Abstract: The use of a compound for preparing a pharmaceutical composition to reduce levels of TNF?, IL-6, and/or IL-1?. The compound can be used to treat immune or metabolic disorders associated with high levels of TNF?, IL-6, IL-1?, or with high levels of ACE-2 and the respective cardiac, renal and blood-pressure-related consequences, including the problems associated with treatments involving antibodies, or cell therapies, or conditions such as hypertension, myocarditis, pericarditis, coagulopathies, thrombotic, cardiovascular or renal events, or type-2 diabetes, and diseases caused by viruses such as influenza or coronavirus. The in-vivo administration of the composition of the invention affects the modulation of cytokine levels in mammals, and said cytokines are related to high levels of ACE-2, have been shown to be correlated with the severity of the disease associated with SARS-CoV-2, and have been identified as indicative markers of the prognosis of the severity thereof.

Abstract: A significant interest lies in compositions that hinder the metastatic process. This process, along with recurrence, is associated with a subset of highly invasive tumorigenic cells expressing CD44. Described herein are CD44-modulating peptide compositions for combination therapy as well as method of use thereof to treat or ameliorate tumors or cancers like ovarian cancer, endometrial cancer, or triple-negative breast cancer.

Abstract: The present invention provides compounds of formula (I) wherein X1, X2, R1 to R6 and A are as described herein, as well as pharmaceutically acceptable salts thereof. Further the present invention is concerned with the manufacture of the compounds of formula (I), pharmaceutical compositions comprising them and their use as medicaments for the treatment of diseases and infections caused by bacteria.

Abstract: Disclosed herein are ?-sheet peptides and their use for treating a bacterial infection and/or limiting bacterial biofilm formation.

Abstract: This disclosure relates to antigenic EBV polypeptides and their use in eliciting antibodies against EBV. Also disclosed are antigenic polypeptides comprising an EBV polypeptide and a ferritin protein.

Abstract: Methods for improving quality of life and/or increasing activity in an aging and/or chronically ill mammal via administration of a composition of egg powder protein are provided.

Abstract: The present invention proposes a gene therapy approach as a potential curative treatment for the USHER syndrome, in particular for the USH1G syndrome, which is characterized by a profound deafness and a severe vestibular defect in humans. More precisely, the present invention concerns a gene therapy involving administering a vector expressing a SANS protein in a time window that is compatible with human ethics and welfare i.e., in post-natal, infant and adult humans in which the auditory system is completed. The present inventors herein show for the first time that it is possible to restore genetically-impaired auditory and vestibular functions in human beings in subjects suffering from an Usher1G syndrome even when the therapeutic vector is administered at this late stage.

Abstract: A recombinant adeno-associated virus (rAAV) comprising an AAV capsid and a vector genome comprising a frataxin gene is provided. Also provided is a composition containing an effective amount of rAAV to ameliorate symptoms of Freidreich's ataxia, including, e.g., reduction in progression towards neurocognitive decline and/or cardiomyopathy.

Abstract: Accordingly, the present invention relates compositions comprising synthetic HDL (sHDL) nanoparticles, methods for synthesizing such sHDL nanoparticles, as well as systems and methods utilizing such sHDL nanoparticles (e.g., in diagnostic and/or therapeutic settings). In particular, the present invention provides compositions comprising sHDL nanoparticles for purposes of preventing, attenuating, and/or treating sepsis and sepsis related disorders in a subject, conditions and symptoms caused by a viral infection (e.g., COVID-19)) in a subject, and conditions and symptoms caused by thrombosis in a subject.

Abstract: The present invention generally relates to an extracellular vesicle (EV) comprising a subunit of a heterodimeric transcription factor, an EV polypeptide, and a monomeric cis-cleaving intein and a method of using the EV.

Abstract: Aspects of the present disclosure are directed to compositions and methods for treating a subject having a neurodegenerative disorder, disease, or condition. Certain aspects relate to treatment with a therapeutically effective amount of a composition comprising a vector encoding an A? peptide variant. Further aspects relate to methods of inhibiting aggregation of endogenous A? peptide in vivo by contacting at least one such peptide with a therapeutically effective amount of an expressed A? peptide variant from a vector encoding the A? peptide variant, said vector in a composition.

