Abstract: The present invention relates to an antibacterial composition containing, as an active ingredient, adenylate kinase or adenosine kinase (ADK) protein derived from Mycobacterium tuberculosis, and a composition for preventing or treating infectious diseases. In addition, the present invention relates to a composition for preventing or treating sepsis or septic shock. Furthermore, the present invention relates to a method for preventing, improving or treating an infectious disease comprising administering the present antibacterial composition. The ADK protein derived from Mycobacterium tuberculosis according to the present invention has excellent antibacterial activity selectively against gram-negative bacteria, and thus can be favorably used as an antibacterial composition against gram-negative bacteria or for the prevention or treatment of infectious diseases caused by gram-negative bacteria.

Abstract: Lysosomal storage diseases can be successfully treated using intraventricular delivery of the enzyme which is etiologically deficient in the disease. The administration can be performed slowly to achieve maximum effect. Surprisingly, effects are seen on both sides of the blood-brain barrier, making this an ideal delivery means for lysosomal storage diseases which affect both brain and visceral organs.

Abstract: This disclosure relates to method for treating Sanfilippo Syndrome B (also Mucopolysaccharidosis III B, MPSIIIB) by enzyme replacement therapy.

Abstract: The subject invention relates to diffusion enhancing compounds and their use alone or with thrombolytic agents for the treatment of disorders resulting from the formation of a thrombus such as a myocardial infarction or stroke.

Abstract: Disclosed herein are compositions and methods for treating celiac sprue.

Abstract: The present invention relates to the effect of plasminogen in the treatment and/or elimination of angiocardiopathy, especially angiocardiopathy caused by diabetes mellitus, thereby providing a new strategy for treating different kinds of angiocardiopathy, especially angiocardiopathy and its related disorders caused by diabetes mellitus.

Abstract: The current invention relates to: procoagulant proteins which may, for example, be fusion proteins or chemical conjugates; methods of producing said procoagulant proteins; polynucleotides that encode said fusion proteins and cells that expresses them. Furthermore, the current invention relates to procoagulant proteins for use as a medicament. Individuals that have a coagulopathy, such as haemophilia A and B with or without inhibitors, may be treated with the procoagulant proteins of the current invention.

Abstract: This disclosure relates to methods and compositions for inducing growth of peripheral nervous system neurons using an effective amount of a botulinum toxin. The disclosure also relates to methods for the treatment of a patient in need thereof such as a patient undergoing nerve transfer surgery, the method comprising administering to the patient an effective amount of a botulinum toxin.

Abstract: The present disclosure relates to processes for the production of peptides and methods of using peptides produced accordingly. Peptides produced according to the present disclosure may be administered for the treatment of autoimmune and/or inflammatory diseases and conditions.

Abstract: Disclosed herein is a different and novel approach to cancer vaccines using a subject's own dendritic cells (DCs) and macrophages (Mphs) in combination to present cancer antigens to the immune system. Further disclosed are methods of producing monocyte-derived autologous DCs and Mphs loaded ex vivo with particular whole irradiated cancer cells which generates optimally activated immunostimulatory antigen-presenting cells (APCs) as a superior method for stimulating robust and long-lasting immunity to a particular cancer in vivo as compared with more traditional vaccination methods. Compositions, methods of use and methods for preparation of these DCs and Mphs with cancer cells are also disclosed herein.

Abstract: The present invention relates to novel peptides derived from Progesterone-associated endometrial protein (PAEP), complexes comprising such peptides bound to recombinant MHC molecules, and cells presenting said peptide in complex with MHC molecules. Also provided by the present invention are binding moieties that bind to the peptides and/or complexes of the invention. Such moieties are useful for the development of immunotherapeutic reagents for the treatment of diseases such as cancer.

Abstract: The present invention provides immunostimulatory combinations. Generally, the immunostimulatory combinations include a TLR agonist and a TNF/R agonist. Certain immunostimulatory combinations also may include an antigen.

Abstract: The present invention relates to a patient-specific tumor treatment targeting individual expression patterns of tumor antigens, in particular shared tumor antigens, and individual tumor mutations. In one aspect, the present invention relates to a method for preventing or treating cancer in a patient comprising the steps of: (i) inducing a first immune response against one or more tumor antigens in the patient, and (ii) inducing a second immune response against one or more tumor antigens in the patient wherein the second immune response is specific for cancer specific somatic mutations present in cancer cells of the patient.

