Abstract: The invention relates to compositions of vault complexes containing recombinant cytokine fusion proteins that include a cytokine and a vault targeting domain, and methods of using the vault complexes to deliver the cytokines to a cell or subject, and methods for using the compositions to treat cancer, such as lung cancer.

Abstract: The present invention is directed to compositions including the cytokines IL-18 and IL-22 or biologically active fragments or variants thereof. In some embodiments, the compositions further include a pharmaceutically acceptable carrier. The compositions can farther include other interleukins such as IL-1?, and IL-1? can be used as a combination therapy with either IL-18 or IL-22 or biologically active fragments or variants thereof.

Abstract: The invention relates to (among other things) a method of administering to a patient suffering from a cancer, the method comprising the steps of: (a) administering an IL-2R?-activating amount of a long acting, IL-2R?-selective agonist; and (b) administering a CTLA-4 pathway-inhibiting amount of an anti-CTLA-4 antibody or a PD-1 pathway-inhibiting amount of an anti-PD-1 antibody.

Abstract: A method of treating a disease associated with intestinal barrier dysfunction in a subject is disclosed. The method comprises administering to the subject a therapeutically effective amount of an agent which downregulates the amount of glucose in intestinal cells, with the proviso that the disease is not Diabetes or obesity. Other agents for treating diseases associated with intestinal barrier dysfunction are also disclosed.

Abstract: The group of inventions is related to medicine, namely infectious diseases, as well as pharmacology, the pharmaceutical industry and biotechnology and provides pegylated interferon lambda having antiviral activity against hepatotropic viruses, wherein said agent has oral bioavailability at least 10%, which ensures high concentration of the agent in the liver, bypassing the systemic circulation, reduces systemic side effects and increases the compliance with therapy, and wherein the method for preparation of the agent comprises irradiating a solution of polyethylene glycol with a molecular weight of from about 400 to about 5,000 Da with ionizing radiation in a dose of 1 to 5 Mrad, mixing the resulting solution with an interferon lambda solution, freezing and cooling of the resulting mixture to a temperature of ?10° C. or below, and the irradiating of the frozen and cooled mixture with ionizing radiation in a dose of 0.1 to 0.5 Mrad.

Abstract: This document relates to methods and materials for preventing cytokine release syndrome (CRS). For example, methods and materials for using one or more catecholamine inhibitors to prevent a mammal from developing CRS are provided.

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 present invention provides a use of IGF-1 in the preparation of medicaments for preventing and/or treating liver tumors, relating to the technological field of prevention and treatment of hepatocarcinoma. In embodiments of the present invention, experiments are carried out on mice, demonstrating that over-expression of IGF-1 in hepatocytes induces the apoptosis of cancerous cells indirectly, and inhibits the occurrence and development of liver tumors; high level of IGF-1 significantly promotes the function of thymus, delays the degeneration of thymus, and does not cause the dysfunction of thymus; high level of IGF-1 significantly promotes the function of spleen T lymphocyte; high level of IGF-1 significantly enhances the number and activity of tumor infiltrating T lymphocytes; long-term over-expression of IGF-1 does not significantly promote the incidence of tumors in all organs and tissues in mice, indicating the safety of high IGF-1 level in the body.

Abstract: The present invention provides modified von Willebrand Factor molecules, methods for their preparation and uses thereof. The invention further provides pharmaceutical compositions for treating coagulation disorders.

Abstract: The present invention provides a pharmaceutical composition, and methods of use thereof, for treating ocular boundary deficiency, symptoms associated therewith, or an undesired condition that is associated with or causes ocular boundary deficiency at the ocular surface. The pharmaceutical composition of the present invention comprises a human PRG4 protein, a lubricant fragment, homolog, or isoform thereof, suspended in an ophthalmically acceptable balanced salt solution. The pharmaceutical composition of the present invention may also comprise one or more ophthalmically acceptable agents selected from the group consisting of an ophthalmically acceptable demulcent, excipient, astringent, vasoconstrictor, emollient, sodium hyaluronate, hyaluronic acid, and surface active phospholipids, in a pharmaceutically acceptable carrier for topical administration.

Abstract: Systems and methods for promoting cellular regeneration in ischemic tissue through administration of pyruvate kinase M2 or a substantially similar therapeutic to the ischemic tissue are disclosed herein.