Abstract: A method of treating sepsis or a sepsis-related condition, comprising the step of: administering to a subject in need of such treatment an effective amount of C1q, wherein the subject is diagnosed with sepsis and wherein C1q protein expression in neutrophils of the subject is below a threshold level. A method of determining sepsis with poor prognosis in a subject, said method comprising: isolating neutrophils from the subject; determining a level of C1q protein in the isolated neutrophils, and administering C1q to the subject if the level of C1q protein is below a pre-determined threshold. Kits and compositions for carrying out methods of treatment and diagnosis are also disclosed.

Abstract: The invention relates to methods for activating, inducing or promoting innate immune memory in a subject in need thereof comprising administering to the subject CATH2 or a derivative thereof. The invention further relates to methods of improving antimicrobial treatment in a subject in need thereof comprising administering to the subject CATH2 or a derivative thereof and to a use of CATH2 or a derivative thereof as an adjuvant for a pathogen-specific vaccine.

Abstract: Disclosed herein are methods of treating age-related macular diseases, comprising administering to a subject in need thereof a vector comprising AIMP2-DX2 and optionally a target sequence for miR-142.

Abstract: The invention features polypeptides that include an extracellular ActRIIa variant. In some embodiments, a polypeptide of the invention includes an extracellular ActRIIa variant fused to an Fc domain monomer or moiety. The invention also features pharmaceutical compositions and methods of using the polypeptides to treat diseases and conditions involving weakness and atrophy of muscles, e.g., Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy, inclusion body myositis, amyotrophic lateral sclerosis, sarcopenia; or cancer cachexia; or metabolic diseases, e.g., obesity, Type-1 diabetes, or Type-2 diabetes.

Abstract: In some embodiments herein, methods, compositions, and uses for modulating lymphatic vessels of the central nervous system are described. In some embodiments, methods, compositions, or uses for treating, preventing, or ameliorating symptoms of a neurological disease comprise increasing flow via meningeal lymphatic vessels are described.

Abstract: The invention relates to variants and fusions of fibroblast growth factor 19 (FGF19), variants and fusions of fibroblast growth factor 21 (FGF21), fusions of fibroblast growth factor 19 (FGF19) and/or fibroblast growth factor 21 (FGF21), and variants or fusions of fibroblast growth factor 19 (FGF19) and/or fibroblast growth factor 21 (FGF21) proteins and peptide sequences (and peptidomimetics), having one or more activities, such as glucose lowering activity, and methods for and uses in treatment of hyperglycemia and other disorders.

Abstract: Provided herein are methods to treat brain functional decline during aging, which involve administration of glucagon-like peptide-1 receptor (GLP-1R) agonists (GLP-1RAs) that treat the aging-associated changes of the brain. The GLP-1R agonist is exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide, taspoglutide, PF-06882961, OWL-833, TTP-273, or any other molecule that activates GLP-1R.

Abstract: Described herein are doses and dosing regimens comprising determining and administering doses of long-acting insulin receptor agonists suitable for once-weekly dosing, such as Weekly Basal Insulin-Fc (BIF).

Abstract: This invention relates to methods of co-administering oral octreotide and digoxin or lisinopril to a subject in need thereof.

Abstract: The present invention relates to use of a collagen composition for increasing telomere length in a cell, for treating or preventing conditions associated with reduced/shortened telomere length, and for dietary supplement and functional food uses for promoting healthy aging and longevity by mitigating telomere shortening.

Abstract: The invention provides topical compositions and methods for using the compositions. The compositions can be used for the treatment of fibrotic or connective tissue disorders involving scarring, sub-dermal plaque accumulations, or fibrosis of muscle tissue. The disorders can be painlessly treated by the topical application of a composition described herein. One or more calcium channel blocker agents can serve as an active ingredient of the compositions, optionally in combination with, for example, one or more of emu oil and superoxide dismutase. The composition can further include pharmaceutically acceptable carriers that can facilitate the non-invasive transdermal delivery of the active(s) to subdermal sites.

