Abstract: The present invention includes compositions and methods for treating disease and disorders associated with pathological calcification or pathological ossification by modulating the level or activity of NPP1 or a mutant thereof, or a mutant NPP4 modified to exhibit ATP hydrolase activity similar to the hydrolase activity of NPP1.

Abstract: The present invention provides, among other things, compositions and methods for CNS delivery of lysosomal enzymes (e.g., recombinant human arylsulfatase A (rhASA)) for effective treatment of lysosomal storage diseases (e.g., Metachromatic Leukodystrophy Disease). In some embodiments, the present invention includes a stable formulation for intrathecal administration comprising an ASA protein and a poloxamer, wherein less than 5% of the ASA protein exists in aggregated form.

Abstract: A composition including a supernatant obtained from co-culture of phagocytes with apoptotic cells. The composition is obtained by a) providing phagocytes, b) providing apoptotic cells, c) optionally washing the cells from step a) and b), d) co-culturing the cells of step a) and b), and e) separating the supernatant from the cells. The composition may be used in preventing or treating a pathological immune response.

Abstract: Provided are compositions useful as therapeutic vaccines (e.g., cancer vaccines), and methods of producing such compositions. The compositions disclosed herein generally employ a stress protein and at least one synthetic peptide, which may be a phosphopeptide or phosphopeptide mimetic, comprising a cancer-specific mutation present in a patient's cancer.

Abstract: The technology relates generally to the field of immunology and relates in part to methods for activating T cells and other cells resulting in an immune response against a target antigen. The technology also relates to costimulation of therapeutic cells that express chimeric antigen receptors that recognize target antigens using chimeric MyD88- and CD40-derived polypeptides. The technology further relates in part to therapeutic cells that express chimeric antigen receptors, wherein the chimeric antigen receptors have an endodomain that includes MyD88- and CD40-derived polypeptides, and methods for treating patients using the modified therapeutic cells.

Abstract: The present invention relates to the modification of a live attenuated strain of Salmonella enterica serovar Typhi, wherein its natural surface-exposed polysaccharide and flagellin antigens may be converted to, or augmented by, those from other strains of Salmonella, including S. enterica serovars Paratyphi, Typhimurium and Enteritidis. The present invention also relates to modified strains of Salmonella enterica serovar Typhi being suitable for use as components of a vaccine for enteric fever and salmonellosis.

Abstract: The invention features probiotic bacteria expressing Clostridium difficile SlpA, or fragment thereof, and its use for the treatment or prevention of Clostridium difficile infection and gut colonization.

Abstract: Provided are mixed carrier, multivalent pneumococcal conjugate compositions comprising 20 different pneumococcal capsular polysaccharide-protein conjugates, wherein each of the conjugates includes a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to either tetanus toxoid or CRM197, wherein the Streptococcus pneumoniae serotypes are selected from 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, wherein two of the capsular polysaccharides are conjugated to tetanus toxoid and the remaining capsular polysaccharides are conjugated to CRMig7, and wherein the two capsular polysaccharides that are conjugated to tetanus toxoid are selected from the group consisting of serotypes 1, 3, and 5. Also provided are methods of producing the mixed carrier, multivalent pneumococcal conjugate compositions and methods of using the same for prophylaxis against Streptococcus pneumoniae infection or disease in a subject.

Abstract: An object of the present invention is to provide immunogenic compositions for protection against S. pneumoniae, in particular against S. pneumoniae serogroup 9, while limiting the number of conjugates. The present invention therefore relates to new immunogenic compositions for use in pneumococcal vaccines and to vaccination of human subjects, in particular infants and elderly, against pneumococcal infections using said immunogenic compositions.

Abstract: Methods and compositions for the treatment of Brucella induced diseases and disorders are disclosed herein. In preferred embodiments, the invention relates to a vaccine compositions and methods of vaccinating comprising: a Brucella canis comprising one or more attenuating gene knockouts; and a pharmaceutically acceptable vaccine carrier.

