Abstract: The invention relates to a placental growth factor (PlGF) to be used as a drug in the prevention and/or treatment of fetal alcohol syndrome disorders (FASD) selected from the group comprising fetal alcohol syndrome (FAS), cerebrovascular disease, and growth retardation in a subject exposed to alcohol in utero. The invention also relates to a pharmaceutical composition or a product comprising the PlGF for the same therapeutic uses.

Abstract: Disclosed herein include methods of inducing expansion of modified effector cells in vivo which comprise administration of a steroid and modified effector cells. Also described herein include methods of inducing expansion of modified T cells (e.g., CAR-T cells or TCR cells) in vivo, which comprise administration of a steroid and modified T cells.

Abstract: Methods and microorganisms for systemically introducing a polypeptide in the bloodstream of a subject. The methods of the invention include administering into the gastrointestinal tract of a subject a bacterium configured to express and produce and release the polypeptide. The bacterium is administered in an amount effective to introduce the polypeptide in the bloodstream of the subject, preferably in a detectable amount. The microorganisms of the invention include lactic acid bacteria, such as Lactobacillus reuteri, that comprise a recombinant gene configured to express a polypeptide to be systemically introduced.

Abstract: The present invention relates, in part, to targeted chimeric proteins with beneficial therapeutic effects, including, for example, effects mediated by chimeric proteins which comprise modified signaling agents two or more targeting moieties. Methods of treatment and pharmaceutical compositions comprising the chimeric proteins are also provided. The present invention finds use in the treatment of various disease and disorders.

Abstract: The present application provides a composition and methods to enhance nerve regeneration utilizing at least one component of neural stem cells or IL12p40. The composition comprises neural stem cells and a neurotrophic factor, which is constructed by IL12p40 as at least one subunit. The methods to enhance nerve regeneration comprise providing a nerve regeneration composition comprising a neurotrophic factor containing IL12p40 as at least one subunit to a subject. The composition of the methods can further comprise neural stem cells.

Abstract: The present invention relates to novel therapies for treating autoimmune and inflammatory diseases. More specifically, the present invention relates to a use of low dose interleukin-2 for the treatment of type I diabetes and other autoimmune and/or inflammatory diseases.

Abstract: The present invention relates to a combination comprising at least an immunocytokine comprising at least a primary binding protein or peptide and a cytokine, fused or conjugated to one another, and a secondary binding molecule capable of binding to at least a section of at least one cytokine comprised in the immunocytokine.

Abstract: The invention is directed to methods of treating cancers using Interferon-? (IFN-?), wherein the IFN-? includes various natural, synthetic and recombinant IFN-? in compositions.

Abstract: The present invention relates to methods to treat a neurodegenerative disease or disorder, e.g., a motor neuron disease in a subject, whereby the subject is administered a recombinant human Mullerian Inhibiting Substance (MIS) protein as disclosed herein, wherein the recombinant human MIS protein comprises a modified Kex cleavage site for increased cleavage. The recombinant human MIS protein can be produced from a pre-proprotein comprising a non-MIS leader sequence or a functional fragment thereof in place of the MIS leader sequence.

Abstract: Intestinal absorption is enhanced in short bowel syndrome patients presenting with colon-in-continuity by treatment with a GLP-2 receptor agonist, such as teduglutide.

Abstract: The invention pertains to a blood coagulation factor replacement product for use in the treatment or prophylaxis of bleedings of patients having an acquired coagulation factor deficiency or for use in the treatment or prophylaxis of bleedings of patients having a congenital deficiency of a coagulation factor. Said product comprises at least isolated prothrombin (Factor II) and isolated Antithrombin III (ATIII), whereby the molar ratio between ATIII to Factor II is at least 1:30. By administration of said product the patient's risk for a thromboembolic complication is reduced.

Abstract: Methods of treating ischemia by modulating ischemic cell bioenergetics are described. For example, the methods include the administration of small molecule, polypeptide, and/or genetic agents that modulate oxidative metabolism and/or glycolytic metabolism in ischemic cells, such as ischemic muscle cells. In some embodiments, the agent is adapted to deliver Cox6a2 or PFKFB3 to the cell. Also described are related pharmaceutical compositions and kits for the treatment of ischemia and ischemic injury related to, for instance, such as peripheral arterial disease, stroke, myocardial infarction, and diabetes.

