TR201808222T4 - PCSK9 aşısı. - Google Patents
PCSK9 aşısı. Download PDFInfo
- Publication number
- TR201808222T4 TR201808222T4 TR2018/08222T TR201808222T TR201808222T4 TR 201808222 T4 TR201808222 T4 TR 201808222T4 TR 2018/08222 T TR2018/08222 T TR 2018/08222T TR 201808222 T TR201808222 T TR 201808222T TR 201808222 T4 TR201808222 T4 TR 201808222T4
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- Turkey
- Prior art keywords
- vol
- pcsk9
- immunogen
- vlp
- immunol
- Prior art date
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- 101001098868 Homo sapiens Proprotein convertase subtilisin/kexin type 9 Proteins 0.000 title claims abstract description 18
- 102100038955 Proprotein convertase subtilisin/kexin type 9 Human genes 0.000 title claims abstract description 17
- 229960005486 vaccine Drugs 0.000 title description 5
- 230000002163 immunogen Effects 0.000 claims abstract description 16
- 108090000765 processed proteins & peptides Proteins 0.000 claims abstract description 12
- 230000000890 antigenic effect Effects 0.000 claims abstract description 5
- 108010071134 CRM197 (non-toxic variant of diphtheria toxin) Proteins 0.000 claims 2
- 101710132601 Capsid protein Proteins 0.000 claims 1
- 241000714209 Norwalk virus Species 0.000 claims 1
- 229960003983 diphtheria toxoid Drugs 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 5
- 229940079593 drug Drugs 0.000 abstract description 2
- 239000003814 drug Substances 0.000 abstract description 2
- 230000001404 mediated effect Effects 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 230000002265 prevention Effects 0.000 abstract 1
- 230000002146 bilateral effect Effects 0.000 description 5
- 241000699670 Mus sp. Species 0.000 description 4
- 229940037003 alum Drugs 0.000 description 4
- 230000008348 humoral response Effects 0.000 description 4
- 238000011725 BALB/c mouse Methods 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 3
- 238000011740 C57BL/6 mouse Methods 0.000 description 2
- 150000001413 amino acids Chemical class 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 102000004196 processed proteins & peptides Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 210000002966 serum Anatomy 0.000 description 2
- NHBKXEKEPDILRR-UHFFFAOYSA-N 2,3-bis(butanoylsulfanyl)propyl butanoate Chemical compound CCCC(=O)OCC(SC(=O)CCC)CSC(=O)CCC NHBKXEKEPDILRR-UHFFFAOYSA-N 0.000 description 1
- 241000428352 Amma Species 0.000 description 1
- 101100117236 Drosophila melanogaster speck gene Proteins 0.000 description 1
- 101001051093 Homo sapiens Low-density lipoprotein receptor Proteins 0.000 description 1
- 102100024640 Low-density lipoprotein receptor Human genes 0.000 description 1
- 241000699666 Mus <mouse, genus> Species 0.000 description 1
- 101100135848 Mus musculus Pcsk9 gene Proteins 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 101800005149 Peptide B Proteins 0.000 description 1
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 1
- 238000002866 fluorescence resonance energy transfer Methods 0.000 description 1
- 102000053786 human PCSK9 Human genes 0.000 description 1
- 230000003053 immunization Effects 0.000 description 1
- 238000002649 immunization Methods 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 108010091742 peptide F Proteins 0.000 description 1
- RJSZPKZQGIKVAU-UXBJKDEOSA-N peptide f Chemical compound C([C@@H](C(=O)N[C@@H](CCSC)C(O)=O)NC(=O)CNC(=O)CNC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CCCCN)NC(=O)CNC(=O)[C@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CCSC)NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)CNC(=O)CNC(=O)[C@@H](N)CC=1C=CC(O)=CC=1)C(C)C)C(C)C)C1=CC=CC=C1 RJSZPKZQGIKVAU-UXBJKDEOSA-N 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000009257 reactivity Effects 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 108700012359 toxins Proteins 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/0005—Vertebrate antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/10—Peptides having 12 to 20 amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/002—Protozoa antigens
- A61K39/005—Trypanosoma antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K7/04—Linear peptides containing only normal peptide links
- C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K7/04—Linear peptides containing only normal peptide links
- C07K7/08—Linear peptides containing only normal peptide links having 12 to 20 amino acids
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
- C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
- C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
- C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
- C12N9/6424—Serine endopeptidases (3.4.21)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21061—Kexin (3.4.21.61), i.e. proprotein convertase subtilisin/kexin type 9
Abstract
Mevcut buluş, PCSK9 aracılığındaki bozuklukların engellenmesi, tedavisi veya iyileştirilmesi için bir immünojenik taşıyıcıya bağlı bir antijenik PCSK9 peptidi içeren yeni immünojenlerin tedarik edilmesi ile ilgilidir. Buluş ayrıca bu ilaçların üretilmesine yönelik yöntemler, bunların immünojenik kompozisyonları ve farmasötik kompozisyonları ve bunların tıp alanında kullanımları ile de ilgilidir.
Description
Tarifname içerisinde atifta bulunulan patent dökümanlari:
Tarifnamede belirtilen patentlestirilmemis literatür:
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SEKILLERDEKI YAZILARIN ANLAMLARI
A = Peptit
B : Insan PCSK9'u
C = LDC reseptörünün EGFA bölgesi
D = Tedavi grubu (VLP üzerinde peptit)
E :Kontrol peptidi
F :Immünize edilmemis kontrol
G = Log Iki tarafli Anti-insan PCSK9 Titeri
H = Tedavi gruplari n=8. Her bir benek, bir fare için iki tarafli Ab
titresini teinsil eder. Ortalama +/- SE, çizgilerle temsil edilir.
