Abstract: The current invention discloses methods to modify protein and peptide and antigen to treat disease such as pathogen infection, autoimmune diseases and cancer. The method involves increasing the molecular weight of the protein by connecting multiple peptide units with site specific conjugation to extend the in vivo half life. The current invention also discloses methods to construct activatable enzyme, which becomes active when they reach the treatment target, therefore provide higher specificity for treatment. The current invention also relates to methods to treat disease with hemopurification.

Abstract: This invention provides methods and compositions for modulating movement of eukaryotic cells with migratory capacity. More specifically, the invention provides anti-fugetactic agents and methods for the use thereof in enhancing an immune response.

Abstract: Protein-based vaccines against infectious agents, including malaria and Zika virus, are described. The protein-based vaccines include an antigen domain and an immature dendritic cell targeting domain and are administered in combination with an adjuvant.

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 invention relates to vaccines for treating prostate inflammation and benign prostate hyperplasias (stages I and II) comprising Lactobacillus strains in an inactivated form and carriers and/or excipients commonly used in vaccine preparations.

Abstract: Viruses, and particularly genetically engineered, replication deficient viruses such as adenoviruses, poxviruses, MVA viruses, and baculoviruses which encode one or more antigens of interest, such as TB, malarial, and HIV antigens, are spray dried with a mannitol-cyclodextrin-trehalose-dextran (MCTD) to form a powder where the viability of the viruses are maintained at a suitable level for mass vaccinations after spray drying, and where the viability of the viruses are maintained at suitable level over a period of storage time, even in the presence of humidity.

Abstract: The present invention provides exosomes isolated from an animal, wherein the animal (a) has overcome a disease caused by a pathogen, and (b) it is free from the pathogen that causes the diseases. The invention also provides process for obtaining these exosomes and the use thereof in therapy.

Abstract: The present invention relates to immortalized porcine alveolar macrophages (PAMs), to cell cultures comprising such PAMs, to methods for the immortalization of PAMs, to methods of replicating PRRS virus on immortalised PAMs and to methods for the preparation of vaccines comprising PRRSV.

Abstract: The present invention is directed to a sequence modification of the H7 hemagglutinin glycoprotein of the Influenza A/Shanghai/2/2013 H7 sequence together with vaccines derived therefrom. In addition, the invention further comprises method for improving the efficacy of vaccine antigens by modifying T cell epitopes.

Abstract: The present technology is directed to a sequence modification of the H7 hemagglutinin glycoprotein of the Influenza A/Shanghai/2/2013 H7 sequence together with vaccines derived therefrom. In addition, the invention further comprises method for improving the efficacy of vaccine antigens by modifying T cell epitopes.

Abstract: The present invention is directed to a sequence modification of the H7 hemagglutinin glycoprotein of the Influenza A/Shanghai/2/2013 H7 sequence together with vaccines derived therefrom. In addition, the invention further comprises method for improving the efficacy of vaccine antigens by modifying T cell epitopes.

Abstract: Provided are a highly-safe recombinant vaccinia virus that is effective in preventing the onset of symptoms due to infection by novel influenza viruses, and a vaccine for the novel influenza viruses containing the recombinant vaccinia virus. This recombinant vaccinia virus is capable of expressing the hemagglutinin protein genes of the novel influenza virus. This novel influenza vaccine contains the recombinant vaccinia virus.

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 invention relates, in general, to human immunodeficiency virus (HIV), and, in particular, to a method of inducing neutralizing antibodies to HIV and to compounds and compositions suitable for use in such a method.

Abstract: The present disclosure relates to a vaccine composition, wherein the vaccine composition comprises an immune amount of fowl adenovirus Fiber-2 protein or an immune amount of a live vector recombined with gene of the fowl adenovirus Fiber-2 protein, and a pharmaceutically acceptable carrier. The vaccine composition can provide effective immune protection against different serotypes of adenoviruses and provide a protection rate of 100% at low levels of immunogenic components, showing good immunological efficacy.

Abstract: A method of enhancing immune response is provided, including covalent linking an amphipathic peptide to an antigen to form an antigen-complex composition; and administering the antigen-complex to a subject. In addition, a novel antigen-complex with amphipathic helical structure is provided as well, in which the ability of antigen delivery could be improved.

