Abstract: The invention relates to variants and fusions of fibroblast growth factor 19 (FGF19), variants and fusions of fibroblast growth factor 21 (FGF21), fusions of FGF19 and/or FGF21, and variants or fusions of FGF19 and/or FGF21 proteins and peptide sequences (and peptidomimetics), having one or more activities, such as bile acid homeostasis modulating activity, and methods for and uses in treatment of bile acid and other disorders.

Abstract: The invention relates to variants and fusions of fibroblast growth factor 19 (FGF19), variants and fusions of fibroblast growth factor 21 (FGF21), fusions of FGF19 and/or FGF21, and variants or fusions of FGF19 and/or FGF21 proteins and peptide sequences (and peptidomimetics), having one or more activities, such as bile acid homeostasis modulating activity, and methods for and uses in treatment of bile acid and other disorders.

Abstract: Methods of treating metabolic and/or lipid disorders are provided comprising administering to a patient in need thereof a therapeutically effective amount of Nrg4, an Nrg4 variant, or a biologically active fragment thereof.

Abstract: Methods and therapeutic compositions for treating respiratory diseases, such as chronic obstructive pulmonary disease (COPD) and devices for administering the therapeutic compositions. Methods for treatment include producing a protein solution, producing a concentrated bone marrow aspirate (cBMA), optionally combining the protein solution and cBMA to form an therapeutic composition, and optionally saturating the autologous therapeutic composition with hydrogen gas, and administering the therapeutic composition to a subject in need thereof. The present methods, compositions and devices are useful for treating COPD and the progression of COPD.

Abstract: Provided are formulations for proteins to be injected into mammals. Specifically, formulations for recombinant IL-12 in mice and primates.

Abstract: A targeting peptide that specifically binds to an IL13 receptor (e.g., wherein said targeting peptide is not an IL13 fragment) is described. The targeting peptide is optionally conjugated to at least one effector molecule. In some embodiments, the peptide specifically binds to the IL13R?2 protein.

Abstract: This disclosure relates to a modified ?-helical bundle cytokine, with reduced activity via an ?-helical bundle cytokine receptor, wherein the ?-helical bundle cytokine is specifically delivered to target cells. Preferably, the ?-helical bundle cytokine is a mutant, more preferably it is a mutant interferon, with low affinity to the interferon receptor, wherein the mutant interferon is specifically delivered to target cells. The targeting is realized by fusion of the modified ?-helical bundle cytokine to a targeting moiety, preferably an antibody. This disclosure relates further to the use of such targeted modified ?-helical bundle cytokine to treat diseases. A preferred embodiment is the use of a targeted mutant interferon, to treat diseases, preferably viral diseases and tumors.

Abstract: The invention provides isolated peptides, fragments and derivatives thereof and pharmaceutical compositions comprising same that are useful for the prevention or treatment of cancer metastasis.

Abstract: The present invention provides polypeptide derivatives of IGFBP-3 that are resistant to proteolytic cleavage. These IGFBP-3 derivatives are useful in a variety of therapeutic and diagnostic applications. Also provided are pharmaceutical compositions and kits comprising such IGFBP-3 derivatives and methods for using these derivatives for the treatment of a variety of disorders.

Abstract: The present invention relates to a covalent complex of von Willebrand Factor (VWF) and Factor VIII, wherein the complex is modified such that it has an extended half-life in vivo. The invention further relates to a method of producing the complex, as well as the therapeutic or prophylactic use of the complex for treating or preventing bleeding events.

Abstract: The present invention relates to an injectable preparation comprising particles or fibrils with length less than 10 ?m and at least one pharmaceutically acceptable vehicle or excipient. The particles or fibrils comprise proteins or peptides inducing adhesion and activation of the platelets, or even aggregation thereof. The preparation is useful for treating hemorrhages.

Abstract: The present invention relates to pharmaceutical compositions enhancing the therapeutic effect of biologically active peptides, especially peptides derived from human lactoferrin. The compositions are useful for the treatment and/or prevention of wounds, scars, and post surgical adhesions.