Abstract: Provided are combinations, compositions and kits containing a hyaluronan degrading enzyme, such as a soluble hyaluronidase, for treatment of hyaluronan-associated conditions, diseases and disorders. In one example, the products include an additional agent or treatment. Such products can be used in methods for administering the products to treat the hyaluronan-associated diseases and conditions, for example, hyaluronan-associated cancers, for example, hyaluronan-rich tumors. The methods include administration of the hyaluronan degrading enzyme composition alone or in combination with other treatments. Also provided are methods and compositions for providing sustained treatment effects in hyaluronan-associated diseases and conditions.

Abstract: Formulations and methods of treatment are disclosed for prevention and/or treatment of visual loss from age-related macular degeneration. The disclosed formulations include botulinum neurotoxin. The disclosed formulations may be applied to an intraocular or extraocular region of a patient. If applied to an extra ocular region of a patient, the botulinum-based pharmaceutical formulation may then be transported to the intra-ocular region of the patient, allowing the active ingredient(s) to penetrate into the choroid, neuro-retina, and/or retinal pigment epithelium without direct injection into the eye, eliminating risk of retinal detachment, retinal break, retinal hemorrhage, and blindness. Additionally, relative timing of botulinum application and specific staging of wet, exudative macular degeneration relative to the paraorbital applications are disclosed.

Abstract: The invention provides methods for enhancing the delivery of viral vectors to the eye of a subject by administering a proteasome inhibitor or and a viral vector ending a gene of interest to the eye.

Abstract: Disclosed herein are recombinant CMV vectors comprising heterologous antigens and microRNA recognition elements to silence expression of CMV genes in the presence of microRNA derived from myeloid cells, an active UL128 protein and an active UL130 protein. Also disclosed are recombinant CMV vectors comprising heterologous antigens and microRNA recognition elements to silence expression of CMV genes in the presence of microRNA derived from myeloid cells, an inactive UL128 protein and an inactive UL130 protein. Also disclosed are methods of generating an unconventional immune response using these vectors. Such an immune response is characterized by generation of a CD8+ T cell response that is predominantly restricted by MHC-II.

Abstract: Methods of treating a patient with human immunodeficiency virus are disclosed. The method includes a providing intradermal and intravenous doses of a aTh1 composition that can increase the CD4+ cells in a patient that are resistant to HIV. The description includes a method for viral load reduction and a viral purge method. The regimen leads to a spike in the viral load and a then a return to baseline or lower levels of the virus and can lead to reduction and/or elimination of the latent viral reservoirs. Kits configured to provide intradermal doses and intravenous doses according to the regimen are also included.

Abstract: The invention provides immunomodulatory pharmaceutical compositions that include a synthetic peptide and one or more immune tolerance enhancers.

Abstract: A method for preparing a personalized cancer vaccine is disclosed. CTC as well as DNA and RNA or ctDNA and ctRNA are separated or enriched to a certain ratio; 13-20 types of DNAs having tumor-specific somatic mutations, RNA, or short-chain peptide, i.e., tumor neoantigen, which can cause a change in a protein sequence and can be closely bind to an human HLA type I or II receptory and TCR, and can further activate CD8+T cells or CD4+T helper cells, are separated. Further, a personalized cancer vaccine is prepared within 4-6 weeks, and is used for stimulating immune response in a cancerous object. Furthermore, antigens capable of stimulating anti-cancer immunity can be captured under an almost noninvasive condition, so that sequencing time and introduced errors can be reduced.

Abstract: Disclosed herein in one aspect is a pharmaceutical composition comprising a plurality of neoantigenic peptides and a pharmaceutically acceptable carrier, each neoantigenic peptide comprising a tumor-specific neoepitope capable of binding to an HLA protein in a subject, each tumor-specific neoepitope comprising a tumor-specific mutation present in a tumor, wherein (a) the composition comprises neoantigenic peptides comprising tumor-specific mutations present in at least 1% of subjects in a population of subjects suffering from cancer; (b) the composition comprises neoantigenic peptides comprising tumor-specific neoepitopes which bind to HLA proteins present in at least 5% of subjects in the population; and (c) the composition comprises at least one neoantigenic peptide capable of eliciting an immune response against a tumor present in at least 5% of the subjects in the population of subjects suffering from cancer.

