Abstract: The present disclosure describes methods of treating a cancer based on the targeted disruption of alpha connexin 43-zonula occludens-1 (ZO-1) interaction. The methods may include administering to a subject an effective amount of a composition comprising a peptide with a contiguous sequence of amino acids representing a portion of the carboxy terminus of an alpha connexin protein or conservative variant thereof, wherein said carboxy terminus includes the sequence up to the transmembrane domain, optionally in combination with administration of a chemotherapeutic agent. In embodiments, the cancer is glioma and the chemotherapeutic agent is temozolomide. The methods may also include administration of vectors encoding the peptide or host cells comprising the vectors. Also described are compositions for treating a cancer comprising one or more peptides, nucleic acids, vectors, and/or host cells, optionally in combination with a chemotherapeutic agent such as temozolomide.

Abstract: The present invention relates to complexes of lactoferrin, osteopontin and iron. In particular the invention relates to a composition comprising at least 2 g/kg of lactoferrin-osteopontin-iron complex for use in the treatment or prevention of iron deficiency. An aspect of the invention is a fortified foodstuff comprising a lactoferrin- osteopontin-iron complex. Further aspects of the invention are a process for fortifying a food product with iron and the use of a lactoferrin-osteopontin-iron complex to fortify a food product with iron.

Abstract: A glycosylated pleiotropic peptide pituitary adenylate cyclase-activating polypeptide (PACAP) which can both agonize PAC1 receptors, causing neuroprotective effects, and antagonize VPAC receptors, causing anti-inflammation in several models of acute neuronal damage and neurodegenerative diseases, including ALS, PD, migraines, and certain forms of dementia, is described. Also described is a method of relieving symptoms of ALS, PD, migraines, and certain forms of dementia, comprising administering to a subject in need thereof an effective amount of a glycosylated PACAP.

Abstract: The invention relates to the use of agents that bind the complement protein C5 in the treatment of diseases associated with inappropriate complement activation and in particular in the treatment of myasthenia gravis.

Abstract: The invention relates to the use of agents that bind the complement protein C5 in the treatment of diseases associated with inappropriate complement activation, and in particular in the treatment of peripheral nerve 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: The present invention relates to methods and compositions for the prevention and treatment of keratin-based skin diseases. In particular, the application describes compositions and methods of treating a patient suffering from skin blistering comprising the use of phase II enzyme inducers.

Abstract: The use and screening of modulators of apoptosis is disclosed. The modulators may be, for example, modulator of NF-?B activity. The modulators may be used, for example, in the treatment of NF-?B-mediated diseases, conditions, and injuries.

Abstract: Methods of stimulating collagen production, including stimulation of chondrocyte production, at the site of a defect. Methods include administering to the site of a defect at least two proteins from the group IL-1ra, sTNF-RI, sTNF-RII, IGF-I, EGF, HGF, PDGF-AB, PDGF-BB, VEGF, TGF-?1, and sIL-1RII.

Abstract: The present invention relates to methods and pharmaceutical compositions for the treatment of acute exacerbation of chronic obstructive pulmonary disease. In particular, the invention relates to relates to a polypeptide selected from the group consisting of IL-22 polypeptides or IL-17 polypeptides for use in a method for the treatment of acute exacerbation of chronic obstructive pulmonary disease in a subject in need thereof.

Abstract: Interleukin-10 (IL-10) conjugated via a linker to one or more polyethylene glycol (PEG) molecules at a single amino acid residue of the IL-10, and a method for preparing the same, are provided. The method produces a stable mono-pegylated IL-10, which retains IL-10 activity, where pegylation is selective for the N-terminus on one subunit of IL-10 with little or no formation of monomeric IL-10. The method also provides a substantially homogenous population of mono-PEG-IL-10.

Abstract: This invention provides a method of treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome comprising administering to the patient laquinimod as an add-on therapy to or in combination with interferon-?. This invention also provides a package and a pharmaceutical composition comprising laquinimod and interferon-? for treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention also provides laquinimod for use as an add-on therapy or in combination with interferon-? in treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention further provides use of laquinimod and interferon-? in the preparation of a combination for treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome.