Abstract: The invention relates to a method for treating endometriosis, by administering DNase I, and, in particular, for treating a patient with a cell-free DNA level above normal, a fortiori if this cell-free DNA has a methylation profile typical of endometriosis.

Abstract: Compositions and methods are described for the delivery of a fully human-glycosylated (HuGly) ?-L-iduronidase (IDUA) to the cerebrospinal fluid of the central nervous system (CNS) of a human subject diagnosed with mucopolysaccharidosis I (MPS I).

Abstract: The present invention relates to a composition for storing a liquid formulation of botulinum toxin for a long period of time at a low temperature and, more specifically, to a liquid-phase pharmaceutical composition and a method for maintaining biological activity of botulinum toxin by using same, wherein the composition comprises, as active ingredients, (i) botulinum toxin, (ii) hyaluronic acid or a pharmaceutically acceptable salt thereof, and (iii) one or more additives selected from the group consisting of saccharides, a non-ionic surfactant, and a stabilizer. The composition according to the present invention has a remarkable effect of physically and chemically stabilizing botulinum toxin and preventing the tertiary structure of botulinum toxin from denaturing, thus making it possible to expand the formulation of botulinum toxin from conventionally limited dry agents to liquid-phase agents.

Abstract: The invention relates to stable liquid neurotoxin formulations which are free of animal proteins, comprising a surfactant, an amino acid selected from tryptophan and tyrosine, a buffer comprising sodium, chloride and phosphate ions, which have a pH between 5.5 and 8, and which are stable for 2 months. These compositions are suitable for use in therapy and in particular for administration to a patient to achieve a desired therapeutic or aesthetic effect. The invention also relates to the use of an amino acid selected from tryptophan and tyrosine to protect a proteinaceous neurotoxin from degradation in a liquid composition which is free of animal derived proteins.

Abstract: Disclosed herein are compositions and methods for use in treating headache.

Abstract: The present invention describes method for reducing Delayed Graft Function (DGF) and Ischemia/Reperfusion Injury (IRI) by intra-renal infusion of a C1 esterase inhibitor.

Abstract: Described herein are mRNA-based and peptide-based therapeutic vaccines comprising modified TNFR2 sequences complementary to variants of Homo sapiens TNFR2 genes and methods for treating subjects having atherosclerosis.

Abstract: The present invention provides in certain embodiments compositions comprising at least one CD200 inhibitor, and methods of reversing or modulating immune suppression in a patient having a disease or disorder arising from abnormal cell growth, function or behavior, which method comprises administering to a patient in need thereof a CD200 inhibitor composition.

Abstract: Disclosed are compositions and methods comprising the administration of pulsed dendritic cells and an immunoregulator molecule inhibitor for the treatment of cancer.

Abstract: The present invention relates to a trypanosomal vaccine comprising an FLA1 binding protein, as well as to pharmaceutical compositions comprising said vaccine and their uses in vaccination to prevent or treat trypanosomal infection in a mammal. Thus, also provided are a method of preventing or treating trypanosomal infection comprising administering said vaccine and a kit of parts comprising a medical instrument or other means for administering.

Abstract: The present disclosure relates to Staphylococcus aureus leukocidin A (LukA) and leukocidin B (LukB) variant polypeptides, and polynucleotides encoding the LukA, LukB and LukAB variant polypeptides. The present disclosure further relates to vaccine compositions comprising these LukA and LukB variants, and methods of generating an immune response against Staphylococcus aureus in a subject.

Abstract: A method of preventing and treating viral infections in animals (and preferably ASFV in porcine), by inhibiting viral ligand interactions with critical cellular receptors that are involved either directly (endo/pinocytosis)) or indirectly (infection through RBCs that have been aggregated by viral interactions) with cellular entry in an animal and preventing and treating the viral infection in the animal. A method of treating a viral infection in an individual with a virus that is both lysogenic and lytic. A composition for treating a viral infection in an individual with a virus that is both lysogenic and lytic. A vaccine for preventing viral infection, including whole and/or partial domains of proteins of both a lysogenic and lytic phase of a virus.