Abstract: The present disclosure describes compositions for intestinal delivery of enzyme formulations and methods of treating health problems with these formulations. More specifically, the enzyme formulations include at least one histaminase and various methods of treatment of physical conditions, such as inflammation, allergy, histamine intolerance, and intestinal cancer.

Abstract: This disclosure relates to compositions for use in treatment of a retinal degenerative disease, such as age related macular degeneration. The described compositions include agents for activating p38 and/or JNK signaling through the activation of TAK1 in the retinal pigment epithelium of a subject diagnosed with the disease. Methods of treatment of a retinal degenerative disease using the described compositions are also provided.

Abstract: Bacteria which co-express protease inhibitors and protease sensitive therapeutic agents, which are surface displayed, secreted and/or released and result in their localized production and maintenance within a target tissue and inactivation outside of the target tissue, thereby increasing therapeutic activity and reducing the systemic toxicity. The bacteria may be attenuated, non-pathogenic, low pathogenic or a probiotic. Protease sensitivity may be further accomplished by engineering protease degradation sites within the therapeutic agents, further enhancing the inactivation outside of the target tissue while retaining activity within the target tissue through co-expression of a protease inhibitor. Novel chimeric proteins secreted by bacteria, including chimeric toxins targeted to neoplastic cells, tumor matrix cells and cells of the immune system, and combination therapies of these protease inhibitor:chimeric toxin-expressing bacteria together with small-molecule and biologic agents are also described.

Abstract: Provided herein are prime-boost regimens and materials used therein. The prime-boost regimens enhance the immune response to a target antigen. The vaccines used for boost are comprised of recombinant attenuated metabolically active Listeria that encodes an expressible antigen that is cross-reactive with the target antigen. In some examples, the immune response is a cellular immune response.

Abstract: The present invention provides an antigenically restricted subset of the highly variant PfEMP1 rosetting antigen which possess epitopes which may be exploited to raise immune responses effective against many diverse strains and isolates of the malaria parasite, Plasmodium falciparum. In this regard, the invention provides one or more P. falciparum Erythrocyte Membrane Protein-1 (PfEMP1) antigen(s) or a fragment or fragments thereof, for use in raising immune responses in humans.

Abstract: The application is directed to in-vitro-reared Plasmodium sporozoites of human host range wherein sporogony from gametocyte stage to sporozoite stage is external to mosquitoes, and methods of producing the same. Provided herein are in vitro-reared infectious Plasmodium sporozoites (SPZ) of human host range, particularly P. falciparum, P. vivax, P. ovale, P. malariae, and P. knowlesi, wherein sporogony from gametocyte stage to sporozoite stage is external to mosquitoes, and methods of producing the same.

Abstract: The present invention relates to an immunogenic composition comprising: a) one or more antigen of M. hyorhinis and one or more antigens of M. hyosynoviae; and b) a pharmaceutically acceptable carrier. Furthermore, the present invention relates to an immunogenic composition that comprises a) one or more mycoplasma antigens of mycoplasma bacteria selected from the group consisting of M. hyorhinis, M. hyopneumoniae and M. hyosynoviae; and b) one or more components of a eukaryotic cell system. Moreover, the present invention also provides an immunogenic composition obtained by a method comprising a) cultivation of a mycoplasma bacteria selected from the group consisting of M. hyorhinis, M. hyopneumoniae and M. hyosynoviae in a serum-reduced, eukaryotic cell system; b) obtaining an antigen of such mycoplasma bacteria; and c) addition of a pharmaceutically acceptable carrier.

Abstract: The present invention relates to a process for stabilizing an adjuvant containing vaccine composition, an adjuvanted vaccine composition in dry form and in particular a process for stabilizing an influenza vaccine composition, particularly an adjuvanted influenza vaccine composition in dry form.

Abstract: A novel alcohol and CTAB free process for purification of capsular polysaccharides, wherein the C-polysaccharide, protein, nucleic acid content of the purified polysaccharide is substantially reduced The said process is cost efficient and less laborious.