Abstract: The invention concerns the use of hepcidin for the diagnosis and therapy of disorders of iron homeostasis. Hepcidin can be used in the treatment of disorders resulting from iron overload, while inhibitors of hepcidin can he used in the treatment of anaemia.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: In alternative embodiments, provided are methods for treating, ameliorating or protecting (preventing) congestive heart failure (CHF) or a diabetes-related cardiac dysfunction, comprising: providing a urocortin 2-encoding and/or a urocortin 3-encoding nucleic acid, transcript or message, or gene, operatively linked to a transcriptional regulatory sequence, optionally contained in an expression vehicle or a vector such as an adeno-associated virus (AAV), e.g., an AAV8 serotype; and administering to an individual or a patient in need thereof, such as a type 2 diabetic (T2DM), e.g., by IV administration, thereby treating, ameliorating or protecting against (preventing) the T2DM and/or the diabetes-related cardiac dysfunction in the individual or patient.

Abstract: There is provided a novel series of synthetic analogs of hGH-RH(1-29)NH2 (SEQ ID NO: 1) and hGH-RH(1-30)NH2. Of particular interest are those carrying PhAc, N-Me-Aib, Dca, Ac-Ada, Fer, Ac-Amc, Me-NH-Sub, PhAc-Ada, Ac-Ada-D-Phe, Ac-Ada-Phe, Dca-Ada, Dca-Amc, Nac-Ada, Ada-Ada, or CH3—(CH2)10—CO-Ada, at the N-Terminus and ?-Ala, Amc, Apa, Ada, AE2A, AE4P, ?-Lys(?-NH2), Agm, Lys(Oct) or Ahx, at the C-terminus. These analogs inhibit the release of growth hormone from the pituitary in mammals as well as inhibit the proliferation of human cancers, and inhibit the hyperplastic and benign proliferative disorders of various organs, through a direct effect on the cancerous and non-malignant cells. The stronger inhibitory potencies of the new analogs, as compared to previously described ones, result from replacement of various amino acids.

Abstract: The subject matter of this invention is directed towards chemically and thermodynamically stable single-chain insulin (SCI) analogues that are resistant to deamidation and fibrillation. The invention further discloses improved methods for the recombinant expression, purification and refolding of SCI.

Abstract: This invention relates to compositions comprising collagen binding peptides coupled to nanoparticles. The invention also relates to a method of imaging a collagenous matrix using a composition comprising collagen binding peptides coupled to nanoparticles.

Abstract: The invention relatesto a hemostatic composition in powder form comprising collagen of the fibrillar type comprising a content of fibrous collagen and/or fibrillar collagen of at least 70% by weight relative to the total weight of the collagen, and at least one monosaccharide, and optionally, at least one compound selected from coagulation factors and glycosaminoglycans. The invention further relates to a method for preparing such composition, and to a unit comprising such composition and a spraying device.

Abstract: The invention provides compositions and methods for treating celiac sprue.

Abstract: The present invention provides methods of administering Factor IX; methods of administering chimeric and hybrid polypeptides comprising Factor IX; chimeric and hybrid polypeptides comprising Factor IX; polynucleotides encoding such chimeric and hybrid polypeptides; cells comprising such polynucleotides; and methods of producing such chimeric and hybrid polypeptides using such cells.

Abstract: Provided are methods and materials for treating a neurological, behavioural, psychological, psychiatric, or personality disorder or syndrome in an individual, which disorder or syndrome is associated with a plurality of aberrant thoughts, behaviors and/or dispositions to behaviour. The methods comprise (i) selecting an individual suffering from, or believed to suffer from, said disorder or syndrome; and (ii) selecting a set of effector junctions in the individual, wherein at least one of said aberrant thoughts, behaviors or dispositions is modifiable by modulation of transmission across the set of effector junctions; (iii) treating the individual with an agent (for example botulinum toxin or a derivative or analog thereof) or intervention which causes blockade of or interference with the set of effector junctions, wherein blockade of the set of effector junctions results in an inhibition of the plurality of aberrant thoughts, behaviors and/or dispositions associated with the disorder.

