Abstract: The invention provides, inter alia, compositions useful for, e.g., raising an immune response to HIV-1, and associated methods of raising an immune response to HIV in a mammalian subject. In some embodiments, the compositions are bivalent immunogenic compositions comprising two (or, in some embodiments more than two) human immunodeficiency virus (HIV) clade C envelope gp120 polypeptide antigens, together with a liposome-based adjuvant, such as the adjuvant known as AS01.

Abstract: The present invention generally relates to an immunogenic construct,useful for redirecting an EBV-existing immune response towards an undesired target cell and/or microorganism, to methods for preparing said conjugate, to a pharmaceutical applications comprising said conjugate, and to medical applications thereof.

Abstract: In one embodiment, the invention provides a composition that includes therapeutically effective amount of any unadulterated pollen listed in FIG. 1. The invention is comprised of specific mass(es) of the unadulterated pollen composition of one or multiple pollens per daily dose, a range of mass of vitamin A, a range of mass of vitamin D, and a suspension buffer facilitating absorption of the therapeutic composition. The duration of the therapeutically effective amount of unadulterated pollen will preferably be administered 0-52 weeks prior to exposure to the allergen and for a period of 6-8 weeks. It could also be administered as a maintenance treatment during the allergic exposure and for multiple years. In some embodiments, the invention provides a method for treating allergies including administering an effective amount of a composition comprised of unadulterated pollen, vitamin A, vitamin D and a suspension buffer as shown in FIG. 1.

Abstract: The invention provides delivery systems comprised of stabilized multilamellar vesicles, as well as compositions, methods of synthesis, and methods of use thereof. The stabilized multilamellar vesicles comprise terminal-cysteine-bearing antigens or cysteine-modified antigens, at their surface and/or internally.

Abstract: A vaccine composition is disclosed that contains a vaccine antigen and a neutrophil inhibitor in amounts effective to promote an IgA and/or an IgG response to the antigen in a subject. Also disclosed is a method for enhancing immune response to a vaccine antigen in a subject that involves co-administering to the subject the vaccine antigen and an adjuvant composition comprising a neutrophil inhibitor in an amount effective to promote an IgA and/or IgG response to the vaccine antigen in the subject.

Abstract: The present disclosure relates to branched and linear chimeric compounds containing both nucleic acid and non-nucleic acid moieties, as well as to polynucleotides. The present disclosure also relates to uses thereof for stimulating an immune response, and to methods for preparation of the branched chimeric compounds.

Abstract: Compositions and methods for co-expressing a secretable vaccine protein (such as gp96-Ig) and T-cell co-stimulatory molecules from a single vector, among others, are provided herein. Materials and methods for using gp96-Ig vaccination and T-cell co-stimulation to treat a clinical condition (e.g., cancer) in a subject also are provided.

Abstract: The invention provides a pro-resolving mediator for use in the reduction of reactogenicity induced by administration of a vaccine or immunogenic composition comprising at least an antigen, and vaccines or immunogenic compositions comprising such a pro-resolving mediator.

Abstract: The invention relates to novel Muramyl Dipeptide (MDP) derivative compound of structural Formula-VIII, a process for synthesis, intermediates used in the synthesis and use thereof; wherein R1 and R2 both are hydrogen; or R1 is hydrogen and R2 is alkyl or aryl; or R1 is alkyl or aryl and R2 is hydrogen; or R1 and R2 both are alkyl or aryl (same or different groups); wherein alkyl group constitute C1-C6 alkyl or higher (both linear and branched) with or without heteroatoms; and aryl group constitute phenyl, substituted phenyl, heteraryl, arylalkyl and polynuclear aromatics. These compounds possess excellent pharmacological properties, in particular immunomodulating properties for use as adjuvant in vaccine formulations. These compounds are, particularly useful as adjuvants in vaccines.

Abstract: Disclosed herein is a vaccine comprising an antigen and IL-33. Also disclosed herein is a method for increasing an immune response in a subject in need thereof. Further disclosed herein is a method for treating cancer in a subject in need thereof. The methods may comprise administering the vaccine to the subject.

Abstract: The present invention relates to an agent which inhibits Kallikrein-8 for use in the treatment or prevention of Alzheimer's disease and/or its precursor stages, as well as to methods, kits and uses relating thereto, including diagnostic tools.

