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Description
[本発明1001]
抗原とアジュバントとの投与によって対象における免疫応答を誘発する方法であって、抗原がポリマーソームの第1集団と関連づけられ、アジュバントがポリマーソームの第2集団と関連づけられ、それら2つのポリマーソーム集団が対象に投与される、方法。
[本発明1002]
(a)抗原が、
ポリマーソームの第1集団内への該抗原の封入によって、
ポリマーソームの第1集団のうちのポリマーソームの周囲膜への該抗原の組込みによって、
共有結合によるポリマーソームの外表面への該抗原のコンジュゲーションによって、および/もしくは
非共有結合によるポリマーソームの外表面への該抗原のコンジュゲーションによって、
ポリマーソームの第1集団と関連づけられ、ならびに/または
(b)アジュバントが、
ポリマーソームの第2集団内への該アジュバントの封入によって、
ポリマーソームの第2集団のうちのポリマーソームの周囲膜への該アジュバントの組込みによって、
共有結合によるポリマーソームの外表面への該アジュバントのコンジュゲーションによって、および/もしくは
非共有結合によるポリマーソームの外表面への該アジュバントのコンジュゲーションによって、
ポリマーソームの第2集団と関連づけられる、
本発明1001の方法。
[本発明1003]
ポリマーソームの第1集団が、該ポリマーソーム内に封入された抗原を有し、
ポリマーソームの第2集団が、該ポリマーソーム内に封入されたアジュバントを有する、
本発明1002の方法。
[本発明1004]
2つのポリマーソーム集団が、経口投与、鼻腔内投与、粘膜表面への投与、吸入、皮内投与、腹腔内投与、皮下投与、静脈内投与および筋肉内投与からなる群より選択される投与経路によって投与される、前記本発明のいずれかの方法。
[本発明1005]
対象が、ヒトを含む哺乳類動物、または非哺乳類動物である、前記本発明のいずれかの方法。
[本発明1006]
対象が哺乳類動物であり、かつがん、ウイルス感染症および細菌感染症からなる群より選択される疾患に対してワクチン接種され、対象が好ましくはヒトであり、かつ好ましくはコロナウイルス感染症に対してワクチン接種され、コロナウイルスが好ましくはMERS-CoV、SARS-CoV-2またはSARS-CoV-1である、本発明1005の方法。
[本発明1007]
(a)対象が非哺乳類動物であり、かつウイルス感染症および細菌感染症からなる群より選択される疾患に対してワクチン接種される、または
(b)哺乳類動物が、ヤギ、ヒツジ、ウシ、もしくはブタであり、該動物が、好ましくは、
(i)ブタであり、かつブタ流行性下痢ウイルスに対してワクチン接種される、もしくは
(ii)有蹄動物であり、かつ口蹄疫ウイルスに対してワクチン接種される、
本発明1005の方法。
[本発明1008]
封入抗原が、可溶性のまたは可溶化された抗原である、前記本発明のいずれかの方法。
[本発明1009]
抗原、好ましくは可溶性のまたは可溶化された封入抗原が、
(i)ポリペプチド、
(ii)糖質、
(iii)アンチセンスオリゴヌクレオチドではなく、好ましくはDNA分子またはmRNA分子である、ポリヌクレオチド、
(iv)(i)および/または(ii)および/または(iii)の組合せ
からなる群より選択される、前記本発明のいずれかの方法。
[本発明1010]
ポリマーソームの第1集団および/または第2集団が酸化安定性である、前記本発明のいずれかの方法。
[本発明1011]
封入抗原が、膜タンパク質(MP)または膜結合型ペプチド(MAP)の可溶性部分を含み、
好ましくは該抗原が、インフルエンザヘマグルチニン、ブタインフルエンザヘマグルチニン、スパイクタンパク質、例えばブタ流行性下痢ウイルススパイクタンパク質、ヒト病原性コロナウイルスのスパイクタンパク質、例えばMERS-CoVスパイクタンパク質、SARS-CoV-2スパイクタンパク質、またはSARS-CoV-1スパイクタンパク質、卵白アルブミン(OVA)、B16ペプチドまたはMC38ペプチドの可溶性部分を含み、
さらに好ましくは該抗原が、SEQ ID NO:1、SEQ ID NO:2、SEQ ID NO:3、SEQ ID NO:4、SEQ ID NO:5、SEQ ID NO:6、SEQ ID NO:7、SEQ ID NO:8、SEQ ID NO:9、SEQ ID NO:10、SEQ ID NO:11、SEQ ID NO:12、SEQ ID NO:13、SEQ ID NO:14、SEQ ID NO:43~46、SEQ ID NO:34~41、SEQ ID NO:48~51、およびSEQ ID NO:65からなる群より選択されるポリペプチド配列と少なくとも60%以上(例えば少なくとも65%、少なくとも70%、少なくとも75%、少なくとも80%、少なくとも85%、少なくとも90%、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%または100%)同一であるポリペプチドを含む、
