Abstract: The present invention provides methods and compositions to reduce binding of fibrinogen to the ClfA in a gram positive bacterial infections using monoclonal antibody, a polyclonal antibody, an antigen-binding antibody fragment or a composition that specifically binds to a portion of ClfA with the sequence of SEQ ID No: 15, SEQ ID NO: 16, SEQ ID NO: 17, and SEQ ID NO: 18.

Abstract: The present invention generally provides methods and compositions for eliciting an immune response against Neisseria spp. bacteria in a subject, particularly against a Neisseria meningitidis serogroup B strain.

Abstract: This invention is directed to composition, vaccines, tools and methods in the treatment and prevention of Bordetella pertussis. In particular, the invention is directed to a three-pronged approach that involves removal of the nonessential vaccine components, use of a nondenatured, genetically detoxified mutant, and adding virulence factors.

Abstract: The present invention relates to attenuated, immunogenic West Nile virus chimeras built on a dengue virus backbone for the production of immunogenic, live, attenuated West Nile virus vaccines.

Abstract: Described herein are improved purification methods for virus vaccines and compositions. Also described are Zika, Chikungunya, dengue and yellow fever vaccines and methods of producing and administering said vaccines to subjects in need thereof.

Abstract: The invention is directed to isolated Tilapia Lake Virus or TiLV, and isolated nucleic acids sequences and polypeptides thereof. The invention also relates to probes and primers, and to antibodies against antigens from TiLV, and use of these reagents for detecting the presence or absence of TiLV in an animal. The invention also relates to iRNAs which target nucleic acid sequences of TiLV. The invention is also related to immunogenic compositions, including antibodies and vaccines, for inducing an immune response against TiLV in an animal. The invention is also related to gene constructs and cells comprising TiLV and isolated nucleic acids sequences and polypeptides thereof for use in developing prophylactic and therapeutic agents.

Abstract: Disclosed herein are compositions and methods useful for immunizing a subject against disease caused by influenza A. Disclosed methods comprise administering to the subject an immunoprotective dose of an immunogenic composition. In certain aspects, the immunogenic composition is a vaccine comprised of a recombinant chimeric hemagglutinin polypeptide. In certain aspects, the subject is a mammal. In further aspects, the mammal is a pig. In still further aspects, the mammal is a human.

Abstract: Provided are compositions and methods that involve recombinant Newcastle disease viruses (rNDVs), and recombinant vectors that encode them. The rNDVs comprise and/or encode a combination of at least two proteins that are hemagglutinin (HA), neuraminidase (NA) protein, matrix 1 protein (M1), or nonstructural 1 protein (NS1). The HA, NA, protein, M1, and nonstructural 1 protein (NS1) are from Avian Influenza virus (AIV). Method are provided and involve administering an immunologically effective amount rNDV to avian animals to stimulate a protective immune response the rNDV administration constitutes a first (prime) immunization, which can be followed by a second (boost) administration with an avirulent NVD that may include/encode an AIV HA. The avian animals can survive challenges from pathogenic and highly pathogenic NVD and AIV.

Abstract: The present invention relates, in general, to attenuated swine influenza viruses having an impaired ability to antagonize the cellular interferon (IFN) response, and the use of such attenuated viruses in vaccine and pharmaceutical formulations. In particular the invention relates to attenuated swine influenza viruses having modifications to a swine NS1 gene that diminish or eliminate the ability of the NS1 gene product to antagonize the cellular IFN response. These viruses replicate in vivo, but demonstrate decreased replication, virulence and increased attenuation, and therefore are well suited for use in live virus vaccines, and pharmaceutical formulations.

Abstract: Described herein, are Bovine immunodeficiency virus gag protein (“Bgag”) recombinant virus like particles (“VLPs”) including one or more different types of target pathogen proteins. Also described, are compositions including the Bgag VLPs and the methods of making and using the novel Bgag VLP.

Abstract: Herpes Simplex Virus-2 (HSV-2) infection is a major health concern. The present disclosure provides, inter alia, certain highly effective vaccines and immunogenic compositions against HSV-2. The antigens can be used therapeutically or prophylactically.

Abstract: Disclosed herein is a vaccine comprising an antigen and a protein, peptide, or carbohydrate of Chlamydia spp., or a fragment thereof, wherein the antigen is not derived from a Chlamydia spp. Also disclosed are methods of treating or preventing diseases comprising administering to a subject a vaccine, wherein the vaccine comprises an antigen and a protein, peptide, or carbohydrate of Chlamydia spp., or a fragment thereof, wherein the antigen is not derived from a Chlamydia spp.