Abstract: The invention provides a vaccine composition comprising a flavi peptide comprising one or more CD8+ T cell epitopes.

Abstract: A mammalian expression system comprising an attenuated, recombinant Ranavirus that has at least one foreign expression element using a unique combination of mammalian transcriptional and translational enhancement elements is disclosed. In other contemplated embodiments, a mammalian expression system comprising a virus, wherein the virus is engineered to express at least two vaccine antigens is disclosed. In addition, methods of delivering human antigens to a mammal are disclosed that include: providing a non-mammalian virus, engineering a recombinant virus that can express at least one foreign molecule by modifying the non-mammalian virus, and using the recombinant Ranavirus to express and deliver foreign antigens to a mammal.

Abstract: Disclosed herein are compositions that include antigen-encoding nucleic acid sequences and/or antigen peptides. Also disclosed are nucleotides, cells, and methods associated with the compositions including their use as vaccines, including vectors and methods for a heterologous prime/boost vaccination strategy.

Abstract: In Provided are embodiments of a recombinant nucleic acid comprising a nucleotide sequence encoding a live-attenuated kin chimeric Herpes Simplex Vims Type-1 (HSV-1) VC2 virus and a nucleotide sequence encoding a heterologous polypeptide operably linked to a promoter, wherein the heterologous polypeptide can replace the glycoprotein C (gC) openreading frame (ORF) in VC2, and wherein the nucleotide sequence encoding the heterologous polypeptide can encode the influenza virus hemagglutinin A or a fragment thereof. The constructs may be incorporated in a vaccine effective in generating antibodies against influenza hemagglutinin.

Abstract: The invention is directed to immunogenic compositions and method of treatment comprising a peptide or nucleic acid that encodes the peptide that induces an immune response in a mammal that is protective against infection by one or more pathogens. The peptide sequence contains multiple epitopes, wherein at least one epitope is a composite epitope which is a combination of two or more conserved epitopes of the pathogen wherein the amino acid sequence of the composite is not an amino acid sequence of the pathogen. In addition, the invention is directed to vaccines comprising the peptide or nucleic acid that encodes the peptide for treating and preventing an infection in mammals such as animals and humans.

Abstract: Currently, the steps performed prior to release of influenza strains to vaccine manufacturers involve passaging influenza virus through eggs. The invention aims to provide procedures useful in manufacturing influenza vaccines, in which the use of eggs is reduced, and preferably is avoided altogether. For instance, rather than use chicken eggs for influenza vaccine isolation, MDCK cells (Madin Darby canine kidney cells) may be used e.g. growing in suspension, growing in a serum-free medium, growing in a protein-free medium, being non-tumorigenic, grown in the absence of an overlay medium, etc.

Abstract: Vaccines that elicit broadly protective anti-influenza antibodies. The vaccines comprise nanoparticles that display HA trimers from Group 2 influenza virus on their surface. The nanoparticles are fusion proteins comprising a monomeric subunit (e.g., ferritin) joined to stabilized stem regions of Group 2 influenza virus HA proteins. The fusion proteins self-assemble to form the HA-displaying nanoparticles. Also provided are fusion proteins, and nucleic acid molecules encoding such proteins, and assays using nanoparticles of the invention to detect anti-influenza antibodies.

Abstract: The present invention relates to immunogenic compositions comprising recombinantly constructed polypeptides useful for preparing vaccines, in particular for reducing one or more clinical signs caused by a rotavirus infection. More particular, the present invention is directed to an immunogenic composition containing (i) a fusion protein comprising in N- to C-terminal direction (A) an immunogenic fragment of a rotavirus VP8 protein and (B) an immunoglobulin Fc fragment such as, for example, an IgG Fc fragment, and (ii) an immunogenic substance, different from said fusion protein, wherein said immunogenic composition is usable in a method of reducing one or more clinical signs, mortality or fecal shedding caused by a rotavirus infection in swine.

Abstract: An isolated polypeptide comprising an amino acid sequence corresponding to the amino acid residues forming a full or partial ?-helical domain, the hinge domain, the ?-triple spiral domain and a full or partial globular head domain of an avian reovirus sigma C protein, and lacking the amino acid sequence that is N-terminal to said ?-helical domain is provided. Furthermore, a vaccine comprising, or a viral vector expressing, at least one of the isolated polypeptides of the present invention is provided.

