Abstract: This invention relates to transduction of cargo molecules into living cells, such as protein transduction, in particular a delivery molecule for transduction of a cargo into a cell comprising: a cargo-binding molecule and/or a cargo; a glycosaminoglycan (GAG) binding element, which is capable of binding to GAG on the surface of the cell; and a protein transduction domain. Methods of transduction, methods of producing or modifying cargo for transduction, delivery molecules for transduction and methods of treatment using transduction, or using transduced cells are also provided.

Abstract: The present invention provides novel drug discovery platforms and methods for treating type I diabetes.

Abstract: A peptide with anti-inflammatory activity is described, wherein the peptide comprises at least one amino acid sequence among SEQ ID NO: 2 to SEQ ID NO: 179, the peptide has above 80% homology of amino acid sequence with above-mentioned sequences, or the peptide is the fragment of the above-mentioned peptides. The peptides that have at least one amino acid sequence of SEQ ID NO: 2 to SEQ ID NO: 179 shows outstanding efficacy in both suppressing inflammation and in prophylactic means. Therefore, the composition comprising those peptides can be used as anti-inflammatory pharmaceutical compositions or as cosmetic compositions, in turn, treating and preventing a variety of different types of inflammatory diseases.

Abstract: This invention generally relates to cationic oil-in-water emulsions that contain high concentrations of cationic lipids and have a defined oil:lipid ratio. The cationic lipid can interact with the negatively charged molecule thereby anchoring the molecule to the emulsion particles. The cationic emulsions described herein are useful for delivering negatively charged molecules, such as nucleic acid molecules to cells, and for formulating nucleic acid-based vaccines.

Abstract: The invention relates to compositions of vault complexes for use as adjuvants for stimulating a cellular immune response to an antigen, for example a tumor antigen, and methods of using the vault complexes in the treatment of diseases, such as cancer.

Abstract: The present invention relates to a composition comprising a lysosomal enzyme conjugated to a negatively charged scavenger receptor ligand. In some embodiments, the lysosomal enzyme is conjugated to the scavenger receptor ligand by way of a linker. The present invention also relates to a composition comprising lysosomal enzyme encapsulated by a liposome, said liposome externally comprising a negatively charged scavenger receptor ligand. The invention further encompasses a method of treating a lysosomal storage disease with the compositions listed above. The invention further encompasses a method of treating a lysosomal storage disease with an acylated, acetylated, or aconitylated lysosomal enzyme.

Abstract: The technology provided herein generally relates to novel fusion proteins suitable as human and/or animal vaccines against parasites or pathogens of the phylum Apicomplexa. In particular, the present disclosure relates to novel fusion proteins as a basis for vaccines against Plasmodium parasites, including P. falciparum, P. vivax, P. malariae, P. ovale and P. knowlesi. Nucleic acid molecules encoding said fusion proteins, vectors, host cells containing the nucleic acids and methods for preparation and producing such fusion proteins; antibodies induced or generated by the use of said fusion proteins or said nucleic acid molecules encoding said fusion proteins and the use of such antibodies or recombinant derivatives for passive immunotherapy; methods for producing such fusion proteins; compositions and methods for using such fusion proteins for the prevention and treatment of malaria are also encompassed by the present disclosure.

Abstract: TGF-? growth factor and its latent complex are conjugated to magnetic micro- or nanoparticles and to magnetic micro- or nanodiscs. By exposing the resulting conjugates to magnetic fields, the TGF-? growth factor can be released from its latent complex in vivo, potentially making it useful in tissue engineering and regenerative medicine. And by exposing a conjugate of TGF-? growth factor and a magnetic particle to a sufficiently strong, radiofrequency magnetic field, the TGF-? growth factor can be denatured and thereby deactivated, potentially making it possible to avoid triggering tumorigenesis, atherosclerosis, fibrotic disease, and cancer.

Abstract: The present invention provides a process called “Immune Banking” that enhances vaccine efficacy by exploiting existing humoral responses. The process involves tagging new antigens with molecular markers recognized by an existing antibody response. This recognition of the tagged vaccine components enhances adaptive immune responses to the new vaccine.