前記本発明のいずれかの方法。
[本発明1012]
ポリマーソームの第1集団および/もしくは第2集団が、以下の特性:
(i)ポリマーソームの第1集団および/もしくは第2集団が酸化安定性膜を含む、ならびに/または
(ii)ポリマーソームの第1集団および/もしくは第2集団が合成物である、ならびに/または
(iii)ポリマーソームの第1集団および/もしくは第2集団が非封入抗原を含まないか、もしくは非封入抗原と混合されている、ならびに/または
(iv)ポリマーソームの第1集団および/もしくは第2集団が両親媒性ポリマーの膜を含む、ならびに/または
(v)ポリマーソームの第1集団および/もしくは第2集団が、ベシクル膜を形成する両親媒性合成ブロック共重合体を含む、ならびに/または
(vi)ポリマーソームの第1集団および/もしくは第2集団が70nm超の直径を有し、好ましくは該直径が約100nm~約1μm、もしくは約100nm~約750nm、もしくは約100nm~約500nm、もしくは約125nm~約250nm、約140nm~約240nm、約150nm~約235nm、約170nm~約230nm、もしくは約220nm~約180nm、もしくは約190nm~約210nmの範囲にあり、最も好ましくは該直径が約200nmである、ならびに/または
(vii)ポリマーソームの第1集団および/もしくは第2集団がベシクルの形態を有する、
(viii)ポリマーソームの第1集団および/もしくは第2集団が自己集合性である、
(ix)ブロック共重合体もしくは両親媒性ポリマーが本質的に非免疫原性もしくは本質的に非抗原性であり、好ましくはブロック共重合体もしくは両親媒性ポリマーが非免疫原性もしくは非抗原性である、
のうちの1つまたは複数を有する、前記本発明のいずれかの方法。
[本発明1013]
ポリマーソームの第1集団および/または第2集団が、
ジブロックもしくはトリブロック(A-B-AもしくはA-B-C)共重合体を含むか、もしくはそれからなる両親媒性ポリマー
を含むか、またはそれから形成される、前記本発明のいずれかの方法。
[本発明1014]
(a)両親媒性ポリマーが共重合体ポリ(N-ビニルピロリドン)-b-PLAを含み、
(b)両親媒性ポリマーがポリ(ブタジエン)-ポリ(エチレンオキシド)(PB-PEO)ジブロック共重合体であるか、両親媒性ポリマーがポリ(ジメチルシロキサン)-ポリ(エチレンオキシド)(PDMS-PEO)ジブロック共重合体、もしくはポリ(ジメチルシロキサン)-ポリ(アクリル酸)(PDMS-PAA)であり、PB-PEOジブロック共重合体が好ましくは5~50ブロックPBおよび5~50ブロックPEOを含むか、もしくはPB-PDMSジブロック共重合体が好ましくは5~100ブロックPDMSおよび5~100ブロックPEOを含み、
(c)両親媒性ポリマーがポリ(ラクチド)-ポリ(エチレンオキシド)/1-パルミトイル-2-オレオイル-sn-グリセロ-3-ホスホ-L-セリン(PLA-PEO/POPC)共重合体であり、好ましくはPLA-PEO/POPCが75対25(例えば75/25)のPLA-PEO対POPC(例えばPLA-PEO/POPC)の比を有し、
(d)両親媒性ポリマーがポリ(カプロラクトン)-ポリ(エチレンオキシド)/1-パルミトイル-2-オレオイル-sn-グリセロ-3-ホスホ-L-セリン(PCL-PEO/POPC)共重合体であり、好ましくはPCL-PEO/POPCが75対25(例えば75/25)のPCL-PEO対POPC(例えばPCL-PEO/POPC)の比を有し、
(e)両親媒性ポリマーがポリブタジエン-ポリエチレンオキシド(BD)であり、ならびに/または
(f)ポリマーソームの第1集団および/もしくは第2集団が、ジブロック共重合体PBD 21 -PEO 14 (BD21)および/もしくはトリブロック共重合体PMOXA 12 -PDMS 55 -PMOXA 12 を含む、
前記本発明のいずれかの方法。
[本発明1015]
ポリマーソームの第1集団および/または第2集団が脂質ポリマーを含む、前記本発明のいずれかの方法。
[本発明1016]
ポリマーソームの第2集団と関連づけられたアジュバントが、CpGオリゴデオキシヌクレオチド(すなわちCpG ODN)、細菌およびマイコバクテリアの細胞壁由来の構成要素ならびにタンパク質からなる群より選択される、前記本発明のいずれかの方法。
[本発明1017]
以下の工程を含む、ポリマーソーム中の封入抗原または封入アジュバントを生産するための方法:
(i)両親媒性ポリマーをクロロホルムに溶解する工程であって、好ましくは両親媒性ポリマーがポリブタジエン-ポリエチレンオキシド(BD)である、工程、
(ii)ポリマーフィルムを形成させるために、溶解した両親媒性ポリマーを乾燥させる工程、