Abstract: Provided herein are methods of treating beta-thalassemia in a subject comprising administering to the subject an activin type II receptor (ActRII) signaling inhibitor (e.g., an activin ligand trap) and utilizing one or more in vitro cell culture methods provided herein in (i) selection of the subject to be treated according to the methods provided herein; and/or (ii) monitoring of the subject being treated according to the methods provided herein.

Abstract: The present disclosure describes combination therapies comprising an anti-IL-10 antibody or antigen-binding fragment thereof and a CpG-C type oligonucleotide, and the use of the combination therapies for the treatment of cancer.

Abstract: Disclosed herein are PSMA binding proteins with improved binding affinities, and robust aggregation profiles. Also described are multispecific binding proteins comprising a PSMA binding protein according to the instant disclosure. Pharmaceutical compositions comprising the binding proteins disclosed herein and methods of using such formulations are further provided.

Abstract: Methods for treating cancer, e.g., in conjunction with anti-cancer therapy, like immunotherapy, and for identifying candidate therapeutic agents, by targeting myeloid derived suppressor cells expressing Tspan33.

Abstract: The invention relates to a combination comprising (i) a compound A comprising a mitochondrial targeting group linked to a group capable of releasing hydrogen sulfide or a pharmaceutically acceptable salt thereof or a prodrug thereof, an inhibitor of the thioredoxin antioxidant system or a pharmaceutically acceptable salt thereof or a prodrug thereof, and/or a nitroxide or a pharmaceutically acceptable salt thereof or a prodrug thereof; and (ii) a photosensitizer or photosensitizer precursor; for use in photodynamic therapy.

Abstract: The present disclosure provides methods of treating a biological tissue using a proton beam. A method includes the steps of: irradiating a proton beam to a biological tissue containing a reactant. The reactant includes a composite. The composite reacts with at least one proton from the proton beam and releases at least one ? particle or ? rays. The ? particle or ? rays reacts with the biological tissue. Another method includes the steps of: providing a reactant, the reactant comprising a composite; introducing the reactant into a biological tissue, the reactant being distributed in the biological tissue; and irradiating the biological tissue with the proton beam. The composite reacts with at least one proton from the proton beam to release at least one ? particle or ? rays, and the ? particle or the ? rays reacts with the biological tissue.

Abstract: The invention relates generally to neuroprotection and repair in neurological disorders involving Tau dysfunction (including Alzheimer's disease). The invention describes AND INCLUDES a direct interaction between proteins FKBP52 and Tau. More particularly, the invention relates to a method for screening a drug for the prevention and treatment of neurological disorders involving Tau dysfunction comprising the following steps: a) determining the ability of a candidate compound, to modulate the interaction between a Tau polypeptide and a FKBP52 polypeptide and b) selecting positively the candidate compound that modulates said interaction. The present invention finally relates to diagnostic, prognostic, and monitoring assays of neurological disorders involving Tau dysfunction.

Abstract: This invention describes novel immunogenic complexes, which are designed to trigger a robust host immune response against cancer cells by co-opting the immune system's natural ability to eliminate pathogen-infected host cells. The immunogenic complexes, referred to as microbial mimetics (MM) have unique physical and biochemical properties, which are designed to simulate a pathogenic infection of similar sized bacteria and viruses, permitting tumor-associated and tumor-specific peptide antigens to be presented to immune cells as microbial constituents. The MM are well-suited to mimic a systemic infection with microbe sized particles comprised largely of tumor antigens. Under this framework, tumor cells may be eliminated in the ensuing immune response. The microbial mimetics exhibit unique properties, including size tunability and contain antigenic cargo complexed to immune stimulatory molecules, which synergize to potentiate immune responses.

Abstract: The present invention is directed to methods for treating diarrhea, both chronic or acute forms, by the administration of a therapeutically or prophylactically effective amount of antibodies and fragments thereof having binding specificity for CGRP. In particular the methods prevent or reduce diarrhea in conditions or treatments resulting in elevated CGRP levels, e.g., in the GI tract (colon) that are associated with diarrhea and/or improper electrolyte and fluid excretion from the bowel or urinary system. More specifically, this invention relates to treatments using the anti-CGRP antibodies and fragments described herein, and binding fragments thereof.

