Abstract: To formulate amphiphilic pharmacological agents (in particular, amphiphilic immunopotentiators) in oil-in-water emulsions the invention provides an oil-in-water emulsion comprising an aqueous phase, an oil phase, a surfactant, and a phospholipid.

Abstract: High loading of lipophilic pharmacological agents (in particular, lipophilic immunopotentiators) in oil-in-water emulsions can result in crystallisation of the lipophilic agent. To overcome this problem the invention uses an oil-in-water emulsion in combination with a crystallisation inhibitor, and this combination provides emulsions which can be loaded with high levels of lipophilic pharmacological agents.

Abstract: When using squalene in a vaccine adjuvant, there is a possibility of contamination with polychlorinated biphenyls (PCBs). Environmental exposure to PCBs may adversely affect children's immune responses to routine vaccinations. Thus the invention uses squalene with low or no PCB contamination, particularly when derived from shark liver.

Abstract: An adjuvant composition comprising monophosphoryl lipid A or a derivative of monophposphoryl lipid A adsorbed onto an aluminium salt particle.

Abstract: A pharmaceutical composition comprising a lipid component; an amphiphilic emulsifier; and a polar liquid carrier. The lipid component and the amphiphilic emulsifier form free-moving lipid-carrying micelles (LMs) in the polar liquid carrier. The pharmaceutical composition is free of hemoglobin and fluorocarbon and can be used for treating conditions related to lack of blood supply and to raise the blood pressure.

Abstract: The invention relates to a pharmaceutical composition for the modulation of effector T cell responses made of one or more preparations and comprising a therapeutically effective dose of at least one recombinant human C3-derivative and of at least one antigen or allergen.

Abstract: The invention provides methods of cultivating microalgae photoautotrophically outdoors to prepare concentrated microalgae products containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) docosahexaenoic acid, two long-chain polyunsaturated fatty acids found in fish oil that are very important for human and animal health. It also provides concentrated microalgae products containing EPA and DHA and purified lipid products containing EPA and DHA purified from microalgae.

Abstract: The disclosure provides compositions relating to thermostable vaccines and methods of preparing same. Specifically, the disclosure provides for methods of preparing thermostable vaccines based on a recombinant ricin neurotoxin protein and uses of co-adjuvants to develop a composition capable of eliciting an immune response in a subject.

Abstract: This invention relates to adjuvant formulations comprising various combinations of triterpenoids, sterols, immunomodulators, polymers, and Th2 stimulators; methods for making the adjuvant compositions; and the use of the adjuvant formulations in immunogenic and vaccine compositions with different antigens. This invention further relates to the use of the formulations in the treatment of animals.

Abstract: Lipid conjugates for enhanced delivery of cargo to the lymph nodes are disclosed. The lipid conjugates typically include three domains: a lipophilic domain that binds to albumin, a polar block domain, and a cargo such as a molecular adjuvant or immunostimulatory compound (such as an oligonucleotide) or antigenic peptide. Depending on the cargo, the length and compositions of the polar block can be tailored to push the equilibrium toward albumin binding, stable micelle formation, or cell insertion. The conjugates can be administered to a subject, for example, a subject with cancer or an infection, to induce or enhance a robust immune response in the subject.

Abstract: Provided in some embodiments are compositions comprising a compound having a structure according to Formula A or Formula B: or a pharmaceutically acceptable salt, tautomer or hydrate thereof, where X2 is a bond or linker, X3 is bond or —PO4—, and X1, R1, R2, R3, and n are described herein. Also provided in some embodiments are methods for making and using such compounds and compositions.

Abstract: Essentially pure compounds of the formulas (I) to (XX) are provided. Compositions and methods for enhancing or stimulating an immune response are also provided. The compounds, provided are advantageous in that the compounds are essentially pure and free from contaminants encountered when such compounds are purified from natural sources.

Abstract: The present invention relates to the use of trisaccharide derivates comprising a substituted trisaccharide core, which trisaccharide core is fully substituted with fatty acid ester groups, and optionally one or more anionic groups as adjuvants, to the trisaccharide derivates as such, to a method for preparing such trisaccharides, to trisaccharides obtained with such method, to adjuvant compositions comprising such trisaccharide derivates and to a vaccine or kit comprising such adjuvant compositions.

Abstract: The present invention relates to compositions forming a low viscosity mixture of: a) at least one neutral diacyl lipid, such as a diacyl glycerol; b) at least one phospholipid, such as a phosphatidyl choline; c) at least one biotolerable solvent, such as an oxygen containing solvent; d) at least one GLP-1 analogue; wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The invention further relates to methods of treatment comprising administration of such compositions, especially in treating diabetes, and to pre-filled administration devices and kits containing the formulations.