(iii)工程(ii)の乾燥させた両親媒性ポリマーフィルムに、可溶化された抗原もしくは可溶性アジュバントを加える工程であって、該アジュバントが、好ましくは、CpGオリゴデオキシヌクレオチド(すなわちCpG ODN)、細菌およびマイコバクテリアの細胞壁由来の構成要素ならびにタンパク質からなる群より選択され、該抗原が、以下:
(a)ポリペプチドであって、好ましくはポリペプチド抗原が前記本発明のいずれかに従い、さらに好ましくはポリペプチド抗原が、インフルエンザヘマグルチニン、ブタインフルエンザヘマグルチニン、スパイクタンパク質、例えばブタ流行性下痢ウイルススパイクタンパク質、ヒト病原性コロナウイルスのスパイクタンパク質、例えばMERS-CoVスパイクタンパク質もしくはSARS-CoV-2スパイクタンパク質、卵白アルブミン(OVA)、B16ペプチドまたはMC38ペプチドの可溶性部分を含み、最も好ましくはポリペプチド抗原が、SEQ ID NO:1、SEQ ID NO:2、SEQ ID NO:3、SEQ ID NO:4、SEQ ID NO:5、SEQ ID NO:6、SEQ ID NO:7、SEQ ID NO:8、SEQ ID NO:9、SEQ ID NO:10、SEQ ID NO:11、SEQ ID NO:12~14、SEQ ID NO:43~46、SEQ ID NO:34~41、SEQ ID NO:48~51、およびSEQ ID NO:65からなる群より選択されるポリペプチド配列と少なくとも60%以上(例えば少なくとも65%、少なくとも70%、少なくとも75%、少なくとも80%、少なくとも85%、少なくとも90%、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%または100%)同一である、ポリペプチド、
(b)糖質、
(c)アンチセンスオリゴヌクレオチドではなく、好ましくはDNA分子もしくはmRNA分子である、ポリヌクレオチド、
(d)(a)および/もしくは(b)および/もしくは(c)の組合せ
からなる群より選択される、工程、
(iv)ポリマーベシクルを形成させるために、工程(iii)のポリマーフィルムを再水和する工程、
(v)任意で、ポリマーベシクル単分散ベシクルを精製するために、工程(iv)のポリマーベシクルを濾過する工程、ならびに/または
(vi)任意で、工程(iv)もしくは工程(v)のポリマーベシクルを非封入抗原から単離する工程。
[本発明1018]
本発明1017に規定したポリマーソーム中の封入抗原または封入アジュバントを生産するための方法によって生産される、ポリマーソーム。
[本発明1019]
本発明1001~1016のいずれかに規定したポリマーソームの第1集団および第2集団を含む、組成物。
[本発明1020]
本発明1001~1016のいずれかに規定したポリマーソームの第1集団および第2集団または本発明1019に規定した組成物を含み、薬学的に許容される賦形剤または担体をさらに含む、ワクチン。
[本発明1021]
本発明1001~1016のいずれかに規定したポリマーソームの第1集団および第2集団または本発明1019に規定した組成物を含む、キット。
[本発明1022]
それを必要とする対象(例えばヒト)において感染性疾患、がんまたは自己免疫疾患を処置または防止する方法であって、本発明1001~1016に規定したポリマーソームの第1集団および第2集団または本発明1019に規定した組成物の治療有効量を対象に投与する工程を含み、好ましくは感染性疾患がウイルス感染性疾患または細菌感染性疾患である、方法。
[本発明1023]
医薬として使用するための、本発明1001~1016のいずれかに規定したポリマーソームの第1集団および第2集団または本発明1019に規定した組成物。
したがって本願は、本明細書において以下に記載し、特許請求の範囲において特徴づけ、添付の実施例および図面によって例示する、投与された場合に抗原の免疫原特性を改良する2つの別個のポリマーソーム集団、そのような2つのポリマーソーム集団の生産方法およびそのような2つのポリマーソーム集団を含む組成物を提供することによって、前記の需要を満たす。
[Invention 1001]
A method of inducing an immune response in a subject by administering an antigen and an adjuvant, wherein the antigen is associated with a first population of polymersomes, the adjuvant is associated with a second population of polymersomes, and the two populations of polymersomes are A method administered to a subject.