Abstract: The present invention relates to BVD virus and to its uses, to vaccines and combination vaccines comprising such a virus, their use as a medicament, their use in the treatment of Bovine Viral Diarrhea and to methods for the preparation of such vaccines.

Abstract: Embodiments of the present invention report compositions and methods for vaccinating a subject using trivalent dengue virus vaccine compositions. In some embodiments, more than one vaccine composition may be administered to a subject in different anatomical locations in order to induce a rapid response to at least three of four dengue virus serotypes. In certain embodiments, administration of a trivalent dengue virus vaccine composition can be combined with administration of a monovalent dengue virus vaccine composition.

Abstract: Provided herein are attenuated influenza viruses and methods of making attenuated influenza viruses.

Abstract: Certain embodiments of the present invention provide immunogenic compositions that comprise one or more peptides having an amino acid sequence selected from the group consisting of NLLTTPKFT and RMLGDVMAV and methods for administering such compositions to a mammal and thereby inducing in the mammal a CD8+ T cell-dependent protective immunity against an HSV-1 infection, an HSV-2 infection, an HSV-1 condition, an HSV-2 condition, or combinations thereof.

Abstract: The invention relates to adjuvanted vaccine formulations, in particular influenza vaccines for intranasal delivery. Provided is an adjuvanted influenza vaccine formulation, comprising (i) peptidoglycan microparticles obtained from a Gram-positive bacterium and (ii) at least one influenza virus antigen or antigenic preparation thereof, which antigen or antigenic preparation is not fused or otherwise covalently attached to a proteinaceous peptidoglycan binding moiety.

Abstract: Disclosed is a composition comprising: i) HBsAg, a fragment thereof, a variant thereof, or the mixture of at least two of them, ii) HBcAg1-X, a fragment thereof, a variant of the antigen or the antigen fragment, or the mixture of at least two of them, wherein X is an integer of from 149 to 183, iii) CpG-ODN, 21 bases long, which is a phosphorothioate oligonucleotide and includes two or more copies of 5?-NTCGTT-3? motifs. The use of the composition in the treatment of HBV-infection and HBV-induced diseases, and the therapy methods of HBV-infection and HBV-induced diseases are also disclosed.

Abstract: A pharmaceutical composition comprising a water-soluble polymer matrix in which are dispersed droplets of oil, the composition comprising at least one immunomodulator selected from an adjuvant, an antigen or a combination thereof. A method of manufacturing shaped compositions comprises mixing an aqueous solution of a water-soluble polymer with an oil-based liquid to form a water-in-oil emulsion, at least one of the aqueous solution and the oil-based liquid comprising an antigen or an adjuvant or a combination thereof, and then causing or allowing the resultant suspension to solidify into one or more beads or other shaped elements.

Abstract: This invention describes novel adjuvant compositions and formulations with excellent stability at refrigerated and room temperatures and up to and about 37° C. that can be produced at remarkably low costs. This invention describes novel vaccine compositions and formulations to treat and prevent urinary tract infections caused by gram-negative bacteria including Escherichia coli and multi-drug resistant E. coli. This invention also describes methods of administration of said novel vaccine compositions and formulations and methods of treatment to prevent and treat urinary tract infections caused by gram-negative bacteria including E. coli and multi-drug resistant E. coli.

Abstract: Novel compositions derived from antigen-binding sites of immunoglobulins having affinity for IL-31 are provided. The compositions exhibit immunological binding properties of antibody molecules capable of binding specifically to a human IL-31. CDR regions derived from same or different immunoglobulin moieties are provided. Also provided are single chain polypeptides wherein VH and VL domains are attached. The sFv molecules can include ancillary polypeptide moieties which can be bioactive, or which provide a site of attachment for other useful moieties. The compositions are useful in specific binding assays, affinity purification schemes, drug or toxin targeting, imaging, and genetic or immunological therapeutics for inflammatory diseases. The invention thus provides novel polypeptides, the DNAs encoding those polypeptides, expression cassettes comprising those DNAs, and methods of inducing the production of the polypeptides.