Abstract: The present invention is directed to a digestive enzyme composition comprising an enterically coated digestive enzyme product, administrable nutritional medium, and a pharmaceutically acceptable low viscosity oily ingredient. The process for the preparation of the digestive enzyme composition comprises adding an enterically coated digestive enzyme product to a administrable nutritional medium and pharmaceutically acceptable low viscosity oily ingredient. The invention further provides a method for treating a patient suffering from exocrine pancreatic insufficiency related condition comprising administering to the patient a therapeutically effective dose of the digestive enzyme composition by means of a feeding tube.

Abstract: Methods and compositions are disclosed for treating disorders of the contact activation system, comprising the administration of at least one C1-Inhibitor (C1-INH) and at least one Factor XII (FXII) inhibitor.

Abstract: Immunogenic compositions, cancer vaccines and methods for treating cancer comprising FMS, the fucose-enriched polysaccharide fraction from Reishi F3, are provided. Compositions comprise fucose-enriched Reishi polysaccharide fraction (FMS) MW=˜35 kDa, wherein the FMS is isolated by size-exclusion chromatography from Reishi F3, and the FMS comprises polysaccharides having primarily a backbone selected from 1,4-mannan and 1,6-?-galactan, wherein the backbone is linked to a terminal fucose-containing side-chain Immunogenic compositions comprising glycolipid adjuvants are provided. Antibodies generated by immunogenic compositions disclosed herein bind cancer cells comprising antigens Globo H, Globo H, Gb3, Gb4, Gb5 (SSEA-3) and SSEA-4 on the cell surface.

Abstract: Strains of Sarcocystidae selected from Toxoplasma spp or Neospora spp isolated from their natural environment and having an immunostimulant effect, for the use thereof in the prevention or the treatment, in a mammal, of a pathology associated with an apicomplexan of the family Cryptosporidiidae.

Abstract: The present invention relates to compositions and methods for the prevention and treatment of neurodegenerative diseases, such Alzheimer's disease, that are caused by misfolding, aggregating proteins. The compositions and methods of the present invention comprise a vaccine formulation comprising an antigen selected from the group consisting of i) amyloid-? or a peptide that has in its amino acid sequence part of the amyloid-? amino acid sequence, ii) hyperphosphorylated tau protein or one of its hyperphoshorylated peptides, or iii) a combination of antigens derived from groups i) and ii) and that are formulated with a non-acylated or deacylated, natural or synthetic, bidesmosidic triterpene glycoside carrying an aldehyde or ketone group, which acts as an adjuvant or immune agonist. These vaccine formulations are capable of stimulating a Th2 immunity or antibody response against antigens such as amyloid-? and tau derived antigens, but not a Th1 immune response.

Abstract: The present invention utilizes carrier particles to present antigen peptides and proteins to the immune system in such a way as to induce antigen specific tolerance. The carrier particle is designed in order to trigger an immune tolerance effect. The invention is useful for treatment of immune related disorders such as autoimmune disease, transplant rejection and allergic reactions.

Abstract: A novel vaccine that can induce sufficiently high cell-mediated immunity is disclosed. The vaccine of the present invention contains, as an effective component, a polypeptide comprising a tandem repeat structure in which an MHC class I epitope region derived from an antigen protein and a spacer sequence are linked to each other alternately and repeatedly at least three times, or a recombinant vector which comprises a polynucleotide encoding said polypeptide and is capable of expressing said polypeptide in vivo. The spacer sequence is, for example, a sequence generated as an amino acid sequence inevitably encoded by a single base sequence which is designed such that the MHC class I epitope region derived from the antigen protein, an MHC class II epitope region derived from the antigen protein, and at least one higher-order-structure-stabilizing region are encoded by different reading frames in said single base sequence.

Abstract: Provided is a tumor antigen peptide and the like that is useful in the prevention and/or treatment of cancer. The present invention pertains to: a peptide comprising the amino acid sequence of sequence number 3, sequence number 4, sequence number 5, sequence number 6, or sequence number 11; a polyepitope peptide resulting from joining a plurality of epitope peptides and containing at least one of the aforementioned peptides as one epitope peptide; a polynucleotide coding for at least one of the polyepitope peptides or the peptides; a pharmaceutical composition containing the above as active ingredients; a cancer prevention and/or treatment agent characterized by inducing CTLs; and the like.