[Invention 1002]
(a) the antigen is
By encapsulation of said antigen within a first population of polymersomes,
by incorporation of the antigen into the surrounding membrane of polymersomes of the first population of polymersomes,
by conjugation of the antigen to the outer surface of the polymersome by covalent bonding, and/or
By non-covalent conjugation of the antigen to the outer surface of the polymersome,
associated with the first population of polymersomes and/or
(b) the adjuvant is
By encapsulating the adjuvant within a second population of polymersomes,
by incorporation of said adjuvant into the surrounding membrane of polymersomes of the second population of polymersomes,
by covalently conjugating the adjuvant to the outer surface of the polymersome; and/or
By non-covalently conjugating the adjuvant to the outer surface of the polymersome,
associated with a second population of polymersomes,
The method of the invention 1001.
[Invention 1003]
a first population of polymersomes having an antigen encapsulated within the polymersomes;
a second population of polymersomes having an adjuvant encapsulated within the polymersomes;
The method of the invention 1002.
[Invention 1004]
by a route of administration wherein the two polymersome populations are selected from the group consisting of oral administration, intranasal administration, administration to mucosal surfaces, inhalation, intradermal administration, intraperitoneal administration, subcutaneous administration, intravenous administration and intramuscular administration. The method of any of the preceding inventions, wherein:
[Invention 1005]
The method of any of the preceding inventions, wherein the subject is a mammal, including a human, or a non-mammalian animal.
[Invention 1006]
The subject is a mammal and is vaccinated against a disease selected from the group consisting of cancer, viral infection and bacterial infection, the subject is preferably human, and preferably against coronavirus infection and the coronavirus is preferably MERS-CoV, SARS-CoV-2 or SARS-CoV-1.
[Invention 1007]
(a) the subject is a non-mammalian animal and is vaccinated against a disease selected from the group consisting of viral infections and bacterial infections, or
(b) the mammal is a goat, sheep, cow, or pig, preferably comprising
(i) is a pig and is vaccinated against swine epidemic diarrhea virus, or
(ii) is an ungulate and is vaccinated against foot and mouth disease virus;
The method of the invention 1005.
[Invention 1008]
Any of the preceding methods of the invention, wherein the encapsulated antigen is a soluble or solubilized antigen.
[Invention 1009]
an antigen, preferably a soluble or solubilized encapsulated antigen,
(i) a polypeptide;
(ii) carbohydrates;
(iii) polynucleotides, preferably DNA or mRNA molecules, which are not antisense oligonucleotides;
(iv) a combination of (i) and/or (ii) and/or (iii)
The method of any of the preceding inventions, selected from the group consisting of:
[Invention 1010]
The method of any of the preceding inventions, wherein the first population and/or the second population of polymersomes are oxidatively stable.
[Invention 1011]
the encapsulated antigen comprises a soluble portion of a membrane protein (MP) or membrane-associated peptide (MAP);
Preferably said antigen is influenza hemagglutinin, swine influenza hemagglutinin, a spike protein such as swine epidemic diarrhea virus spike protein, human pathogenic coronavirus spike protein such as MERS-CoV spike protein, SARS-CoV-2 spike protein, or including soluble portions of SARS-CoV-1 spike protein, ovalbumin (OVA), B16 peptide or MC38 peptide,
More preferably, the antigen is SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:7 ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:43-46, SEQ ID NO:43-46 A polypeptide sequence selected from the group consisting of ID NO:34-41, SEQ ID NO:48-51, and SEQ ID NO:65 and at least 60% or more (e.g., at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99% or 100%) identical,
The method of any of the preceding inventions.
[Invention 1012]
The first and/or second population of polymersomes have the following properties:
(i) the first and/or second population of polymersomes comprises an oxidatively stable membrane, and/or
(ii) the first and/or second population of polymersomes is synthetic, and/or
(iii) the first and/or second population of polymersomes are free of or mixed with non-encapsulated antigen, and/or
(iv) the first population and/or the second population of polymersomes comprise membranes of amphiphilic polymers, and/or
(v) the first population and/or the second population of polymersomes comprise amphiphilic block copolymers that form vesicle membranes, and/or
(vi) the first population and/or the second population of polymersomes have a diameter greater than 70 nm, preferably the diameter is from about 100 nm to about 1 μm, or from about 100 nm to about 750 nm, or from about 100 nm to about 500 nm, or about 125 nm to about 250 nm, about 140 nm to about 240 nm, about 150 nm to about 235 nm, about 170 nm to about 230 nm, or about 220 nm to about 180 nm, or about 190 nm to about 210 nm, most preferably the diameter is about 200 nm. and/or