Abstract: A microcapsule encapsulates a payload agent, the microcapsule having a microcapsule shell material that is rupturable (e.g., to release the encapsulated payload agent) via a retro-dimerization reaction.

Abstract: A composition for enhanced bioavailability of curcumin including purified curcuminoid and purified essential oil of turmeric. A method to prepare a composition for enhanced bioavailability of curcumin having purified curcuminoid and purified essential oil of turmeric.

Abstract: A tissue adhesive including cyanoacrylate and polyethylene glycol (PEG), wherein the PEG remains a polyether and wherein the tissue adhesive is bioabsorbable. A tissue adhesive including cyanoacrylate bulk monomer and cyanoacrylate nanoparticles containing a therapeutic therein. A kit for applying tissue adhesive, including the tissue adhesive described above and an applicator. Methods of accelerating degradation of a cyanoacrylate tissue adhesive applying a tissue adhesive, closing an internal wound, administering a therapeutic to tissue, treating cancer, and preventing infection in a wound. Methods of method of making a bioabsorbable tissue adhesive and making a therapeutic tissue adhesive.

Abstract: The present invention provides novel, serum-stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides serum-stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (e.g., one or more interfering RNA molecules), methods of making the SNALP, and methods of delivering and/or administering the SNALP (e.g., for the treatment of cancer). In particular embodiments, the present invention provides tumor-directed lipid particles that preferentially target solid tumors. The tumor-directed formulations of the present invention are capable of preferentially delivering a payload such as a nucleic acid to cells of solid tumors compared to non-cancerous cells.

Abstract: A composition comprising intact killed bacterial cells that contain a therapeutic nucleic acid, a drug or a functional nucleic acid is useful for targeted delivery to mammalian cells. The targeted delivery optionally employs bispecific ligands, comprising a first arm that carries specificity for a killed bacterial cell surface structure and a second arm that carries specificity for a mammalian cell surface receptor, to target killed bacterial cells to specific mammalian cells and to cause endocytosis of the killed bacterial cells by the mammalian cells. Alternatively, the delivery method exploits the natural ability of phagocytic mammalian cells to engulf killed bacterial cells without the use of bispecific ligands.

Abstract: The present invention is directed to carrier systems comprising ether-lipids conjugated to one or more bioactive ligands and exposed on the surface of the carrier system for use in targeted delivery and/or antigen display systems. Optionally one or more further bioactive agents may be encapsulated or embedded within or attached to or adsorbed onto the carrier system. The present invention is further directed to methods of their preparation and their uses in medical applications, such as targeted delivery of bioactive agents to specific tissues or cells and antigen display systems for the study, diagnosis, and treatment of traits, diseases and conditions that respond to said bioactive agents.

Abstract: The present invention relates to triorthogonal reagents useful for site-specifically modifying a protein with two orthogonal groups that can be subsequently functionalized in a single one-pot procedure. This approach relies on the selective tagging of proteins containing an appended farnesyltransferase or geranylgeranyltransferase I substrate sequence. The incorporation of a bifunctional ethynyl-hydroxybenzaldehyde into the farnesyl or geranylgeranyl group facilitates the facile labeling of proteins with two different moieties.

Abstract: Provided herein are methods for ameliorating an adverse effect of systemic administration of a PEG hyaluronan degrading enzyme to a subject. The methods involve systemically administering a PEGylated hyaluronan degrading enzyme, particularly a PEGylated hyaluronidase, such as any of the animal or bacterial hyaluronidases, to the subject and administering an amount of a corticosteroid sufficient to ameliorate the adverse effect. Also provided are method of treating a hyaluronan-associated disease or condition for single-agent therapy or combination therapy.

Abstract: This disclosure features compounds that are useful as pro-drugs of epoxy ketone protease inhibitors.

Abstract: Peptides that specifically bind erythrocytes are described. These are provided as peptidic ligands having sequences that specifically bind, or as antibodies or fragments thereof that provide specific binding, to erythrocytes. The peptides may be prepared as molecular fusions with therapeutic agents, tolerizing antigens, or targeting peptides. Immunotolerance may be created by use of the fusions and choice of an antigen on a substance for which tolerance is desired.