Abstract: The instant disclosure provides aquaporin DNA tolerizing vaccines and methods of using such vaccines for treating individuals having neuromyelitis optica (NMO) and NMO spectrum disorders. Aspects of the methods include administering to the individual, in need thereof, an effective amount of an aquaporin DNA tolerizing vaccine to reduce one or more symptoms of NMO or an NMO spectrum disorder. Compositions and kits for practicing the methods of the disclosure are also provided.

Abstract: Described herein are methods and compositions relating to methods of inhibiting neutrophils, e.g., inhibiting NET release or NETosis, by means of a DEspR inhibitor, e.g., an anti-DEspR antibody reagent. In some embodiments, the methods can relate to the treatment of a disease, e.g., cancer or a disease wherein neutrophils; NETs; or NETosing or NETting neutrophils contribute to pathogenesis, chronicity, or worsening of disease. In some embodiments, the DEspR inhibitor can be a bi-specific reagent or an antibody-drug conjugate.

Abstract: Novel therapeutic immunotherapy compositions comprising at least two vectors, each vector encoding a functional CAR, whereby the combination of vectors results in the expression of two or more non-identical binding domains, wherein each vector encoded binding domain(s) are covalently linked to a transmembrane domain and one or more non-identical intracellular signaling motifs are provided herein as well as are methods of use of same in a patient-specific immunotherapy that can be used to treat cancers and other diseases and conditions.

Abstract: The present invention relates to novel vaccines against malaria infections, based on recombinant adenovirus vectors. Described are capsid modified replication deficient adenovirus particle encoding and displaying circumsporozoite (CS) protein NANP-repeats (CSshort) from a malaria-causing parasite, preferably P. falciparum, via a minor capsid protein IX and encoding a heterologous protein as a transgene. In a particular embodiment, said replication incompetent vectors of rare serotypes such as human adenovirus 35 (HAdV35) and human adenovirus 26 (HAdV26) comprise nucleic acid encoding the CS protein, as a transgene, from a malaria-causing parasite and encoding and displaying the NANP-repeat from a malaria-causing parasite (1) directly fused to the protein IX, (2) fused to protein IX via a flexible linker or (3) an alpha-helical viral origin spacer SP1 to ensure both humoral and cellular responses against the selected antigens.

Abstract: A vaccine includes at least one bacterial antigen capable of producing an immune response in a host when the vaccine is administered at a dose that is sufficient for preventing or treating Q fever in the host. The vaccine composition confers immunity against Q fever without the reactogenic side effects observed in prior art vaccines.

Abstract: The invention relates to compositions and methods for treating inflammatory diseases and disorders in a subject in need thereof. In certain aspects, the invention relates to immunogenic compositions (e.g., vaccines) to diminish the number or pathogenic effects of one or more bacteria associated with the development or progression of an inflammatory disease or disorder.

Abstract: Embodiments disclosed herein provide compositions, methods, and uses for respiratory syncytial viruses (RSV) and immunogenic compositions thereof. Certain embodiments provide RSV having cleavage-resistant mutated attachment (G) glycoproteins. In some embodiments, the cleavage-resistant G protein mutants increase production of live attenuated RSV in host cells. Also provided are methods for amplifying RSV in host cells, wherein the amplified RSV has full length G protein. In certain embodiments, the amplified RSV having full length G protein is formulated into immunogenic compositions, including vaccines. Other embodiments provide methods for inducing an effective immune response against RSV infection in a subject.

Abstract: The present invention relates to the provision of immunogenic or vaccine compositions comprising at least one recombinant Zika virus antigen, wherein the at least one recombinant Zika virus antigen is encoded by at least one nucleic acid sequence encoding at least one E-protein of a Zika virus or a functional fragment thereof. Further provided are nucleic acid molecules and a recombinant chimeric virus encoding and/or comprising selected antigens from a Zika virus, which are suitable as vaccine compositions. Preferably, the sequences encoding at least one Zika virus antigens suitable for eliciting an immune response are operably linked to a non-flavivirus derived vector backbone. Further provided are methods for purifying the recombinant chimeric virus particles or the immunogenic composition. Finally, there is provided an immunogenic/vaccine composition for use in a method of preventing or treating a Zika virus disease.