Abstract: The present invention relates to vaccine and treatment of novel coronavirus (SARS-CoV-2) infection (COVID-19) in mammals. Particularly, the invention relates to coronavirus vaccine and method for preparation thereof. More particularly, the present invention discloses preparation of coronavirus vaccine comprising an inactivated, purified SARS-CoV2 as active ingredient. The present invention also discloses a method for preparation of killed-inactivated SARS-CoV-2 virus which is used as antigen in the vaccine composition. The present invention further relates to the method of antigen preparation including inactivation and purification of virus, SARS-CoV-2 vaccine preparation, composition, formulation and use of the same to elicit immune response against the SARS-CoV-2 in mammals, and it is also suitable for immunizing human subjects.

Abstract: Live attenuated viruses for protection against the novel coronavirus Sars-CoV-2 are provided. The live attenuated chimeric virus strains are based on a live attenuated influenza A or B virus (LAIVA/B), used a master backbone, which includes deletion of the viral virulence element, the NS1 (non-structural protein 1) (DeLNS1), engineered to express one or more antigens of the Sars-CoV-2 (herein, CoV2Ag). The chimeric virus strain is referred to generally herein, as DelNS1-A/B-Sars-CoV-2-CoV2Ag. The DelNS1-A/B-Sars-CoV-2-CoV2Ag strain preferably shows spontaneous cold adaption with preference to grow at 30-33° C. Compositions including the chimeric virus also provided as a co-composition with a LAIVA/B. The DelNS1-A/B-Sars-CoV-2-CoV2Ag strain can be used to protect a subject in need thereof, against a challenge of Sars-CoV-2. The co-compositions can be used to protect a subject in need thereof, against a challenge of Sars-CoV-2 and influenza A and/or B.

Abstract: Disclosed is a method of making a nanostructure by solubilizing a recombinant component B (compB) protein from inclusion bodies with a solubilization solution, thereby generating a product sample comprising product compB protein.

Abstract: The present application relates to a self-sustained release immune adjuvant suspension comprising microparticles composed of a lipid soluble immune adjuvant and a surfactant, the balance being a dispersant, wherein the lipid soluble immune adjuvant is coated with the surfactant to form the microparticles which are dispersed in the dispersant to form a suspension. The self-sustained release immune adjuvant suspension can be retained in a tumor for a long time and can maintain a sustained release property, and can also inhibit the growth of distal metastatic tumors and reduce the probability of tumor recurrence by means of an immune response. The present application further provides a preparation method for a self-sustained release immune adjuvant suspension, and use of the self-sustained release immune adjuvant suspension in a sensitizing formulation used for tumor therapies, such as, radiotherapy, chemotherapy, or thermotherapy.

Abstract: This disclosure describes the use of solanesol as an adjuvant in vaccine compositions, as well as related prophylactic and therapeutic methods. Solanesol may be used to replace squalene in vaccine compositions with similar or superior immunostimulatory effects. Solanesol, which is solid at room temperature, may be formulated for use in vaccine compositions by heating above its melting temperature in an aqueous solution to form a dispersion.

Abstract: There are cases of CD20-positive cancer where the cancer is tolerant to obinutuzumab and cases where the cancer recurs after an obinutuzumab-containing treatment. For CD20-positive cancer that is tolerant to obinutuzumab or CD20-positive cancer that has recurred following an obinutuzumab-containing treatment, a type II anti-CD20 antibody is used in combination with one or more compounds selected from the group consisting of prednisolone, doxorubicin, vincristine, and salts and prodrugs thereof. Among these compounds, prednisolone, doxorubicin, and salts and prodrugs thereof may be selected. Furthermore, among these compounds, prednisolone or a salt or prodrug thereof may be selected.

Abstract: The present disclosure relates to combination therapies useful for the treatment of cancer. In particular, the invention relates to the combined use of a PD-1 inhibitor, a TGF-beta inhibitor, and a MCT4 inhibitor to treat cancer.