Abstract: The invention encompasses compositions, kits and methods for modifying bacteria, preferably naturally occurring bacteria, in situ. These can be used to treat, prevent or cure microbiome-associated diseases or disorders by modulating the molecules expressed and/or secreted by bacterial populations of the microbiome in a specific manner. The genomic modifications can modify the interactions between part or all of these populations and the host in a way that decreases their deleterious potential on host health. The compositions, kits and methods of the invention do not result in the direct death of these populations or a direct significant inhibition of their growth. The invention further includes methods for screening for genetic modifications in the bacteria, for determining the efficiency of vectors at inducing these genetic mutations, and for determining the effects of these mutations on bacterial growth.

Abstract: The present invention relates to methods of improving body composition and reducing body fat percentage in an individual. The present invention relates to methods comprising administering to an individual a Bacillus subtilis composition wherein the individual's body fat percentage is reduced.

Abstract: The present invention relates to a composition comprising as an active ingredient a strain having excellent ability to produce formic acid for preventing or treating obesity or metabolic syndromes caused by obesity; and to a food composition and a health functional food each comprising the active ingredient. The strain having excellent ability to produce formic acid according to the present invention not only has effects of reducing body weight and inhibiting fat accumulation in organs, but also has activity to effectively lower blood triglyceride and cholesterol levels, and therefore, the composition comprising the strain as an active ingredient can be favorably used as a composition capable of preventing/alleviating or treating obesity or metabolic syndromes caused by obesity. Therefore, the strain having excellent ability to produce formic acid according to the present invention can be favorably used as a material for a medical product or health food.

Abstract: Provided herein are, inter alia, microbial compositions and methods of using the same. The microbial compositions provided include, inter alia, therapeutically effective amounts of Lactobacillus johnsonii, Faecalibacterium prausnitzii, Akkermansia muciniphila, Myxococcus xanthus and Pediococcus pentosaceus and are particularly useful for methods of treating and preventing inflammatory diseases.

Abstract: Disclosed are novel probiotic formulations. The formulations of the present disclosure comprise microorganisms of the species Pediococcus acidilactici and at least one of Leuconostoc mesenteroides and Lactobacillus reuteri. The formulations of the present disclosure can be used to prevent or treat gastrointestinal disease conditions, including notably gastrointestinal diseases associated with low gastrointestinal mannitol.

Abstract: Isolates strains of gastrointestinal bacteria from wolves are provided for use as probiotics. In some embodiments, the isolated strains are for use as probiotics in canine subjects such as domestic dogs. In some embodiments, the isolated strains may be used to treat or prevent intestinal dysbiosis in the subject. Also provided are compositions comprising at least one isolated strain of wolf probiotic bacteria and related methods for making same.

Abstract: The invention relates to methods, kits and compositions for reducing the level of or eliminating Bacteroides in situ. The invention encompasses methods of preventing myocarditis, treating myocarditis or dilated cardiomyopathy, or limiting progression of myocarditis toward dilated cardiomyopathy in a subject in need thereof, comprising reducing the amount of Bacteroides sp. in the subject. The invention further encompasses methods of diagnosis of a subject as having myocarditis or dilated cardiomyopathy. The invention also encompasses compositions preventing myocarditis, treating myocarditis or dilated cardiomyopathy, or limiting progression of myocarditis toward dilated cardiomyopathy in a subject in need thereof.

Abstract: The present invention provides a combination therapy of genetically modified vaccinia virus (particularly oncolytic vaccinia virus) and another cancer therapy for use in treating cancer, and a pharmaceutical composition and a combination kit for use in the therapy. More specifically, the invention provides a therapy with vaccinia virus containing a polynucleotide encoding interleukin-7 (IL-7) and a polynucleotide encoding interleukin-12 (IL-12) in combination with an immune checkpoint inhibitor, and a pharmaceutical composition and a combination kit for use in the therapy.

Abstract: The subject invention provides compositions and methods for reducing atmospheric methane and/or nitrous oxide emissions using livestock feed additives and/or supplements. In preferred embodiments, a composition comprising a beneficial microorganism and/or a growth by-product thereof is contacted with animal feed and/or drinking water prior to the animal ingesting it. The composition is capable of, for example, controlling methanogenic microorganisms within the animal's digestive system, and thus, reducing the amount of enteric methane emissions produced from the animal and from the animal's waste.