(vii) the first population and/or the second population of polymersomes have the morphology of vesicles,
(viii) the first and/or second population of polymersomes are self-assembling;
(ix) the block copolymer or amphiphilic polymer is essentially non-immunogenic or essentially non-antigenic, preferably the block copolymer or amphiphilic polymer is non-immunogenic or non-antigenic is
The method of any of the preceding inventions, comprising one or more of
[Invention 1013]
a first population and/or a second population of polymersomes comprising:
Amphiphilic polymers comprising or consisting of diblock or triblock (ABA or ABC) copolymers
The method of any preceding invention comprising or formed from:
[Invention 1014]
(a) the amphiphilic polymer comprises the copolymer poly(N-vinylpyrrolidone)-b-PLA,
(b) the amphiphilic polymer is poly(butadiene)-poly(ethylene oxide) (PB-PEO) diblock copolymer or the amphiphilic polymer is poly(dimethylsiloxane)-poly(ethylene oxide) (PDMS-PEO) ) diblock copolymer, or poly(dimethylsiloxane)-poly(acrylic acid) (PDMS-PAA), and the PB-PEO diblock copolymer preferably contains 5-50 block PB and 5-50 block PEO. or the PB-PDMS diblock copolymer preferably comprises 5-100 block PDMS and 5-100 block PEO,
(c) the amphiphilic polymer is poly(lactide)-poly(ethylene oxide)/1-palmitoyl-2-oleoyl-sn-glycero-3-phospho-L-serine (PLA-PEO/POPC) copolymer; , preferably PLA-PEO/POPC has a ratio of PLA-PEO to POPC (e.g. PLA-PEO/POPC) of 75 to 25 (e.g. 75/25),
(d) the amphiphilic polymer is a poly(caprolactone)-poly(ethylene oxide)/1-palmitoyl-2-oleoyl-sn-glycero-3-phospho-L-serine (PCL-PEO/POPC) copolymer; , preferably PCL-PEO/POPC has a ratio of PCL-PEO to POPC (e.g. PCL-PEO/POPC) of 75 to 25 (e.g. 75/25),
(e) the amphiphilic polymer is polybutadiene-polyethylene oxide (BD) and/or
(f) the first and/or second population of polymersomes comprises the diblock copolymer PBD21- PEO14 ( BD21) and/or the triblock copolymer PMOXA12 - PDMS55 - PMOXA12 ;
The method of any of the preceding inventions.
[Invention 1015]
The method of any of the preceding inventions, wherein the first population and/or the second population of polymersomes comprise lipid polymers.
[Invention 1016]
Any of the preceding claims, wherein the adjuvant associated with the second population of polymersomes is selected from the group consisting of CpG oligodeoxynucleotides (i.e., CpG ODNs), bacterial and mycobacterial cell wall-derived components and proteins. Method.
[Invention 1017]
A method for producing encapsulated antigens or encapsulated adjuvants in polymersomes comprising the steps of:
(i) dissolving the amphiphilic polymer in chloroform, preferably the amphiphilic polymer is polybutadiene-polyethylene oxide (BD);
(ii) drying the dissolved amphiphilic polymer to form a polymer film;
(iii) adding a solubilized antigen or a soluble adjuvant to the dried amphiphilic polymer film of step (ii), said adjuvant preferably being a CpG oligodeoxynucleotide (i.e. CpG ODN), selected from the group consisting of components and proteins from bacterial and mycobacterial cell walls, wherein said antigen is:
(a) a polypeptide, preferably wherein the polypeptide antigen is according to any of the above inventions, more preferably the polypeptide antigen is influenza hemagglutinin, swine influenza hemagglutinin, spike protein, e.g. swine epidemic diarrhea virus spike protein; A spike protein of a human pathogenic coronavirus, such as the MERS-CoV spike protein or the SARS-CoV-2 spike protein, ovalbumin (OVA), the soluble portion of the B16 peptide or the MC38 peptide, most preferably the polypeptide antigen comprises SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO :9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12-14, SEQ ID NO:43-46, SEQ ID NO:34-41, SEQ ID NO:48-51, and SEQ ID NO:9 A polypeptide sequence selected from the group consisting of NO:65 and at least 60% or more (e.g., at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 96%) %, at least 97%, at least 98%, at least 99% or 100%) identical polypeptides,
(b) carbohydrates;
(c) a polynucleotide, preferably a DNA or mRNA molecule, which is not an antisense oligonucleotide;
(d) a combination of (a) and/or (b) and/or (c)
a step selected from the group consisting of
(iv) rehydrating the polymer film of step (iii) to form polymer vesicles;
(v) optionally filtering the polymeric vesicles of step (iv) to purify polymeric vesicle monodisperse vesicles, and/or
(vi) optionally isolating the polymeric vesicles of step (iv) or step (v) from non-encapsulated antigen.
[Invention 1018]
Polymersomes produced by the method for producing encapsulated antigens or encapsulated adjuvants in polymersomes as defined in the invention 1017.
[Invention 1019]
A composition comprising a first population and a second population of polymersomes as defined in any of the inventions 1001-1016.
[Invention 1020]
A vaccine comprising the first and second populations of polymersomes as defined in any of inventions 1001-1016 or a composition as defined in invention 1019, further comprising a pharmaceutically acceptable excipient or carrier.
[Invention 1021]
A kit comprising the first and second populations of polymersomes as defined in any of the inventions 1001-1016 or a composition as defined in the invention 1019.
