Abstract: The present invention includes compositions and methods for treating a breast cancer cell, a metastatic breast cancer cell, or a triple negative breast cancer cell comprising: identifying a subject in need for treatment for a breast cancer cell, a metastatic breast cancer cell, or a triple negative breast cancer cell; and administering a therapeutically effective amount of a formulation that leads to the presentation of an immunogenic SP17 protein or peptide antigen on an antigen presenting cell to activate T cells that are SP17-specific T cells, wherein the SP17-specific T cells impair the growth of the breast cancer cell, the metastatic breast cancer cell, or the triple negative breast cancer cell growth.

Abstract: Provided is a method for inducing immunity for therapy of a cancer(s). The method includes the step of administering to an individual with cancer at least one polypeptide selected from the polypeptides (a) or (b) below, and/or a recombinant vector(s) that comprise(s) a polynucleotide(s) encoding the at least one polypeptide, the recombinant vector(s) being capable of expressing the polypeptide(s) in vivo: (a) a polypeptide in any one of the amino acid sequences of SEQ ID NOs: 2, 4, 8, 10 and 12; and (b) a polypeptide having a sequence identity of not less than 95% to the polypeptide (a).

Abstract: Methods of neutralizing circulating antibody and mitigating the risk of clinically significant adverse responses to incompatible transfusions and transplantations are described. The methods comprise the administration to the subject of dispersible antigen-lipid constructs.

Abstract: Methods of producing purified clostridial toxin comprising tangential flow filtration, hydrophobic interaction chromatography and anion exchange chromatography are disclosed. These methods provide good yields of C. difficile toxin having a purity of about 90% or greater. Highly purified Clostridial toxins, toxoids (e.g., prepared by inactivating the toxin as disclosed herein) and compositions comprising these toxins and/or toxoids are also disclosed. Methods of using the purified toxins and/or toxoids for example, to elicit an immune response against Clostridium (e.g., C. difficile) are also disclosed.

Abstract: In one aspect, the invention relates to an isolated polypeptide comprising an amino acid sequence that is at least 95% identical to SEQ ID NO: 71. In another aspect, the invention relates to an immunogenic composition including an isolated non-lipidated, non-pyruvylated ORF2086 polypeptide from Neisseria meningitidis serogroup B, and at least one conjugated capsular saccharide from a meningococcal serogroup.

Abstract: The present invention provides an immunogenic composition capable of eliciting an immune response when administered to a human or non-human animal, wherein the composition comprises an isolated protein with one or more of the following properties: i) about 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or more percent sequence identity to the protein of SEQ ID No: 1 or a fragment, derivative or analog thereof; ii) is a modified factor H binding protein, wherein the factor H binding protein has been modified at least at the position equivalent to position 318 as defined in FIG. 6 (SEQ ID No: 2); iii) does not bind to factor H; and iv) the immune response elicited is cross reactive with two or more of variant 1 factor H binding protein, variant 2 factor H binding protein and variant 3 factor H binding protein from N. meningitidis; and uses thereof.

Abstract: The invention provides proteins from Neisseria meningitidis, including the amino acid sequences and the corresponding nucleotide sequences. The proteins are predicted to be useful antigens for vaccines and/or diagnostics.

Abstract: A composition comprising (a) Neisseria meningitidis serogroup B outer membrane vesicles (OMVs), and (b) an immunogenic component selected from other Neisseria proteins, or immunogenic fragments thereof. Component (b) preferably includes a protein from a different NmB strain from that from which the OMV of component (a) is derived. The OMVs are preferably obtained by deoxycholate extraction. Optionally, the composition may also comprise a protective antigen against other pathogens.

Abstract: Disclosed are compositions and methods comprising vectors and a reverse genetics competent unit comprising one or more recombinant influenza viruses. Recombinant influenza viruses comprising swine RNA polymerase I promoter are disclosed. Constructs comprising swine RNA polymerase I promoter nucleic acid sequences are also provided. Methods of inducing protecting immunity with the recombinant influenza viruses are disclosed. In certain embodiments, the reverse genetics competent unit comprises pathogenic units necessary for producing pathogens de novo from a nucleotide-based vector for influenza virus in swine.