J = Tek tek fareler n=l (20-04-09)
K : Log Iki tarafli Anti-fare PCSK9 Titeri
M = VR_X Peptit Immünojenleri
O = Veriler, her bir gruptan 4 farenin serumlarinda ortalama +/-
Standart Sapmayi gösterir.
P = FRET Orani
R = Plazma Seyreltmesi
S : Log (Plazma seyreltme faktörü)
T = lmmünizasyon
U : PCSK9 (seritler) ve EGP-Aidan (bosluk doldurma) olusan
kompleks. EGF-A disindaki LDLR alanlari ile etkilesebilen potansiyel
PCSK9 bölgeleri, elips ile isaret edilir.
V : PCSK9 (seritler) ve EGF-A”dan (bosluk doldurma) olusan
kompleks; burada VR_
peptitlerine karsilik gelen amino asitler gösterilir.
Y : Ornek Titeri l/x
Z = Kontrol VLP
A1 = BALB/c Fare Serumlari
B1 = VR_X Peptit Immünojeni
(Tasiyici ve Ad juvan)
D] = Log Iki tarafli Titeri (SEM)
El = Iki tarafli Log Titeri (SEM)
F1 = Islem görmemis
Gl : C57BL/6 Fare Serumlari
Hl = Fare PCSK9 Reaktivitesi
J 1 = Serum Kolesterolü
K1 : C57BL/6 disi fareleri
LI = Anti-Insan PCSK9 Hümoral Tepkileri
M1 : VR_X Peptit Immünojeni
(V LP kon jugati+Alum+CpG)
Nl = Anti-Fare PCSK9 Hümoral Tepkileri
01: VR_X Peptit Immünojeni
(VLP + ALUM içinde CpG)
Pl = *VR9.25 ve VR_9.27, PCSK9,un ayrismamis bir N-terin bölgesi
içerisindedir; vurgulanan tortu, sekans içinde en yakin olandir (aa
R1 : PCSK9 (seritler) ve EGF-A”dan (bosluk doldurma) olusan
kompleks; burada VR_9.25/VR_, VR_ peptitlerine karsilik
gelen amino asitler gösterilir.
Sl = Tasiyici
Tl = Oligomer/polimer sablonu
Ul : Anti jenik peptit
Vl : Baglayici
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ptide Immunogens
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BALB/c female mice
. paieeiiun
-lsdzrwniv-dm) Ol`6
- (wniv-d'm) 9'6
- (sdawniv-cnn) 9'6
hp/ßw) ioiaisaioqo Lunias
.. (xewiaiu-wgo) apiidad ioiiuog
~(9d0'wnIV-d1/\) apiidad ioiiuoo
phde Immunogen
(Carricr and Adjuvant)
- (xewioiii-wa:)) 0 vs
- (9d3~wniv-d1/\) ova
- (xeWJBtM'WIJD) 96
- (ada-wriiv-d'm) 9'6
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d e gugga
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- (xeweui-wuo) apüdad ioiiuoa
-(sdo-wniv-d1^) apiided ioiiuoo
ptide lmmunogen
(Camer and Adjuvant)
Anti-Human PCSK9 Humoral Responses
BALB/c Mouse Sera (OD
(was) Jaiii ieooidwea 601
Ãimuoeea GMSOd ueiunH
»05'5
-8Z'6
›-92'6
~6i`6
~8i'6
›-9'6
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ptide Immu nogen
(VLP conjugate + Alum + CpG)
. paieaiiun
Anti-Mouse PCSK9 Humoral Responses
BALB/c Mouse Sera (OD
ptide lmmunogen
(VLP conjugate + Alum + CpG)
~ 92'6
›- 22'6
› 62'6
- 92'6
› 92'6
›- 9215
m . apgidsd ioiiuog
...F paiesnun
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v Q 8 -m
0 &o _sira _g
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o 0000 -paieaiiun
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wma ”Sagma mîov :wa m›
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8:& ms 55, :E 83&
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37:00 L
Claims (4)
1. Bir iminünojenik tasiyiciya bagli en az bir anti jenik PCSK9 peptidi içeren bir immünojen; buradaki antijenik PCSK9 peptidi, seçilir ve burada adi geçen immünojenik tasiyici, Difteri Toksoidi, CRM197 veya HBcAg, HBsAg, Qbeta, PP7, PPV veya Norwalk Virüsü VLP”den seçilen bir VLP arasindan seçilir.
2. Istem 1°e göre bir immünojen; burada adi geçen immünojenik tasiyici, CRM197 veya Qbeta VLP arasindan seçilir.
3. 1 ila 2 arasi isteinlerden birine göre bir immünojen; buradaki 332,1iin olusturdugu gruptan seçilir.
4. 1 ila 3 istemlerinden birine göre immünojen; burada adi geçen anti jenik PCSK9 peptidi ayrica sunlardan birini de içerir: - C terminalinde, (G).,C, (G)nSC veya (G)nK formülüne sahip bir gruptan seçilen bir tamsayidir, - N termiiialinde, C(G)n, CS(G)n veya K(G)ll forinülüne sahip bir gruptan seçilen bir tamsayidir, - C terminalinde, (G)nC, (G)nSC veya (G),,K formülüne sahip bir gruptan seçilen bir tamsayidir; ve N terminalinde, C(G)n, CS(G)n veya K(G)11 formülüne sahip bir baglayici; buradaki n, 0, l, 2, 3, 4, 5, 6, 7, 8, 9 ve 10°un olusturdugu gruptan seçilen bir tamsayidir.
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