Abstract: A method for synthesizing influenza virus-like particles (VLPs) within a plant or a portion of a plant is provided. The method involves expression of influenza HA in plants and the purification by size exclusion chromatography. The invention is also directed towards a VLP comprising influenza HA protein and plant lipids. The invention is also directed to a nucleic acid encoding influenza HA as well as vectors. The VLPs may be used to formulate influenza vaccines, or may be used to enrich existing vaccines.

Abstract: The present invention provides an immunogenic influenza composition in a dose volume suitable for human use, comprising an influenza virus antigen or antigenic preparation thereof and an adjuvant composition comprising an oil-in-water emulsion, wherein said oil-in-water emulsion comprises a metabolisable oil at a level of below 11 mg and an emulsifying agent at a level of below 5 mg and optionally a tocol or a sterol at a level of below 12 mg. Suitably the amount of influenza antigen per strain per dose is 15 ?g HA or a low amount such as less than 15 ?g HA.

Abstract: The invention relates to a truncated L1 protein of the Human Papillomavirus Type 16, a virus-like particle consisting of the protein, a vaccine comprising said virus-like particle, and the use of the vaccine in the prevention of cervical cancer.

Abstract: The invention provides an agent for preventing or treating a condition characterized by the presence of unwanted cells, the agent comprising: (i) a targeting moiety that is capable of targeting to the unwanted cells; and (ii) a T cell antigen, wherein the T cell antigen can be released from the targeting moiety by selective cleavage of a cleavage site in the agent in the vicinity of the unwanted cells.

Abstract: The present invention relates to polypeptides comprising one or more antibody single domains, or antigen-binding fragments thereof, directed against Tumor Necrosis Factor-alpha, in particular, two light chain variable domains in dimeric form, where the dimer has high solubility. It also relates to methods of using anti-Tumor Necrosis Factor-alpha polypeptides in treating inflammatory disorders, including rheumatoid arthritis. Compositions and methods for enhancing therapeutic potential of anti-Tumor Necrosis Factor-alpha polypeptides are provided, including linking the polypeptide to an albumin-binding domain and/or de-immunizing the polypeptide, to provide therapeutic agents with good solubility, enhanced serum half-life, and/or reduced immunogenicity, while substantially maintaining the specific binding properties of the anti-Tumor Necrosis Factor-alpha polypeptides.

Abstract: A composition for preventing or treating cervical cancer comprising a human papillomavirus plasmodium and an immunity enhancer is provided. A fusion protein including a fusion polypeptide recombined to transform a 3D structure of E6 and E7, which are antigens against types 16 and 18 human papillomavirus (HPV), a signal peptide for secreting the fusion polypeptide outside the cells and an immunity enhancer peptide present in an individual is also provided. The fusion protein may be useful in treating HPV-triggered tumors by inducing an immune response specific to the antigens against the HPV types 16 and 18.

Abstract: The invention comprises a method for inducing broadly cross-neutralizing antibodies against cutaneous and mucosal papillomavirus types or against heterologous papillomavirus types in humans comprising administering to a human in need thereof an immunogenic peptide or protein (or polynucleotide encoding therefor), where the immunogenic peptide or protein is: (a) a peptide or protein of at least 10 amino acid residues in length having a sequence corresponding to either a sequence from the N terminal amino acids 1-200 of papillomavirus L2 protein (for cross-neutralizing antibodies against cutaneous and mucosal papillomavirus types) or a sequence from the N terminal amino acids 1-88 of papillomavirus L2 protein (for cross-neutralizing antibodies against heterologous papillomavirus types), (b) a peptide or protein of at least 10 amino acid residues in length with at least 55% identity with the sequence from (a), or (c) a peptide or protein as defined in either (a) or (b) which is conjugated or fused to a protein o

Abstract: The present application is related to a modified protein comprising a protein having a coiled coil domain and a peptide having the sequence such as shown in SEQ ID NO 1: ZXBBBBZ that is linked to the coiled coil domain wherein: Z is any amino acid or is absent; X is any amino acid; B is an arginine (R) or a lysine (K). Said modified protein is in particular an antigen or a carrier protein, associated to an antigen. This modified protein has an increased affinity for negatively charged polymers such as nucleic acids or heparin, and shows an increased immunogenicity.