Abstract: Provided herein are nucleic acid sequences that encode novel consensus amino acid sequences of HA hemagglutinin, as well as genetic constructs/vectors and vaccines expressing the sequences. Also provided herein are methods for generating an immune response against one or more Influenza A serotpyes using the vaccines that are provided.

Abstract: In certain embodiments, the disclosure relates to the polynucleotide sequences of respiratory syncytial virus (RSV). In certain embodiments, the disclosure relates to isolated or recombinant nucleic acids and polypeptides comprising desirable nucleic acid sequences and mutations disclosed herein. In certain embodiments, isolated or recombinant RSV comprising the nucleic acids and polypeptides disclosed herein (e.g., attenuated recombinant RSV) are also provided, as are immunogenic compositions including such nucleic acids, polypeptides, and RSV genomes that are suitable for use as vaccines. Attenuated or killed RSV containing these nucleic acids and mutation in the form of copied nucleic acids (e.g., cDNAs) are also contemplated.

Abstract: Disclosed are compositions, vectors, kits, and methods for inducing an immune response against avian infectious bronchitis virus (IBV). In particular, the compositions, vectors, kits, and methods may be utilized to immunize poultry against disease associated with IBV infection or to protect poultry from IBV infection altogether.

Abstract: The invention relates to compositions and methods for inducing a protective immune response against a poxvirus in a human neonate or infant of less than 6 months of age. The invention encompasses administering a single high dose of an MVA to a human neonate or infant of less than 6 months of age, wherein the administration induces protective T- and B-cell responses against a poxvirus in the human neonate or infant.

Abstract: The present invention relates to a poxvirus vector comprising a nucleic acid sequence encoding a fusion protein comprising: (i) a peanut allergen selected from list consisting of at least two peanut allergens from ara h 1, ara h 2, ara h 3, ara h 4, ara h 5, ara h 6. ara h 7, ara h 8, ara h 9, ara h I O and ara h I I or a derivative or part thereof having at least 70% sequence identity thereto, and (ii) a profeasome degradation tag to enhance intracellular degradation of the fusion protein. Methods of desensitizing or inducing tolerance to a peanut allergen and/or suppressing an allergic response to a peanut allergen are also disclosed.

Abstract: Allergen preparation comprising an allergen in an oil-in-water emulsion.

Abstract: Disclosed are synthetic nanocarrier compositions, and related methods, comprising immunosuppressants and MHC Class II-restricted epitopes of an allergen that provide tolerogenic immune responses specific to the allergen.

Abstract: Disclosed are synthetic nanocarrier methods, and related compositions, comprising administering MHC Class I-restricted and/or MHC Class II-restricted epitopes of an antigen and immunosuppressants in order to generate tolerogenic immune responses against the antigen, such as the generation of antigen-specific CD8+ regulatory T cells.

Abstract: The present invention discloses liquid stable bovine vaccines that comprise a live attenuated virus, and a sugar alcohol. The present invention also discloses the manufacture of such vaccines and methods of protecting an animal by administration of such vaccines.

Abstract: Disclosed herein is a vaccine comprising an antigen and IL-23. Also disclosed herein are methods for increasing an immune response in a subject. The methods may comprise administering the vaccine to the subject in need thereof.

Abstract: Provided is a method for enhancing the efficacy of cancer vaccines, such as tumor vaccines. The method involves administering to an individual who is in need of therapy for a tumor an anti-cancer agent and an agent that causes depletion of myeloid cells and/or inhibits recruitment of myeloid cells to the tumor. The effect of the anti-cancer agent on the tumor is greater relative to the effect of the anti-cancer agent in the absence of the anti-myeloid cell agent. Also provided is a method for identifying candidates for the therapy. This approach involves determining if an individual has a tumor characterized by undesirable myeloid cell proliferation and/or tumor infiltration and/or myeloid cell recruitment to the tumor, and if such determination is made, designating the individual as a candidate for the therapy. In one embodiment, the identification of the individual as such a candidate is followed by the therapeutic approach.