Abstract: The present disclosure includes a compound of formula (1): wherein cancer antigen peptide A is an MHC class I-restricted peptide consisting of 7 to 30 amino acid residues and containing at least one cysteine residue, wherein the cysteine residue of the cancer antigen peptide A binds to R1 via a disulfide bond; and R1 is hydrogen, a group of formula (2), the group of formula (3), or cancer antigen peptide D, wherein the group of formula 2 is wherein Xa and Yd independently represent a single bond or a divalent peptide group consisting of 1 to 4 amino acid residues, provided that the sum of the number of amino acid residues in Xa and Ya is an integer of 0 to 4, and the cancer antigen peptide B is an MHC class II-restricted peptide consisting of 9 to 30 amino acid residues, wherein the amino group of the N-terminal amino acid of the cancer antigen peptide B binds to Ya in the formula (2), and the carbonyl group of the C-terminal amino acid of the cancer antigen peptide B binds to the hydroxyl group in

Abstract: Described herein are compositions and methods for making and using recombinant bacteria that are capable of regulated attenuation and/or regulated expression of one or more antigens from Clostridium Perfringens as vaccines to prevent necrotic enteritis (NE).

Abstract: The invention relates to immunogenic compositions comprising a capsular polysaccharide (CP) from Streptococcus agalactiae, commonly referred to as group B streptococcus (GBS), conjugated to a carrier protein, and optionally including an aluminum-based adjuvant. The invention further relates to methods for inducing an immune response in subjects against GBS and/or for reducing or preventing invasive GBS disease in subjects using the compositions disclosed herein. The resulting antibodies can be used to treat or prevent GBS infection via passive immunotherapy.

Abstract: The disclosure generally provides recombinant proteins comprising Tobamovirus capsid proteins and an immunogenic epitope of an antigen of interest. The recombinant protein can be used to assemble an array comprising a plurality of associated recombinant proteins that can enhance the immunogenicity of the epitope and induce and/or enhance an immune response to the antigen. The disclosure also provides compositions, such as vaccines, that include the recombinant protein as well as methods for inducing and/or enhancing an immune response in a mammal.

Abstract: Described herein are processes for purifying infectious virus particles and uses of protamine in such processes.

Abstract: Aspects of the disclosure relate to nucleic acid vaccines. The vaccines include one or more RNA polynucleotides having an open reading frame encoding one or more Chikungunya antigen(s), one or more Zika virus antigens, and one or more Dengue antigens. Methods for preparing and using such vaccines are also described.

Abstract: Aspects of the disclosure relate to nucleic acid vaccines. The vaccines include one or more RNA polynucleotides having an open reading frame encoding one or more Chikungunya antigen(s), one or more Zika virus antigens, and one or more Dengue antigens. Methods for preparing and using such vaccines are also described.

Abstract: The present invention provides novel methods and compositions for use in preventing infection with at least one type of influenza virus, including the use of peptides or compositions comprising a peptide comprising, consisting or consisting essentially of an amino acid sequence selected from the group of sequences as shown in SEQ ID Nos: 1 to 53, or functional derivatives or homologues thereof.

Abstract: The present invention describes a liquid vaccine composition of a live enveloped virus and a pharmaceutically acceptable carrier, whereby the carrier is a natural deep-eutectic solvent (NADES), and the vaccine has a water activity of less than about 0.8. The NADES provides a stabilisation of the sensitive virus for prolonged time and at ambient temperature. In general, the liquid vaccine compositions according to the invention, in different compositions for the various enveloped viruses, show remarkable capabilities of stabilisation. This overcomes the need for lyophilisation, a great economic benefit. Also the liquid nature of the vaccines facilitates administration to human or animal targets.

Abstract: Provided are methods for identifying patient populations infected with HIV that can be targeted by antibodies that bind to HIV gp120 V3 glycan region.

Abstract: This disclosure relates to methods of promoting immune responses against HIV and compositions related thereto. In certain embodiments, this disclosure relates to methods of vaccinating for HIV comprising administering to the subject a priming composition followed by a boosting composition. In certain embodiments, the priming composition comprises a recombinant virus such as recombinant MVA that encodes an Env protein of HIV or segment thereof. In certain embodiments, the boosting composition comprises a trimeric cyclically permuted gp120 chimeric protein reported herein or DNA encoding the same.