Abstract: Methods are provided for the treatment of subjects with cognitive or neuropsychiatric impairment induced by substance addiction and for increasing cognitive function in a subject with substance addiction. In some embodiments, the methods include administering to the subject a therapeutically effective amount of a major histocompatibility complex (MHC) molecule including covalently linked first, second, and third domains; wherein the first domain is an MHC class II ?1 domain and the second domain is an MHC class II ?1 domain; or wherein the first domain is an MHC class I ?1 domain and the second domain is an MHC class I ?2 domain; and wherein the third domain is covalently linked to the first domain and comprises an antigen of the central or peripheral nervous system.

Abstract: The invention provides an agent for preventing or treating a condition characterized by the presence of unwanted cells, the agent comprising: (i) a targeting moiety that is capable of targeting to the unwanted cells; and (ii) a T cell antigen, wherein the T cell antigen can be released from the targeting moiety by selective cleavage of a cleavage site in the agent in the vicinity of the unwanted cells.

Abstract: A fusion protein of pyrroloquinoline quinone glucose dehydrogenase (PQQGDH) and a cytochrome is disclosed. PQQGDH is, for example, a water-soluble PQQGDH derived from Acinetobacter calcoaceticus. The cytochrome is, for example, an electron transfer domain of quinohemoprotein ethanol dehydrogenase from Comamonas testosteroni. The fusion protein of the present invention shows intramolecular electron transfer from PQQ, a redox center, to the cytochrome, which allow construction of a direct electron transfer-type glucose sensor which requires no electron mediators.

Abstract: The present invention provides compounds, pharmaceutically acceptable compositions thereof, and methods of using the same.

Abstract: An isolated protein or peptide selected from the group consisting of Bordetella colonization factor A (BcfA) protein and antigenic fragments thereof is described, along with an isolated nucleic acid encoding the same, antibodies that bind to the same, methods of producing an immune response in a mammalian subject in need thereof by administering the proteins, peptides or antibodies, and pharmaceutical compositions comprising the same.

Abstract: Immunogenic compositions are provided herein that are useful for inducing an immune response specific against group A streptococcus (GAS). Immunogenic compositions provided herein are multivalent and comprise a plurality of immunogenic peptides or fusion polypeptides comprising the immunogenic peptides that induce an immune response against GAS. The immunogenic compositions provided herein induce an immune response against the GAS serotypes represented by an immunogenic peptide (derived from an M protein or Spa protein) comprised within the immunogenic composition and also induce an immune response against serotypes that are unrepresented by any immunogenic peptide included in the immunogenic composition. Methods for using the compositions for inducing an immune response against GAS and for treating or reducing the likelihood of occurrence of a GAS infection are also provided.

Abstract: The present invention relates to the use of immunogenic peptides comprising a T-cell epitope derived from an allograft antigen and a redox motif such as C-(X)2-[CST] or [CST]-(X)2-C in the prevention and/or treatment of allograft rejection and in the manufacture of medicaments therefore.

Abstract: Polypeptides comprising at least one carboxy-terminal peptide (CTP) of chorionic gonadotrophin attached to the carboxy terminus but not to the amino terminus of a coagulation factor and polynucleotides encoding the same are disclosed. Pharmaceutical compositions comprising the polypeptides and polynucleotides of the invention and methods of using and producing same are also disclosed.

Abstract: The present invention relates to means and methods for determining neurotoxin activity. Specifically, it relates to a polypeptide having caspase activity comprising a large subunit and a small subunit wherein the caspase further comprises a neurotoxin cleavage site which upon cleavage activates the caspase activity. Also encompassed are polynucleotides encoding the polypeptides as well as vectors or host cells comprising the polynucleotides. The present invention further relates to a method for determining neurotoxin activity in a sample based on the polypeptide of the invention as well as the use of the polypeptide for determining neurotoxin activity in a sample, in general.

Abstract: The present invention provides new compositions and methods for preventing and treating pathogen infection. In particular, the present invention provides compounds having an anchoring domain that anchors the compound to the surface of a target cell, and a therapeutic domain that can act extracellularly to prevent infection of a target cell by a pathogen, such as a virus. The present invention also comprises therapeutic compositions having sialidase activity, including protein-based compounds having sialidase catalytic domains. Compounds of the invention can be used for treating or preventing pathogen infection, and for treating and reducing allergic and inflammatory responses. The invention also provides compositions and methods for enhancing transduction of target cells by recombinant viruses. Such compositions and methods can be used in gene therapy.