Abstract: The present invention regards nanoparticles comprising a sterol and a component derived from Quillaja saponaria Molina selected from quillaja acid and quillaja saponin, which nanoparticles do not comprise a phospholipid. It also relates to a composition comprising the nanoparticles, and the use thereof as adjuvant, especially in vaccines, as carriers for amphipathic or hydrophobic molecules and as agents for treatment of cancer. Further, it regards a method for producing the phospholipid-free nanoparticles, a method for the treatment of cancer and a method for assessing the applicability of the cancer treating method.

Abstract: The present invention provides novel enterobactin-carrier protein conjugates and salmochelin-carrier protein conjugates, such as compounds of Formula (I), and salts thereof. The present invention also provides compositions, kits, and methods that involve the compounds of Formula (I) and are useful in inducing an immune response, treating a bacterial infection and/or inflammatory bowel disease in a subject, preventing a bacterial infection and/or inflammatory bowel disease in a subject, or inhibiting the growth of or killing a bacterium.

Abstract: Disclosed is are formulations comprising a multivesicular liposome and MTX, the administration of which results in a Cmax of MTX between 5% and 50% of the Cmax of an immediate release dosage form of MTX, the duration of which lasts from about 1 to about 30 days. Also disclosed are methods of treating autoimmune diseases and cancer by administering these formulations of MTX.

Abstract: The invention pertains to a method to sporulate coccidial oocysts purified from animal faeces (5), the method comprising providing the purified oocysts as a layer (40) on a supporting surface (22), maintaining the layer at least intermittently in an oxygen containing gaseous environment (60) having a relative humidity of at least 15% and maintaining the temperature of the oocysts between 19° C. and 37° C. The invention also pertains to sporulated oocysts obtained with this method and to a vaccine containing such sporulated oocysts.

Abstract: The present invention provides compounds, compositions, and methods for detecting, diagnosing and treating cancers such as glioblastoma multiforme.

Abstract: The present invention provides bis-polymer lipid-peptide conjugates containing a hydrophobic block and headgroup containing a helical peptide and two polymer blocks. The conjugates can self-assemble to form helix bundle subunits, which in turn assemble to provide micellar nanocarriers for drug cargos and other agents. Particles containing the conjugates and methods for forming the particles are also disclosed.

Abstract: The invention relates to compositions of vault complexes containing recombinant membrane lytic proteins, such as an adenovirus protein VI lytic domain, and methods of using the vault complexes to facilitate delivery and entry of a biomolecule into a cell or subject.

Abstract: The invention improves TdaP vaccines by including a TLR agonist in them. This agonist can provide stronger protection, longer-lasting protection, and/or can reduce the amount of antigen which is required to achieve a particular immune response.

Abstract: Provided herein are methods for rational design of nicotine haptens. More particularly, provided herein are methods for designing, selecting, and synthesizing nicotine haptens and nicotine hapten conjugates. Also provided herein are novel nicotine haptens and methods for using nicotine haptens to treat nicotine addiction.

Abstract: The invention includes monoclonal and polyclonal antibodies, and antigen-binding fragments thereof, having specific binding affinity for 4,6-diamino-5-(formylamino)pyrimidine (FAPY-adenine); hybridomas producing such antibodies; immunoconjugates comprising an antibody or antigen-binding fragment of the invention coupled to a moiety; and in vitro and in vivo methods for using such antibodies, antibody fragments, and conjugates based on binding to FAPY-adenine; nucleic acids encoding the heavy and/or light chains of the antibodies; vectors comprising the nucleic acid sequences encoding the heavy and/or light chains; host cells comprising and, optionally, expressing the nucleic acid sequences; and methods for the production of the aforementioned materials.

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: The invention is directed to multi-functional N-maleimidyl polymer derivatives comprising a water soluble and non-peptidic polymer backbone having a terminal carbon, such as a poly(alkylene glycol), the terminal carbon of the polymer backbone being directly bonded to the nitrogen atom of a N-maleimidyl moiety without a linking group therebetween. The invention also provides two methods of preparing such linkerless N-maleimidyl polymer derivatives.

Abstract: The present invention provides a pharmaceutical composition containing recombinant hemoglobin protein or tetramer or dimer or subunit for tissue oxygenation and treating cancer. The recombinant hemoglobin protein or tetramer or dimer or subunit-based therapeutic agent is also effective for treating cancer. The recombinant hemoglobin or tetramer or dimer or its subunit moiety can target cancer cells and the therapeutic moiety (i.e. active agent/therapeutic drug) can kill the cancer cells efficiently. The recombinant hemoglobin or tetramer or dimer or its subunit-based therapeutic agent used in the present invention can be used in the treatment of various cancers such as pancreatic cancer, leukemia, head and neck cancer, colorectal cancer, lung cancer, breast cancer, liver cancer, nasopharyngeal cancer, esophageal cancer, prostate cancer, stomach cancer and brain cancer.