Abstract: The invention relates to compositions including a substance useful as an adjuvant for potentiating an immune response, and methods of using the composition in individuals with infections of tissue within or adjacent to a transformation zone, such as the transformation zone of the cervix or anal canal.

Abstract: An influenza vaccine adjuvanted with a sub-micron oil-in-water emulsion elicits significantly higher immune responses in human pediatric populations. Compared to an existing unadjuvanted pediatric influenza vaccine, the adjuvanted vaccines provided herein can induce in children a longer persistence of high serum antibody titers and also longer seroconversion and seroprotection. The improvement in immune responses is seen for both influenza A virus and influenza B virus strains, but it is particularly marked for influenza B virus. Moreover, while the existing vaccine provides poor immunity in children after a single dose, the adjuvanted vaccine provides high seroprotection rates against the influenza A virus H3N2 subtype even after a single dose. Furthermore, the adjuvanted vaccine offers significantly better seroprotection against mismatched strains of influenza A virus.

Abstract: The disclosure provides adjuvants, immunogenic compositions, and methods useful for vaccination and immune response. In particular, the disclosure provides a class of adjuvants comprising cationic lipid:co-lipid mixtures and methods for delivering formulated compositions.

Abstract: Microparticles with adsorbent surfaces, methods of making such microparticles, and uses thereof, are disclosed. The microparticles comprise a polymer, such as a poly(?-hydroxy acid), a polyhydroxy butyric acid, a polycaprolactone, a polyorthoester, a polyanhydride, and the like, and are formed using cationic, anionic, or nonionic detergents. The surface of the microparticles efficiently adsorb biologically active macromolecules, such as DNA, polypeptides, antigens, and adjuvants. Also provided are compositions of an oil droplet emulsion having a metabolizable oil and an emulsifying agent. Immunogenic compositions having an immunostimulating amount of an antigenic substance, and an immunostimulating amount of an adjuvant composition are also provided.

Abstract: The present invention relates to a cationic lipid having one or more biodegradable groups located in a lipidic moiety (e.g., a hydrophobic chain) of the cationic lipid. These cationic lipids may be incorporated into a lipid particle for delivering an active agent, such as a nucleic acid. The invention also relates to lipid particles comprising a neutral lipid, a lipid capable of reducing aggregation, a cationic lipid of the present invention, and optionally, a sterol. The lipid particle may further include a therapeutic agent such as a nucleic acid.

Abstract: Microparticles with adsorbent surfaces, methods of making such microparticles, and uses thereof, are disclosed. The microparticles comprise a polymer, such as a poly(?-hydroxy acid), a polyhydroxy butyric acid, a polycaprolactone, a polyorthoester, a polyanhydride, and the like, and are formed using cationic, anionic, or nonionic detergents. The surface of the microparticles efficiently adsorb biologically active macromolecules, such as DNA, polypeptides, antigens, and adjuvants. Also provided are compositions of an oil droplet emulsion having a metabolizable oil and an emulsifying agent. Immunogenic compositions having an immunostimulating amount of an antigenic substance, and an immunostimulating amount of an adjuvant composition are also provided.

Abstract: This disclosure provides adjuvant compositions that are capable of modulating the immune response in a subject. These adjuvant compositions may also be used enhance the immunogenicity of antigens. Also provided are methods of making the adjuvant compositions as well as methods of using the adjuvant compositions.

Abstract: The invention provides provides immunogenic compositions comprising neoplastic cells expressing a cytokine (GM-CSF) formulated with at least one TLR agonist and methods of using the composition to induce or enhance an immune response.

Abstract: An improved method for the manufacture of an oil-in-water emulsion involves circulation of emulsion components between a first container and a second container via a homogenizer and/or via a microfluidization device. Usefully, all of the emulsion components from the first container are emptied before being returned.

Abstract: An improved method for the manufacture of an oil-in-water emulsion involves three procedures: (i) preparation of a preliminary emulsion; (ii) micro fluidization of the preliminary emulsion to reduce its droplet size; and (iii) filtration of the microfluidized emulsion through a hydrophilic membrane. The emulsions are useful as vaccine adjuvants.

Abstract: This disclosure provides adjuvant compositions that are capable of modulating the immune response in a subject. These adjuvant compositions may also be used enhance the immunogenicity of antigens. Also provided are methods of making the adjuvant compositions as well as methods of using the adjuvant compositions.

Abstract: The present invention provides processes for the production of a submicron oil in water emulsion comprising the steps of preparing a submicron oil in water emulsion; pre-filtering the oil in water emulsion through a first sterile grade filter and again filtering the oil in water emulsion through a second sterile grade filter.

Abstract: The present invention provides an immunogenic composition comprising one or more antigens and a Toll-like receptor (TLR) agonist in an orally (e.g. sublingually) administered composition.