Abstract: The invention relates to a new adjuvant and to its use in combination with an antigen.

Abstract: In one aspect, the invention relates to an immunogenic composition that includes a mutant Clostridium difficile toxin A and/or a mutant Clostridium difficile toxin B. Each mutant toxin includes a glucosyltransferase domain having at least one mutation and a cysteine protease domain having at least one mutation, relative to the corresponding wild-type C. difficile toxin. The mutant toxins may further include at least one amino acid that is chemically crosslinked. In another aspect, the invention relates to antibodies or binding fragments thereof that binds to said immunogenic compositions. In further aspects, the invention relates to isolated nucleotide sequences that encode any of the foregoing, and methods of use of any of the foregoing compositions.

Abstract: The invention relates to methods for the temporal administration of EDA agonists, in particular EDI200, which correlate to optimal therapeutic response windows required for the formation of any EDA-dependent structures such as ectodermal appendages. Use of the methods described allow for the design of targeted therapeutic dosing and administration regimens in order to correct or alter abnormal phenotypes associated with genetic disorders, in particular, XLHED.

Abstract: Embodiments of the invention are directed to methods and compositions of multitype HPV polypeptides.

Abstract: Disclosed are: a cell capable of expressing an exogenous GITRL or an exogenous GITRL derivative; a method for producing the cell; a therapeutic or prophylactic agent comprising the cell as an active ingredient; use of the cell in the manufacture of a therapeutic or prophylactic agent; a method comprising a step of administering the cell to a subject; a viral vector carrying a gene encoding a GITRL or a GITRL derivative; a therapeutic or prophylactic agent comprising the viral vector as an active ingredient; use of the viral vector in the manufacture of a therapeutic or prophylactic agent; and a method comprising a step of administering the viral vector to a subject.

Abstract: The present invention relates to means and methods for determining neurotoxin activity. Specifically, it relates to a polypeptide having caspase activity comprising a large subunit and a small subunit wherein the caspase further comprises a neurotoxin cleavage site which upon cleavage activates the caspase activity. Also encompassed are polynucleotides encoding the polypeptides as well as vectors or host cells comprising the polynucleotides. The present invention further relates to a method for determining neurotoxin activity in a sample based on the polypeptide of the invention as well as the use of the polypeptide for determining neurotoxin activity in a sample, in general.

Abstract: Novel double and triple fusion reporter gene constructs harboring distinct imagable reporter genes are provided, as well as applications for the use of such double and triple fusion constructs in living cells and in living animals using distinct imaging technologies.

Abstract: Improved anti-HPV immunogens and nucleic acid molecules that encode them are disclosed. Immunogens disclosed include those having consensus HPV 6, HPV 11, HPV 33 and HPV58 E6 and E7. Pharmaceutical composition, recombinant vaccines comprising and live attenuated vaccines are disclosed as well methods of inducing an immune response in an individual against HPV are disclosed.

Abstract: The present invention relates to the use of immunogenic peptides comprising a T-cell epitope derived from a viral vector antigen and a redox motif such as C-(X)2-[CST] or [CST]-(X)2-C in the prevention and/or suppression of immune responses to viral vectors and in the manufacture of medicaments therefore.

Abstract: A combination of anti-neoplastic agents that provides increased activity over monotherapy, or in some cases at least an unexpected lack of negative interaction. In particular, the drug combination that includes a MAGE-A3 immunotherapeutic, in combination with a B-Raf inhibitor, particularly N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide, or a pharmaceutically acceptable salt thereof, and/or a MEK inhibitor, particularly N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)6,8-dimethy; -2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide, or a pharmaceutically acceptable salt or solvate thereof is described.

Abstract: The present invention relates to a hypoallergenic molecule consisting of Bet v Ia or an allergen having at least 40% identity to Bet v Ia comprising mutations of at least four amino acid residues in the region of amino acids 100 to 125 of Bet v Ia or its corresponding region of the allergen having at least 40% identity to Bet v 1a.

Abstract: The invention relates to improved variants of the anti-serum albumin immunoglobulin single variable domain DOM7h-11, as well as ligands and drug conjugates comprising such variants, compositions, nucleic acids, vectors and hosts.