Abstract: The present invention relates to combination therapies for the treatment of a variety of disorders in mammals, including hepatic disorders and cancer. The combination of agents includes naturally-occurring (versus synthetic) oligonucleotides, particularly immunostimulatory oligodeoxynucleotides such as CpG ODNs, obtained from a natural source and one or more extracts from a Gram positive bacteria, such as Lactobacillus spp.

Abstract: Fraction A of Quil A can be used together with at least one other adjuvant for the preparation of an adjuvant composition, where the included adjuvant components act synergistically to enhance level of immune response and have synergistic immunomodulating activity on the co-administered antigens or immunogens. Other adjuvants can comprise saponins, naturally occurring, synthetic or semisynthetic saponin molecules; e.g. saponins and saponin fractions from Quil A, cell wall skeleton, block polymers, TDM, lipopeptides, LPS and LPS-derivatives, Lipid A from different bacterial species and derivatives thereof, e.g., monophosphoryl lipid A, CpG variants, CT and LT or fractions thereof.

Abstract: Iscom particles can be used as an adjuvant for preparing of an antigenic composition which comprises live micro-organisms and/or killed micro-organisms and/or antigenic molecules. A composition may comprise at least one iscom particle and one or more live micro-organisms and/or killed micro-organisms and/or antigenic molecules. A kit can comprise at least one compartment containing at least one living organism and at least one compartment containing at least one iscom particle.

Abstract: The present invention relates, in part, to compositions and methods for enhancement of an immune response by partial mTOR inhibition, e.g., with low, immune enhancing, doses of an mTOR inhibitor, such as RAD001.

Abstract: The present invention is drawn to compositions and methods to enhance an immune response in order to prevent or treat infections or hyperproliferative diseases such as cancer. More particularly, the composition is an immunostimulatory intracellular signaling peptide fused directly or indirectly to a peptide that leads to multimerization into complexes of three or more units, where the intracellular signaling peptide must be present in a complex of three or more units in order to stimulate an immune response. Inserting this fusion construct into viruses like HIV-1 or introducing it into dendritic cells or tumor cells is predicted to lead to a positive therapeutic effect in humans, non-human mammals, birds, and fish.

Abstract: A method of treating pulmonary metastasis of osteosarcoma cells (pOSs) in a subject in need thereof includes administering to the subject a therapeutically effective amount of an agent that interferes with VCAM-1/?4?1 signaling between pOSs expressing VCAM-1 and pulmonary macrophages (MACs) expressing ?4?1.

Abstract: The present invention relates to methods for detecting and monitoring NK cells in paraffin-embedded tissue samples. Also provided are antibodies, antibody fragments, and derivatives thereof that specifically bind to NKp46 present on the surface of NK cells in paraffin-embedded tissue samples.

Abstract: The present disclosure relates to the use of nucleic acid (e.g., mRNA) combination therapies for the treatment of cancer. The disclosure provides compositions, and methods for their preparation, manufacture, and therapeutic use, wherein those compositions comprise at least two polynucleotides (e.g., mRNAs) in combination wherein the at least two polynucleotides are selected from the group consisting of (i) a polynucleotide encoding an immune response primer (e.g., IL23), (ii) a polynucleotide encoding an immune response co-stimulatory signal (e.g., OX40L), (iii) a polynucleotide encoding a checkpoint inhibitor (e.g., an anti CTLA-4 antibody), and, (iv) a combination thereof. The therapeutic methods disclosed herein comprise, e.g., the administration of a combination therapy disclosed herein for the treatment of cancer, e.g., by reducing the size of a tumor or inhibiting the growth of a tumor, in a subject in need thereof.

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: This disclosure describes, in one aspect, a composition that includes a ?-glucan component and an antibody component that specifically binds to the ?-glucan. In another aspect, this disclosure describes a method of increasing a subject's response to ?-glucan immunotherapy. Generally, the method includes identifying the subject as a low binder of ?-glucan and administering to the subject a composition that comprises a ?-glucan moiety conjugated to the therapeutic antibody. In some cases, the therapeutic antibody can be an anti-tumor antibody.

Abstract: The present invention relates to a novel anti-PD-L1 antibody formulation. In particular, the invention relates to an aqueous pharmaceutical formulation of the anti-PD-L1 antibody Avelumab.

Abstract: The present invention relates to CIpB expressing bacteria and their impact on obesity. The present invention relates to bacterial CIpB protein and CIpB expressing bacteria and their impact on eating disorders. The invention further relates to compositions comprising antibiotic directed against at least one CIpB expressing bacterium as well as probiotics not expressing CIpB protein and their use in the treatment or prevention of eating disorders. The invention also relates to diagnostic tools for determining whether a subject is likely to respond to a method of treating eating disorders and to methods of immunization against eating disorders.

