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1. (WO2018079702) LACTOFERRIN/ALBUMIN FUSION PROTEIN AND PRODUCTION METHOD THEREFOR
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Pub. No.: WO/2018/079702 International Application No.: PCT/JP2017/038866
Publication Date: 03.05.2018 International Filing Date: 27.10.2017
IPC:
C12N 15/09 (2006.01) ,A01K 67/027 (2006.01) ,A61K 38/38 (2006.01) ,A61K 38/40 (2006.01) ,A61P 9/10 (2006.01) ,A61P 35/00 (2006.01) ,A61P 39/04 (2006.01) ,A61P 43/00 (2006.01) ,C07K 14/765 (2006.01) ,C07K 14/79 (2006.01) ,C07K 19/00 (2006.01) ,C12N 1/15 (2006.01) ,C12N 1/19 (2006.01) ,C12N 1/21 (2006.01) ,C12N 5/10 (2006.01) ,C12P 21/02 (2006.01)
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15
Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09
Recombinant DNA-technology
A HUMAN NECESSITIES
01
AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
K
ANIMAL HUSBANDRY; CARE OF BIRDS, FISHES, INSECTS; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
67
Rearing or breeding animals, not otherwise provided for; New breeds of animals
027
New breeds of vertebrates
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
16
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17
from animals; from humans
38
Albumins
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
16
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17
from animals; from humans
40
Transferrins, e.g. lactoferrins, ovotransferrins
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
9
Drugs for disorders of the cardiovascular system
10
for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Antineoplastic agents
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
39
General protective or antinoxious agents
04
Chelating agents
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
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SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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Drugs for specific purposes, not provided for in groups A61P1/-A61P41/108
C CHEMISTRY; METALLURGY
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ORGANIC CHEMISTRY
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PEPTIDES
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435
from animals; from humans
76
Albumins
765
Serum albumin, e.g. HSA
C CHEMISTRY; METALLURGY
07
ORGANIC CHEMISTRY
K
PEPTIDES
14
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
435
from animals; from humans
79
Transferrins, e.g. lactoferrins, ovotransferrins
C CHEMISTRY; METALLURGY
07
ORGANIC CHEMISTRY
K
PEPTIDES
19
Hybrid peptides
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MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
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Micro-organisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving micro-organisms or compositions thereof; Processes of preparing or isolating a composition containing a micro-organism; Culture media therefor
14
Fungi; Culture media therefor
15
modified by introduction of foreign genetic material
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1
Micro-organisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving micro-organisms or compositions thereof; Processes of preparing or isolating a composition containing a micro-organism; Culture media therefor
14
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16
Yeasts; Culture media therefor
19
modified by introduction of foreign genetic material
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1
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20
Bacteria; Culture media therefor
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modified by introduction of foreign genetic material
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Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
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21
Preparation of peptides or proteins
02
having a known sequence of two or more amino acids, e.g. glutathione
Applicants:
株式会社NRLファーマ NRL PHARMA, INC. [JP/JP]; 神奈川県川崎市高津区坂戸3-2-1 KSP東棟 East Bldg. KSP, 3-2-1, Sakado, Takatsu-ku, Kawasaki-shi, Kanagawa 2130012, JP
Inventors:
佐藤 淳 SATO Atsushi; JP
加賀谷 伸治 KAGAYA Shinji; JP
Agent:
小林 浩 KOBAYASHI Hiroshi; JP
今里 崇之 IMAZATO Takayuki; JP
鈴木 康仁 SUZUKI Yasuhito; JP
Priority Data:
2016-21207728.10.2016JP
2017-04489309.03.2017JP
Title (EN) LACTOFERRIN/ALBUMIN FUSION PROTEIN AND PRODUCTION METHOD THEREFOR
(FR) PROTÉINE DE FUSION LACTOFERRINE/ALBUMINE ET SON PROCÉDÉ DE PRODUCTION
(JA) ラクトフェリン/アルブミン融合タンパク質及びその製造方法
Abstract:
(EN) The present invention provides a lactoferrin fusion protein having high clinical utility and a production method therefor. The present invention further provides: a lactoferrin fusion protein that retains the biological activity of native lactoferrin while having a significantly extended in vivo life span, and that has more clinical utility than native lactoferrin and recombinant lactoferrin; and a production method therefor. With this fusion protein or a variant thereof, the ability of lactoferrin to bind iron is retained, and therefore at least the important biological activity of lactoferrin that is based on the iron-binding ability is retained. Additionally, this fusion protein or variant thereof has bioavailability and resistance to protease, and thus can exhibit biological activity in vivo over a long period. Furthermore, this fusion protein is not easily broken down by pepsin in the stomach.
(FR) La présente invention concerne une protéine de fusion lactoferrine présentant une utilité clinique élevée et son procédé de production. La présente invention concerne en outre : une protéine de fusion lactoferrine qui conserve l'activité biologique de la lactoferrine d'origine naturelle tout en présentant une durée de vie in vivo significativement étendue, et qui présente plus d'utilité clinique que la lactoferrine d'origine naturelle et la lactoferrine recombinante; et son procédé de production. Grâce à cette protéine de fusion ou son variant, la capacité de la lactoferrine à se lier au fer est conservée, et par conséquent au moins l'activité biologique importante de la lactoferrine qui est basée sur la capacité de liaison au fer est conservée. De plus, cette protéine de fusion ou son variant présente une biodisponibilité et une résistance à la protéase, et ainsi peut faire preuve d'activité biologique in vivo sur une longue durée. En outre, cette protéine de fusion n'est pas facilement décomposée par la pepsine dans l'estomac.
(JA) 本発明は、臨床的有用性の高いラクトフェリン融合タンパク質及びその製造方法等を提供する。さらに、本発明は、天然ラクトフェリンの生物活性を保持し体内寿命が有意に延長されており、天然ラクトフェリン及び遺伝子組換え型ラクトフェリンよりも臨床的有用性に優れるラクトフェリン融合タンパク質及びその製造方法等を提供する。本発明の融合タンパク質はその改変体は、ラクトフェリンが有する鉄の結合能が保持されており、したがって、少なくとも鉄結合能に基づくラクトフェリンの重要な生物活性が保持されている。また、生体学的利用能、プロテアーゼに対する抵抗性を有しているため、体内で長時間にわたって生物活性を発揮することができる。さらに、本発明の融合タンパク質は、胃でのペプシンによる消化分解を受けにくくなるという特徴を有する。
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Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: Japanese (JA)
Filing Language: Japanese (JA)