Abstract: A biomarker Hsp90 for predicting an efficacy of a c-Met inhibitor, selecting a subject for application of a c-Met inhibitor, or monitoring an efficacy of a c-Met inhibitor, and a relevant method of using Hsp90.

Abstract: The present disclosure is directed to adeno-associated viral vector monoclonal antibody constructs and compositions thereof, methods of improving locomotor function after spinal cord injury, methods of treating neurodegenerative diseases.

Abstract: Novel methods of treating pancreatic cancer are provided. In one embodiment, the method comprises determining NOTCH mRNA expression levels in pancreatic cancer cells. In another embodiment, the method further comprises administering to a subject in need thereof a therapeutically effective dose of a NOTCH antagonist.

Abstract: Herein are provided methods for reducing or eliminating cancer in a patient in need of cancer treatment, by providing cholesterol deprivation therapy (CDT) in conjunction with antibodies directed against cholesterol-deprived tumor cells. Further provided are methods of enhancing the efficacy of other cancer treatments, by administering CDT and antibodies directed against cholesterol-deprived tumor cells, in combination with additional anti-cancer therapies.

Abstract: A liquid pharmaceutical composition containing human immunoglobulin G, preferably at 230 g/l or higher. The composition, suitable for subcutaneous or intramuscular administration, can be used to treat various diseases, e.g., an antibody production defect and Kawasaki disease.

Abstract: The present disclosure provides topical biophotonic materials and methods useful in phototherapy. In particular, the topical biophotonic materials of the present disclosure include a cohesive matrix, and at least chromophore which can absorb and emit light from within the topical biphotonic material, wherein the topical biophotonic material is elastic. The topical biophotonic materials and the methods of the present disclosure are useful for promoting wound healing and skin rejuvenation, as well as treating acne and various other skin disorders.

Abstract: The invention provides the use of a photosensitiser which is a derivative (e.g. an ester) of 5-aminolevulinic acid (5-ALA), or a pharmaceutically acceptable salt thereof, in the manufacture of a composition for use in methods of photodynamic therapy (PDT) on an animal, wherein said PDT comprises: (a) administering to said animal a composition comprising said photosensitiser; and (b) photoactivating said photosensitiser, and side-effects (e.g. pain and/or erythema) of said PDT are prevented or reduced by use of one or more of (i)-(iv): (i) said composition comprises said photosensitiser in a concentration of less than 10% wt (e.g. 0.5 to 8% wt), (ii) said composition is administered for less than 2 hours (e.g. 30 minutes to 90 minutes) prior to said photoactivation, (iii) said photoactivation is carried out with a light source having a fluence rate of less than 50 mW/cm2 (e.g. 5 to 40 mW/cm2), (iv) said photoactivation is carried out with sunlight.

Abstract: A composition for treating neurodegeneration, including an antibiotic, an antifungal agent, and a lipophilic potentiating agent in synergistically effective amounts. A method of treating neurodegeneration, by administering a synergistically effective amount of the composition to an individual suffering from neurodegeneration, and treating neurodegeneration. A method of reducing and/or eliminating symptoms of neurodegeneration, by administering a synergistically effective amount of the composition to an individual suffering from neurodegeneration, and reducing and/or eliminating the individual's symptoms of neurodegeneration. A method of reducing and/or eliminating lesions from neurodegeneration. A method of recovering mobility of an individual suffering from neurodegeneration.