Abstract: This invention relates to a neoadjuvant therapy for bladder cancer in bladder cancer patients who are scheduled for a cystectomy and methods of carrying out such a neoadjuvant therapy. In particular the invention relates to a composition comprising hexyl 5-ALA ester (HAL) or a pharmaceutically acceptable salt thereof for use in a neoadjuvant therapy for bladder cancer in a bladder cancer patient who is scheduled for a cystectomy, the therapy comprises instilling said composition into the bladder of said patient and exposing the inside of said bladder to light.

Abstract: Provided are methods and compositions for treating ocular conditions characterized by the presence of unwanted choroidal neovasculature, for example, neovascular age-related macular degeneration. The selectivity and sensitivity of, for example, a photodynamic therapy (PDT)-based approach can be enhanced by combining the PDT with an anti-FasL factor, for example, an anti-FasL neutralizing antibody.

Abstract: The invention provides methods and pharmaceutical compositions for preventing or treating alopecia, such as chemotherapy-induced alopecia (CIA). The pharmaceutical compositions of the invention comprises an effective amount of a vitamin D compound in a formulation that topically delivers the vitamin D compound to the epidermis layer but substantially avoids the dermis layer. In chemotherapy patients, the pharmaceutical compositions of the invention can be administered either before or concurrent with the chemotherapy medication.

Abstract: A guided bone regeneration material is disclosed. The guided bone regeneration material includes biodegradable fibers produced by an electrospinning method. The biodegradable fibers produced by the method include a silicon-releasing calcium carbonate and a biodegradable polymer. The silicon-releasing calcium carbonate is a composite of siloxane and calcium carbonate of vaterite phase. The biodegradable fibers may be coated with apatite. When the guided bone regeneration material is immersed in a neutral aqueous solution, silicon species ions are eluted from the calcium carbonate. The guided bone regeneration material excels in bone reconstruction ability.

Abstract: Methods of treatment using bendamustine formulations designed for small volume intravenous administration are disclosed. The methods conveniently allow shorter administration time without the active ingredient coming out of solution as compared to presently available formulations.

Abstract: The present invention is based, in part, upon the discovery of charged lipids that provide advantages when used in lipid particles for the in vivo delivery of a therapeutic agent. As such, described herein are compounds useful for delivering a nucleic acid to a cell.

Abstract: Compounds that are PSMA ligands, pharmaceutical compositions comprising these compounds, methods for treating and detecting cancers in a subject, methods for identifying cancer cells in a sample are described herein.

Abstract: This invention provides for a compound of formula (I): or a pharmaceutically acceptable salt thereof, wherein R1-R4, L and X are defined herein. The compounds of formula (I) and pharmaceutically acceptable salts thereof are cationic lipids useful in the delivery of biologically active agents to cells and tissues.

Abstract: Improved formulations for topical treatment that ensure at least localized transdermal or systemic delivery of an active agent through skin, nails or hair follicles are disclosed.

Abstract: The present invention relates to a pharmaceutical composition comprising a solid dispersion of a drug. In the composition, the drug is in substantially amorphous form.

Abstract: The present disclosure relates to a novel polymeric nano-formulation of a composition comprising an active ingredient and a polyethylene glycol (PEG)-polybutylene glycol (PBG) copolymer. The present disclosure also relates to a method of preparing such a composition and its use in the preparation of a medicament.

Abstract: An aqueous dispersion, useful for forming a film, comprises a silicone composition dispersed in an aqueous phase. The silicone composition comprises a product of a reaction of (a) an alkenyl-containing organopolysiloxane having an average per molecule of at least 2 alkenyl groups and (b) an Si H containing siloxane having an average per molecule of at least 2 Si H moieties. The dispersion also comprises a hydrosilylation catalyst and polyvinyl alcohol. The composition is stabilised in dispersion form by the polyvinyl alcohol dissolved in the aqueous phase. The dispersion is an effective method of delivering a pharmaceutically or cosmetically active ingredient by topical application.

Abstract: The invention provides methods, compositions and kits relating to hydrogel foams.

Abstract: The subject invention is directed to a pharmaceutical composition comprising an open matrix network carrying a pharmaceutically active ingredient, wherein the open matrix network comprises inulin.

Abstract: An aqueous solution comprising a cationic polymer dissolved in water, wherein said cationic polymer comprises a hydrophobic quaternary ammonium group covalently attached to a hydroxyethyl cellulose polymer backbone. Also, a method of delivering a drug to a mucosal surface in a living body, said method comprising applying the aqueous solution to said mucosal surface.