[Invention 1022]
A method of treating or preventing an infectious disease, cancer or autoimmune disease in a subject (e.g. a human) in need thereof, comprising: A method comprising administering to a subject a therapeutically effective amount of a composition as defined in invention 1019, preferably wherein the infectious disease is a viral or bacterial infectious disease.
[Invention 1023]
A first population and a second population of polymersomes as defined in any of the inventions 1001-1016 or a composition as defined in the invention 1019 for use as a medicament.
The present application thus provides two distinct polymersomes that improve the immunogenic properties of an antigen when administered, as described hereinbelow, characterized in the claims and illustrated by the accompanying examples and figures. These needs are met by providing populations, methods of producing two such populations of polymersomes, and compositions comprising two such populations of polymersomes.
Claims (19)
抗原がポリマーソームの第1集団と関連づけられ、アジュバントがポリマーソームの第2集団と関連づけられ、ポリマーソームの第1および第2集団がそれぞれ、ベシクル膜を形成する両親媒性合成ブロック共重合体を含み、
ポリマーソームの第1集団が、該ポリマーソーム内に封入された抗原を有し、ポリマーソームの第2集団が、該ポリマーソーム内に封入されたアジュバントを有し、該両親媒性ポリマーがポリ(ブタジエン)-ポリ(エチレンオキシド)(PB-PEO)ジブロック共重合体であるか、該両親媒性ポリマーがポリ(ジメチルシロキサン)-ポリ(エチレンオキシド)(PDMS-PEO)ジブロック共重合体であり、
抗原がポリマーソームの第1集団と関連づけられ、アジュバントがポリマーソームの第2集団と関連づけられ、それら2つのポリマーソーム集団が対象に投与される、
前記医薬。 A medicament comprising first and second populations of polymersomes for use in inducing an immune response in a subject by administration of an antigen and an adjuvant, the medicament comprising:
an antigen is associated with a first population of polymersomes, an adjuvant is associated with a second population of polymersomes, and the first and second populations of polymersomes each contain an amphiphilic synthetic block copolymer that forms a vesicle membrane. including,
A first population of polymersomes has an antigen encapsulated within the polymersome, a second population of polymersomes has an adjuvant encapsulated within the polymersome, and the amphiphilic polymer has a poly( butadiene)-poly(ethylene oxide) (PB-PEO) diblock copolymer, or the amphiphilic polymer is a poly(dimethylsiloxane)-poly(ethylene oxide) (PDMS-PEO) diblock copolymer,
an antigen is associated with a first population of polymersomes, an adjuvant is associated with a second population of polymersomes, and the two polymersome populations are administered to the subject;
The said medicine.
(b)哺乳類動物が、ヤギ、ヒツジ、ウシ、もしくはブタであり、該動物が、好ましくは、
(i)ブタであり、かつブタ流行性下痢ウイルスに対してワクチン接種される、もしくは
(ii)有蹄動物であり、かつ口蹄疫ウイルスに対してワクチン接種される、
請求項3記載の医薬。 (a) the subject is a non-mammalian animal and is vaccinated against a disease selected from the group consisting of viral infections and bacterial infections; or (b) the subject is a non-mammalian animal and is vaccinated against a disease selected from the group consisting of viral infections and bacterial infections; a pig, and the animal is preferably a pig;
(i) is a pig and is vaccinated against porcine epidemic diarrhea virus; or (ii) is an ungulate and is vaccinated against foot-and-mouth disease virus.
The medicament according to claim 3.
(i)ポリペプチド、
(ii)糖質、
(iii)アンチセンスオリゴヌクレオチドではなく、好ましくはDNA分子またはmRNA分子である、ポリヌクレオチド、
(iv)(i)および/または(ii)および/または(iii)の組合せ
からなる群より選択される、前記請求項のいずれか一項記載の医薬。 The antigen, preferably a soluble or solubilized encapsulated antigen, is
(i) polypeptide;
(ii) carbohydrates;
(iii) a polynucleotide, preferably a DNA or mRNA molecule, rather than an antisense oligonucleotide;
(iv) A medicament according to any one of the preceding claims, selected from the group consisting of a combination of (i) and/or (ii) and/or (iii).