Abstract: The number of acne lesions in a human subject is reduced by administering to the subject a pharmaceutical composition that includes a pharmaceutically acceptable carrier and a therapeutically effective amount of an agent that selectively binds IL-1?. Anxiety and other psychiatric conditions are also improved with this treatment.

Abstract: The present invention provides, among other things, a method of intra-articular delivery of messenger RNA (mRNA), comprising administering into a joint of a subject in need of delivery a composition comprising an mRNA encoding a protein, such that the administering of the composition results in expression of the protein encoded by the mRNA in the joint.

Abstract: Provided are methods and compositions for treating cancer using an effective amount of a PD-1 antagonist (e.g., an antibody) in combination with a DR4 or DR5 agonist (e.g., an antibody).

Abstract: A neutron capture therapy system capable of eliminating amyloid ?-protein includes a neutron capture therapy device and a compound capable of specifically binding to the amyloid ?-protein having a nuclide with a large thermal neutron capture cross section. The neutron capture therapy device includes a neutron source, a beam shaping assembly and a collimator, the neutrons released by the neutron source pass through the beam shaping assembly and are slowed into a neutron beam within a certain energy range. The neutron beam irradiates the compound, and the energy generated by the reaction thereof can destroy the structure of the amyloid ?-protein. The neutron capture therapy system can specifically eliminate the amyloid ?-protein, and reduce the damage to the tissues surrounding the amyloid ?-protein.

Abstract: The present invention provides a pharmaceutical composition, the pharmaceutical composition comprising a pharmaceutically active substance, an apatite-based matrix, and a surface modifying agent. Further, the apatite-based matrix comprises calcium ion, phosphate ion, hydrogen carbonate ion, magnesium ion and iron ion. Also, the surface modifying agent comprises a protein, a polymer or a combination thereof. Further, a method of producing the pharmaceutical composition (200) is disclosed.

Abstract: The present invention relates generally to stable formulations comprising CTLA4Ig molecules, including lyophilized, and liquid formulations for administration via various routes including, for example, routes such as intravenous (IV) and subcutaneous (SC) for treating immune system diseases and tolerance induction.

Abstract: The present invention relates to an injectable pharmaceutical formulation comprising a compound of formula (I) said formulation being buffered to a pharmaceutically acceptable pH-value, especially a pH-value of from 2 to 6, in particular a pH value of from 3 to 5.5, preferred a pH-value of about 4 to 5, particularly preferred about 5.

Abstract: A composition includes a pharmaceutical dosage form configured to dinsintegrate in saliva and maintain a pH of 4 or less within the saliva during the time the dosage form is dissolving therein. The dosage form includes a therapeutically effective amount of melatonin in a carrier matrix, a disintegrant, and a sufficient amount of acid to impart the pH to the saliva. The amount of disintegrant is sufficient to cause the dosage form to completely disintegrate in the saliva within ten minutes from contacting the saliva.

Abstract: In a patch comprising a support layer and an adhesive agent layer, the adhesive agent layer comprises asenapine and/or a pharmaceutically acceptable salt thereof, isopropyl palmitate, and an adhesive base agent.

Abstract: The present invention relates to the use of proline for reducing the viscosity of a protein preparation.

Abstract: The disclosure provides biomaterials including scaffolds that include blood products including blood fractions and products including platelets for administration to subjects in need thereof. More specifically, the scaffolds based on step growth polymers are enriched with blood extracts that contain platelet rich plasma (PRP) and/or extracts of platelets. Compositions comprising a biomaterial or precursor thereof and a blood extract are provided, as are methods of making and using the biopolymers or precursors thereof. Kits and articles of manufacture comprising the biopolymers or precursors thereof are also described.

Abstract: A granulation formulation of 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide or pharmaceutically acceptable salt thereof, which is adapted for reconstitution with an aqueous vehicle, and associated oral suspension.

Abstract: The invention provides compounds having the general formula I: Y—X—Z ??I and salts thereof, wherein the variables X, Y, and Z have the meaning as described herein, and compositions containing such compounds and methods for using such compounds and compositions.

Abstract: The present invention relates to a protein conjugate in which a physiologically active polypeptide and a biocompatible material are linked through a fatty acid derivative, thus having an extended duration of physiological activity compared to that of a natural type, and a method of preparing the same. The protein conjugate of the present invention in which a biocompatible material, fatty acid, and a physiologically active polypeptide are linked was confirmed to have an increased half-life of the physiologically active polypeptide, and thus can be widely used in the field of protein drugs.

