WO2018175633A1 - Procédés d'induction de réponses immunitaires antipaludiques et compositions associées - Google Patents

Procédés d'induction de réponses immunitaires antipaludiques et compositions associées Download PDF

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Publication number
WO2018175633A1
WO2018175633A1 PCT/US2018/023628 US2018023628W WO2018175633A1 WO 2018175633 A1 WO2018175633 A1 WO 2018175633A1 US 2018023628 W US2018023628 W US 2018023628W WO 2018175633 A1 WO2018175633 A1 WO 2018175633A1
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WO
WIPO (PCT)
Prior art keywords
hepcidin
composition
seq
mini
subject
Prior art date
Application number
PCT/US2018/023628
Other languages
English (en)
Inventor
Lakhmir Chawla
Sanjeev Krishna
Original Assignee
La Jolla Pharmaceutical Company
St. George's Hospital Medical School D.B.A. St. George's, University Of London
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by La Jolla Pharmaceutical Company, St. George's Hospital Medical School D.B.A. St. George's, University Of London filed Critical La Jolla Pharmaceutical Company
Publication of WO2018175633A1 publication Critical patent/WO2018175633A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • A61P33/02Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
    • A61P33/06Antimalarials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/12Ketones
    • A61K31/122Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/136Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/357Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/366Lactones having six-membered rings, e.g. delta-lactones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/47064-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4709Non-condensed quinolines and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/473Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/65Tetracyclines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/002Protozoa antigens
    • A61K39/015Hemosporidia antigens, e.g. Plasmodium antigens
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/52Bacterial cells; Fungal cells; Protozoal cells
    • A61K2039/522Bacterial cells; Fungal cells; Protozoal cells avirulent or attenuated
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the malaria vaccine is administered to the subject and, after a period of time, the chemoprophylaxis is administered to the subject.
  • the chemoprophylaxis is administered to a subject who develops malaria after treatment with the vaccine (e.g., to avoid treating subjects who successfully develop an immune response and/or eradicate the administered Plasmodium falciparum).
  • the hepcidin or mini-hepcidin and the malaria vaccine are in the same composition.
  • the hepcidin or mini-hepcidin and the malaria vaccine are in separate compositions and may be administered at the same time or sequentially.
  • A10 is L-Cys, L-Ser, L-Ala, D-Cys, D-Ser, or D-Ala;
  • the malaria vaccine further comprises an adjuvant and a pharmaceutically acceptable carrier.
  • adjuvant refers to an agent that stimulates the immune system and increases the response to a vaccine.
  • Vaccine adjuvants are well-known to those of skill in the art.
  • carrier refers to an ingredient other than the active component(s) in a formulation. The choice of carrier will to a large extent depend on factors such as the particular mode of administration or application, the effect of the carrier on solubility and stability, and the nature of the dosage form. Pharmaceutically acceptable carriers for polypeptide antigens are well known in the art.
  • the subject is further administered a malarial chemoprophylaxis (e.g., chloroquine, tetracycline, proguanil, chlorproguanil, pyronaridine, lumefantrinel, mefloquine, dapsone, atovaquone, artesunate and artemisinin).
  • the malaria vaccine may comprise a radiation attenuated PfSPZ.
  • the composition disclosed herein may be administered at the same time or sequentially.
  • the malaria vaccine may comprise a chemoattenuated PfSPZ vaccine.
  • materials which can serve as pharmaceutically-acceptable carriers include: (1) sugars, such as lactose, glucose and sucrose; (2) starches, such as corn starch and potato starch; (3) cellulose, and its derivatives, such as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate; (4) powdered tragacanth; (5) malt; (6) gelatin; (7) talc; (8) excipients, such as cocoa butter and suppository waxes; (9) oils, such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; (10) glycols, such as propylene glycol; (11) polyols, such as glycerin, sorbitol, mannitol and polyethylene glycol; (12) esters, such as ethyl oleate and ethyl laurate; (13) agar; (14) buffering agents, such as magnesium hydroxide and aluminum hydrox
  • Treating" a disease in a subject or “treating” a subject having a disease refers to subjecting the subject to a pharmaceutical treatment, e.g., the administration of a drug, such that at least one symptom of the disease is decreased or prevented from worsening.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Toxicology (AREA)
  • Microbiology (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne des méthodes et des compositions pour vacciner des sujets contre la malaria, ou sinon favoriser le développement d'une réponse immunitaire contre Plasmodium falciparum. Selon certains aspects, l'invention concerne des compositions comprenant un vaccin antipaludique et de l'hepcidine ou une mini-hepcidine.
PCT/US2018/023628 2017-03-22 2018-03-21 Procédés d'induction de réponses immunitaires antipaludiques et compositions associées WO2018175633A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762474894P 2017-03-22 2017-03-22
US62/474,894 2017-03-22