Abstract: The present invention relates to a method for treating liver steatosis or non-alcoholic fatty liver by using a 2-monoacylglycerol degrading enzyme. More particularly, the present invention provides a method for treating metabolic syndrome such as liver steatosis, non-alcoholic fatty liver, hyperlipidemia, type 2 diabetes, and/or obesity by using a 2-monoacylglycerol degrading enzyme, in which the 2-monoacylglycerol degrading enzyme completely degrades triglyceride into fatty acids and glycerol in a digestive tract such that fat absorption is delayed and blood absorption of triglyceride is decreased, and in which, in a case where monoacylglycerol is degraded by a monoacylglycerol lipase in a digestive tract, although degraded products of the monoacylglycerol are absorbed into digestive epithelial cells, recombination thereof into triglyceride in the digestive epithelial cells is delayed or energy consumption is promoted during this process.

Abstract: Provided herein are methods of selecting subjects having cancer for combination therapy that includes administering an anti-hyaluronan agent, such as a polymer-conjugated hyaluronan-degrading enzyme. Combination therapies can include, in addition to the anti-hyaluronan agent, a tumor-targeted taxane and, optionally, a chemotherapeutic agent such as a nucleoside analog. Combinations for performing the methods are provided, as are uses of the combinations for selecting subjects for treatment. The combination therapy can be used in methods of treating cancers, and in particular solid tumor cancers.

Abstract: The present invention relates to microbial lysozyme, compositions comprising such and uses thereof.

Abstract: The present invention relates to a method for preventing atherosclerosis, comprising administeringh a prophylactically effective amount of plasminogen to a subject susceptible to atherosclerosis. The present invention further relates to a medicament, a pharmaceutical composition, an article of manufacture and a kit comprising plasminogen which are useful for preventing atherosclerosis.

Abstract: Pharmaceutical compositions that stabilize a Clostridial toxin active ingredient are described. The compositions can be liquid or solid compositions, and comprise a surfactant and an antioxidant. In some embodiments, the compositions comprise a surfactant selected from a poloxamer and a polysorbate; an antioxidant selected from methionine, N-acetyl cysteine, ethylenediaminetetraacetic acid and combinations thereof, and, optionally, a tonicity agent and/or a lyoprotector selected from, for example, trehalose, sucrose.

Abstract: A vaccine composition against infection by Trypanosoma cruzi comprising at least one Trypanosoma cruzi trans-sialidase mutant protein (SEQ 1) and, as adjuvant, a mixture of a highly purified mineral oil and mannide monooleate.

Abstract: The invention is directed to T cell epitopes wherein said epitopes comprises a peptide or polypeptide chain comprising at least a portion of an immunoglobulin constant or variable region. The invention also relates to methods of using and methods of making the epitopes of the invention.

Abstract: Provided herein are nicotine polymer-stabilized nanoparticles, formulations thereof, and vaccines. Also provided herein are methods of treating and/or preventing nicotine addiction in a subject in need thereof.

Abstract: It is an object to provide a combination therapy effective in cancer immunotherapy. The object is achieved by providing an anti-tumor agent, including a transformed Bifidobacterium containing DNA encoding a WT1 protein and DNA encoding a GNB/LNB substrate-binding membrane protein derived from a Bifidobacterium, the transformed Bifidobacterium being designed to display the WT1 protein as an antigen on a surface of the transformed Bifidobacterium, the anti-tumor agent being for use in combination with an immunosuppression inhibitor. The transformed Bifidobacterium can be used as an oral tumor vaccine.

Abstract: The disclosure features immunomodulatory therapeutic compositions of an mRNA encoding an activating oncogene mutation peptide and an mRNA encoding a polypeptide that enhances immune responses to the activating oncogene mutation peptide, for example an mRNA encoding an immune potentiator. The disclosure also features methods of using the same, for example, to stimulate anti-cancer immune responses.