Abstract: The present application provides compounds of Formula (B): or pharmaceutically acceptable salts thereof, wherein D is a residue of a biologically active drug, which underdo hydrolysis under physiological conditions to release the biologically active drug and which are useful in the treatment of disorders that could be beneficially treated with the drug.

Abstract: Compositions and methods for increasing efficiency of cardiac metabolism are provided.

Abstract: Provided herein are coacervate compositions including cytokines, and methods of making and using the same. The coacervate can be formed by the mixing of an active agent, such as a drug or protein with the polyanion, such as heparin or heparan sulfate, and a custom-made polycation (e.g., PEAD or PELD). The coacervates can be used in the treatment of diseases and disorders where targeted treatment is desired, for example in treatment of cancers.

Abstract: Pegylated interleukin-15—related molecules and the identification thereof are described. The pegylated interleukin-15 molecules exhibit properties and characteristics that make them candidates for therapeutic use. Pharmaceutical compositions and methods of use are also described herein. 1C.

Abstract: Provided herein are polymers, pH-sensitive polymers and/or linkers; conjugates comprising said polymers and/or linkers, optionally, coupled to one or more agents and/or targeting moieties; and particles (e.g., nanoparticles comprising the aforesaid polymers, linkers and/or conjugates), which can be used to enhance the delivery and/or efficacy of one or more agents in a subject.

Abstract: The present disclosure provides bioorthogonal compositions for delivering agents in a subject. The disclosure also provides methods of producing the compositions, as well as methods of using the same.

Abstract: The present invention provides a glycosaminoglycan derivative in which a group derived from glycosaminoglycan and a group derived from a physiologically active substance having at least one of a carboxy group and a hydroxy group are coupled by covalent bond with a spacer therebetween, in which the spacer is selected in accordance with the decomposition rate of the covalent bond to the group derived from the physiologically active substance.

Abstract: The present invention relates to Fc variants with optimized Fc ligand binding properties, methods for their generation, Fc polypeptides comprising Fc variants with optimized Fc ligand binding properties, and methods for using same.

Abstract: The present invention provides methods of administering Factor VIII (processed FVIII, single chain FVIII, or a combination thereof); methods of administering chimeric and hybrid polypeptides comprising Factor VIII; chimeric and hybrid polypeptides comprising Factor VIII; polynucleotides encoding such chimeric and hybrid polypeptides; cells comprising such polynucleotides; and methods of producing such chimeric and hybrid polypeptides using such cells.

Abstract: Disclosed is a protein complex, comprising a physiologically active polypeptide, a dimeric protein and a non-peptidyl polymer having three functional ends (3-arm), with the linkage of both the physiologically active polypeptide and the dimeric protein to the 3-arm non-peptidyl polymer via respective covalent bonds. The protein complex guarantees the long acting activity and biostability of a physiologically active polypeptide. Having the ability to maintain the bioactivity of physiologically active polypeptides or peptides highly and to significantly improve the serum half life of the polypeptides or peptides, the protein complex can be applied to the development of sustained release formulations of various physiologically active polypeptide drugs. Also, it utilizes raw materials including the physiologically active polypeptides without significant loss, thereby increasing the production yield. Further, it can be easily purified.

Abstract: Novel biomolecular conjugates containing non-natural aromatic chemical moieties covalently coupled to a diazonium compound and methods of their use are disclosed.

Abstract: There is disclosed an antibody drug conjugate (ADC) having an IgG antibody that binds to a CD38 target conjugated at a Cys site in the hinge region of an IgG antibody. There is further disclosed a method for treating multiple myeloma comprising providing an effective amount of a CD38 ADC.

Abstract: The present invention relates to an antibody-drug conjugate comprising a drug conjugated to an antibody, a preparation method thereof and the use thereof.

Abstract: The present invention provides compositions comprising at least one biologically active agent (D) chemically conjugated to a peptide or oligopeptide with overall hydrophilicity (Pep). In some embodiments, the composition comprises D-Pep wherein the biologically active agents are linked to the Pep molecule via an chemical linker, such as amino acid linker. These compositions can be mixed with the other compositions to provide mixtures of nanofiber hydrogel structures that also can be used to locally deliver biologically active agents to tissues of interest. The methods and compositions disclosed herein are useful for sustained drug release when administered in situ to the tissue of interest.