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: Provided herein are combinations of therapies that provide for the treatment, including regression, of atherosclerosis and/or improvement of cardiovascular outcomes. Generally described, this includes a first, non-PCSK9 LDL-C lowering agent (such as a statin or other non-PCSK9 LDL-C lowering therapy), combined with a second, PCSK9 inhibitor therapy (such as a PCSK9 antibody or anti-RNA). The application of both therapies, at adequately elevated levels so as to reduce the LDL-C level of the subject to very low levels, for an adequate period of time, has been determined to provide an added benefit of further protection from atherosclerosis and improve a subject's cardiovascular outcomes.

Abstract: Provided is a method of reducing a number of viable microbes, including contacting microbes with an antibiotic compound and applying pulses of electricity having a duration of between about 50 nanoseconds and about 900 nanoseconds. The pulses of electricity may have an intensity between about 20 kV/cm and about 40 kV/cm. The pulses of electricity may be applied at a frequency of between about 0.1 Hz and about 10 Hz. The microbes may be a gram-negative or a gram-positive strain of bacteria and the antibiotic may be applied at a concentration for a duration, wherein applying the antibiotic to the strain at the concentration for the duration does not reduce a viable number of bacteria of the strain as much, or at all, when the pulses of electricity are not also applied.

Abstract: Disclosed herein are compositions comprising polymeric perfluorocarbon nanoemulsions and methods of their production, as well as methods for their use in imaging, examination, diagnosis and/or treatment of neurological and psychiatric diseases, as well as for ultrasound- mediated localized drug release into the brain.

Abstract: The present invention generally relates to the transdermal delivery of substances, e.g., for warming skin. Some aspects of the invention are generally directed to formulations that are able to deliver warming sensations to the skin to the skin within seconds, as opposed to minutes as in certain prior art formulations. In some embodiments, the composition may include warming agents, such as vanillyl butyl ether, which have an onset time of less than 1 minute, in addition to more longer-term warming agents such as oleoresin of capsicum. Other components, such as menthoxypropanediol, may be used in some cases, e.g., to provide a cooling sensation in addition to the warming effects of the warming agents. Surprisingly, this may enhance the warming effect of the warming agent. In addition, in some cases, the formulation may contain a nitric oxide donor, such as L-arginine, which may increase blood flow in the skin, and/O or a high salt environment to facilitate delivery into the skin.

Abstract: The present disclosure relates to photo-immunoconjugate formulations comprising a nanoparticle carrier comprising first and second therapeutic agents coupled to the nanoparticle carrier, and a photosensitizer molecule coupled to the first therapeutic agent or the nanoparticle carrier, and methods of treating cancer via administration of the photo-immunoconjugate formulations.

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: Provided is a core-shell structure having an excellent immediate effect in transdermal absorption of an active ingredient. A core-shell structure comprising a core portion containing an active ingredient, and a shell portion containing a surfactant having an HLB value of 4 to 14, the core portion being solid, and the surfactant containing a saturated hydrocarbon group having 7 to 15 carbon atoms or an unsaturated hydrocarbon group having 7 to 17 carbon atoms.

Abstract: The present invention relates to process for preparing a drug delivery composition comprising the steps of a) preparing a masterbatch comprising a drug and a first polymer by (i) extruding the first polymer, wherein said first polymer has a melting temperature below 140° C.; and (ii) introducing the drug during extrusion of the first polymer, with a drug content between 0.1% and 90%, based on the total weight of the masterbatch; and b) introducing the masterbatch in a polymer-based matrix during production of the drug delivery composition, wherein step a) is performed at a temperature at which the first polymer is in a partially or totally molten state, and step b) is performed at a temperature at which both the first polymer and at least a polymer of the polymer-based matrix are in a partially or totally molten state.

Abstract: The present invention provides implants comprising a therapeutic drug and a polymer containing polylactic acid (PLA) and optionally polyglycolic acid (PGA). The present invention also provides methods of maintaining a therapeutic level of a drug in a subject, releasing a therapeutic drug at a substantially linear rate, and treating schizophrenia and other diseases and disorders, utilizing implants of the present invention.