Abstract: The disclosure relates to cancer ribonucleic acid (RNA) vaccines, as well as methods of using the vaccines and compositions comprising the vaccines. In particular, the disclosure relates to concatemeric mRNA cancer vaccines encoding several cancer epitopes on a single mRNA construct, i.e. poly-epitope mRNA constructs or poly-neo-epitope constructs. The disclosure further relates to p53 and KRAS mutations, as well as incorporation of immune enhancers such as STING, e.g. mRNA constructs further encoding an immune stimulator or adjuvant. The disclosure further relates to inclusion of universal T cell epitopes, such as tetanus or diphtheria toxins to elicit an enhanced immune response.

Abstract: The present invention provides a particle comprising a polypeptide and at least one malaria antigen, and a composition or vaccine comprising thereof, its use in medicine, particularly in the prevention or treatment of malaria infections.

Abstract: Vaccine vectors capable of eliciting an immune response to enteric bacteria and methods of using the same are provided. The vaccine vectors include a polynucleotide encoding a PAL polypeptide. The PAL polypeptide may be expressed on the surface of the vaccine vector. The vaccine vector may also include a second polypeptide encoding an immunostimulatory polypeptide such as a CD154 polypeptide or an HMGB1 polypeptide.

Abstract: The present embodiments provide compositions and methods related to novel recombinant protein immunogens, comprising specific portions of alpha helical domains (aHD) and proline rich regions (PRD) of pneumococcal surface protein A (PspA), which portions are linked to provide aHD-PRD constructs. The aHD and PRD proteins constituting the aHD-PRD constructs are selected to maximize cross-reactivity and provide protection against a broad spectrum of pneumococcal serotypes. Immunogenic compositions, including vaccines, comprising at least one aHD PRD construct may also include a non-linked aHD portion. Also provided are recombinant nucleic acid molecules that encode aHD-PRD constructs, vectors and recombinant host cells containing such molecules, aHD-PRD expression products, use of such nucleic acid molecules to express aHD-PRD constructs by recombinant techniques, and use of the expression products to elicit an immune or protective response against pneumococcal disease in a suitable host.

Abstract: The present invention provides mRNAs usable as vaccines against lassa virus (LASV) infections. Further, the invention relates to (pharmaceutical) compositions and vaccines comprising said mRNAs and their use for treatment or prophylaxis of a lassa virus infection. The present invention further features a kit comprising the mRNAs, (pharmaceutical) compositions or vaccines and a method for treatment or prophylaxis of lassa virus infections using said mRNAs, pharmaceutical) compositions or vaccines.

Abstract: The invention provides isolated polynucleotide molecules that comprise a DNA sequence encoding an infectious RNA sequence encoding a genetically-modified North American PRRS virus, methods to make it and related polypeptides, polynucleotides, and various components. Vaccines comprising the genetically modified virus and polynucleotides and a diagnostic kit to distinguish between naturally infected and vaccinated animals are also provided.

Abstract: The present application generally relates to the development of a universal influenza vaccine, or production of antibodies, capable of providing broad protection against various strains of the flu, using an informational spectrum method (ISM) to identify the common structural characteristics of influenza antigens.

Abstract: The present invention is directed to an artificial nucleic acid and to polypeptides suitable for use in treatment or prophylaxis of an infection with Henipavirus, particularly Hendra virus and/or Nipah virus or a disorder related to such an infection. In particular, the present invention concerns a Hendra virus and/or Nipah virus vaccine. The present invention is directed to an artificial nucleic acid, polypeptides, compositions and vaccines comprising the artificial nucleic acid or the polypeptides. The invention further concerns a method of treating or preventing a disorder or a disease, first and second medical uses of the artificial nucleic acid, polypeptides, compositions and vaccines. Further, the invention is directed to a kit, particularly to a kit of parts, comprising the artificial nucleic acid, polypeptides, compositions and vaccines.

Abstract: The present invention relates to mRNAs suitable for use as mRNA-based vaccines against infections with MERS coronaviruses. Additionally, the present invention relates to a composition comprising the mRNAs and the use of the mRNAs or the composition for the preparation of a pharmaceutical composition, especially a vaccine, e.g. for use in the prophylaxis or treatment of MERS coronavirus infections. The present invention further describes a method of treatment or prophylaxis of infections with MERS coronavirus using the mRNA sequences.