Abstract: The present application relates to composition of matter, processes and use of composition of matter relating to flavivirus peptides and epitopes, for example, for therapeutic or preventative vaccination against a flavivirus, and/or for inducing, enhancing, or sustaining an immune response against a flavivirus, and/or for detecting an infection with or an exposure to a flavivirus in a subject. The flavivirus may be for example the Zika and/or Dengue virus.

Abstract: The present invention relates to recombinant measles virus expressing Zika virus proteins and their applications, in particular in inducing preventive protection against Zika virus. The present invention is directed to recombinant measles virus (MV) expressing at least (i) the precursor of membrane (prM) protein of a Zika virus (ZIKV), and the envelope (E) protein of a ZIKV or a truncated version thereof, or (ii) the E protein of a ZIKV or a truncated version thereof, and concerns recombinant infectious particles of said MV-ZIKV able to replicate in a host after an administration, and also Virus Like Particles (VLPs) that contain these ZIKV proteins at their surface. The present invention provides means, in particular nucleic acids, vectors, cells and rescue systems to produce these recombinant infectious particles and VLPs.

Abstract: The present invention relates to an immunogen-carrier, wherein the immunogen-carrier is preferably a virus-like particle (VLP) composed of a plurality of a modified PCV2 ORF2 protein. In particular, the present invention belongs to the field of compliance markers and marker vaccines which allow for the differentiation between infected and vaccinated individuals. In particular, it relates to a compliance marker for vaccines including a subunit antigen, and a DIVA (Differentiating Infected from Vaccinated Animals) system which makes it possible to differentiate between animals infected with a pathogen and animals treated with a subunit antigen derived from said pathogen.

Abstract: Disclosed herein is a composition comprising a nucleic acid sequence encoding a Mayaro Virus antigen that elicits an immune response in a mammal. Also disclosed herein is a nucleic acid sequence encoding an anti-Mayaro Virus antibody, a fragment thereof, a variant thereof. Also disclosed herein is a method of generating a synthetic antibody in a subject by administering the composition to the subject. The disclosure also provides a method of preventing and/or treating a Mayaro virus infection in a subject using said composition and method of generation.

Abstract: Disclosed herein is a photochemical preparation method of an autologous plasma inactivated vaccine for the treatment of acquired immune deficiency syndrome (AIDS), including the following steps: drawing autologous blood from an AIDS patient to form blood to be treated; separating the blood to obtain plasma to be treated; adding a photosensitizer into the plasma to be treated to form plasma to be inactivated; and subjecting the plasma to be inactivated to photochemical inactivation to obtain the autologous plasma inactivated vaccine.

Abstract: The present disclosure relates to a foot-and-mouth disease virus vaccine composition, especially a recombinant bivalent vaccine composition against type O and type A foot-and-mouth disease viruses. The present disclosure further relates to a method for preparing the foot-and-mouth disease virus vaccine composition, and a use of the foot-and-mouth disease virus vaccine composition in preparing medicines for preventing and/or controlling foot-and-mouth disease in animals.

Abstract: Provided herein are optimized recombinant influenza HA polypeptides that elicit immune responses. Also provided are compositions and kits comprising the optimized HA polypeptides as well as methods of making and using the optimized HA polypeptides.

Abstract: The disclosure provides for an isolated recombinant influenza virus having at least one of: a PB2 viral segment encoding PB2 with residue at position 540 that is not asparagine or a residue at position 712 that is not glutamic acid, a PA viral segment encoding PA with a residue at position 180 that is not glutamine or a residue at position 200 that is not threonine, or a PB1 viral segment encoding PB1 with a residue at position 149 that is not valine, a residue at position 684 that is not glutamic acid or a residue at position 685 that is not aspartic acid, or any combination thereof, and methods of making and using the virus.

Abstract: The present invention relates to nucleic acid regulatory elements that are able to enhance endothelial cell-specific expression of genes, methods employing these regulatory elements and uses of these elements. Expression cassettes and vectors containing these nucleic acid regulatory elements are also disclosed. The present invention is particularly useful for applications using gene therapy, more particularly endothelial cell-directed gene therapy, and for vaccination purposes.