Abstract: The invention relates to a method for producing a ribonucleic acid (RNA) molecule composition comprising n different RNA molecule species, the method comprising a step of RNA in vitro transcription of a mixture of m different deoxyribonucleic acid (DNA) molecule species in a single reaction vessel in parallel, i.e. simultaneously, and a step of obtaining the RNA molecule composition. Also provided is the RNA composition provided by the inventive method and a pharmaceutical composition comprising the same as well as a pharmaceutical container. Moreover, the invention provides the RNA composition and the pharmaceutical composition for use as medicament.

Abstract: The present application discloses methods for removing residual impurities from protein preparations. Such methods include addition of an anionic detergent to a solution comprising proteins of interest and cellular contaminants under non-precipitating conditions and passing the solution through an ion exchange column.

Abstract: This invention relates to Hendra virus and Nipah virus immunogenic compositions and methods of use. The invention further relates to immunogenic compositions comprising Hendra virus G glycoprotein, and methods of protecting against Nipah virus infection and disease. The invention also relates to methods of distinguishing subjects vaccinated with the immunogenic compositions of the invention from those infected with Hendra and/or Nipah virus.

Abstract: Described is a vaccine against Respiratory Syncytial Virus (RSV). More specifically, described is a recombinant subunit vaccine comprising the ectodomain of the RSV-encoded Small Hydrophobic (SH) protein. The ectodomain of SH is referred to as SHe. The ectodomain is typically presented as an oligomer, or pentamer. Further described are antibodies, raised against the ectodomain or specific for the ectodomain, and their use for protecting a subject against RSV infection and/or for treatment of an infected subject.

Abstract: The present application relates to the field of human immunology, in particular, a herpes simplex virus (HSV) vaccine. The subunit vaccine composition comprises isolated surface glycoproteins from herpes simplex viruses, fusion proteins or fragments thereof mixed in varied combination with a nanoemulsion, which is a potent immune enhancer.

Abstract: Disclosed herein are chimeric genes, compositions of chimeric genes, and compositions of polypeptides that are useful for the generation, enhancement, or improvement of an immune response to a target antigen. Some embodiments of the compositions include chimeric genes encoding hepatitis D antigen (HDAg) protein in combination with one or more self-cleavage 2A polypeptides and a preS 1 polypeptide. In certain embodiments the self-cleavage polypeptide is P2A.

Abstract: Provided is a recombinant Hansenula polymorpha-based high dosage hepatitis B vaccine, an HBsAg pure stock solution yield of a recombinant Hansenula polymorpha fermentation broth used for producing the hepatitis B vaccine being 300 mg/L-400 mg/L.

Abstract: The invention relates to a pharmaceutical composition comprising Tofacitinib or a pharmaceutically acceptable salt thereof, and at least one antigen, allergen or autoallergen for use in medicine. Also encompassed is the use of said composition as a tolerogenic vaccine in the treatment or prevention of an immune disease. The invention further relates to Tofacitinib or a pharmaceutically acceptable salt thereof for use in tolerogenic vaccination. Another aspect of the invention is the use of Tofacitinib or a pharmaceutically acceptable salt thereof in the treatment or prevention of allergic rhinitis and/or autoimmune disease. Further the invention refers to a kit of parts comprising Tofacitinib or a pharmaceutically acceptable salt thereof, and at least one antigen or allergen.

Abstract: The invention provides a targeted bacteriophage-polymer complex comprising a recombinant targeted-bacteriophage and a cationic polymer. The complex has a net positive charge. The invention provides methods of preparing bacteriophages and complexes thereof, and to their uses for the delivery of transgenes in a variety of gene therapy applications.

Abstract: The present disclosure relates to a composition comprising PIC for treatment of cancer. More particularly, the present disclosure discloses a composition for treatment of cancer comprising polyinosinic-polycytidylic acid, an antibiotic or polyamine compound, a positive ion, and optionally a virus, and the use thereof in manufacture of a medicament for treatment of cancer.