Abstract: The present invention is directed to reduced and highly oxidized polysaccharides, such as alginates, that are useful for encapsulating therapeutic or diagnostic agents, or lipid based nanoparticles, e.g., liposomes or virosomes, encapsulating therapeutic or diagnostic agents, prior to their delivery into a subject, as well as methods for making and using them.

Abstract: A composition for transdermal delivery of pharmaceuticals including a permeation enhancer comprising at least one jojoba constituent, an active pharmaceutical ingredient, and an excipient base.

Abstract: The disclosure relates to rifamycin analog compounds, intermediates and precursors thereof, and pharmaceutical compositions capable of inhibiting bacterial growth (e.g., S. aureus growth) and treating bacterial infections (e.g., S. aureus infections). The disclosure further relates to antibody-drug conjugates of rifamycin analog compounds and antibodies, for example, antibodies specific for infectious disease-related targets such as membrane glycoprotein receptor (MSR1), wall teichoic acids (WTA) or Protein A, and methods of use thereof to inhibit bacterial growth and treat bacterial infections.

Abstract: The present invention relates to an improved process for the synthesis of linker-drug vc-seco-DUBA and its intermediates, as well as to the use of said improved process in a process for preparing an antibody-drug conjugate comprising the vc-seco-DUBA linker-drug.

Abstract: The invention provides anti-CD2 antibodies, antigen-binding fragments thereof, and antibody-drug conjugates thereof, for use as agents to treat a stem cell disorder, cancer, or autoimmune disease, among other hematological and proliferative diseases. The compositions and methods described herein can be used to deplete populations of CD2+ cells, such as CD2+ cancer cells and CD2+ immune cells, and can be used to prepare a patient for hematopoietic stem cell transplantation.

Abstract: Provided herein are functionalized monoclonal antibodies (mAbs) including antibody fragments covalently linked to a peptide compound through a disulfide linkage. The disulfide linkage is between a cysteine in the Fab region of the antibody or fragment thereof and a thiol moiety of a side chain amino acid of the peptide compound. The covalently formed complexes including provided herein form highly stable and versatile drug delivery and diagnostic compositions.

Abstract: Compositions are disclosed which include a CAQK peptide linked or conjugated to a cargo composition, where the peptide selectively homes the composition to a site of nervous system injury in a subject.

Abstract: A method of killing cells of a targeted cell type in a patient body that utilizes nanoparticles having a first portion, which when exposed to a target portion of a targeted cell type, binds to the target portion and a second portion, joined to the first portion, and comprised of a low resistivity material. The nanoparticles are introduced into a contact area where they contact cells of the targeted cell type. Contemporaneously, the contact area is exposed to a varying magnetic field of insufficient strength to increase the temperature of any part of the patient body by more than ten degrees Celsius, but which creates a current at the nanoparticles sufficient to disrupt function of the targeted cell type.

Abstract: The present invention provides a method for producing a cyclodextrin-panobinostat adduct, comprising: a) providing a first aqueous solution comprising a buffering agent, the solution having a pH in the range 2.0 to 4.0; b) dissolving panobinostat in said first aqueous solution to provide a second aqueous solution; and c) mixing said second aqueous solution comprising panobinostat with a third aqueous solution comprising a cyclodextrin to form a fourth aqueous solution comprising a cyclodextrin-panobinostat adduct. Also provided is an artificial cerebrospinal fluid (CSF) solution comprising the cyclodextrin-panobinostat adduct and medical uses of the cyclodextrin-panobinostat adduct, including in the treatment of brain tumours.

Abstract: A composition comprising at least one AAV vector formulated for central nervous system delivery is described. The composition comprises at least one expression cassette which contains sequences encoding an anti-neoplastic immunoglobulin construct for delivery to the brain operably linked to expression control sequences therefor and a pharmaceutically acceptable carrier. The anti-neoplastic immunoglobulin construct may be an immunoglobulin modified to have decreased or no measurable affinity for neonatal Fc receptor (FcRn). Also provided are methods of using these constructs in preparing pharmaceutical compositions and uses thereof in anti-neoplastic regimens, particularly for primary and/or metastatic cancers of the brain.