Abstract: The present invention provides monoclonal antibodies that bind to the Middle East Respiratory Syndrome—Coronavirus (MERS-CoV) spike protein, and methods of use. In various embodiments of the invention, the antibodies are fully human antibodies that bind to MERS-CoV spike protein. In some embodiments, the antibodies of the invention are useful for inhibiting or neutralizing MERS-CoV activity, thus providing a means of treating or preventing MERS infection in humans. In some embodiments, the invention provides for a combination of one or more antibodies that bind to the MERS-CoV spike protein for use in treating MERS infection. In certain embodiments, the one or more antibodies bind to distinct non-competing epitopes comprised in the receptor binding domain of the MERS-CoV spike protein.

Abstract: The present invention provides DNA vaccines for the treatment or prevention of an allergic response. The vaccines comprise the coding sequence for Allergen X or fragments thereof fused in-frame with the lumenal domain of the lysosomal associated membrane protein (LAMP) and the targeting sequence of LAMP. The vaccines allow for presentation of properly configured three dimensional epitopes for production of an immune response when administered to a subject. The vaccines can be multivalent molecules, and/or can be provided as part of a multivalent vaccine containing two or more DNA constructs.

Abstract: A method for delivering allergens to a pharmacist in a pre-diluted kit form, comprising providing a bulk container of base concentrate antigen containing at least one antigen at a predetermined concentrated level, creating a sequential and more diluted sequence of antigens, providing a plurality of end-use sealable containers that can receive a finite end amount of diluted antigens, dispensing from each of sequential bulk containers a finite end amount of diluted antigens into one of the plurality of end-use sealable containers, wherein the end-use seal containers filled from each of the sequential bulk containers comprises a group of end-use sealable containers associated with each of the sequential bulk containers, sealing each of the end-use containers after diluted antigens are disposed therein, and disposing a select number of the sealed end-use sealable containers from each of the groups of end-use sealable containers into a container comprising a kit.

Abstract: Compositions including one or more antigens and one or more integrin activating compounds capable of adjuvanting the one or more antigens contained and increasing an immune response to the one or more antigen in a vaccine preparation.

Abstract: A composition is for use as a medicament. The composition contains nanoparticles, wherein the nanoparticles contain a polymer selected from the group consisting of PLGA, PLA, PGA, PCL and poly(meth)acrylates, or a lipid. Further, the composition may contain nanoparticles made of a polymer selected from PLGA, amino alkyl methacrylate copolymers, methacrylic acid copolymers, methacrylic ester copolymers, and ammonio alkyl methacrylate copolymers.

Abstract: Disclosed is a single unit oral dosage form having, in combination, inositol and an extended release clonidine or extended release guanfacine. In one aspect, a method for treating ADHD and/or associated symptoms thereof includes administering to an ADHD patient the single unit oral dosage form. In another aspect, a method for treating ADHD and/or associated symptoms thereof includes administering to an ADHD patient inositol in combination with extended release clonidine or extended release guanfacine, whether administered separately or as a single dosage form.

Abstract: Provided herein are methods for treating a bone-related disorder in a subject. At least one of a microtubule altering drug, for example, a microtubule disrupting drug or a microtubule stabilizing drug, a TRPV4 agonist or a NOX2 activator is administered to the subject. Also provided are related methods for treating a bone-related disorder in the subject, by further administering at least one of an anti-sclerostin agent, a parathyroid hormone agonist, a bisphosphonate, an estrogen mimic, or a selective estrogen receptor modulator is further administered to the subject with the at least one of a microtubule altering drug, a TRPV4 agonist or a NOX2 activator.

Abstract: The present invention pertains to compounds and their combination for use in the prevention or therapy of a subject suffering from an autoimmune disease such as diabetes type 1. Provided are antagonists of T-cells that are used in combination with antagonists of the cytokine CXCL10, sequentially or concomitantly, in a subject suffering from an autoimmune disease, in particular diabetes type 1.

Abstract: The present invention relates to the medical field, in particular to the modulation of electrical polarization of neurons.

Abstract: Compositions comprising a fluorescein component and benoxinate component and the corresponding uses of these compositions are described herein. These compositions have improved storage life and the fluorescein component and/or benoxinate component minimally degrade after 12 to 18 months of storage.