Abstract: Proposed is a composition for preventing, ameliorating or treating acne symptoms including a Sesamum indicum seed extract, a Quercus robur bark extract and a Houttuynia cordata extract as active ingredients, and at least one natural substance of a Cirsium japonicum extract and Thuja orientalis as an additional active ingredient. The composition for preventing, ameliorating or treating acne symptoms contains, as active ingredients, natural extracts having the effects of prevention, amelioration or treatment of acne by exhibiting high antibacterial activity against C. acnes, which is a strain causative of acne.

Abstract: Methods and compositions for increasing sexual desire and pleasure in a mammal are provided. In at least one embodiment, a composition comprising at least (1) damiana (Turnera diffusa) extract, (2) theacrine, (3) ginseng, (4) vitamin C, (5) vitamin B12, (6) saffron, (7) potassium nitrate is provided as an oral dosage unit. The claimed composition provides improved sexual desire and pleasure in female mammals.

Abstract: Compositions and methods for treating respiratory ailments are disclosed.

Abstract: The present invention provides methods of treating a coronavirus, COVID-19 disease. COVID-19 disease is caused by the coronavirus, SARS-COV-2. Treatment of the SARS-COV-2 infection could be achieved by administering a single element or a combination of elements in the protocol of therapies comprising of 1) A laxative 2) A Nutritious Meal followed by a cup of green tea, raw honey, lemon. milk and a dessert of pear d'anjou and strawberries 3) Administering drugs and vitamins. These drugs could be anti-parasitic, antiviral, antibacterial and/or immunomodulatory. 4) Providing for the subject infected with the SARS-COV-2 to enjoy the treat of a plain water hot bathtub bath. Some Epsom Salt should be added to the plain water hot bathtub bath. The subject should be encouraged to spend at least 30 minutes in the hot bathtub bath. 5) A Physical Exercise session. 6 Claims, 0 Drawing Sheets.

Abstract: A pharmaceutical composition and a health functional food composition for preventing, treating, or improving muscular diseases have licorice extract or a fraction thereof, or a compound isolated therefrom or a pharmaceutically acceptable salt thereof, as an active ingredient. The licorice extract or a fraction thereof, the compound or salt thereof induce the myoblasts proliferation and promote the differentiation into myotubes, and since the licorice extract or a fraction thereof, the compound or salt thereof has an excellent effect on regenerating damaged muscles, various muscle diseases are effectively prevented, improved or treated using the composition.

Abstract: Disclosed are a pharmaceutical composition for treatment of attention deficit hyperactivity disorder and a food composition for alleviation of attention deficit hyperactivity disorder, each of which contains as an active ingredient a mixture extract of Longan Arillus, Salviae Miltiorrhizae Radix, Gastrodiae Rhizoma, and Liriopis seu Ophiopogonis Tuber, wherein the compositions containing as an active ingredient a mixture extract of Longan Arillus, Salviae Miltiorrhizae Radix, Gastrodiae Rhizoma, and Liriopis seu Ophiopogonis Tuber of the present disclosure inhibits the hyperactivity of glutamate receptors, which is known to be a cause of attention deficit hyperactivity disorder, alleviates clinical symptoms (attention decrease and hyperactivity) of child patients, and shows an improvement effect in fMRI examination results, and thus can be advantageously used as a medicine for attention deficit hyperactivity disorder or a food for alleviation of attention deficit hyperactivity disorder.

Abstract: The present invention is directed to methods of treating cancer and inhibiting proliferation of cancer cells with compositions comprising extracts prepared from Terminalia chebula fruits (for instance AyuFlex®), Terminalia bellerica fruits (for instance Ayuric®), Phyllanthus emblica fruits (for instance Capros®), Withania somnifera roots and leaves (for instance Sensoril®), Shilajit (for instance PrimaVie®), Azadirachta indica leaves and twigs (for instance PhytoBGS®), and/or combinations thereof, including a trivalent chromium complex with extracts of Shilajit and P. emblica (e.g. Crominex-3+®). Combinations of the extracts with anti-cancer drugs, and related methods, are also described.

Abstract: The disclosure relates to compositions and methods of treating cancer in a subject. The method comprises administering to a patient in need of treatment an effective amount of supercritical CO2 neem extract. The disclosure also relates to a process for preparing a CO2 extract of Azadirachta indica and herbal compositions thereof for the treatment of oral and colon cancers. The methods comprise a process for preparing a standardized SCO2 extract of Azadirachta indica leaves and herbal compositions of the same for oral use.