Abstract: The present invention provides antagonizing antibodies that bind to programmed cell death protein 1 (PD-1) and methods of using same. The anti-PD-1 antibodies can be used therapeutically alone or in combination with other therapeutics to treat cancer and other diseases.

Abstract: The present invention develops a vaccine composition against and treatment or prevention on inflammation and lung injury (particularly hyperoxia-induced lung injury) and progression of periodontitis. Tn immunization increases serum anti-Tn antibody titers, while it decreases lavaged protein and cytokines, and also decreases mean linear intercept and lung injury score. Furthermore, the improvement in lung injury is accompanied by a decrease in NF-?B activity.

Abstract: The present invention includes antibodies and antigen-binding fragments thereof that specifically bind to human or cynomolgous monkey LAG3 as well as immunoglobulin chains thereof and polynucleotides encoding the same along with injection devices comprising such antibodies or fragments. Vaccines including such antibodies and fragments as well as compositions comprising the antibodies and fragments (e.g., including anti-PD1 antibodies) are included in the invention. Methods for treating or preventing cancer or infection using such compositions are also provided. In addition, methods for recombinant expression of the antibodies and fragments are part of the present invention.

Abstract: The present invention includes antibodies and antigen-binding fragments thereof that specifically bind to human or cynomolgous monkey LAG3 as well as immunoglobulin chains thereof and polynucleotides encoding the same along with injection devices comprising such antibodies or fragments. Vaccines including such antibodies and fragments as well as compositions comprising the antibodies and fragments (e.g., including anti-PD1 antibodies) are included in the invention. Methods for treating or preventing cancer or infection using such compositions are also provided. In addition, methods for recombinant expression of the antibodies and fragments are part of the present invention.

Abstract: Disclosed are methods and compositions for targeting antibodies to amyloid deposits. For example, amyloid-reactive peptides that bind amyloid deposits are administered to a subject. Antibodies to the amyloid-reactive peptides are then administered to the subject. Upon administration of the antibodies, the amyloid-reactive peptides bind the antibodies and thus pre-target the antibodies to the amyloid deposits. In other examples, an amyloid-reactive fusion peptide contains an epitope of a known antibody. When the fusion peptide is administered to a subject, the fusion peptide binds amyloids in the subject. Administration to the subject of the known antibody that binds the epitope of the fusion peptide then targets the antibody to the amyloid deposit to which the fusion peptide is bound.

Abstract: The invention relates to a liquid pharmaceutical formulation comprising an antibody or antigen-binding fragment thereof, cyclodextrin and methionine. In addition, it relates to a method for reducing precipitation of an antibody or an antigen-binding fragment thereof in a liquid pharmaceutical formulation through addition of methionine and cyclodextrin. In particular, the liquid pharmaceutical formulations comprises an anti-sclerostin antibody, hydroxypropyl-gamma cyclodextrin and methionine and may be used in the treatment of a bone disorder associated with at least one of low bone formation, low bone mineral density, low bone mineral content, low bone mass, low bone quality and low bone strength, and especially for treating osteoporosis.

Abstract: Biopharmaceutical compositions and drug products disclosed herein exhibit reduced amounts of subvisible particle formation. Compositions and drug products disclosed herein comprise a protein and a surfactant or stabilizer including high percentage amounts (e.g., at least 97%) of a long-chain fatty acid ester. Also disclosed herein are methods of preparing and storing such compositions and drug products.

Abstract: Methods for removing, reducing, dispersing, disrupting or eradicating biofilms present on a surface may include contacting the biofilm with a composition including an agent that reduces the potency of an aminopeptidase in the biofilm. The agent may reduce expression, secretion or extracellular activity of the aminopeptidase in the biofilm. The biofilm may be formed by P. aeruginosa or P. stutzeri. The composition may enhance the sensitivity of P. aeruginosa to ciprofloxacin. Methods of determining the number of bacterial population in biofilm or a culture containing bacterial aggregate may include dispersing the bacterial aggregate or biofilm by using a composition comprising exogenous PslG. The number of bacteria may be determined based on the dispersed bacteria.