Abstract: A high drug loading system is described comprising of at least one anticancer drug; at least one peptide; and at least one nucleic acid.

Abstract: Provided are compositions and methods for delivery of therapeutic agents, such as chemically stabilized antisense oligonucleotides useful in RNA silencing. The compositions include interfering nanoparticles (iNOPs) associated with one or more agents. Several functional iNOP derivatives are provided which allow for targeted delivery of agents to specific cell types as well as exhibiting reduced cellular toxicity.

Abstract: The present invention relates to an immunogenic and a non-toxic glycoconjugate comprising Bordetella pertussis LOS-derived oligosaccharide and pertussis toxin, a method of preparing such glycoconjugate, the pharmaceutical composition, a vaccine composition containing such glycoconjugate, and an application of the glycoconjugate. The glycoconjugate is prepared as a vaccine component for protection against infections caused by Bordetella pertussis.

Abstract: Compounds for targeted immunotherapy, compositions comprising the compounds and use of the compounds in the treatment of diseases such as cancer are disclosed. The compounds having the structure of formula TM-Ln-AM, wherein TM is a targeting moiety, AM is an activating moiety that is capable of activating a human dendritic cell, NK cell, or tumor cell, or a combination thereof, Ln is a linker, and n is an integer selected from 0 and 1.

Abstract: Novel modulators, including antibodies and derivatives thereof, and methods of using such modulators to treat proliferative disorders are provided.

Abstract: In certain embodiments, this disclosure relates to pharmaceutical formulations for polypeptide and lipophilic moiety conjugates suitable for injection into humans and other animals and methods of preparation. In certain embodiments, the disclosure relates to a method of preparing the formulation comprising lyophilizing, solubilizing in ammonium acetate, filtering to create mono-disperse particles, re-lyophilizing, and solubilizing the micelles in a dextrose solution for injection.

Abstract: The present application provides methods of preventing and treating the toxic effects of exposure to organophosphate agents. In embodiments, targeted cationic liposome complexes delivering nucleic acid molecules encoding butyrylcholinesterase and a polyproline rich peptide are administered. Suitably, the administration is via inhalation or via aerosol. Also provided are cationic liposome complexes and methods of making the complexes for such administration.

Abstract: The invention relates to cosmetic mRNAs encoding elastin, and methods of using such mRNAs.

Abstract: Disclosed herein are pharmaceutical compositions having the sequence Arg-Ser-Cys-Ile-Asp-Thr-Ile-Pro-Lys-Ser-Arg-Cys-Thr-Ala-Phe-Gln-Cys-Lys-His-Ser-Xaa-Lys-Tyr-Arg-Leu-Ser-Phe-Cys-Arg-Lys-Thr-Cys-Gly-Thr-Cys (SEQ ID NO:1). The disclosed compositions can include an acid or amide at the C-terminus of SEQ ID NO: 1 and the polypeptide can be attached to an organic or inorganic chemical entity that has an anionic charge. The polypeptide can be detectably labeled for diagnostic purposes. Methods of manufacturing and using the pharmaceutical compounds are also disclosed.

Abstract: An aqueous approach to synthesize capped SnS quantum dots (QDs) followed by optional capping molecule extension by attaching one or more extending molecules to the capping molecule via peptide bond formation at elevated temperature. The capped SnS QDs may have a capping molecule:Sn:S molar ratio of 16:3:1 to 16:12:1. A suspension of SnS QDs was heat-treated at 200° C. for 0.5-4 hrs. The obtained SnS QDs showed an NIR emission peak at 820-835 nm with an excitation wavelength at 690 nm. The as synthesized SnS QDs were found to have high positive zeta potential of ˜30 mV and thus were toxic to cells. By neutralizing the SnS QDs the cytotoxicity was reduced to an accepted level. The heat-treatment step can be obviated by adding a glycerol solution containing S2? anions and capping molecule to a glycerol solution of Sn2+ ions.