好ましくは該抗原が、インフルエンザヘマグルチニン、ブタインフルエンザヘマグルチニン、スパイクタンパク質、例えばブタ流行性下痢ウイルススパイクタンパク質、ヒト病原性コロナウイルスのスパイクタンパク質、例えばMERS-CoVスパイクタンパク質、SARS-CoV-2スパイクタンパク質、またはSARS-CoV-1スパイクタンパク質、卵白アルブミン(OVA)、B16ペプチドまたはMC38ペプチドの可溶性部分を含み、
さらに好ましくは該抗原が、SEQ ID NO:1、SEQ ID NO:2、SEQ ID NO:3、SEQ ID NO:4、SEQ ID NO:5、SEQ ID NO:6、SEQ ID NO:7、SEQ ID NO:8、SEQ ID NO:9、SEQ ID NO:10、SEQ ID NO:11、SEQ ID NO:12、SEQ ID NO:13、SEQ ID NO:14、SEQ ID NO:43~46、SEQ ID NO:34~41、SEQ ID NO:48~51、およびSEQ ID NO:65からなる群より選択されるポリペプチド配列と少なくとも60%以上(例えば少なくとも65%、少なくとも70%、少なくとも75%、少なくとも80%、少なくとも85%、少なくとも90%、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%または100%)同一であるポリペプチドを含む、
前記請求項のいずれか一項記載の医薬。 the encapsulated antigen comprises a soluble portion of a membrane protein (MP) or membrane-associated peptide (MAP);
Preferably the antigen is influenza hemagglutinin, swine influenza hemagglutinin, a spike protein such as porcine epidemic diarrhea virus spike protein, a human pathogenic coronavirus spike protein such as MERS-CoV spike protein, SARS-CoV-2 spike protein, or Contains a soluble portion of the SARS-CoV-1 spike protein, ovalbumin (OVA), B16 peptide or MC38 peptide;
More preferably, the antigen is SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:43-46, SEQ A polypeptide sequence selected from the group consisting of ID NO:34-41, SEQ ID NO:48-51, and SEQ ID NO:65 and at least 60% (e.g., at least 65%, at least 70%, at least 75%, (at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99% or 100%) identical;
A medicament according to any one of the preceding claims.
(i)ポリマーソームの第1集団および/もしくは第2集団が酸化安定性膜を含む、ならびに/または
(ii)ポリマーソームの第1集団および/もしくは第2集団が合成物である、ならびに/または
(iii)ポリマーソームの第1集団および/もしくは第2集団が70nm超の直径を有し、好ましくは該直径が約100nm~約1μm、もしくは約100nm~約750nm、もしくは約100nm~約500nm、もしくは約125nm~約250nm、約140nm~約240nm、約150nm~約235nm、約170nm~約230nm、もしくは約220nm~約180nm、もしくは約190nm~約210nmの範囲にあり、最も好ましくは該直径が約200nmである、ならびに/または
(iv)ブロック共重合体もしくは両親媒性ポリマーが本質的に非免疫原性もしくは本質的に非抗原性であり、好ましくはブロック共重合体もしくは両親媒性ポリマーが非免疫原性もしくは非抗原性である、
のうちの1つまたは複数を有する、前記請求項のいずれか一項記載の医薬。 The first population and/or the second population of polymersomes have the following properties:
(i) the first population and/or the second population of polymersomes comprises an oxidatively stable membrane; and/or (ii) the first population and/or the second population of polymersomes are synthetic; and/or (iii) the first population and/or the second population of polymersomes have a diameter of greater than 70 nm, preferably the diameter is from about 100 nm to about 1 μm, or from about 100 nm to about 750 nm, or from about 100 nm to about 500 nm, or from about 125 nm to about 250 nm, from about 140 nm to about 240 nm, from about 150 nm to about 235 nm, from about 170 nm to about 230 nm, or from about 220 nm to about 180 nm, or from about 190 nm to about 210 nm, and most preferably the diameter is about 200 nm. and/or (iv) the block copolymer or amphiphilic polymer is essentially non-immunogenic or essentially non-antigenic, preferably the block copolymer or amphiphilic polymer is be antigenic or non-antigenic;
A medicament according to any one of the preceding claims, having one or more of the following.
ジブロックもしくはトリブロック(A-B-AもしくはA-B-C)共重合体を含むか、もしくはそれからなる両親媒性ポリマー
を含むか、またはそれから形成される、前記請求項のいずれか一項記載の医薬。 The first population and/or the second population of polymersomes are
A medicament according to any of the preceding claims, comprising or being formed from an amphiphilic polymer comprising or consisting of a diblock or triblock (ABA or ABC) copolymer.
(b)ポリマーソームの第1集団および/もしくは第2集団が、ジブロック共重合体PBD21-PEO14(BD21)および/もしくはトリブロック共重合体PMOXA12-PDMS55-PMOXA12を含む、
前記請求項のいずれか一項記載の医薬。 (a) the amphiphilic polymer is polybutadiene-polyethylene oxide (BD), and/or (b) the first population and/or the second population of polymersomes are diblock copolymers PBD 21 -PEO 14 (BD21 ) and/or triblock copolymer PMOXA 12 -PDMS 55 -PMOXA 12 ,
A medicament according to any one of the preceding claims.
