Abstract: The present invention relates to dry compositions of rhGH polymer prodrug containing a lyoprotectant and, optionally, one or more than one excipient. Such compositions are stable for at least 1 year, when stored at 2-8° C. The invention further relates to methods of manufacturing said compositions, containers comprising such composition as well as a kit of parts.

Abstract: The invention is a pharmaceutical composition of human insulin or insulin analog that includes citrate, treprostinil and stabilizing agents, that has faster pharmacokinetic and/or pharmacodynamic action than commercial formulations of existing insulin analog products and that is stable for commercial use.

Abstract: Provided herein are placental extracellular matrix (ECM) compositions and methods of making the same. Also provided herein are uses of the placental ECM compositions provided herein.

Abstract: A method of promoting wound healing or connective tissue reconstruction and a method of treating ischemia in a subject in need thereof are disclosed. The methods comprising topically administering to the subject about 10-30 mg per cm2 wound tissue of Erythropoietin and about 100-300 mg per cm2 wound tissue of Fibronectin, thereby promoting wound healing or connective tissue reconstruction or treating ischemia in the subject. Unit dosage forms, pharmaceutical compositions, cosmetic compositions and formulations comprising Erythropoietin and/or Fibronectin are also disclosed.

Abstract: The present invention relates to Surfactant Protein D (SP-D) or nucleic acids encoding SP-D or variants thereof such as surfactant protein A or mannan binding lectin for use in the treatment and/or prevention of a parasitic infection. Methods for determining the presence of a parasitic infection by determining levels of SP-D in a sample are also disclosed. Also disclosed are helminths for treating allergy, inflammation or infection.

Abstract: The invention is directed to treatment of systemic DNA mutation diseases accompanied with development of somatic mosaicism and elevation of blood extracellular DNA. The inventive method comprises introducing a DNASE enzyme into the systemic blood circulation of a patient in doses and regimens which are sufficient to decrease average molecular weight of circulating extracellular blood DNA in the blood of said patient.

Abstract: The present application provides for compositions comprising high concentrations of acid ?-glucosidase in combination with an active site-specific chaperone for the acid ?-glucosidase, and methods for treating Pompe disease in a subject in need thereof, that includes a method of administering to the subject such compositions. The present application also provides methods for increasing the in vitro and in vivo stability of an acid ?-glucosidase enzyme formulation.

Abstract: The present invention relates to methods of inhibiting scar formation in a skin wound as well as methods of promoting tissue regeneration in a skin wound in a subject in need thereof comprising administering in or near said wound an effective amount of one or more neurotoxins.

Abstract: The present invention relates to the composition comprising crystalline xylose-isomerase and at least one salt of a metal and/or alkaline earth metal for the treatment and prevention of non-alcoholic fatty liver disease and other fructose-related disorders.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T cells ex vivo and transfer into patients. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T cells ex vivo and transfer into patients. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T cells ex vivo and transfer into patients. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: The invention relates to methods of producing, and compositions comprising, an isolated alpha (2?8) or (2?9) oligosialic acid derivative bearing a non-reducing end enriched for one or more de-N-acetyl residues and resistant to degradation by exoneuraminidase. A representative production method involves: (i) treating an alpha (2?8) or (2?9) oligosialic acid precursor having a reducing end and a non-reducing end with sodium borohydride under conditions for de-N-acetylating the non-reducing end; and (ii) isolating alpha (2?8) or (2?9) oligosialic acid derivative having one or more de-N-acetylated residues and a non-reducing end that is resistant to degradation by exoneuraminidase. Isolated alpha (2?8) or (2?9) oligosialic acid derivatives that comprise a non-reducing end de-N-acetyl residue are provided, as well as antibodies specific for the derivatives, compositions comprising the derivatives, kits, and methods of use including protection against and detection of E. coli K1 and N.

Abstract: This application relates to immunogenic compositions comprising a Staphylococcus aureus Type 5 capsular saccharide conjugated to a carrier protein to form a S. aureus Type 5 capsular saccharide conjugate.