Abstract: Disclosed is are formulations comprising a multivesicular liposome and MTX, the administration of which results in a Cmax of MTX between 5% and 50% of the Cmax of an immediate release dosage form of MTX, the duration of which lasts from about 1 to about 30 days. Also disclosed are methods of treating autoimmune diseases and cancer by administering these formulations of MTX.

Abstract: The present invention relates, in part, to a biocompatible hydrophobic-core carrier comprising a carrier, and a plurality of hydrophobic groups covalently linked to the polymeric carrier. The hydrophobic groups are capable of dissociably linking load molecules such as therapeutic agents. The hydrophobic-core carrier may also comprise protective side chains, orienting molecules, and targeting molecules.

Abstract: This invention relates to a method for treating or preventing a disease by raising an innate immune response in a subject, the method comprising administering to the subject an effective amount of a composition comprising a TLR2 moiety in solution, wherein the TLR2 moiety comprises a TLR2 agonist and wherein the disease is not treated or prevented by a humoral or cellular immune response directed against the TLR2 moiety.

Abstract: The present invention relates to a nucleic acid sequence, comprising or coding for a coding region, encoding at least one peptide or protein comprising a pathogenic antigen or a fragment, variant or derivative thereof, at least one histone stem-loop and a poly(A) sequence or a polyadenylation signal. Furthermore the present invention provides the use of the nucleic acid for increasing the expression of said encoded peptide or protein. It also discloses its use for the preparation of a pharmaceutical composition, especially a vaccine, e.g. for use in the treatment of infectious diseases. The present invention further describes a method for increasing the expression of a peptide or protein comprising a pathogenic antigen or a fragment, variant or derivative thereof, using the nucleic acid comprising or coding for a histone stem-loop and a poly(A) sequence or a polyadenylation signal.

Abstract: The present disclosure is directed to progastrin monoclonal antibodies, fragments thereof, compositions comprising progastrin monoclonal antibodies, and methods of making and using progastrin monoclonal antibodies and compositions thereof. The present disclosure is directed to methods of treating colorectal cancer with progastrin monoclonal antibodies and compositions comprising progastrin monoclonal antibodies or fragments thereof. The present disclosure is further directed to methods comprising detection of progastrin, including methods of diagnosing colorectal cancer and methods of monitoring efficacy of anti-cancer therapy in subjects suffering from colorectal cancer.

Abstract: The present invention provides a method for the purification of complexes comprising a stress protein complexed to a peptide or peptide fragment, from a source mixture, typically a cell lysate. The improved method of the invention provides for protein complexes to be purified using ion exchange based methods, without the need to use chemicals such as chaotropes and ampholytes. The purified complexes can be used as the immunogenic determinant in vaccine compositions for the treatment or prevention of infectious diseases or cancerous conditions.

Abstract: An intraorally administrable vaccine composition useful to be a preventive or therapeutic agent for infectious diseases, and effectively induces a systemic immune response or a mucosal immune response is provided. A vaccine composition for administration to the oral cavity of a human or an animal, the vaccine composition containing at least one antigen derived from an infectious disease, and at least one selected from the group consisting of a toll-like receptor 4 (TLR4) agonist, a toll-like receptor 2/6 (TLR2/6) agonist, and cyclic dinucleotide, or a derivative or salt thereof.

Abstract: The invention is directed to multi-functional N-maleimidyl polymer derivatives comprising a water soluble and non-peptidic polymer backbone having a terminal carbon, such as a poly(alkylene glycol), the terminal carbon of the polymer backbone being directly bonded to the nitrogen atom of a N-maleimidyl moiety without a linking group therebetween. The invention also provides two methods of preparing such linkerless N-maleimidyl polymer derivatives.