Abstract: The present invention is directed colloidal microcrystalline compositions, particularly for suspending particles in low viscosity fluids, produced by co-attrition of a mixture of microcrystalline cellulose and at least a polysaccharide in the presence of acidic attrition aid; their preparation; and, products made therewith.

Abstract: The present invention provides compositions and methods for the targeted delivery, release and/or formation of a drug compound at a target site(s) within the body of an individual, such as a diseased and/or inflamed tissue in the body of the individual. These compositions may comprise a halogenated phenol ring cleavably linked to a core structure of a drug compound. Due to the variety of substituents that may be utilized in forming the different types of linkages, numerous examples of drug compounds linked to a halogenated phenol ring are proposed. The present invention further provides compositions comprising halogenated phenol starting compounds that do not undergo cleavage during a dehalogenation reaction to form a drug compound in a targeted tissue when administered to an individual. Methods of administering these non-cleaving compounds are further provided.

Abstract: Disclosed are molecules for treating non-del(5q) MDS that mimic allelic deficiency in del5q MDS to sensitize the malignant clones of patient without del(5q). The disclosed molecule contains an inhibitor of Cdc25C, an inhibitor of PP2Ac?, or a combination thereof, and a toll like receptor-9 (TLR9) targeting ligand. The molecule can also contain lenalidomide, or an analogue or derivative thereof. Also disclosed is a composition comprising the disclosed molecule in a pharmaceutically acceptable carrier. Also disclosed is a method for treating non-del(5q) meylodysplastic syndrome (MDS) in a subject by administering to the subject a therapeutically effective amount of the disclosed pharmaceutical composition.

Abstract: Polythioaminal polymers are made from hexahydrotriazine precursors and dithiol precursors. The precursors are blended together and subjected to mild heating to make the polymers. The polymers have the general structure wherein each R1 is independently an organic or hetero-organic group, each R2 is independently a substituent having molecular weight no more than about 120 Daltons, X and Z are each a sulfur-bonded species, at least one of X and Z is not hydrogen, and n is an integer greater than or equal to 1. X and Z may be hydrogen or a functional group, such as a thiol-reactive group. The reactive thiol groups of the polythioaminal may be used to attach thiol-reactive end capping species. By using water soluble or water degradable dithiols, such as polyether dithiols, water soluble polythioaminals may be made. Some such polymers may be used to deliver therapeutics with non-toxic aqueous degradation products.

Abstract: In one aspect, the present application relates to an aminothiol-conjugate of formula (I), wherein Core Linker R1, R2, R3, m, n, and p are as described above. The present invention also relates to a method of treating a subject in need of aminothiol therapy using an aminothiol-conjugate of formula (I).

Abstract: Disclosed herein are compositions and methods for reducing the antigenicity of molecules, wherein the molecule comprises a uricase. The antigenicity of a molecule may be reduced or eliminated by conjugating at least one branched polymer to the molecule to form a molecule-polymer conjugate. The branched polymer may include a backbone and a plurality of side chains, each side chain covalently attached to the backbone.

Abstract: Disclosed herein are molecules and pharmaceutical compositions that induce an insertion, deletion, duplication, or alteration in an incorrectly spliced mRNA transcript to induce exon skipping or exon inclusion. Also described herein include methods for treating a disease or disorder that comprises a molecule or a pharmaceutical composition that induces an insertion, deletion, duplication, or alteration in an incorrectly spliced mRNA transcript to induce exon skipping or exon inclusion.

Abstract: The present disclosure relates to compounds of formula (I): RCG1-L-P??(I) wherein RCG1 represents a reactive chemical group being reactive towards a chemical group present on a polypeptide such as an antibody; P represents H, OH or an activated O; and L represents a specific linker. The disclosure also relates to cryptophycin payloads, as well as to cryptophycin conjugates, to compositions containing them and to their therapeutic use, especially as anticancer agents. The disclosure also relates to the process for preparing these conjugates.

Abstract: This document relates to conjugates of TNF inhibitors or derivatives thereof and functionalized (e.g., mono- or bi-functional) polymers (e.g., polyethylene glycol and related polymers) as well as methods and materials for making and using such conjugates.

Abstract: Isolated or recombinant anti-LGR4 monoclonal antibodies are provided. In some cases, antibodies of the embodiments can be used for the detection, diagnosis and/or therapeutic treatment of human diseases, such as cancer.

Abstract: Disclosed herein are recombinant adenoviruses with one or more nucleotide sequences inserted between two viral transcription units, formulations comprising the recombinant adenoviruses, and methods of treatment using the recombinant adenoviruses. In some embodiments, the one or more nucleotide sequences are inserted in an IX-E2 insertion site and/or an L5-E4 insertion site.