Abstract: An active agent delivery composition is provided that allows topical delivery of active agents including vitamin A and its derivatives. A polyhalogenic vehicle serves as a coupler for an active agent and a silicone carrier so as to allow solubilization of active agents not normally miscible in silicones and providing a moisture maintaining composition.

Abstract: The present invention discloses nerve growth factor composition and an injection powder comprising the following components: 10 ?g/mL-100 ?g/mL of a nerve growth factor; 10 mg/mL-80 mg/mL of disaccharide stabilizer; 0 mg/mL-30 mg/mL of an amino acid stabilizer; 0.01 mg/mL-1 mg/mL of surfactant, 10 mg/mL-50 mg/mL of a supporting agent; a pH buffer for maintaining the nerve growth factor composition at 6.0-7.4, and solvent being water. The nerve growth factor composition and the injection powder can avoid the potential risk resulting from the virus of other unknown components carried in albumin by using a disaccharide or a combination of a disaccharide and an amino acid instead of albumin as a stabilizer; not only have protective effect on mNGF, but also can ensure the stability of hNGF and rhNGF in the preparation, transportation and storage processes, and have better medication safety and quality control.

Abstract: A medical device including an implantable medical prosthesis that can be reshaped into a scaffold to support the bodily tissues and bones. Additionally, the medical prosthesis relates to an intraluminal graft that would prevent the walls of the passageway from collapsing and includes a polymer containing additives. The base polymers and additives are biodegradable and/or bioabsorbale. The composite matrix of polymer and additives have lowered density through foaming having either closed cell foam or open cell foam or combination thereof. Alternately, the structural member of the device can be a hollow continuous tube or made of many hollow tubes (short) joined on ends thus making hollow longitudinal cells.

Abstract: The present invention relates to an aqueous ophthalmic composition that contains (A) vaseline and (B) at least one selected from the group consisting of a vinyl-based polymer compound, a saccharide, an amino acid, polyalcohol, a preservative, a sulfa drug, a vitamin, an inorganic salt compound, an ocular muscle modulator component, a vasoconstrictor, a stabilizer, polyoxyethylene polyoxypropylene glycol, and a vegetable oil.

Abstract: The present application discloses an acid labile lipophilic molecular conjugate of cancer chemotherapeutic agents and methods for reducing or substantially eliminating the side effects of chemotherapy associated with the administration of a cancer chemotherapeutic agent to a patient in need thereof.

Abstract: The present invention concerns improved methods and compositions for preparing SN-38 conjugates of proteins or peptides, preferably immunoconjugates of antibodies or antigen-binding antibody fragments. More preferably, the SN-38 is attached to the antibody or antibody fragment using a CL2A linker, with 1-12, more preferably 6-8, alternatively 1-5 SN-38 moieties per antibody or antibody fragment. Most preferably, the immunoconjugate is prepared in large scale batches, with various modifications to the reaction scheme disclosed herein to optimize yield and recovery in large scale. Other embodiments concern optimized dosages and/or schedules of administration of immunoconjugate to maximize efficacy for disease treatment and minimize side effects of administration.

Abstract: An agent comprising: an algin crosslinked with acetal linkages; and at least one cation coupled to the crosslinked algin.

Abstract: The present invention features a method of treating leptomeningeal carcinomatosis in a subject using a peptide-therapeutic conjugate as exemplified by the agent ANG1005.

Abstract: The present invention relates to compositions comprising growth hormone linked to extended recombinant polypeptide (XTEN), isolated nucleic acids encoding the compositions and vectors and host cells containing the same, and methods of making and using such compositions in treatment of growth hormone-related diseases, disorders, and conditions.

Abstract: Compositions and methods are provided including a transporter peptide derived from the loop2 domain of the neuronally-derived lynx protein which can be conjugated to an effector agent to form a transporter-effector complex for transport of the therapeutic effector agent to a target that is found across the blood brain barrier.

Abstract: The present invention provides methods for preparation of stable multivalent pneumococcal polysaccharide-protein conjugate vaccine formulations. Instant stable formulations show optimal percent adsorption for each conjugate wherein, aggregation can be prevented by employing i) Individual or separate adsorption for conjugates that otherwise show lower percent adsorption by combined adsorption ii) Histidine-Succinic acid buffer system along with shift in pH from neutral pH to acidic pH iii) a polysaccharide to protein ratio between 0.5 to about 1.4 iv) a six-bladed Rushton type turbine impeller in formulation vessels.