Abstract: The invention provides a conjugate comprising an antigen and a carrier molecule, wherein the carrier molecule comprises a spr0096 antigen and a spr2021 antigen. spr0096 and spr2021 are Streptococcus pneumoniae antigens. The conjugate may be used in a method for raising an immune response in a mammal, the method comprising administering the conjugate to the mammal. Also provided are pharmaceutical compositions, particularly vaccines, comprising the conjugate.

Abstract: Described herein are compositions and methods useful for allowing for the absorption (passage) of agents of interest, such as therapeutic agents, across epithelial and mucosal barriers and/or into certain subcellular compartments of the cell, such as the recycling endosome (RE), Golgi, and the endoplasmic reticulum (ER).

Abstract: The present invention concerns compositions and methods of use of antibodies or antibody fragments that bind to an epitope located within the second cysteine-rich domain (Cys2, amino acid residues 1575-1725) of MUC5AC. The antibodies bind with high specificity and selectivity to pancreatic cancer and are of use for therapy, detection and/or diagnosis of pancreatic cancer. In preferred embodiments, therapeutic antibody may be conjugated to at least one therapeutic agent, such as 90Y. Both in vivo and in vitro detection of pancreatic cancer may be performed with the subject methods and compositions. Specific dosages of radiolabeled antibody and/or gemcitabine, of use in human pancreatic cancer patients, are disclosed herein.

Abstract: The invention is in the field of salt forms of an immunopotentiator compound and their formulation for in vivo use. In particular the invention relates to arginine salts.

Abstract: Methods are provided for the treatment of a retinal disorder or optic neuritis in a subject. In some embodiments, the methods include administering a therapeutically effective amount of an 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, wherein the amino terminus of the ?1 domain is covalently linked to the carboxy terminus of the ?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, wherein the amino terminus of the ?2 domain is covalently linked to the carboxy terminus of the ?1 domain; and wherein the third domain is covalently linked to the first domain and comprises a retinal antigen or an antigen of the central or peripheral nervous system.

Abstract: Provided is a method for solid phase synthesis of liraglutide, comprising the following steps: A), Fmoc-Gly-resin being obtained by coupling resin solid phase carrier with glycine with N-end protected by Fmoc(Fmoc-Gly-OH) in the presence of activator system; B) according to the peptide sequence of the main chain of liraglutide, successively coupling with amino acids with N-ends protected by Fmoc and protected side chains by the method for solid phase synthesis, wherein lysine employs Fmoc-Lys(Alloc)-OH; C) removing the protective group, Alloc, from the side chain of lysine; D) coupling the side chain of lysine with Palmitoyl-Glu-OtBu by the method for solid phase synthesis; E) cleavage, removing protection groups and resin to obtain crude liraglutide; F) purifying and lyophilizing to obtain liraglutide.

Abstract: Processes and compositions to produce, package, and purify virus like particles containing heterologous cargo molecules utilizing self assembling proteins and protease treatment coupled with simple precipitation and filtration methods are described.

Abstract: An adjuvant composition which comprises an anionic macromolecule component particularly an ionic polysaccharide such as DEAE-dextran, and a saponin component, particularly an immunostimulating complex component. Immunogenic compositions comprising an immunogen and this adjuvant composition are also disclosed together with methods of use thereof.

Abstract: Disclosed are immunogenic conjugates which elicit an immune response to Plasmodium proteins. In particular examples, the Plasmodium proteins include sexual stage surface proteins, circumsporozoite protein (CSP), or immunogenic portions of CSP. Also provided herein are immunogenic compositions including one or more of the disclosed immunogenic conjugates and a pharmaceutically acceptable carrier. Further provided is a method of eliciting an immune response to Plasmodium in a subject, comprising administering to the subject an immunogenic composition disclosed herein.

Abstract: The invention relates to a kit of parts, suitable for use in a therapy of cancer, wherein said kit comprises: (i) a recombinant protein comprising one or several polypeptides bearing one or several epitopes of one or several tumor-associated antigens, said polypeptides being inserted in the same or different permissive sites of an adenylate cyclase (CyaA) protein or of a fragment thereof, wherein said CyaA fragment retains the property of said adenylate cyclase protein to target Antigen Presenting Cells or a mixture of such recombinant proteins wherein at least one of said epitopes, or tumor associated antigens, or insertion sites of CyaA protein, or fragment of said CyaA protein is different between the various recombinant proteins in the mixture; and said kit of parts further comprises at least one of the following compounds; (ii) an agent, suitable for modulating a regulatory immune response in a patient ad optionally; (iii) an adjuvant component suitable for activating the innate immune response in a pa