Abstract: Stable formulations for parenteral injection of peptide drugs and methods of using such stable formulations are provided. In particular, the present invention provides stable formulations for parenteral injection of glucagon and methods of using such glucagon formulations to treat hypoglycemia, especially severe hypoglycemia in emergency situations.

Abstract: Methods for the treatment of CD30-expressing cancers are provided. The methods comprise administering to a subject in need thereof a weekly dose of from about 0.8 mg/kg to about 1.8 mg/kg of an antibody-drug conjugate compound having formula (I); or a pharmaceutically acceptable salt thereof; wherein: mAb is an anti-CD30 antibody unit, S is a sulfur atom of the antibody, A- is a Stretcher unit, and p is from about 3 to about 5.

Abstract: The present disclosure provides a method of treating NAFLD, NASH, and atherosclerosis, comprising administering glycine-containing tripeptide molecule, or a pharmaceutically acceptable salt thereof to a subject.

Abstract: In various aspects and embodiments the invention provides compositions and methods useful in the treatment of acute lung injury (ALI).

Abstract: Provided are an ABC transporter peptide inhibitor XH-14C and an application thereof in the treatment of a tumor with multidrug resistance mediated by an ABC transporter. In the application, the peptide inhibitor XH-14C shown in SEQ ID NO: 1 is administered in combination with an ABC transporter substrate chemotherapeutic drug. This disclosure also provides a pharmaceutical composition for treating a tumor with multidrug resistance mediated by the ABC transporter, containing the peptide XH-14C shown in SEQ ID NO: 1 and an ABC transporter substrate chemotherapeutic drug.

Abstract: A therapeutic nanoparticle containing a cationic polypeptide and a polyanionic molecule, in which the cationic polypeptide, exerting antibacterial activity, forms electrostatic interaction with the polyanionic molecule, and the therapeutic nanoparticle has a diameter of less than 50 nm. Also disclosed are a pharmaceutical composition, a treatment method, and a preparation method, all related to the therapeutic nanoparticle.

Abstract: The present disclosure provides methods of treating an autoimmune disease by administering at least a B-cell Activating Factor (BAFF) polypeptide to a subject in need thereof.

Abstract: Compositions for and methods of preventing, reversing or treating viral infection-induced organ failure provided. The compositions are also suitable for treating and/or preventing COVID-19 and influenza. The compositions and methods employ MG53, which can be in the form of recombinant human MG53. The MG53 may also be administered as a composition that expresses and releases MG53 after in vivo administration of said composition to a subject.

Abstract: The invention provides compositions and methods for ameliorating symptoms associated with hyperglycemia by administering a Zn-?2-glycoprotein or a functional fragment thereof, methods of decreasing plasma insulin levels, methods of increasing skeletal muscle mass, and methods of bringing about a weight reduction or reduction in obesity, Also provided are pharmaceutical compositions for use thereof.

Abstract: [Problem to be solved] To provide a pharmaceutical composition for treating a disease caused by an RNA virus. [Solution] A pharmaceutical composition for a disease caused by an RNA virus or an inhibitor of RNA virus replication, comprising retinoic acid receptor responder protein 3 and/or an mTOR inhibitor.

Abstract: Disclosed are methods of treating metabolic diseases, such as non-alcoholic fatty liver disease (NAFLD), including nonalcoholic steatohepatitis (NASH), and Type II diabetes. In some examples, the method includes administration of an effective amount of a (pro)renin receptor (PRR) antagonist to a subject in need thereof, such as a patient at risk of acquiring or afflicted with NAFLD, NASH and/or Type II diabetes, to prevent, inhibit, and/or reduce one or more signs or symptoms associated with NAFLD, NASH and/or Type II diabetes, such as by reducing the severity of liver steatosis.

Abstract: Provided herein are compositions comprising peptide amphiphiles, glycosylated peptide amphiphiles (GPAs), supramolecular nanostructures assembled therefrom, and methods of use thereof. The peptide amphiphiles described herein may extend the half-life of bone morphogenic proteins, promote cell differentiation, suppress proliferation, and increase chemosensitivity of cells. Accordingly, the compositions described herein may be used for cancer treatment methods. In particular, provided herein are bone morphogenic proteins bound to peptide amphiphiles and glycosylated peptide amphiphiles or composites thereof, and methods of use of the same for the treatment of cancer. Also, provided herein are bone morphogenic proteins bound to peptide amphiphiles and glycosylated peptide amphiphiles or composites thereof, and methods of use of the same in a combinatorial approach together with chemotherapeutic medications for the treatment of cancer.

