワクチン。 SARS-- comprising administering a polypeptide , nanoparticle, composition, nucleic acid, pharmaceutical composition, or vaccine to a subject in need thereof in an amount effective to treat or limit the onset of an infectious disease. A polypeptide according to claim 1 or 2, a nanoparticle according to any one of claims 3 to 9, for use in a method of treating or limiting the development of CoV-2 infection, according to claim 10. A composition according to claim 11, a nucleic acid molecule according to claim 11, a pharmaceutical composition according to claim 14, or a vaccine according to claim 15, comprising:
Optionally, the method comprises a plurality of nanoparticles according to claim 9 , a pharmaceutical composition comprising a plurality of nanoparticles according to claim 9 , or a vaccine comprising a plurality of nanoparticles according to claim 9. comprising administering to said subject,
Optionally, an immune response against SARS-CoV-2 in said subject, wherein said subject is not infected with SARS-CoV-2 and said administration limits the development of a SARS-CoV-2 infection in said subject. induces
Optionally, said administering comprises administering a first dose and a second dose, said second dose being administered for about 2 weeks to about 12 weeks, or about Administered for 4 weeks to about 12 weeks ,
Preferably, said administration comprises:
(a) administering to said subject a prime dose of a DNA, mRNA, or adenovirus vector vaccine, wherein said DNA, mRNA, or adenovirus vector vaccine comprises an amino acid sequence of SEQ ID NOs: 125-137 and at least 75 %, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% amino acid sequence identity. administering the code to said subject;
(b) administering to said subject a boost dose of a polypeptide , nanoparticle, composition, nucleic acid, pharmaceutical composition, or vaccine , or
The administration is
(a) administering to said subject a prime dose of a polypeptide , nanoparticle, composition, nucleic acid, pharmaceutical composition, or vaccine;
(b) administering to said subject a boost dose of a DNA, mRNA, or adenovirus vector vaccine, wherein said DNA, mRNA, or adenovirus vector vaccine comprises an amino acid sequence of SEQ ID NOs: 125-137 and at least 75 %, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% amino acid sequence identity. and administering the code to the subject ,
Optionally, the immune response comprises the generation of neutralizing antibodies against SARS-CoV-2;
Optionally, said immune response comprises the generation of a SARS-CoV-2 spike protein antibody specific response with a mean geometric titer of at least 1×10 5 , or
said subject is infected with a severe acute respiratory (SARS) virus, including but not limited to SARS-CoV-2, and said administration treats a SARS virus infection in said subject. A polypeptide according to claim 1 or 2, a nanoparticle according to any one of claims 3 to 9, a composition according to claim 10, a nucleic acid molecule according to claim 11, which induces an immune response. , the pharmaceutical composition according to claim 14, or the vaccine according to claim 15 .
（Ｉ）（ａ） 好ましくは配列番号１又は５のアミノ酸配列を含む、請求項１～２のいずれか一項に記載のポリペプチドと、
（ｂ） 配列番号１５２～１５９からなる群から選択されるアミノ酸配列と少なくとも７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％又は１００％同一のアミノ酸配列を含む第１のタンパク質であって、括弧内の残基は任意であり、存在してもしなくてもよく、好ましくは、前記第１のタンパク質は配列番号１５５のアミノ酸配列を含む、第１のタンパク質、又は、
（ＩＩ）（ａ） 好ましくは配列番号１又は５のアミノ酸配列を含む、請求項１～２のいずれか一項に記載のポリペプチドをコードする核酸と、
（ｂ） 配列番号１５２～１５９からなる群から選択されるアミノ酸配列と少なくとも７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％又は１００％同一のアミノ酸配列を含む第１のタンパク質をコードする核酸であって、括弧内の残基は任意であり、存在してもしなくてもよく、好ましくは、前記第１のタンパク質は配列番号１５５のアミノ酸配列を含む、第１のタンパク質をコードする核酸、又は、
