Dose selection of adjuvanted synthetic nanocarriers

• US 9,764,031 B2
• Filed: 05/20/2015
• Issued: 09/19/2017
• Est. Priority Date: 05/26/2010
• Status: Expired due to Fees

• Current Assignee: Selecta Biosciences, Inc. (Cartesian Therapeutics, Inc.)
• Original Assignee: Selecta Biosciences, Inc. (Cartesian Therapeutics, Inc.)
• Inventors: Ilyinskii, Petr, Lipford, Grayson B., Zepp, Charles
• Primary Examiner(s): STANFIELD, CHERIE MICHELLE
• Application Number:
  US14/717,451
• Publication Number:
  US 20150328309A1
• Time in Patent Office: 853 Days
• CPC Class Codes: A61K 2039/54 characterised by the route of administration
• CPC Class Codes: A61K 2039/541 Mucosal route
• CPC Class Codes: A61K 2039/542 oral/gastrointestinal
• CPC Class Codes: A61K 2039/543 intranasal
• CPC Class Codes: A61K 2039/555 characterised by a specific combination antigen/adjuvant
• CPC Class Codes: A61K 2039/55511 Organic adjuvants
• CPC Class Codes: A61K 2039/55522 Cytokines; Lymphokines; Interferons
• 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 2039/6093 Synthetic polymers, e.g. polyethyleneglycol [PEG], Polymers or copolymers of (D) glutamate and (D) lysine
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/4745 condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48
• CPC Class Codes: A61K 31/7115 Nucleic acids or oligonucleotides having modified bases, i.e. other than adenine, guanine, cytosine, uracil or thymine
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 39/0005 Vertebrate antigens from snakes A61K39/38
• CPC Class Codes: A61K 39/0013 Therapeutic immunisation against small organic molecules, e.g. cocaine, nicotine
• CPC Class Codes: A61K 39/35 Allergens
• CPC Class Codes: A61K 39/385 Haptens or antigens, bound to carriers
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/02 : Inorganic compounds
• CPC Class Codes: A61K 47/22 : Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 47/24 : containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 47/58 : obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
• CPC Class Codes: A61K 47/593 : Polyesters, e.g. PLGA or polylactide-co-glycolide
• CPC Class Codes: A61K 47/60 : the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
• CPC Class Codes: A61K 47/646 : the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
• CPC Class Codes: A61K 47/68 : the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
• CPC Class Codes: A61K 47/6921 : the form being a particulate, a powder, an adsorbate, a bead or a sphere
• CPC Class Codes: A61K 47/6929 : the form being a nanoparticle, e.g. an immuno-nanoparticle
• CPC Class Codes: A61K 47/6931 : the material constituting the nanoparticle being a polymer
• CPC Class Codes: A61K 9/5153 : Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: A61P 1/16 : for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 : Antiasthmatics
• CPC Class Codes: A61P 11/08 : Bronchodilators
• CPC Class Codes: A61P 17/00 : Drugs for dermatological disorders
• CPC Class Codes: A61P 17/04 : Antipruritics
• CPC Class Codes: A61P 25/28 : 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
• CPC Class Codes: A61P 25/30 : for treating abuse or dependence
• CPC Class Codes: A61P 25/34 : Tobacco-abuse
• CPC Class Codes: A61P 25/36 : Opioid-abuse
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/00 : Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• 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 31/12 : Antivirals
• CPC Class Codes: A61P 31/14 : for RNA viruses
• CPC Class Codes: A61P 31/16 : for influenza or rhinoviruses
• CPC Class Codes: A61P 31/20 : for DNA viruses
• CPC Class Codes: A61P 31/22 : for herpes viruses
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/04 : Immunostimulants
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 39/02 : Antidotes
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/00 : Drugs for disorders of the endocrine system
• 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

Disclosed are synthetic nanocarrier compositions with coupled adjuvant compositions as well as related methods.

Claims

1. A method comprising:

providing a dose of adjuvant and a dose of antigen, wherein at least a portion of the dose of adjuvant is coupled to synthetic nanocarriers,

generating an antibody titer against the antigen through administration of the dose of adjuvant and the dose of antigen to a subject, and

choosing the dose of adjuvant to be less than a separate dose of adjuvant that results in an antibody titer similar to that generated through administration of the dose of adjuvant and the dose of antigen to the subject.

2. The method of claim 1, wherein the adjuvant comprises an agonist for Toll-Like Receptors 3, 4, 5, 7, 8, or 9 or a combination thereof.

3. The method of claim 2, wherein the adjuvant comprises an agonist for Toll-Like Receptors 3, an agonist for Toll-Like Receptors 7 and 8, or an agonist for Toll-Like Receptor 9.

4. The method of claim 3, wherein the adjuvant comprises R848, immunostimulatory DNA, or immunostimulatory RNA.

5. The method of claim 1, wherein the dose of adjuvant comprises two or more types of adjuvants.

6. The method of claim 1, wherein a portion of the dose of adjuvant is not coupled to the synthetic nanocarriers.

7. The method of claim 1, wherein more than one type of antigen are administered to the subject.

8. The method of claim 1, wherein at least a portion of the dose of antigen(s) is coupled to the synthetic nanocarriers.

9. The method of claim 1, wherein at least a portion of the dose of antigen(s) is not coupled to the synthetic nanocarriers.

10. The method of claim 1, wherein at least a portion of the dose of antigen(s) is coadministered with the synthetic nanocarriers.

11. The method of claim 1, wherein at least a portion of the dose of antigen(s) is not coadministered with the synthetic nanocarriers.

12. The method of claim 1, wherein the antigen(s) comprise a B cell antigen and/or a T cell antigen.

13. The method of claim 12, wherein the T cell antigen comprises a T-helper cell antigen.

14. The method of claim 1, wherein the antigen(s) comprise a B cell antigen or a T cell antigen and a T-helper cell antigen.

15. The method of claim 1, wherein the administration is by a route that comprises subcutaneous, intramuscular, intradermal, oral, intranasal, transmucosal, rectal;

ophthalmic, transdermal or transcutaneous administration, or a combination thereof.

16. The method of claim 1, wherein the synthetic nanocarriers comprise lipid nanoparticles, polymeric nanoparticles, metallic nanoparticles, surfactant-based emulsions, dendrimers, buckyballs, nanowires, virus-like particles, peptide or protein particles, nanoparticles that comprise a combination of nanomaterials, spheroidal nanoparticles, cuboidal nanoparticles, pyramidal nanoparticles, oblong nanoparticles, cylindrical nanoparticles, or toroidal nanoparticles.

17. The method of claim 1, wherein the synthetic nanocarriers comprise one or more polymers.

18. The method of claim 17, wherein the one or more polymers comprise a polyester.