Abstract: The invention describes vaccine compositions combined in the same proportion with the extracellular domains of growth factor receptors Her1 and Her2 or fragments thereof and furthermore very small size proteoliposomes derived from proteins of the outer membrane of Neisseria meningitidis and GM3 ganglioside (VSSP-GM3), administered subcutaneously. The disclosed compositions, which induce the production of antibodies are used for the treatment of malignancies and offer advantages because they completely remove the tumor mass thus preventing tumor regression due to the emergence of resistant variants.

Abstract: The present invention relates to a composition comprising at least one mRNA encoding a combination of antigens capable of eliciting an (adaptive) immune response in a mammal, wherein the antigens are selected from the group consisting of PSA (Prostate-Specific Antigen), PSMA (Prostate-Specific Membrane Antigen), PSCA (Prostate Stem Cell Antigen), STEAP (Six Transmembrane Epithelial Antigen of the Prostate), MUC1 (Mucin 1) and PAP (Prostatic acid phosphatase). The invention furthermore relates to a vaccine comprising at least one mRNA encoding such a combination of antigens and to the use of said composition (for the preparation of a vaccine) and/or of the vaccine for eliciting an (adaptive) immune response for the treatment of prostate cancer (PCa), preferably of prostate adenocarcinoma, locally limited, locally advanced, metastatic, castration-resistant (hormone-refractory), metastatic castration-resistant and non-metastatic castration-resistant prostate cancers, and diseases or disorders related thereto.

Abstract: Multilayer films comprised of polypeptide epitopes and a toll-like receptor ligand. The multilayer films are capable of eliciting an immune response in a host upon administration to the host. The multilayer films can include at least one designed peptide that includes one or more polypeptide epitopes from a virus, bacteria, fungus or parasite.

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: Fusion proteins include full-length flagellin or portions of flagellin fused to at least one Clostridium difficile antigen. Fusion proteins can include a first Clostridium difficile antigen that replaces at least a portion or the entirety of domain 3 of flagellin and a second Clostridium difficile antigen fused to the carboxy terminal amino acid of flagellin. Fusion proteins can also include at least one Clostridium difficile antigen fused to the most carboxy terminus of portions of flagellin or full length flagellin. Methods that employ fusion proteins are administered to humans to ameliorate Clostridium difficile associated disease.

Abstract: Compositions, methods and kits are provided for preparing an atoxic C. difficile protein that elicits an immune response in the subject specific for TcdA and TcdB. Atoxic Clostridium difficile toxin proteins were expressed in an endotoxin-free Bacillus system to develop a vaccine to reduce or treat incidence and severity of C. difficile infection (CDI).

Abstract: The invention provides proteins from Staphylococcus aureus including amino acid sequences and the corresponding nucleotide sequences. The proteins are useful for vaccines, immunogenic compositions, diagnostics, enzymatic studies and also as targets for antibiotics.

Abstract: A method for immunising a subject against serogroup X meningococcus by administering a vaccine comprising one, two or all three of: (i) a meningococcal fHbp antigen; (ii) a meningococcal NHBA antigen; and/or (iii) a meningococcal NadA antigen. The vaccine may also include meningococcal outer membrane vesicles.

Abstract: The present invention provides EV71 virus-like particles and a preparation method and application thereof. The method comprises: connecting a P1 protein gene and a 3CD protease gene of an EV71 virus with a PMV plasmid to construct a PMV-P1-3CD recombinant expression plasmid; then transforming a Hansenula polymorpha AU-0501 expression strain with the PMV-P1-3CD recombinant expression plasmid to obtain an AU-PMV-P1-3CD recombinant expression strain; fermenting and culturing the recombinant expression strain, and inducing the recombinant expression strain to express the EV71 virus-like particle protein with methanol; centrifuging and collecting mycelia for homogeneous breakage at a high pressure; and purifying the supernatant through ion-exchange chromatography, hydrophobic chromatography, and molecular sieve chromatography, so as to obtain EV71 virus-like particles.

Abstract: The present invention relates to an adjuvant comprising at least one immunosuppressive domain for use in a vaccine.

Abstract: Described herein is the generation of optimized H1N1 influenza HA polypeptides for eliciting a broadly reactive immune response to H1N1 influenza virus isolates. The optimized HA polypeptides were developed through a series of HA protein alignments, and subsequent generation of consensus sequences, based on selected H1N1 viruses isolated from 1918-2012. Provided herein are optimized H1N1 HA polypeptides, and compositions, fusion proteins and VLPs comprising the HA polypeptides. Further provided are codon-optimized nucleic acid sequences encoding the HA polypeptides. Methods of eliciting an immune response against influenza virus in a subject are also provided by the present disclosure.