Abstract: The present invention relates to a recombinant adenoviral vector for generating immunity against enterovirus infection. In one embodiment, the recombinant adenoviral vector of the invention comprises an expression cassette encoding a PI protein and a 3 CD protease of an enterovirus. In another embodiment, the recombinant adenoviral vector of the invention comprises an expression cassette encoding a 3C protease or a 3CD protease of an enterovirus. The present invention also relates to a vaccine composition comprising the recombinant adenoviral vector as described. A method of inducing an immune response in a subject against enterovirus infection using the recombinant adenoviral vector and the vaccine composition is provided. Further provided is a method for producing virus like particles of an enterovirus by expressing the adenoviral vector as described herein in mammalian cells.

Abstract: The present invention relates to a novel porcine parvovirus, to proteins of the virus and to vaccines based upon the virus and proteins thereof. The invention also relates to DNA fragments comprising a gene of the virus and to DNA vaccines based upon genes of the virus. Further the invention relates to antibodies that are reactive with the novel virus and to diagnostic tests for the detection of the virus or antibodies against the virus.

Abstract: The present invention relates to the discovery of compositions and methods for therapeutic immunization for treatment of chronic hepatitis B. Methods of the invention include a method generating an evolved high titer hybrid-hepatitis B virus (HBV) vector, methods of treating and/or preventing HBV, and methods of inducing a memory T and B cell immune response against HBV infection in a subject administered the VLV composition produced thereby. Furthermore, the invention encompasses a pharmaceutical composition for vaccinating a subject to protect the subject against infection with HBV.

Abstract: Mixed allergen compositions of two or more different allergens are provided. In some instances, the mixed allergen compositions include: a nut allergen; an animal allergen; and at least one of: a non-nut plant allergen; a biotic agent; and a vitamin Also provided are methods of administering the mixed allergen compositions to a subject. The mixed allergen compositions find use in a variety of applications, including health maintenance, immune balance, gut balance, immune support, health improvement and therapeutic applications.

Abstract: Disclosed is a method for the treatment of AD, wherein an immune stimulating pharmaceutical composition comprising an aluminium salt is administered to a patient having AD or having a risk to develop AD in an effective amount.

Abstract: Pharmaceutical composition comprising an antibody specifically recognizing CD38 and cyclophosphamide.

Abstract: The invention relates to a method for treating protozoal gastrointestinal disorders in immunocompromised patients. It includes a method for the isolation of a factor from the milk of hyperimmunized animals in a substantially pure form, and to the use of said factor in combination with vitamins and minerals.

Abstract: A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Abstract: A solid dosage form of an antibody-based medicinal preparation comprising an effective amount of a carrier treated with a dilution containing at least one antibody to a biologically active molecule.

Abstract: The invention relates generally to neuroprotection and repair in neurological disorders involving Tan dysfunction (including Alzheimer's disease). The invention describes AND INCLUDES a direct interaction between proteins FKBP52 mid 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 Tan 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: An abuse deterrent pharmaceutical composition including an acid soluble salt of a pharmaceutically active ingredient and a buffering ingredient; wherein the acid soluble salt of the pharmaceutically active ingredient and the buffering ingredient retard release of the pharmaceutically active ingredient when the composition is ingested in excess of an intended dosage.

Abstract: The embodiments provide a percutaneous absorption composition for a basic medicament having improved transdermal absorbability. The percutaneous absorption composition comprises a sorbic acid and/or a metal sorbate as a percutaneous absorption promotor. The molar ration of the sorbic acid and/or the metal sorbate to the basic medicament is 0.5-2.5. The composition of the present disclosure may further comprise a basic component.

Abstract: An object of the present invention is to provide a patch preparation having an excellent skin permeability of medicament using an acid additional salt of basic medicament. Provided is a patch preparation comprising a support and an adhesive layer on one surface of the support, wherein the adhesive layer contains a basic medicament, a fatty acid-based ionic liquid, and potassium salts and/or potassium ions. Said potassium salts and/or potassium ions are generated as a result of reaction of an acid addition salt of the basic medicament with a compound capable of generating potassium ion in the adhesive layer.