Abstract: Disclosed are an antibody drug conjugate IB, which uses ether linkages for connection, and improves the water solubility, stability and cytotoxicity in vivo and in intro, and an intermediate, a pharmaceutical composition, and uses of the antibody drug conjugate. The antibody drug conjugate has simple synthetic steps and a high yield.

Abstract: Provided are methods and compositions for delivering a nucleic acid, protein, and/or ribonucleoprotein payload to a cell. Also provided are delivery molecules that include a peptide targeting ligand conjugated to a protein or nucleic acid payload (e.g., an siRNA molecule), or conjugated to a charged polymer polypeptide domain (e.g., poly-arginine such as 9R or a poly-histidine such as 6H, and the like). The targeting ligand provides for (i) targeted binding to a cell surface protein, and (ii) engagement of a long endosomal recycling pathway. As such, when the targeting ligand engages the intended cell surface protein, the delivery molecule enters the cell (e.g., via endocytosis) but is preferentially directed away from the lysosomal degradation pathway.

Abstract: The present invention relates to insulin and/or an insulin analogue conjugate, and a use thereof, wherein the insulin and/or insulin analogue have improved in vivo durability and stability by linking the same with an Fe region of immunoglobulin. The insulin and/or an insulin analogue conjugate of the present invention show an in vivo activity similar to that of insulin. In addition, the insulin and/or insulin analogue conjugate of the present invention are long-acting formulations of insulin and/or the analogue thereof, in which serum half-life is remarkably increased, and therefore, the present invention provides remarkable insulin and/or an insulin analogue conjugate, which do not induce hypoglycemia, a drawback of insulin treatment.

Abstract: Methods of forming cyclosporin/cyclodextrin complex nanoparticles and microparticles, and administration of the nano- and microsuspension formed to an eye of a human or animal in the form of aqueous eye drops suitable to elicit or enhance tear formation and for treatment of diseases of the eye and surrounding areas. The aqueous eye drop composition contains cyclosporin and a mixture of ?-cyclodextrin and ?-cyclodextrin as well as one or more stabilizing polymers. ?-Cyclodextrin solubilizes cyclosporin while ?-cyclodextrin promotes formation of cyclosporin/cyclodextrin complex aggregates. The polymers stabilize the aqueous nano- and microsuspension.

Abstract: The present disclosure discloses a human sDR5-Fc fusion protein in the preparation of adjuvant therapy for myocardial ischemia-reperfusion injury. The sDR5-Fc antibody fusion protein of the disclosure is prepared by connecting the 182 amino acids in DR5 extracellular domain with the human anti-Fc fragments. It has been tested that the sDR5-Fc antibody fusion protein of the disclosure can basically avoid Fc-mediated ADCC effect and can significantly reduce the area of myocardial infarction in rats of myocardial ischemia-reperfusion models. The disclosure has great potential for development as a candidate drug for the preparation of new drugs for the treatment of myocardial ischemia-reperfusion injury.

Abstract: The present invention relates to a complexed RNA, comprising at least one RNA complexed with one or more oligopeptides, wherein the oligopeptide, which has the function of cell-penetrating peptide (CPP), has a length of 8 to 15 amino acids and has the empirical formula (Arg)l;(Lys)m;(His)n;(Om)o;(Xaa)x with the majority of residues being selected from Arg, Lys, His, Orn. The invention further relates to a method for transfecting a cell or an organism, thereby applying the inventive complexed RNA. Additionally, pharmaceutical compositions and kits comprising the inventive complexed RNA, as well as the use of the inventive complexed RNA for transfecting a cell, tissue or an organism and/or for modulating, preferably inducing or enhancing, an immune response are disclosed herein.