(ii)ポリマーソームの第1集団および/または第2集団が脂質ポリマーを含む、
前記請求項のいずれか一項記載の医薬。 (i) the PB-PEO diblock copolymer comprises 5-50 blocks PB and 5-50 blocks PEO, or the PB-PDMS diblock copolymer preferably comprises 5-100 blocks PDMS and 5-100 blocks PEO; and/or (ii) the first population and/or the second population of polymersomes comprises a lipid polymer;
A medicament according to any one of the preceding claims.
抗原がポリマーソームの第1集団と関連づけられ、アジュバントがポリマーソームの第2集団と関連づけられ、ポリマーソームの第1および第2集団が、ベシクル膜を形成する両親媒性合成ブロック共重合体を含み、
ポリマーソームの第1集団が、該ポリマーソーム内に封入された抗原を有し、ポリマーソームの第2集団が、該ポリマーソーム内に封入されたアジュバントを有し、
該両親媒性ポリマーがポリ(ブタジエン)-ポリ(エチレンオキシド)(PB-PEO)ジブロック共重合体であるか、該両親媒性ポリマーがポリ(ジメチルシロキサン)-ポリ(エチレンオキシド)(PDMS-PEO)ジブロック共重合体である、ワクチン。 A vaccine comprising first and second populations of polymersomes, further comprising a pharmaceutically acceptable excipient or carrier;
an antigen is associated with a first population of polymersomes, an adjuvant is associated with a second population of polymersomes, the first and second populations of polymersomes comprising an amphiphilic synthetic block copolymer forming a vesicle membrane; ,
a first population of polymersomes has an antigen encapsulated within the polymersomes; a second population of polymersomes has an adjuvant encapsulated within the polymersomes;
The amphiphilic polymer is poly(butadiene)-poly(ethylene oxide) (PB-PEO) diblock copolymer, or the amphiphilic polymer is poly(dimethylsiloxane)-poly(ethylene oxide) (PDMS-PEO). A vaccine that is a diblock copolymer.
抗原がポリマーソームの第1集団と関連づけられ、アジュバントがポリマーソームの第2集団と関連づけられ、ポリマーソームの第1および第2集団が、ベシクル膜を形成する両親媒性合成ブロック共重合体を含み、
ポリマーソームの第1集団が、該ポリマーソーム内に封入された抗原を有し、ポリマーソームの第2集団が、該ポリマーソーム内に封入されたアジュバントを有し、
該両親媒性ポリマーがポリ(ブタジエン)-ポリ(エチレンオキシド)(PB-PEO)ジブロック共重合体であるか、該両親媒性ポリマーがポリ(ジメチルシロキサン)-ポリ(エチレンオキシド)(PDMS-PEO)ジブロック共重合体である、前記医薬。 A medicament comprising a first and a second population of polymersomes for use in treating or preventing an infectious disease, cancer or autoimmune disease in a subject in need thereof, the medicament comprising:
an antigen is associated with a first population of polymersomes, an adjuvant is associated with a second population of polymersomes, the first and second populations of polymersomes comprising an amphiphilic synthetic block copolymer forming a vesicle membrane; ,
a first population of polymersomes has an antigen encapsulated within the polymersomes; a second population of polymersomes has an adjuvant encapsulated within the polymersomes;
The amphiphilic polymer is poly(butadiene)-poly(ethylene oxide) (PB-PEO) diblock copolymer, or the amphiphilic polymer is poly(dimethylsiloxane)-poly(ethylene oxide) (PDMS-PEO). The medicament is a diblock copolymer.
抗原がポリマーソームの第1集団と関連づけられ、アジュバントがポリマーソームの第2集団と関連づけられ、ポリマーソームの第1および第2集団がそれぞれ、ベシクル膜を形成する両親媒性合成ブロック共重合体を含み、
ポリマーソームの第1集団が、該ポリマーソーム内に封入された抗原を有し、ポリマーソームの第2集団が、該ポリマーソーム内に封入されたアジュバントを有し、該両親媒性ポリマーがポリ(ブタジエン)-ポリ(エチレンオキシド)(PB-PEO)ジブロック共重合体であるか、該両親媒性ポリマーがポリ(ジメチルシロキサン)-ポリ(エチレンオキシド)(PDMS-PEO)ジブロック共重合体である、使用。 Use of a first and second population of polymersomes for the manufacture of a medicament for the treatment of a disease selected from the group consisting of cancer, autoimmune diseases, infectious diseases, comprising:
an antigen is associated with a first population of polymersomes, an adjuvant is associated with a second population of polymersomes, and the first and second populations of polymersomes each contain an amphiphilic synthetic block copolymer that forms a vesicle membrane. including,
A first population of polymersomes has an antigen encapsulated within the polymersome, a second population of polymersomes has an adjuvant encapsulated within the polymersome, and the amphiphilic polymer has a poly( butadiene)-poly(ethylene oxide) (PB-PEO) diblock copolymer, or the amphiphilic polymer is poly(dimethylsiloxane)-poly(ethylene oxide) (PDMS-PEO) diblock copolymer, use.
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