Abstract: A composition for extending the half-life of a crystalline antibody, including synergistically effective amounts of a half-life-extending compound and a crystalline antibody. A composition for extending the half-life of a crystalline antibody including synergistically effective amounts of lactulose and a crystalline anti-PCSK9 antibody. A method of extending the half-life of a crystalline antibody, by administering a synergistically effective amount of a half-life-extending compound and a crystalline antibody to an individual, and extending the half-life of the crystalline antibody. A method of promoting antibody recycling by affecting a receptor for an antibody to recycle the antibody.

Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

Abstract: The invention provides novel amphiphilic drug-drug conjugates useful as cancer therapeutics, and compositions and methods thereof.

Abstract: The invention provides interfering RNA molecule-ligand conjugates useful as a delivery system for delivering interfering RNA molecules to a cell in vitro or in vivo. The conjugates comprise a ligand that can bind to a low density lipoprotein receptor (LDLR) or LDLR family member. Therapeutic uses for the conjugates are also provided.

Abstract: The invention relates to a method of synthesis of a biopolymer derivative, preferably a chitosan derivative, comprising the formation of a peptide bond. The invention also relates to the biopolymer derivative, and use of the biopolymer derivative, preferably a chitosan derivative. The biopolymer derivative has broad uses in the industry, environmental protection and can be used in pharmaceutical and cosmetic compositions. The invention also relates to a composition for prevention of symptoms of allergy caused by heavy metals, especially palladium, cobalt, chromium and gold, in particular nickel.

Abstract: Hyaluronic acid modified with sphingosine-1-phosphate, and a medicine comprising the hyaluronic acid as an active ingredient, wherein the medicine can alleviate hepatic disorder caused by hypoxia/reoxygenation by protecting the liver sinusoidal endothelial cells, and the medicine can prevent and/or treat liver failure due to liver transplantation, hepatectomy, or other surgeries associated with liver ischemia/reperfusion.

Abstract: The present invention provides pharmacological compounds including an effector moiety conjugated to a binding moiety that directs the effector moiety to a biological target of interest. Likewise, the present invention provides compositions, kits, and methods (e.g., therapeutic, diagnostic, and imaging) including the compounds. The compounds can be described as a protein interacting binding moiety-drug conjugate (SDC-TRAP) compounds, which include a protein interacting binding moiety and an effector moiety. For example, in certain embodiments directed to treating cancer, the SDC-TRAP can include an Hsp90 inhibitor conjugated to a cytotoxic agent as the effector moiety.

Abstract: The present invention provides pharmacological compounds including an effector moiety conjugated to a binding moiety that directs the effector moiety to a biological target of interest. Likewise, the present invention provides compositions, kits, and methods (e.g., therapeutic, diagnostic, and imaging) including the compounds. The compounds can be described as a protein interacting binding moiety-drug conjugate (SDC-TRAP) compounds, which include a protein interacting binding moiety and an effector moiety. For example, in certain embodiments directed to treating cancer, the SDC-TRAP can include an Hsp90 inhibitor conjugated to a cytotoxic agent as the effector moiety.

Abstract: The invention provides bipartite inhibitors of bacterial RNA polymerase having the general structural formula (I): X-?-Y??(I) wherein X is an moiety that binds to the rifamycin binding site of a bacterial RNA polymerase, Y is a moiety that binds to the GE23077 binding site of a bacterial RNA polymerase, and ? is a linker. The invention also provides compositions comprising such compounds, methods of making such compounds, and methods of using said compounds. The invention has applications in control of bacterial gene expression, control of bacterial growth, antibacterial chemistry, and antibacterial therapy.

Abstract: The disclosure describes methods and therapeutic compositions comprising polymers modified with N-alkyl-hydroxy groups comprising one or more carbon atoms. The compositions are useful for gene delivery, and exhibit broad-spectrum antiviral activity and low toxicity in vitro.

Abstract: Provided herein are water-soluble prodrugs, compositions comprising such prodrugs, and related methods of making and administering the same. The prodrugs of the invention comprise a water-soluble polymer having three or more arms, at least three of which are typically covalently attached to an active agent, e.g., a small molecule. The conjugates of the invention provide an optimal balance of polymer size and structure for achieving improved drug loading, since the conjugates of the invention possess three or more active agents releasably attached to a multi-armed water-soluble polymer. The prodrugs of the invention are therapeutically effective, and exhibit improved properties in-vivo when compared to unmodified parent drug.