Abstract: The present invention relates to a topical homeopathic remedy for skin conditions generally known as dermatitis. The present invention further relates to a composition forming said topical homeopathic remedy, a process for creating such composition and a method of using same. The present invention may comprise a combination of at least one of the following compounds: arnica montana, calcarea carbonica, calendula officinalis, herpes zoster, hypericum, mezereum, rhus toxicodendron, and variolinum, polymerized in a mixture of calcium montmorillonite and water.

Abstract: This invention relates to novel penetrating compositions including one or more effectors included within a water soluble composition, immersed in a hydrophobic medium. The invention also relates to methods of treating or preventing diseases by administering such penetrating compositions to affected subjects.

Abstract: The present invention relates to formulations of nucleotide reverse transcriptase inhibitors (NRTIs), preferably [2-(6-Amino-pur: in-9-yl)-1-methyl-ethoxymethy]-phosphonic acid (tenofivir, PMPA), or a physiologically functional derivative thereof, wherein the formulations contain a low level of glycerin. Human immunodeficiency vims (HIV) infection and related diseases are a major public health problem worldwide. One approach to the problem of HIV/AIDS is to reduce the risk of transmission of HIV and thus reduce the number of individuals who become newly infected.

Abstract: Pharmaceutical formulations comprising a clostridial derivative and a permeabilizing agent for intravesical instillation are disclosed.

Abstract: Disclosed are: a substance transfer carrier to an extracellular matrix-producing cell in the lung, which comprises a retinoid; a therapeutic agent for fibroid lung, which utilized the carrier; and a preparation kit of the therapeutic agent.

Abstract: Disclosed is a concentrate for dilution comprising a S1P receptor agonist or a pharmaceutically acceptable salt thereof, propylene glycol and optionally glycerin. This formulation is adapted for patients in a difficult condition to swallow.

Abstract: This invention relates to stable pharmaceutical compositions of 5,10-methylene-(6R)-, -(6S)-, or -(6R,S)-tetrahydrofolate (MTHF), by adjusting a basic pH and the simultaneous use of citrate. Stabilisation is effected even in the absence of a reducing agent. The present invention is particularly suitable for producing lyophlisation solutions and lyophilisates or dry powders and dry mixtures, since the stable MTHF solutions can be used in high concentrations for filling corresponding vessels such as vials, ampoules, etc. The lyophilisates have a surprisingly long shelf life and are surprisingly stable. They can be reconstituted without problems by adding wateror aqueous solutions, and the final clear injection solutions again exhibit excellent stability properties. Moreover, the present invention even makes it possible to prepare difficulty soluble calcium 15 or acidic salts of MTHF in high concentrations and as physiologically compatible isotonic solutions.

Abstract: The invention concerns pharmaceutical compositions containing a hydrogen sulphate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide and solvates, crystalline forms and amorphous forms thereof, to the use of said compositions as a medicament; and to processes for the preparation of said compositions.

Abstract: The invention relates to taxoid compositions having improved stability.

Abstract: The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol or Amitriptyline HCl and mannitol.

Abstract: The present disclosure provides novel powder daptomycin formulations which have improved chemical stability and faster reconstitution times when in the solid state. Some examples of the compositions comprise daptomycin and sucrose.

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: Various adhesive compositions are described which comprise one or more essential oils. The adhesive compositions may optionally comprise one or more active agents such as pharmaceutical agents. Also described are related methods of improving the stability of essential oil(s) in adhesive compositions by incorporating polyvinylpyrrolidone. Also described are related methods of using the compositions and articles incorporating such compositions.

Abstract: Dapsone and dapsone/adapalene compositions can be useful for treating a variety of dermatological conditions. The compositions of this disclosure include dapsone and/or adapalene in a polymeric viscosity builder. Subject compositions can be adjusted to optimize the dermal delivery profile of dapsone to effectively treat dermatological conditions and improve the efficiency of pharmaceutical products applied to the skin. Use of the polymeric viscosity builder provides compositions with increased concentrations of diethylene glycol monoethyl ether relative to compositions without the polymeric viscosity builder.