Abstract: The present invention provides a process for the production of an oil in water emulsion comprising the steps of: a) dissolving a surfactant in a volume of water or aqueous solution to produce a surfactant solution; and b) diluting the surfactant solution in a volume of water or aqueous solution greater than the volume of the surfactant solution to produce an aqueous phase.

Abstract: Compositions and methods, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response are disclosed based on the discovery of useful immunological adjuvant properties in a synthetic, glucopyranosyl lipid adjuvant (GLA) that is provided in substantially homogeneous form. Chemically defined, synthetic GLA offers a consistent vaccine component from lot to lot without the fluctuations in contaminants or activity that compromise natural-product adjuvants. Also provided are vaccines and pharmaceutical compositions that include GLA and one or more of an antigen, a Toll-like receptor (TLR) agonist, a co-adjuvant and a carrier such as a pharmaceutical carrier.

Abstract: The disclosure provides adjuvants, immunogenic compositions, and methods useful for vaccination and immune response. In particular, the disclosure provides a class of adjuvants comprising cationic lipid:co-lipid mixtures and methods for delivering formulated compositions.

Abstract: A mucosal vaccine producing an antigen-specific mucosal IgA and a blood IgG in the levels capable of exerting an effective immune induction and an infection-preventing effect, which comprises: (a) an AD vehicle consisting of a synthetic peptide and a lipid(s), wherein the synthetic peptide consisting of the amino acid sequence KnLm (wherein n is 4 to 8 and m is 11 to 20); (b) a carboxylvinyl polymer; and, (c) an antigenic protein, in an amount incapable of producing a sufficient mucosal IgA and blood IgG for exerting an effective immune induction and an infection-preventing effect when used by itself. The mucosal vaccine of the invention has an antibody producing ability which is more potent than those of mucosal vaccines of the prior art, and as a result it can exert an excellent effect even with an extremely small amount of an antigen.

Abstract: A method for treating conditions related to lack of blood supply with a lipid based resuscitation fluid is disclosed. The resuscitation fluid contains a lipid component and an aqueous carrier. The lipid component forms an emulsion with the aqueous carrier. The resuscitation fluid can be used to increase the blood pressure and to carry oxygen to tissues. The resuscitation fluid can also be used for preserving the biological integrity of donor organs for transplantation.

Abstract: A method of reducing antifungal drug resistance in which Hsp inhibitors, such as Hsp90 inhibitors, are used.

Abstract: Compositions and methods are provided herein for improved dual immunization strategies that induce in a subject an immune response that includes a humoral immune response and cellular immune response, both CD4 and CD8 T lymphocyte immune responses, thereby providing a complete adaptive immune response to one or more antigens. The methods described are therefore useful for treating and/or preventing (i.e., reducing the likelihood or risk of occurrence) different diseases, disorders, and conditions such as cancers and infectious diseases for which induction of both a humoral immune response and cellular immune response is desired and beneficial.

Abstract: The invention relates to antigenic compositions and to methods for immunizing animals using same. The antigenic compositions comprise a lipid formulation most usually in solid form, and at least one antigenic component. A preferred antigenic component is a living organism. In a preferred embodiment the composition is formulated for oral administration.

Abstract: A vaccine adjuvant which, based on the 100% mass thereof, includes between 10% and 95% of a mineral oil containing: between 0.05 mass-% and 10 mass-% hydrocarbon chains having less than 16 carbon atoms, and between 0.05 mass-% and 5 mass-% hydrocarbon chains having more than 28 carbon atoms. In addition, the adjuvant has a P/N ratio, corresponding to the ratio of the mass quantity of the paraffinic hydrocarbon chains to the mass quantity of the naphthenic hydrocarbon chains, of between 2.5 and 3, the adjuvant being intended for the production of a vaccine composition to prevent coccidiosis.

Abstract: Compounds of formula wherein the variables are defined in the specification, are used in compositions which stimulate T cell responses.

Abstract: Provided herein are methods for inducing a specific immune response in a subject by administering to the subject an immunogenic composition comprising a recombinant expression vector, or a vector particle comprising the recombinant expression vector, which vector comprises a polynucleotide sequence that encodes an immunogen of interest. The methods further comprise administering an adjuvant composition either concurrently or sequentially with the immunogenic composition.

Abstract: An isolated caveolin containing vesicle comprising a caveolin protein and at least one lipid, wherein at least about 30% of the at least one lipid is selected from phosphatidylethanolamine and phosphatidylglycerol is disclosed. Also disclosed is a method of making an isolated caveolin containing vesicle, an isolated caveolin containing vesicle comprising a recombinant caveolin protein, an isolated caveolin containing delivery vesicle, a method of making an isolated caveolin containing delivery vesicle and a method of treatment of a disease or condition by delivery of a molecule using the isolated caveolin containing delivery vesicle.