Abstract: Three conjugation methods for use with the capsular saccharide of Streptococcus agalactiae. In the first method, reductive animation of oxidized sialic acid residue side chains is used, but the aldehyde groups are first aminated, and then the amine is coupled to a carrier via a linker. In the second method, sialic acid residues and/or N-acetyl-glucosamine residues are de-N-acetylated to give amine groups, and the amine groups are coupled to a carrier protein via a linker. In the third method, linkage is via galactose residues in the capsular saccharide rather than sialic acid residues, which can conveniently be achieved using galactose oxidase.

Abstract: The invention relates to nanoemulsions useful for analytical techniques and delivery of cargoes such as pharmaceutically active agents. In particular, the invention relates to nanoemulsions comprising an oil phase dispersed in an aqueous phase and at least two peptide surfactants adsorbed at the liquid-liquid interface, one peptide surfactant comprising a short peptide sequence having ?-helical propensity and at least one second polypeptide surfactant comprising at least two peptide sequences having ?-helical propensity linked by a linking sequence of 3 to 11 amino acid residues. Optionally the at least one second polypeptide surfactant comprises at least one pharmacokinetic modifying agent and/or a targeting agent. Furthermore, the nanoemulsion may further comprise a cargo such as a pharmaceutically active agent.

Abstract: An immunogenic composition containing a glycan conjugate including a carrier protein, and a glycan including Globo H, an immunogenic fragment thereof, or stage-specific embryonic antigen-4 (SSEA-4), wherein the glycan is conjugated with the carrier protein through a linker.

Abstract: The present invention provides anti-Plasmodium immunogenic compositions comprising EVP1 (PFD0495c) or an antigenic portion thereof, as well as methods of immunizing against malaria employing these compositions. In other embodiments, the present invention provides methods of identifying Plasmodium infection employing agents that bind to EVP1 or an antibody generated thereto.

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: The present invention relates to the use of alpha (2) macroglobulin complexes isolated from the serum of a mammal. The invention also relates to methods for making such complexes and compositions comprising alpha (2) macroglobulin complexes, isolated from the serum of a mammal, wherein such compositions are used in methods for the treatment and prevention of cancer and infectious disease. The invention also relates to methods for treating and preventing cancer and infectious disease using such complexes comprising, isolated from the serum of a mammal. The invention also encompasses methods for production of alpha (2) macroglobulin complexes.

Abstract: The present invention relates to bispecific molecules comprising an EGFR binding domain and a distinct IGFIR binding domain for use in diagnostic, research and therapeutic applications. The invention further relates to cells comprising such proteins, polynucleotide encoding such proteins or fragments thereof, and vectors comprising the polynucleotides encoding the innovative proteins. Exemplary bispecific molecules include antibody-like protein dimers based on the tenth fibronectin type III domain.

Abstract: Compositions that include Toll-like Receptor 5 agonists and at least a portion of at least one viral antigen can be employed in methods that stimulate an immune response in a subject, in particular, a protective immune response in a subject. Compositions can be associated with particles and employed in the methods in relatively low doses to provide protective immunity to viral infection.

Abstract: The invention relates to the use of an immunologically reactive microbial transglutaminase or its immunologically reactive parts or analogues, which are present in a complex with gliadin or its immunologically reactive parts or analogues, for the diagnosis and/or therapy control of coeliac disease or sprue as well as gluten sensitivity, and a kit for determining the diagnosis and/or therapy control of coeliac disease or sprue as well as of gluten sensitivity, by means of the previously mentioned complex.

Abstract: The invention relates to the areas of immunology and vaccine delivery. More specifically, it relates to a bacterial vaccine delivery technology with built-in immunostimulatory properties which allows the immobilization of any antigen of interest, without prior antigen modification. Provided is an antigen-loaded immunogenic carrier complex comprising at least one bifunctional polypeptide attached to an immunogenic carrier, said bifunctional polypeptide comprising a peptidoglycan binding domain (PBD) through which the polypeptide is attached to said carrier, fused to an antigen binding domain (ABD) to which at least one antigen of interest is bound. Also provided is a pharmaceutical (e.g. vaccine) composition comprising an antigen-loaded immunogenic carrier complex of the invention.