Abstract: Methods for inducing an immune response against Human Immunodeficiency Virus (HIV) in HIV-infected subjects undergoing antiretroviral therapy (ART) are described. The methods include administering an adenovirus vector primer vaccine and either a Modified Vaccinia Ankara virus (MVA) vector booster vaccine or adenovirus booster vaccine in combination with isolated HIV envelope polypeptides.

Abstract: This invention relates to monovalent and multivalent, monospecific binding proteins and to multivalent, multispecific binding proteins. One embodiment of these binding proteins has one or more binding sites where each binding site binds with a target antigen or an epitope on a target antigen. Another embodiment of these binding proteins has two or more binding sites where each binding site has affinity towards different epitopes on a target antigen or has affinity towards either a target antigen or a hapten. The present invention further relates to recombinant vectors useful for the expression of these functional binding proteins in a host. More specifically, the present invention relates to the tumor-associated antigen binding protein designated RS7, and other EGP-1 binding-proteins. The invention further relates to humanized, human and chimeric RS7 antigen binding proteins, and the use of such binding proteins in diagnosis and therapy.

Abstract: A cannabinoid formulation including a carbon-based antioxidant. Preferably, the formulation is a colloid including C60 and cannabinoids in a lipid-based excipient. The formulation improves shelf life of cannabinoids and inhibits degradation of the cannabinoids over time due to oxidation. The present invention further sequesters, neutralizes, or inhibits, oxidative free radicals in vivo. The action of the C60 prepares the body on a cellular level to enhance the bioactivity of the cannabinoids. The function of the C60 in combination with cannabinoids greatly reduces inflammation, improves metabolism, inhibits free radical degradation of telomeres, and has many other health benefits. The C60 in combination with the cannabinoids enhances the function of the cannabinoids by improving latency and efficacy in vivo.

Abstract: The present specification discloses pharmaceutical compositions, methods of preparing such pharmaceutical compositions, and methods and uses of treating a chronic inflammation and/or an inflammatory disease in an individual using such pharmaceutical compositions.

Abstract: The present specification discloses pharmaceutical compositions, methods of preparing such pharmaceutical compositions, and methods and uses of treating a severe pain in an individual using such pharmaceutical compositions.

Abstract: Pharmaceutical compositions for topical application to skin are provided. In some embodiments, the pharmaceutical compositions comprise a corticosteroid and further comprise a liquid oil component comprising one or more dicarboxylic acid esters and/or monocarboxylic acid esters.

Abstract: Provided are drug delivery compositions and devices useful for the treatment and/or prevention of cancer and metastatic tumors. For example, a drug delivery device is provided that comprises a biodegradable scaffold carrying one or more anti-cancer therapeutic agents that activate the innate immune system (e.g., STING agonists) and/or the adaptive immune system (e.g., anti-PD-1 antibodies). The compositions and devices may include a cytokine (e.g., IL-15 superagonist). The drug delivery device can be implanted in the void volume of a resected tumor to prevent tumor regrowth and tumor metastasis. Also provided are methods of making the drug delivery compositions and devices as well as kits containing materials to provide the compositions and devices.

Abstract: Disclosed are a pharmaceutical composition comprising tacrolimus and a preparation method thereof.

Abstract: Provided are pharmaceutical composition particles which are capable of achieving both of masking of an unpalatable taste and improvement in dissolution properties; an orally disintegrating tablet including the pharmaceutical composition particles; and a method for manufacturing the pharmaceutical composition particles. Each of the pharmaceutical composition particles includes: a core particle containing a water-soluble gelling swelling substance; an intermediate layer containing a drug and coating an outside of the core particle; and an outer layer containing a water-insoluble substance and coating an outside of the intermediate layer. In addition, the orally disintegrating tablet includes the above-described pharmaceutical composition particles.

Abstract: Provided herein is a pharmaceutical formulation comprising a protein based excipient in combination with an active pharmaceutical ingredient (API) wherein said formulation is substantially amorphous and form a substantially homogenous mixture; and further a method for producing said pharmaceutical formulation; and said pharmaceutical formulation for use as a medicament.

Abstract: The disclosure relates to methods of improving safety, efficacy, or both, of pharmaceutically active aminothiol compounds by delivering them in a thiol-protected form and, preferably intracellularly.