Abstract: The present invention relates to micelle drug carriers and methods of using the micelles to deliver drugs to target cells. The micelles are useful, for example, for carrying and targeting drugs for the treatment of cancer to cancer cells. As one example, the disclosure provides pegylated octadecyl lithocholate micelles that are labeled with a peptide ligand for colorectal neo-plasia and that carry the small molecule mTOR inhibitor rapamycin to colorectal cancer cells.

Abstract: The present invention provides a biocompatible conjugate for treating a disease or an injury. The conjugate contains a polymer covalently linked to one or more moieties each containing a polymerizable functional group. The conjugate forms a cross-linked polymer network after being exposed to an elevated level of free radicals associated with the disease or injury.

Abstract: Disclosed is a nanoparticle system consisting of a polymer support or substrate in the form of nanoparticles to which a hydrolase enzyme able to degrade hyaluronic acid and one or more biologically and/or pharmacologically active molecules are covalently bonded, its preparation process and its uses in the diagnostic, prognostic and therapeutic fields.

Abstract: The present invention provides new forms of human ?-N-acetylgalactosaminidase (NAGAL) polypeptide or a functionally active variant or fragment thereof, nucleic acids encoding the same, and related products and uses, including use in methods of treating Fabry disease, Schindler disease or Kanzaki disease.

Abstract: The present invention provides compositions and methods useful for treating disorders amenable to therapy via introduction of multigenic expression vectors. More particularly, the invention provides vectors and polynucleotides encoding polypeptides for treatment of cardiac disorders wherein said polypeptides may comprise a cytokine, a chemokine, and/or an angiogenic polypeptide, or functional derivatives thereof. Also provided, as compositions of the invention, are linkers useful for connecting and expressing functional (biologically active) polypeptides from single, multigenic-expression constructs.

Abstract: In alternative embodiments, provided are methods for increasing levels of and/or upregulating the expression of ApoA-I Binding Protein (APOA1BP, AIBP, or AI-BP) to treat, ameliorate, prevent, reverse, decrease the severity or duration of: a neuropathic pain, including an inflammation-induced neuropathic pain, a nerve or CNS inflammation, a, a post nerve injury pain, a post-surgical pain, a chemotherapeutic-induced peripheral neuropathy (CIPN) (e.g., cisplatin-induced allodynia) a neurodegeneration or neurodegenerative disease or condition, a migraine, and/or a hyperalgesia.

Abstract: Provided is a method for treatment of pathologies caused by cells that have DNA sequences that differ from DNA of healthy human cells. The method utilises targeting of the sequence differences and effects cleavage of the DNA which does not occur in the healthy genome, whereby the cells containing the targeted DNA are killed or inactivated. Preferred systems for effecting such DNA damage is CRISPR systems where a CAS cleaves DNA adjacent to a sequence recognized by the CRISPR. Also disclosed are methods and a computer system for designing and/or producing the targeting nucleic acids.

Abstract: The invention relates to compositions and methods for the preparation, manufacture and therapeutic use of cosmetic polynucleotides, cosmetic primary transcripts and cosmetic mmRNA molecules.

Abstract: The present invention relates to an anti-tumor composition which includes a GM-CSF gene; an Flt3L-TRAIL fusion gene; shRNA inhibiting TGF-? expression; and shRNA inhibiting HSP expression.

Abstract: The present invention discloses a method for diagnosing and detecting cancer by bioimaging using methylene blue nanoparticle as a contrasting agent. The methylene blue nanoparticle of the present invention for use as a topical cancer targeting phototherapeutic agent is composed of only a material of which the composition is clinically used or derived from human bodies, and thus a nanopreparation in which a barrier to clinical entry is low and the possibility of commercialization is very high, exhibits near-infrared fluorescence along with cancer targeting property, a capacity of generating a singlet oxygen and the like. Therefore, the methylene blue nanoparticle in the present invention is able to detect cancerous cells by emitting visible light in irradiation conditions.

Abstract: A fluorescent solution is disclosed for use in a hydraulic or diesel fluid to facilitate detection of injection of the hydraulic of diesel fluid into a human. The fluorescent solution includes a fluorescent dye and a stabilizing agent. The stabilizing agent may be a surfactant. A hydraulic fluid mixture is also disclosed which includes a fluorescent solution and a hydraulic fluid.