1C31 nanoparticles

• US 8,765,148 B2
• Filed: 02/21/2011
• Issued: 07/01/2014
• Est. Priority Date: 02/19/2010
• Status: Expired due to Fees

• Current Assignee: Valneva Austria Gmbh (Valneva SE)
• Original Assignee: Valneva Austria Gmbh (Valneva SE)
• Inventors: Wizel, Benjamin, Riedl, Karin, Lingnau, Karen, Schlosser, Ursula, Weber, Michael, Paucz, Ljubomir, Klade, Christoph, Look, Jee Loon, Ruiz, Christian, Seid, Robert, Wruss, Jrgen, Schlegl, Robert, Reinisch, Christoph
• Primary Examiner(s): Park, H. Sarah
• Application Number:
  US13/578,686
• Publication Number:
  US 20120308618A1
• Time in Patent Office: 1,226 Days
• Field of Search: None
• US Class Current: 424/278.1
• CPC Class Codes: A61K 2039/55516 Proteins; Peptides
• CPC Class Codes: A61K 2039/55555 Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
• CPC Class Codes: A61K 2039/55561 CpG containing adjuvants; Oligonucleotide containing adjuvants
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 39/0011 Cancer antigens
• CPC Class Codes: A61K 39/092 Streptococcus
• CPC Class Codes: A61K 39/118 Chlamydiaceae, e.g. Chlamydia trachomatis or Chlamydia psittaci
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61K 39/40 bacterial
• CPC Class Codes: A61K 39/42 viral
• CPC Class Codes: A61K 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61K 9/51 Nanocapsules; Nanoparticles; nanotubes A61K9/0092; polymeric micelles A61K9/1075; polymersomes A61K9/1273; pure drug nanoparticles A61K9/14; drug nanoparticles with adsorbed surface modifiers A61K9/141; conjugates, e.g. between drug and non-active nanoparticles, A61K47/50; preparations for in vivo diagnosis A61K49/00; with radioactive substances A61K51/00
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/10 : Antimycotics
• CPC Class Codes: A61P 31/14 : for RNA viruses
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 31/20 : for DNA viruses
• CPC Class Codes: A61P 31/22 : for herpes viruses
• CPC Class Codes: A61P 33/00 : Antiparasitic agents
• CPC Class Codes: A61P 33/02 : Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: C12N 2760/16134 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16171 : Demonstrated in vivo effect
• CPC Class Codes: C12N 2760/16234 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 7/00 : Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention discloses pharmaceutical compositions in liquid form comprising a peptide with the amino acid sequence KLKL₅KLK and an oligodeoxynucleotide with the nucleic acid sequence (dIdC)₁₃ and wherein the peptide and the oligodeoxynucleotide are present as sterile-filterable nanoparticles in the composition, thereby forming a suspension, characterized in that the mean particle size of the solid particles is less than 1 μm.

Claims

1. Pharmaceutical composition in an aqueous mixture form comprising a peptide with the amino acid sequence KLKL₅KLK (SEQ ID NO:

1) and an oligodeoxynucleotide with the nucleic acid sequence (dIdC)₁₃ (SEQ ID NO;

2) wherein the peptide and the oligodeoxynucleotide are present as stable complexes, characterized in that

the peptide is present at a concentration of at least 100 nmol/mL and the oligodeoxynucleotide is present at a concentration of at least 4 nmol/mL,

molar ratio of the peptide to the oligodeoxynucleotide is between 20;

1 and 50;

1,

mean particle size of the stable complexes comprising the peptide and the oligodeoxynucleotide is less than 1 μ

m,

sodium ion concentration is from 0 to 25 mM,

the composition optionally comprises Ca2+ ions, phosphate ions, citrate ions, or acetate ions at a concentration of less than 1 mM each,

the composition comprises 3 to 10 mM of Tris (Tris(hydroxymethyl)aminomethane) buffer with a pH of 6 to 7.2, 3 to 20 mM of Histidine buffer with a pH of 6 to 7, or 5 to 10 mM of ammonium bicarbonate buffer with a pH of 7 to 8,

optionally, the composition has a viscosity less than 15 cP, and

optionally, the composition is sterile.

2. Composition according to claim 1, characterized in that the pharmaceutical composition is a vaccine and contains an antigen.

3. Composition according to claim 1, characterized in that the pharmaceutical composition contains an antigen of a human pathogen.

4. Composition according to claim 1, characterized in that the pharmaceutical composition contains one or more carbohydrates.

5. Composition according to claim 3, wherein the antigen is derived from Influenza virus, Hepatitis A, B or C virus (HAV, HBV, HCV), Human Papilloma virus (HPV), Human Immunodeficiency virus (HIV), Herpes Simplex virus (HSV), Parvovirus B19, Tick Borne Encephalitis virus (TBEV), Dengue virus (DENY), Japanese Encephalitis virus (JEV), West Nile virus (WNV), Yellow Fever virus (YFV), Cytomegalovirus (CMV), Mycobacterium tuberculosis, Staphylococcus aureus, Staphylococcus epidermidis, Helicobacter pylori, Streptococcus pyogenes, Streptococcus agalactiae, Chlamydia pneumoniae, Chlamydia trachomatis, Streptococcus pneumoniae, Klebsiella pneumoniae, Neisseria meningitidis, Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, Haemophilus influenzae, Moraxella catarrhalis, Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Clostridium difficile, Shigella flexneri, Campylobacter jejuni, Plasmodium falciparum, Plasmodium vivax, Aspergillus spp. or Candida albicans.

6. The pharmaceutical composition according to claim 2, wherein the antigen is a peptide or a polypeptide.

7. The pharmaceutical composition according to claim 3, wherein the antigen of a human pathogen is from a virus, a bacterium, a fungus or a parasite.

8. The pharmaceutical composition according to claim 7, wherein the antigen of a human pathogen is selected from the group comprising a CD8+ CTL peptide, a CD4+ Th peptide, a polypeptide, a protein, a glycoprotein, a lipoprotein, a virus particle and a whole cell or a subunit thereof.

9. The pharmaceutical composition according to claim 4, wherein the one or more carbohydrates are sucrose and/or sorbitol.

10. The pharmaceutical composition according to claim 1, wherein the composition is sterilized by filtration.