Publications (1)

Publication Number Publication Date
WO2018175633A1 true WO2018175633A1 (fr) 2018-09-27

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2018/023628 WO2018175633A1 (fr) 2017-03-22 2018-03-21 Procédés d'induction de réponses immunitaires antipaludiques et compositions associées

Country Status (1)

Country Link
WO (1) WO2018175633A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010065815A2 (fr) * 2008-12-05 2010-06-10 The Regents Of The University Of California Mini peptides d'hépcidine et leurs procédés d'utilisation
WO2010083111A1 (fr) * 2009-01-16 2010-07-22 Sanaria Inc. Plasmodium purifié et compositions de vaccin
WO2015157283A1 (fr) * 2014-04-07 2015-10-15 Merganser Biotech Llc Peptides mimétiques d'hepcidine et utilisations desdits peptides
WO2017120419A1 (fr) * 2016-01-08 2017-07-13 La Jolla Pharmaceutial Company Procédés d'administration d'hepcidine
WO2018048944A1 (fr) * 2016-09-06 2018-03-15 La Jolla Pharmceutical Company Méthodes de traitement d'une surcharge en fer

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010065815A2 (fr) * 2008-12-05 2010-06-10 The Regents Of The University Of California Mini peptides d'hépcidine et leurs procédés d'utilisation
WO2010083111A1 (fr) * 2009-01-16 2010-07-22 Sanaria Inc. Plasmodium purifié et compositions de vaccin
WO2015157283A1 (fr) * 2014-04-07 2015-10-15 Merganser Biotech Llc Peptides mimétiques d'hepcidine et utilisations desdits peptides
WO2017120419A1 (fr) * 2016-01-08 2017-07-13 La Jolla Pharmaceutial Company Procédés d'administration d'hepcidine
WO2018048944A1 (fr) * 2016-09-06 2018-03-15 La Jolla Pharmceutical Company Méthodes de traitement d'une surcharge en fer

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
PORTUGAL , S. ET AL.: "Host-mediated regulation of superinfection in malaria", NATURE MEDICINE, vol. 17, no. 6, 15 May 2011 (2011-05-15), pages 732 - 737, XP055544040, Retrieved from the Internet <URL:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4200394/pdf/nihms330622.pdf> [retrieved on 20180517] *
PRENTICE, ANDREW M. ET AL.: "Iron and malaria interactions: research needs from basic science to global policy", ADVANCES IN NUTRITION, vol. 3.4, 6 July 2012 (2012-07-06), pages 583 - 591, XP055544038, Retrieved from the Internet <URL:https://academic.oup.com/advances/article/3/4/583/4591520><doi:10.3945/an.111.001230> [retrieved on 20180517] *
WANG, HAI-ZHEN ET AL.: "Hepcidin is regulated during blood-stage malaria and plays a protective role in malaria infection", JOURNAL OF IMMUNOLOGY, 14 November 2011 (2011-11-14), pages 6410 - 6416, XP055494691, Retrieved from the Internet <URL:https://pdfs.semanticscholar.org/1362/3fb3771277e05fb649155cfcab4af6fdlc81.pdf> [retrieved on 20180517] *
YA-QUN, F. A. N. G. ET AL.: "In vivo antimalarial activity of synthetic hepcidin against Plasmodium berghei in mice", CHINESE JOURNAL OF NATURAL MEDICINES, vol. 15.3, 20 March 2017 (2017-03-20), pages 161 - 167, XP029978743, Retrieved from the Internet <URL:https://www.sciencedirect.com/science/article/pii/S1875536417300328> [retrieved on 20180521] *

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