Abstract: The present invention relates to a vaccine, especially a combination vaccine providing at least a first and a second antigenic function, the combination vaccine comprising at least one RNA encoding at least one or more proteins or fragments, variants or derivatives of proteins awarding antigenic function, wherein the first antigenic function being a Fusion (F) protein or a fragment, variant or derivative of a Fusion (F) protein derived from the virus family Paramyxoviridae and the second antigenic function being an Hemagglutinin (HA) protein or a fragment, variant or derivative of an Hemagglutinin (HA) protein derived from the virus family Orthomyxoviridae. Furthermore, the present invention is directed to a kit or kit of parts comprising the components of said combination vaccine and to said combination vaccine for use in a method of prophylactic or therapeutic treatment of diseases, particularly in the prevention or treatment of infectious diseases like RSV and influenza.

Abstract: The invention relates to a method of treating a cancer, the method comprising the steps of administering to a patient an immunogen conjugate, administering to the patient a folate conjugate comprising a folate linked to a hapten, and administering to the patient a tyrosine kinase inhibitor.

Abstract: The present invention provides in certain embodiments conjugates comprising at least one CD200 inhibitor and an adjuvant, and methods of reversing or modulating immune suppression in a patient having a disease or disorder arising from abnormal cell growth, function or behavior, which method comprises administering to a patient in need thereof a composition comprising a CD200 inhibitor and an adjuvant.

Abstract: Compounds described herein can be used for therapeutic purposes. The compounds can be TLR agonists, such as TLR7 or TLR8 agonists. The compounds can be included in pharmaceutical compositions and used for therapies were being a TLR agonist is useful. The pharmaceutical compositions can include any ingredients, such as carries, diluents, excipients, fillers or the like that are common in pharmaceutical compositions. The compounds can be those illustrated or described herein as well as derivative thereof, prodrug thereof, salt thereof, or stereoisomer thereof, or having any chirality at any chiral center, or tautomer, polymorph, solvate, or combinations thereof. As such, the compounds can be used as adjuvants in vaccines as well as for other therapeutic purposes described herein. The compounds can have any one of the formulae. Examples of the compounds can be reviewed in Table 1 and Table A1 for activates.

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: A compound for use in a method of treatment of cancer, including precancerous lesions, and adverse events caused by the disease or anti-cancer agents and treatments, such as cancer cachexia, lymphopenia, neutropenia, febrile neutropenia includes in combination an immunomodulatory and at least one anti-cancer agent or treatment suitable for treating the disease. The immunomodulator is a proteic aggregate of ammonium and magnesium phospholinoleate-palmitoleate anhydride. The anti-cancer agent or treatment suitable for treating the disease provides synergistic effects without additional toxicity when used with the immunomodulatory. The anti-cancer treatment is selected from the following group: surgical procedures, transplantation of bone marrow cells, systemic and localized radiotherapy, and combinations thereof.

Abstract: The present invention relates to RSPO and LGR antagonists, and methods of using the RSPO and LGR antagonists for treating or preventing fibrotic diseases.

Abstract: The invention provides compositions and methods for treating cancers. The method comprises administering a PD-1 axis binding antagonist and an OX40 binding agonist.

Abstract: It is disclosed herein that (a) an anti-tumor DNA vaccine delivered using a MIP DNA vector is a less effective tumor treatment than the corresponding anti-tumor DNA vaccine delivered using a conventional pDNA vector, despite the MIP DNA vector eliciting a higher frequency of antigen-specific CD8+ T cells; and (b) tumor infiltrating CD8+ T cells in animals immunized with the MIP DNA vector express higher levels of the immune checkpoint protein LAG-3 than animals immunized with a conventional pDNA vector, while the expression levels of other immune checkpoint proteins was the same for both groups. Based on these findings, improved methods and compositions for administering DNA vaccines are disclosed. Specifically, DNA vaccines delivered with MIP DNA are administered along with a LAG-3 pathway blocking agent, resulting in a more effective vaccine-induced cellular immune response.