（ＩＩＩ）（ａ） 適切な制御配列に作動可能に連結された請求項１～２のいずれか一項に記載のポリペプチドをコードする核酸を含む発現ベクターであって、好ましくは前記ポリペプチドが配列番号１又は５のアミノ酸配列を含む、発現ベクターと、
（ｂ） 配列番号１５２～１５９からなる群から選択されるアミノ酸配列と少なくとも７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％、又は１００％同一であるアミノ酸配列を含む第１のタンパク質をコードする核酸を含む発現ベクターであって、括弧内の残基は任意であり、存在してもしなくてもよく、前記核酸は、適切な制御配列の作動可能に連結されており、好ましくは、前記第１のタンパク質は配列番号１５５のアミノ酸配列を含む、発現ベクター、又は、
（ＩＶ）（ａ） 適切な制御配列に作動可能に連結された請求項１～２のいずれか一項に記載のポリペプチドをコードする核酸を含む発現ベクターを含む細胞であって、好ましくは前記ポリペプチドが配列番号１又は５のアミノ酸配列を含む、発現ベクターを含む細胞と、
（ｂ） 配列番号１５２～１５９からなる群から選択されるアミノ酸配列と少なくとも７５％、８０％、８５％、９０％、９１％、９２％、９３％、９４％、９５％、９６％、９７％、９８％、９９％、又は１００％同一であるアミノ酸配列を含む第１のタンパク質をコードする核酸を含む発現ベクターを含む細胞であって、括弧内の残基は任意であり、存在してもしなくてもよく、前記核酸は、適切な制御配列に作動可能に連結されており、好ましくは、前記第１のタンパク質は配列番号１５５のアミノ酸配列を含む、発現ベクターを含む細胞、を含むキット。
It is a kit,
(I) (a) a polypeptide according to any one of claims 1 to 2, preferably comprising the amino acid sequence of SEQ ID NO: 1 or 5;
(b) an amino acid sequence selected from the group consisting of SEQ ID NOs: 152-159 and at least 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97; %, 98%, 99% or 100% identical amino acid sequence, wherein the residues in parentheses are optional and may or may not be present, preferably a first protein, wherein the protein comprises the amino acid sequence of SEQ ID NO: 155 , or
(II) (a) a nucleic acid encoding a polypeptide according to any one of claims 1 to 2 , preferably comprising the amino acid sequence of SEQ ID NO: 1 or 5;
(b) an amino acid sequence selected from the group consisting of SEQ ID NOs: 152-159 and at least 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97; %, 98%, 99% or 100% identical amino acid sequence to a first protein, wherein the residues in parentheses are optional and may or may not be present, preferably A nucleic acid encoding a first protein, wherein the first protein comprises the amino acid sequence of SEQ ID NO: 155 , or
(III) (a) An expression vector comprising a nucleic acid encoding a polypeptide according to any one of claims 1 to 2 operably linked to appropriate control sequences, preferably wherein said polypeptide is An expression vector comprising the amino acid sequence of SEQ ID NO: 1 or 5;
(b) an amino acid sequence selected from the group consisting of SEQ ID NOs: 152-159 and at least 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97; %, 98%, 99%, or 100% identical to a first protein, wherein the residues in parentheses are optional and may or may not be present. Optionally, said nucleic acid is operably linked to appropriate control sequences, preferably said first protein comprises the amino acid sequence of SEQ ID NO: 155 , or an expression vector;
(IV) (a) A cell comprising an expression vector comprising a nucleic acid encoding a polypeptide according to any one of claims 1 to 2 operably linked to appropriate control sequences, preferably said A cell containing an expression vector in which the polypeptide comprises the amino acid sequence of SEQ ID NO: 1 or 5;
(b) an amino acid sequence selected from the group consisting of SEQ ID NOs: 152-159 and at least 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97; %, 98%, 99%, or 100% identical to a first protein, wherein the residues in parentheses are optional and are not present. Optionally, said nucleic acid is operably linked to appropriate control sequences, and preferably said first protein comprises the amino acid sequence of SEQ ID NO: 155. kit.
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| US20220016268A1 (en) * | 2020-07-17 | 2022-01-20 | Tonix Pharmaceuticals Holding Corp. | Skin-based testing for detection of cell-mediated immune responses to sars-cov-2 |
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