Abstract: An antimicrobial (anticandidal, antibacterial, antifungal) and antiviral composition which repels insects such as flies, mosquitoes and ticks. The composition includes poloxamer, boron compound, ethyl butyl acetylaminopropionate and preferably hydrogen peroxide. The present composition is a composition which can be applied in different forms via oral, nasal, ophthalmic, otic, local, ventricle, vaginal, rectal, dermal, intravenous, intramuscular, subcutaneous and intradermal route.

Abstract: Described herein are pharmaceutical rectal foam formulations, useful, for example, for the rectal administration of therapeutic agents, such as 5-aminosalicylic acid (5-ASA), as well as methods of making such foam formulations, and therapeutic methods using them.

Abstract: Methods of enabling or improving the ability of a hydrogel to swell in the stomach of an animal and/or increasing the amount of time said hydrogel remains swollen in the stomach are described herein. In one embodiment, a polymer is administered in combination with one or more pH modifying agents which raise and maintain the pH of the micro environment of the polymer and/or the stomach in order inducing swelling in the polymer. The polymer can be a homopolymer, a copolymer, or a polymer blend or composite. In one embodiment, the polymer is a superabsorbent polymer (“SAP”). The polymers can also be administered with one or more active agents, such as appetite suppressants. The pH modifying agent and/or the active agent can be administered simultaneously with the polymer in the same dosage form, simultaneously with the polymer in separate dosage forms, or sequentially. The compositions are formulated for oral administration.

Abstract: The instant invention relates to film-forming compositions suitable for the manufacture of hard capsule shells, which are based on starchy material. The instant invention also relates hard capsule shells made from the film-forming compositions of the invention.

Abstract: Described herein are low protein concentration gelling compositions comprising keratin proteins.

Abstract: The present invention provides the modular design and assembly of novel targeting bio-conjugates, exclusively assembled by means of biotin-biotin binding element conjugation, comprising mono-biotinylated cell binding component, a tetrameric biotin-binding element, and mono-biotinylated payload for therapeutic and diagnostic purposes. In addition, there is provided a method of delivering the payload, such as therapeutic oligonucleotides, via mono-biotinylated targeting devices, such as antibodies or ligands, into eukaryotic cells by means of receptor-mediated endocytosis. The targeting bio-conjugates are suitable for use in the areas of medicine, pharmacy and biomedical research.

Abstract: The present disclosure provides an additive system for use in protein PEGylation. The additive system includes p-aminobenzoic hydrazide used either alone or in combination with aromatic amines, such as 3,5-diaminobenzoic acid, or with ammonium salts such as ammonium chloride or ammonium acetate. The disclosed additive combination provides several benefits including increased reaction rates, higher yields and reduction in the aminoxy-PEG equivalents required to complete the conjugation reaction. Typical reactions can be run by combining the additive or additive system with a solution of a protein and aminoxy-PEG reagent. The solution is adjusted to pH 4 and held at 20-25° C. without stirring until completion, typically within 24 hours.

Abstract: The invention relates to novel prodrugs or conjugates of the general formula (Ia) in which La, n, R and D have the definitions given in the description and which have a structural motif reduced to an asparagine derivative as cleavage site for tumour-associated proteases such as legumain, in which cytotoxic drugs, for example kinesin spindle protein inhibitors, are released by legumain cleavage, and to the use of these prodrugs or conjugates for treatment and/or prevention of diseases, and to the use of these prodrugs or conjugates for production of medicaments for treatment and/or prevention of diseases, especially of hyperproliferative and/or angiogenic disorders, for example cancers. Reduction of the legumain-cleavable substrate peptide sequence to an asparagine derivative as structural motif, as a result of slowed legumain cleavage, achieves an increase in stability in the lysosomes of healthy organs while simultaneously maintaining the high anti-tumour effect.

Abstract: RNA nanoparticles functionalized with a HER2-targeting RNA aptamer and at least one MED1 siRNA for targeted delivery of MED1 siRNA to human cancer cells via human epidermal growth factor receptor 2 (HER2) receptors, pharmaceutical compositions of the inventive RNA nanoparticles, and methods for treating breast, HER2-implicated cancers, and in particular therapeutic-resistant cancer such as tamoxifen-resistant breast cancer, by administering pharmaceutical compositions of the inventive RNA nanoparticles.