Abstract: A biodegradable drug delivery compositions comprising a triblock copolymer containing a polyester and a polyethylene glycol and a diblock copolymer containing a polyester and an end-capped polyethylene glycol, as well as a pharmaceutically active principle is disclosed.

Abstract: The disclosure relates to, among other things, pharmaceutical compositions, such as solid oral dosage forms, comprising itraconazole, methods of making the compositions, and methods of using the same for treating disorders including, but not limited to, fungal infections.

Abstract: Pharmaceutical compositions with synchronized solubilizer release as well as various methods associated therewith, are disclosed and described. More specifically, the aqueous solubility of a drug is enhanced by synchronized release of a solubilizer.

Abstract: A method for preserving and stabilising proteins is disclosed which can be used for the industrial development of formulations of sanitary, pharmaceutical and cosmetic products, particularly cell growth factors and/or proteins such as epidermal growth factor (EGF) and fibroblast growth factor (bFGF). The method includes a dispersion phase, under normal pressure and temperature conditions, in which the proteins are incorporated into an anhydrous medium formed by oily components that have hydrophilic residues and that guarantee interactions with the proteins, while maintaining the native conformation of the proteins, such components being grape seed oil, a base of different components and butylhydroxytoluene.

Abstract: The invention provides a conjugate comprising a biomolecule linked to a fatty acid via a linker wherein the fatty acid has the following Formulae A1, A2 or A3: wherein R1, R2, R3, R4, Ak, n, m and p are defined herein. The invention also relates to a method for manufacturing the conjugate of the invention such as GDF15 conjugate, and its therapeutic uses such as treatment or prevention of metabolic disorders or diseases, type 2 diabetes mellitus, obesity, pancreatitis, dyslipidemia, alcoholic and nonalcoholic fatty liver disease/steatohepatitis and other progressive liver diseases, insulin resistance, hyperinsulinemia, glucose intolerance, hyperglycemia, metabolic syndrome, hypertension, cardiovascular disease, atherosclerosis, peripheral arterial disease, stroke, heart failure, coronary heart disease, diabetic complications (including but not limited to chronic kidney disease), neuropathy, gastroparesis and other metabolic disorders.

Abstract: The present invention relates to an immunogenic composition comprising a continuous aqueous phase and a dispersed phase as droplets and comprising: an amphiphilic lipid, a solubilizing lipid comprising at least one fatty acid glyceride, a co-surfactant comprising at least one chain consisting of alkylene oxide units, a surfactant bearing an antigen of the following formula (I): (L1-X1—H1—Y1)v-G-Z1—Ag??(I), to its preparation method and its uses, notably for producing antibodies, as a drug or in an immunization method.

Abstract: Conjugates of an anti-TNF antibody and one or more nonpeptidic water soluble polymers are provided. Typically, the nonpeptidic water soluble polymer is poly(ethylene glycol) or a derivative thereof. Also provided, among other things, are compositions comprising conjugates, methods of making conjugates, and methods of administering compositions to a patient.

Abstract: Described herein are nanoparticle-based compositions, kits, methods and platforms for delivering drugs to professional APCs (PAPCs) in vivo resulting in a robust and specific immune response to a pathogen, e.g., Leishmania major. The composition, kits, platforms and methods involve the combined use of MHC targeting and immunogenic peptides (e.g., PADRE) with charged (e.g., positively-charged) highly branched polymeric dendrimers (e.g., PAMAM and other dendrimers) as vehicles for the targeted delivery of anti-pathogen agents (e.g., AmB) to PAPCs via MHC class II molecules expressed on the surface of such cells such that the anti-pathogen agent is internalized by the PAPCs. The composition, kits, platforms and methods described herein provide for specific and efficient delivery of anti-pathogen agents (e.g., drugs such as AmBisome®) to PAPCs in vivo that results in a reduction of growth or elimination of the pathogen involving a robust and specific immune response to the pathogen.