Abstract: The present invention discloses a bioactive preparation specific against variola virus infection model strains and applications thereof. The application provided by the present invention specifically is the use of bioactive preparation CH2009 in following (1) or (2): (1) preparing the products for inhibiting poxvirus infection; or (2) using for inhibiting poxvirus infection. Bioactive preparation CH2009 is a bioactive preparation specific against poxvirus infection prepared and obtained from inflammatory skin tissues by intradermal vaccination of New Zealand white rabbit with vaccinia virus, and through the steps such as high temperature and pressure, solvent extraction, acid-base treatment, adsorption, elution, concentration by centrifugation and others.

Abstract: The present disclosure relates to infection-competent, but nonreplicative inactivated modified vaccinia Ankara (MVA) and its use as immunotherapy, alone, or in combination with immune checkpoint blocking agents for the treatment of malignant solid tumors. Particular embodiments relate to inducing an immune response in a subject diagnosed with a solid malignant tumor.

Abstract: Compositions containing a nucleic acid nanostructure having a desired geometric shape and antigens bound to its surface are provided. The nanostructures can be, for example, in the form of a 6-helix bundle or icosahedron. The nanostructure design allows for control of the relative position and/or stoichiometry of the antigen bound to its surface. The antigens displayed on the nanostructure surface are arranged with the preferred number, spacing, and 3D organization to elicit a robust immune response. The displayed antigen can be an HIV immunogen such as eOD-GT6, eOD-GT8, or variants thereof. The compositions may thus be useful as immunogens, vaccines, immunostimulators, adjuvants, and the like. Methods of inducing immune responses, inducing protective immunity, inducing the production of neutralizing antibodies or inhibitory antibodies, inducing tolerance, and treating cancer, infectious or autoimmune diseases are also provided.

Abstract: A cancer immunotherapy method for treating cancer in a patient comprising the steps of: removing lymphocytes from the peripheral blood of the patient; exposing the lymphocytes to one or more of i) a thymosin peptide, ii) a purified immune RNA or DNA. iii) one or more astragalus polysaccharides, iv) one or more letinous edodes polysaccharides, v) a cell wall component of Mycobacterium grannis, Mycobacterium phlei or Mycobaterium subtilis vi) a polysaccharide nucleic acid fraction of bacillus Calmette-Guerin, vii) a transfer factor viii) one or more non steroidal anti inflammatory agents and xi) an enkephalin chosen from methionine enkephalin or leucine enkephalin in vitro and infusing the exposed lymphocytes back into the patient is provided.

Abstract: The present invention is directed to the combination therapy of DLBCL with a BET inhibitor, a Bcl-2 inhibitor and an anti-CD20 antibody.

Abstract: The invention is in the field of antibody formulations, and particularly relates to a pharmaceutical composition of a humanized monoclonal anti-PD-L1 antibody, wherein the pharmaceutical composition comprises 1-150 mg/ml of the humanized monoclonal anti-PD-L1 antibody, a buffer at 3-50 mM, 2-150 mg/ml of an isotonic adjuster/stabilizer and 0.01-0.8 mg/ml of a surfactant, and has a pH of about 4.5-6.8. The formulations prevent antibody aggregates therein from increasing, while enabling better maintenance of the biological binding activity of the antibody for a long time.

Abstract: Described herein are methods, formulations and kits for treating a patient with cancer with anti-VEGF antibodies and albumin-bound chemotherapeutic/anti-VEGF antibody nanoparticle complexes.

Abstract: Contemplated cancer therapies comprise co-administration of aldoxorubicin with an immune therapeutic composition that preferably comprises a vaccine component and a cytotoxic cell component.

Abstract: Provided is a method of combination therapy for prevention or treatment of cancer bone metastasis comprising administering to a patient in need thereof a therapeutically effective amount of an anti-Jagged1 antibody or an antigen-binding fragment thereof and a chemotherapeutic agent. The combination therapy achieves an excellent synergistic effect. In preferred embodiments, the patient is a human female and the cancer is breast cancer.