Abstract: Compositions and methods are provided including a transporter peptide derived from the loop2 domain of the neuronally-derived lynx1 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 concerns methods and compositions for forming cytokine-antibody complexes using dock-and-lock technology. In preferred embodiments, the cytokine-MAb DNL complex comprises an IgG antibody attached to two AD (anchor domain) moieties and four cytokines, each attached to a DDD (docking and dimerization domain) moiety. The DDD moieties form dimers that bind to the AD moieties, resulting in a 2:1 ratio of DDD to AD. The cytokine-MAb complex exhibits improved pharmacokinetics, with a significantly longer serum half-life than either naked cytokine or PEGylated cytokine. The cytokine-MAb complex also exhibits significantly improved in vitro and in vivo efficacy compared to cytokine alone, antibody alone, unconjugated cytokine plus antibody or cytokine-MAb DNL complexes incorporating an irrelevant antibody. In more preferred embodiment the cytokine is G-CSF, erythropoietin or INF-?2b.

Abstract: The present disclosure provides various molecular constructs having a targeting element and an effector element. Methods for treating various diseases using such molecular constructs are also disclosed.

Abstract: The present disclosure provides various molecular constructs having a targeting element and an effector element. Methods for treating various diseases using such molecular constructs are also disclosed.

Abstract: The present disclosure provides various molecular constructs having a targeting element and an effector element. Methods for treating various diseases using such molecular constructs are also disclosed.

Abstract: The present disclosure provides various molecular constructs having a targeting element and an effector element. Methods for treating various diseases using such molecular constructs are also disclosed.

Abstract: The present disclosure provides various molecular constructs having a targeting element and an effector element. Methods for treating various diseases using such molecular constructs are also disclosed.

Abstract: The present invention provides combinations of (a) an immunoconjugate comprising a first antibody engineered to have reduced effector function and an effector moiety, and (b) a second antibody engineered to have increased effector function, for use in treating a disease in an individual in need thereof. Further provided are pharmaceutical compositions comprising the combinations, and methods of using them.

Abstract: Disclosed herein is a bi-specific antibody that specifically directs a therapeutic agent to a cancer cell by targeting a tumor antigen of the cancer cell, and thereby suppresses the growth of the cancer or blocking the invasion or metastasis of the cancer. The bi-specific antibody of the present disclosure includes a first antigen binding site that binds to polyethylene glycol (PEG); and a second antigen binding site that binds to a target ligand, such as a tumor antigen.

Abstract: The present disclosure is directed to compositions and methods for targeting and modulating the epigenetic “state” (e.g., methylation state) of one or more genes. For example, the present disclosure is directed, in part, to transcription activator-like effector (TALE) fusion protein compositions and methods of their use in targeting and modulating the epigenetic state of one or more genes.

Abstract: The present invention discloses an application of ruthenium complexes as nucleic acid vectors into target cell nucleuses. Experimental data shows that ruthenium (II) complexes may be effectively combined with nucleic acid sequence and may effectively change morphologies of long nucleic acid sequences to effectively deliver the nucleic acids into viable cells via transmembrane transport located within cell nucleuses, thus greatly improving transport efficiency of the nucleic acids. Based on this property, nucleic acid sequences can be conveniently transported into cells for gene therapy or fluorescent tracking or the like. The method for preparing a ruthenium coordination complex-nucleic acid complex in accordance with the present invention may provide a more effective and stable ruthenium coordination complex-nucleic acid complex.

Abstract: The present invention relates to a pharmaceutical composition comprising a polyribonucleotide (RNA) and a cationic agent, wherein said pharmaceutical composition is formulated as a solid dosage form for administration to the gastrointestinal (GI) tract. The present invention furthermore relates to the use of such a pharmaceutical composition for systemic delivery of RNA and to a method for systemic delivery of RNA to a subject comprising the step of administering such a pharmaceutical composition to the GI tract. Furthermore, the present invention relates to a kit.