Abstract: The instant invention provides materials and methods for producing immunologically active antigens derived from members of the Picornaviridae virus family. The picornavirus antigens of the invention may be in a form for use as a vaccine administered to a subject in a therapeutic treatment or for the prevention of a picornavirus infection. The picornavirus antigens of the invention may be in the form of an immunogenic composition for use in vaccines which are administered for the prevention of an Enterovirus infection. The instant invention further encompasses immunogenic compositions comprising Human enterovirus A, Human enterovirus B, Human enterovirus C, Human enterovirus D antigens and their use in vaccines for the prevention of an Enterovirus infection.

Abstract: The present invention relates to a recombinant bacterium expressing an antigen that is translocated to the cytosol of a host organism, and uses thereof. To this end, the present invention provides a recombinant bacterium comprising a nucleic acid encoding an antigen that is translocated to the cytosol of a host cell utilizing Type III secretion system. The recombinant bacterium is generally chosen from intracellular pathogens that reside in the phagosome and fail to induce rapid T cell activation. The translocated antigen may be a viral antigen, a bacterial antigen, or a tumour antigen. Methods of imparting immunity using the recombinant bacterium are also provided.

Abstract: The present invention is related with the isolation and cloning of a new gene, the production of the protein encoded by this gene by using recombinant systems, and the use of this antigen in a vaccine formulation as a purified protein and/or naked DNA, to induce an immune response in aquatic organisms against different ectoparasite species, including the known as sea lice, and pathogens associated with these infestations. The vaccine preparations, administered by oral route, immersion bath or injection, demonstrated its efficacy by producing IgM humoral immune response and reducing the number of parasites per fish in the vaccinated fishes.

Abstract: The present invention is related with the isolation and cloning of a new gene, the production of the protein encoded by this gene by using recombinant systems, and the use of this antigen in a vaccine formulation as a purified protein and/or naked DNA, to induce an immune response in aquatic organisms against different ectoparasite species, including the known as sea lice, and pathogens associated with these infestations. The vaccine preparations, administered by oral route, immersion bath or injection, demonstrated its efficacy by producing IgM humoral immune response and reducing the number of parasites per fish in the vaccinated fishes.

Abstract: The present invention relates to antibody molecules against anticoagulants, in particular dabigatran, and their use as antidotes of such anticoagulants.

Abstract: The invention relates to methods for controlling the glycosylation of a RAGE fusion protein. The invention also relates to compositions comprising an amount of a RAGE fusion protein where at least 0.5% of the amount of the RAGE fusion protein is aglycosylated and wherein no more than 53.2% of the amount of the RAGE fusion protein is aglycosylated.

Abstract: Random three- and four-amino acid copolymers having lengths of 14-, 35- and 50-amino acid residues are provided. The random copolymers have amino acids alanine, lysine and one or more of the hydrophobic amino acids valine, phenylalanine, tryptophan and tyrosine. Random three-amino acid copolymer FAK efficiently suppressed EAE induced in SJL/J (H-2S) mice with the encephalitogenic epitope PLP 139-151. Random four-amino acid copolymers VYAK and tryptophan-containing VWAK were efficacious in alleviating severity and duration of symptoms of EAE induced by MBP 85-99 (SEQ ID NO:2), in a humanized mouse model expressing genes for both an HLA-DR-2 linked to multiple sclerosis (MS) in humans and for a T cell receptor from an MS patient.

Abstract: The present invention relates to cholera toxin CTA1 protein fragments, adjuvant compositions, and methods relating to adjuvants for vaccines. The invention also relates to using recombinant CTA1 fragments conjugated to a polypeptide containing a protein transduction domain or cell-penetrating peptide as an immunomodulator.

Abstract: Specific amino acid sequences and peptides and/or peptide mimetics deducted therefrom influencing apoptosis, and the use thereof for the production of pharmaceuticals as diagnostic tools are shown.

Abstract: This invention provides compositions and methods for treating and vaccinating against an Her2/neu antigen-expressing tumor and inducing an immune response against dominant in a non-human animal.

Abstract: The invention relates to a composition suitable for inducing a T cell mediated immune response against an influenza virus in a vertebrate, said composition comprising nucleic acid encoding one or more epitopes of one or more internal proteins of influenza virus, wherein said composition comprises nucleic acid encoding at least two said epitopes, at least one epitope being from each of two or more internal proteins of influenza virus. The invention also relates to uses of same and to methods involving same.