Abstract: Methods for the treatment of patients with HER2-positive, HER2-amplified and/or HER2-mutated advanced cancer by administration of pertuzumab plus trastuzumab are disclosed. In one aspect, the cancer is advanced HER2-positive, HER2-amplified and/or HER2-mutated colorectal, biliary, bladder, urothelial, salivary, lung, pancreatic, ovarian, prostate, or skin cancer. In another aspect, the cancer is HER2-positive, HER2-amplified and/or HER2-mutated colorectal, biliary, bladder, urothelial, salivary, lung, pancreatic, ovarian, prostate, or skin cancer that is refractory to one or more other treatment regimens.

Abstract: This disclosure relates to methods for the prevention of the reduction of disulfide bonds in a polypeptide expressed in a recombinant host cell, comprising, following fermentation, adding phosphate to a harvest solution of the recombinant host cell, wherein the disulfide bond in the polypeptide remains non-reduced.

Abstract: Embodiments of the present invention provide methods for the treatment or prevention of infection-related immune conditions using compositions comprising IgM.

Abstract: This disclosure relates to formulations of peptide agents, e.g., antibodies and antigen-binding fragments thereof, that bind dengue viruses, and methods of their use.

Abstract: An assembly of throat lozenge and applicator has improved therapeutic properties, further augmented by following a method consisting of a heating procedure using a flavor or efficacy-enhancing liquid. The throat lozenge is molded onto a distal end of an applicator adapted for holding the throat lozenge at a desired location within the mouth. The lozenge containing a plurality of cavities of specific depth and placement on the upper surface or shell of the lozenge, that following a proscribed method are filled with a therapeutic liquid. The combination of all elements of the invention and following the method results in improved perceived efficacy.

Abstract: Disclosed are CMV vectors that lack active UL128, UL130, UL146 and UL147 proteins that may also comprise one or more microRNA regulatory elements (MRE) that restrict expression of the CMV. Immunization with the disclosed CMV vectors allow selection of different CD8+ T cell responses—CD8+ T cells restricted by MHC-Ia, MHC-II, or by MHC-E.

Abstract: An ophthalmic formulation having an effective amount of a parasympathomimetic agent comprising pilocarpine, or a pharmaceutically acceptable salt thereof, and one or more ?1 adrenergic agonists or antagonists is disclosed. The ophthalmic formulation may enable treatment of conditions adversely affecting the visual acuity of a patient, including presbyopia. A method of using the disclosed ophthalmic formulation to treat or ameliorate symptoms of presbyopia is also disclosed.

Abstract: The invention provides for modified reovirus nucleic acid sequences and modified reovirus polypeptide sequences as well as reoviruses containing such modified nucleic acid or polypeptide sequences. The invention also provides for pharmaceutical compositions that include reoviruses having a modified sequence as well as methods of making and using such reoviruses.

Abstract: Disclosed herein are glycidol-based polymers, nanoparticles, and methods related thereto useful for drug delivery. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present invention.

Abstract: The present invention provides a gel formulation comprising diclofenac sodium which has superior transdermal flux properties, which may be used for the topical treatment of pain, such as in osteoarthritis.

Abstract: The present invention relates to a controlled release sterile injectable formulation in the form of solution, suspension or sol-gel formulation for intramuscular or subcutaneous administration comprising a therapeutically effective amount of a neurokinin 1 receptor antagonist, in particular Aprepitant or Fosaprepitant or pharmaceutical acceptable salt, derivative or metabolite thereof. It also relates to a process for developing such formulations.

Abstract: A method for removing or controlling or quantifying the presence of aldehydes, in particular acetaldehyde, is described. Such a method is useful in prolonging the shelf life of a pharmaceutical product.

Abstract: Provided herein are oligonucleotides, bicyclic peptides, and peptide-oligonucleotide-conjugates. Also provided herein are methods of treating a muscle disease, a viral infection, or a bacterial infection in a subject in need thereof, comprising administering to the subject oligonucleotides, peptides, and peptide-oligonucleotide-conjugates described herein.