Abstract: The treatment of disease in organisms using Macromolecular interaction modulators and Membrane active immunomodulators, particularly selected azelaic acid esters, individually and in combinations, to modulate communications between biological molecules.

Abstract: The present invention relates to liposome formulations that are physically stable. In particular the present invention relates to steric stabilization of cationic liposomes by incorporating glycolipids into the liposomes. The stabilized liposomes can be used either as an adjuvant for antigenic components or as a drug delivery system. In particular the invention relates to vaccines with adjuvants in aqueous media for immunization, where the final product is stable.

Abstract: Provided is an emulsified composition for diluting a cancer antigen peptide or a dimer thereof. Also provided is a novel cancer vaccine composition or specific CTL inducer that efficiently induces CTL irrespective of the type of cancer antigen peptide when mixing the emulsified composition for dilution and a water phase comprising a cancer antigen peptide or a dimer thereof. The present invention relates to an emulsified composition for diluting a cancer antigen peptide or a dimer thereof, comprising a particular ester, a particular surfactant, a particular emulsifier, and a water phase. The present invention also relates to a cancer vaccine composition or specific CTL inducer obtained by freshly diluting and mixing a water phase comprising a cancer antigen peptide or a dimer thereof with the emulsified composition for dilution.

Abstract: The present invention relates generally to the field of inflammatory diseases of the peripheral nervous system. More particularly, it concerns methods for treating inflammatory diseases of the peripheral nervous system by modulating sphingosine-1-phosphate receptor activity. In one embodiment, the present invention provides a method of treating a subject with chronic inflammatory demyelinating polyneuropathy (CIDP) or other autoimmune neuropathies comprising administering to the subject an effective amount of FTY720.

Abstract: When using squalene in a vaccine adjuvant, there is a possibility of contamination with polychlorinated biphenyls (PCBs). Environmental exposure to PCBs may adversely affect children's immune responses to routine vaccinations. Thus the invention uses squalene with low or no PCB contamination, particularly when derived from shark liver.

Abstract: The present invention relates to an adjuvant comprising a lipopeptide and poly I:C. When the adjuvant of the present invention is used, the level of antigen specific antibody induction is synergistically increased and Th1 type immune response is also induced. Therefore, the adjuvant of the present invention can be very effectively used as an adjuvant in the formulation of preventive and therapeutic vaccines for viral or parasitic infection and cancer.

Abstract: The present invention includes a lipid vesicle. The invention further relates to a method of treating and/or preventing a disease or disorder involving administering such a lipid vesicle to an animal in need thereof.

Abstract: The invention provides an isolated genetically modified non-mammalian organism, wherein the activity of acyl-CoA: sterol acyltransferase/sterol O-acyltransferase (EC 2.3.1.26) and/or diacylglycerol acyltransferase/diacylglycerol O-acyltranferase (EC 2.3.1.20) and/or lecithin cholesterol acyl transferase/phospholipid: diacylglycerol acyltransferase (EC 2.3.1.158) and/or acyl CoA-wax alcohol acyltransferase (EC 2.3.1.75) is reduced or abolished in comparison with a corresponding wildtype organism, methods of use of such an organism, shuttle vehicles for making such an organism and methods for producing such an organism.

Abstract: A method for treating conditions related to lack of blood supply with a lipid based resuscitation fluid is disclosed. The resuscitation fluid contains a lipid component and an aqueous carrier. The lipid component forms an emulsion with the aqueous carrier. The resuscitation fluid can be used to increase the blood pressure and to carry oxygen to tissues. The resuscitation fluid can also be used for preserving the biological integrity of donor organs for transplantation.

Abstract: Disclosed is a method of enhancing the immune response of an animal, including mammals and humans, to prevent or ameliorate immunoinflammatory diseases such as Inflammatory Bowel Disease, increase immune system development, maintain or increase CD4+ and CD8+ T lymphocyte levels, increase immune function, increase immune response against viruses and prevent or ameliorate the Metabolic Syndrome, Type 2 diabetes and obesity by administering orally or parenterally a therapeutically effective amount of punicic acid to the animal.

Abstract: The present invention relates to compositions and methods for preparing gamma-linoleic acid (GLA) in safflower plants, particularly from seeds of safflower. Nucleic acid sequences and constructs encoding one or more fatty acid desaturase sequences are used to generate transgenic safflower plants that contain and express one or more of these sequences and produce high levels of GLA in safflower seeds. Provided are transgenic safflower plants and seeds that produce high levels of GLA. Additionally provided are oils produced from seeds of this invention. The invention also relates to methods of treating a variety of diseases including nervous system disorders, inflammatory conditions, cancer and cardiovascular disorders using the oils of this invention.