Abstract: Two or more Neisserial proteins are joined such that they are translated as a single polypeptide chain. Hybrid proteins are represented by the formula NH2-A-[-X-L-]n-B—COOH where X is an amino acid sequence, L is an optional linker amino acid sequence, A is an optional N-terminal amino acid sequence, B is an optional C-terminal amino acid sequence, and n is an integer greater than I. Proteins where each of the n-X— moieties shares sequence identity to each other —X— moiety, the protein is a ‘tandem protein’.

Abstract: The present invention provides methods of regulating an immunological disorder comprising administering to a subject an effective amount of (i) an autoimmune antigen in conjunction with (ii) an anti-inflammatory cytokine. Compositions including the same are also provided.

Abstract: Provided herein are methods, compositions, and kits for preventing, inhibiting, reducing the severity of, or treating a disease or condition. A pharmaceutical composition provided herein can comprise a nucleic acid sequence encoding an antigen fused to an immune cell product, e.g., MIP-3?, and an adjuvant. The antigen can be from a bacteria, virus, fungus, parasite, or cancer. The antigen can be an Alzheimer's disease antigen.

Abstract: The present invention refers to the use of protein kinase inhibitors and more specifically to the use of inhibitors of the protein kinase c-Jun amino terminal kinase, JNK inhibitor sequences, chimeric peptides, or of nucleic acids encoding same as well as pharmaceutical compositions containing same, for the treatment of various diseases or disorders strongly related to JNK signaling, wherein these diseases or disorders are selected from autoimmune disorders, cardiovascular diseases, cancerous diseases, diabetes, including diabetes type 1 or type 2, inflammatory diseases, hair loss, including Alopecia areata, diseases of the lung, neuronal or neurodegenerative diseases, diseases of the liver, diseases of the spine, diseases of the uterus, viral infectious diseases and depressive disorders.

Abstract: The present invention relates to the preparation and use of recombinant variants of group 6 allergens of the Poaceae (true grasses), which are characterized by reduced IgE reactivity compared with known wild-type allergens and at the same time substantially retained reactivity with T-lymphocytes.

Abstract: The present invention relates to a novel lipoprotein particle, methods for preparing and purifying the same, its use in medicine, particularly in the prevention of malarial infections, compositions/vaccines containing the particle or antibodies against the protein particle such as monoclonal or polyclonal antibodies and use of the same, particularly in therapy. Furthermore, particles with the specific ratio can be prepared by employing yeast, Saccharomyces cerevisiae or Pichia pastoris. In particular it relates to an immunogenic protein particle comprising the following monomers: a. a fusion protein comprising sequences derived from a CS protein of P. vivax and the S antigen of Hepatitis B (CSV-S), and b. S antigen derived from Hepatitis B virus, and characterized in that the ratio of S to CSV-S is in the range 0.1 to 1. Suitably, the ratio of S to CSV-S is in the range 0.19 to 0.30 or 0.68 to 0.80.

Abstract: The present invention relates to the use of immunogenic peptides comprising a T-cell epitope derived from a tumour-associated antigen and a redox motif such as C-(X)2-[CST] or [CST]-(X)2-C in the treatment of a tumour or in the treatment or prevention of a tumour relapse, and in the manufacture of medicaments therefore.

Abstract: A composition for preventing or treating cervical cancer comprising a human papillomavirus plasmodium and an immunity enhancer is provided. A fusion protein including a fusion polypeptide recombined to transform a 3D structure of E6 and E7, which are antigens against types 16 and 18 human papillomavirus (HPV), a signal peptide for secreting the fusion polypeptide outside the cells and an immunity enhancer peptide present in an individual is also provided. The fusion protein may be useful in treating HPV-triggered tumors by inducing an immune response specific to the antigens against the HPV types 16 and 18.

Abstract: Disclosed is an isolated immunoglobulin. Also disclosed are pharmaceutical compositions and medicaments comprising the immunoglobulin, isolated nucleic acid encoding it, vectors, host cells, useful in methods of making it. In some embodiments the immunoglobulin comprises one to twenty-four pharmacologically active chemical moieties conjugated thereto, such as a pharmacologically active polypeptide.