Abstract: The present invention relates to a complexed RNA, comprising at least one RNA complexed with one or more oligopeptides, wherein the oligopeptide, which has the function of cell-penetrating peptide (CPP), has a length of 8 to 15 amino acids and has the empirical formula (Arg)l;(Lys)m;(His)n;(Om)o;(Xaa)x with the majority of residues being selected from Arg, Lys, His, Om. The invention further relates to a method for transfecting a cell or an organism, thereby applying the inventive complexed RNA. Additionally, pharmaceutical compositions and kits comprising the inventive complexed RNA, as well as the use of the inventive complexed RNA for transfecting a cell, tissue or an organism and/or for modulating, preferably inducing or enhancing, an immune response are disclosed herein.

Abstract: The present invention relates to a complexed RNA, comprising at least one RNA complexed with one or more oligopeptides, wherein the oligopeptide, which has the function of cell-penetrating peptide (CPP), has a length of 8 to 15 amino acids and has the empirical formula (Arg)l;(Lys)m;(His)n;(Om)o;(Xaa)x with the majority of residues being selected from Arg, Lys, His, Om. The invention further relates to a method for transfecting a cell or an organism, thereby applying the inventive complexed RNA. Additionally, pharmaceutical compositions and kits comprising the inventive complexed RNA, as well as the use of the inventive complexed RNA for transfecting a cell, tissue or an organism and/or for modulating, preferably inducing or enhancing, an immune response are disclosed herein.

Abstract: The present invention relates to a complexed RNA, comprising at least one RNA complexed with one or more oligopeptides, wherein the oligopeptide, which has the function of cell-penetrating peptide (CPP), has a length of 8 to 15 amino acids and has the empirical formula (Arg)l;(Lys)m;(His)n;(Orn)o;(Xaa)x with the majority of residues being selected from Arg, Lys, His, Orn. The invention further relates to a method for transfecting a cell or an organism, thereby applying the inventive complexed RNA. Additionally, pharmaceutical compositions and kits comprising the inventive complexed RNA, as well as the use of the inventive complexed RNA for transfecting a cell, tissue or an organism and/or for modulating, preferably inducing or enhancing, an immune response are disclosed herein.

Abstract: The present invention relates generally to non-integrating viral delivery system and methods of using the same. The viral delivery systems includes a viral carrier, a heterologous viral episomal origin of replication, a sequence encoding at least one initiator protein specific for the heterologous viral episomal origin of replication, and at least one gene, shRNA, siRNA, miRNA, or other gene-silencing RNA of interest. In certain embodiments, the disclosed system can be used for gene therapy.

Abstract: In one aspect, described herein is a recognition element for splicing modifier (REMS) that can be recognized by a compound provided herein. In another aspect, described herein are methods for modulating the amount of a product of a gene, wherein a precursor RNA transcript transcribed from the gene contains a REMS, and the methods utilizing a compound described herein. More particularly, described herein are methods for modulating the amount of an RNA transcript or protein product encoded by a gene, wherein a precursor RNA transcript transcribed from the gene comprises a REMS, and the methods utilizing a compound described herein. In another aspect, provided herein are artificial gene constructs comprising a REMS, and uses of those artificial gene constructs to modulate functional protein production.

Abstract: The present invention is directed to an inventive polymeric carrier molecule according to generic formula (I) and variations thereof, which allows for efficient transfection of nucleic acids into cells in vivo and in vitro, a polymeric carrier cargo complex formed by a nucleic acid and the inventive polymeric carrier molecule, but also to methods of preparation of this inventive polymeric carrier molecule and of the inventive polymeric carrier cargo complex. The present invention also provides methods of application and use of this inventive polymeric carrier molecule and the inventive polymeric carrier cargo complex as a medicament, for the treatment of various diseases, and in the preparation of a pharmaceutical composition for the treatment of such diseases.

Abstract: Provided herein are compositions and methods for generating an immunogenic response in humans. Further provided are methods for designing such compositions, e.g., for vaccines.

Abstract: The invention relates to methods of identifying a composition useful for the prevention or treatment of noise-induced hearing loss. The method includes exposing a mammalian test subject to a candidate composition and a calibrated sound or noise challenge. Next, a temporary threshold shift (TTS) is monitored in the test subject over a period of time. The monitored TTS is compared with a TTS of a control subject exposed to a control composition. The presence or absence is determined by clinically relevant and statistically significant differences between the monitored TTS in the test subject and the TTS of the control subject, and the presence of a statistically significant difference identifies the candidate composition as useful for prevention or treatment of noise-induced hearing loss.