Abstract: Chemical conjugation is commonly used to enhance the pharmacokinetics, biodistribution, and potency of protein therapeutics, but often leads to non-specific modification or loss of bioactivity. Here, we present a simple, versatile and widely applicable method that allows exquisite N-terminal specific modification of proteins. Combining reversible side-chain blocking and protease mediated cleavage of a commonly used HIS tag appended to a protein, we generate with high yield and purity exquisitely site specific and selective bio-conjugates of TNF-? by using amine reactive NHS ester chemistry. We confirm the N terminal selectivity and specificity using mass spectral analyses and show near complete retention of the biological activity of our model protein both in vitro and in vivo murine models. This methodology is applicable to a variety of potentially therapeutic proteins and the specificity afforded by this technique allows for rapid generation of novel biologics.

Abstract: Provided herein are alpha-conotoxin peptide analogs, including alpha-conotoxin peptide analogs that are covalently attached to polyethylene glycol (PEG), and pharmaceutical compositions of such alpha-conotoxin peptide analogs. Also provided herein are methods of treating or preventing a condition conducive to treatment or prevention by inhibition of an ?9-containing nicotinic acetylcholine receptor (nAChR) (e.g., the ?9?10 subtype of the nAChR) in a subject.

Abstract: The present disclosure belongs to the field of pharmaceutical preparations and relates to the design of a series of lipophilic derivatives by using wild-type penetrating peptide penetratin. These penetratin derivatives have a strong ability to penetrate the ocular tissues and do not cause ocular tissue toxicity. As ocular absorption enhancers, non-invasive routes could be used to achieve intraocular drug delivery and increase the ocular bioavailability of drugs. These penetratin derivatives and the ophthalmic drug delivery system constructed by them are used for eye drop administration, which could replace the intraocular injection with poor patients compliance, which greatly enhances the convenience and safety of the treatment of intraocular and fundus diseases.

Abstract: The invention features a composition comprising a potent cytotoxic compound and a pHLIP® peptide, where, e.g., the cytotoxic compound cannot be used alone due to a lack of targeting. pHLIP® peptide targets cytotoxic compounds to acidic diseased tissue, translocates cytotoxic compounds across plasma membranes into the cytosols of cells in acidic diseased tissues and induces cell death predominantly in the targeted acidic diseased tissue.

Abstract: Methods of treating cancer with antibodies that bind colony stimulating factor 1 receptor (CSF1R) in combination with one or more immune stimulating agents are provided.

Abstract: Described herein are nanoparticle-based compositions, kits and methods and platforms for delivering one or more nucleic acids to a cell.

Abstract: Provided herein are compositions, methods, and devices for the treatment and prevention of atrial fibrillation (AF) using gene therapy techniques. In particular, oxidative stress (OS) and parasympathetic nervous system signaling are inhibited to prevent and/or reverse the electrical remodeling that underlies AF.

Abstract: Methods of using vvectors comprising nucleic acid and nucleic acid variants encoding FVIII protein are disclosed. In particular embodiments, a method of treating a human having hemophilia A includes administering a recombinant adeno-associated virus (rAAV) vector comprising a nucleic acid encoding Factor VIII (FVIII) or nucleic acid variant encoding Factor VIII (FVIII) having a B domain deletion (hFVIII-BDD). In some aspects, a nucleic acid variant has 95% or greater identity to SEQ ID NO:7 and/or a nucleic acid variant has no more than 2 cytosine-guanine dinucleotides (CpGs). In other aspects, a rAAV vector is administered to the human at a dose of less than about 6×1012 vector genomes per kilogram (vg/kg).

Abstract: The present disclosure relates to agents, such as antisense oligonucleotides (oligomers) capable of binding to 5? untranslated region (5?UTR) sequence of survival motor neuron 2 (SMN2) transcripts, and thereby cause the cell to increase the production of SMN2 mRNA and total SMN protein.