Abstract: The present disclosure provides pharmaceutical compositions comprising interferons (IFNs), methods of treating or preventing viral respiratory infections in subjects thereof using IFNs thereby reducing viral respiratory infections, symptoms thereof, inflammation, and minimizing virus propagation. In some embodiments, the pharmaceutical compositions may comprise at least one IFN, an aminoquinoline, a corticosteroid, and one or more pharmaceutically acceptable excipients, carriers, or diluents; and optionally at least one therapeutic agent, and methods of use thereof. Another embodiment may be directed to any of the disclosed pharmaceutical compositions, where the pharmaceutical composition is inhalable.

Abstract: Compositions and methods for treating hyperinsulinemic hypoglycemia, such as hyperinsulinemic hypoglycemia after bariatric surgery, are provided. In some embodiments, an effective amount of the glucagon-like peptide-1 receptor antagonist exendin(9-39) is subcutaneously administered twice per day.

Abstract: A method for prevention or treatment of obesity, reducing body weight and/or food intake, or inducing satiety in a subject, the method comprising the steps of: administration of an effective amount of a GLP-1 agonist to the subject for an initial time period; positioning an electrode adjacent to and spaced from a skin surface of a head of the subject; and applying an electrical impulse through the electrode to a target region in a cerebral cortex of a brain of the patient, wherein the electrical impulse is sufficient to modulate one or more neurons in the target region.

Abstract: A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.

Abstract: A composition in the form of an injectable aqueous solution, the pH of which is between 7.2 and 8.0 (7.2<pH<8.0) and which includes at least A21G human insulin, the composition being intended to be used in a method for treating diabetes, wherein it is administered as a bolus before meals.

Abstract: The invention relates to pharmaceutical compositions and dosage forms comprising full-length recombinant human parathyroid hormone (rhPTH(1-84)). The invention further relates to new and/or improved PTH compositions having improved in-use stability that are resistant to protein degradation in response to physical and chemical stresses.

Abstract: The present invention provides long-term stable pharmaceutical formulations of lyophilized recombinant von-Willebrand Factor (rVWF) and methods for making and administering said formulations.

Abstract: The present invention provides a method for treating, and compositions useful for treating, Flavivirus infections in a human by administering to the human an effective amount of mRNA encoding Mus musculus resistant 2?-5? oligoadenylate synthetase 1b (rOas1b), or variants thereof.

Abstract: Provided are methods of treating metachromatic leukodystrophy comprising administering to a subject in need of treatment a therapeutically effective amount of recombinant arylsulfatase A enzyme.

Abstract: The present invention provides materials and methods for making a subject non-responsive to an antigen. Methods of the invention may comprise contacting the subject with the antigen and a compound that induces anergy. In some embodiments, the antigen may be an autoimmune antigen, examples of which include, but are not limited to acetylcholine receptor for myasthenia gravis, glutamic acid decarboxylase for type I diabetes mellitus and rheumatoid factor in rheumatoid arthritis. In some embodiments, the present invention provides a method of transplanting an organ, tissue, or cells into a subject (e.g. a mammal such as a human).

Abstract: A method of identifying a neoantigen in a tumor of a subject is disclosed. The method comprises: (a) culturing cells of the tumor under conditions which generate single cell clones of the tumor; and (b) analyzing the single cell clones for expression of a neoantigen which is reactive with T cells from the subject, thereby identifying the neoantigen in a tumor of a subject.

Abstract: The present invention provides compositions for treating or preventing cancer and methods of using and making the compositions. The compositions comprise herpes simplex viruses comprising recombinant herpes simplex virus genomes. Further provided are recombinant herpes simplex virus genomes, viruses comprising the recombinant herpes simplex virus genomes, and cancer vaccines and other compositions comprising the viruses.

Abstract: A chimeric antigen receptor is disclosed that includes: (a) an scFv comprising a light chain variable domain (VL) and a heavy chain variable domain (VH), wherein the scFv specifically binds to CCR4; (b) a hinge and transmembrane domain from CD8; (c) an intracellular 4-1BB signaling domain; and (d) an intracellular CD3 zeta signaling domain, wherein (a)-(d) are in N to C terminal order. Uses of the chimeric antigen receptor, such as for treating a malignancy, are also disclosed.

Abstract: Disclosed herein are PSMA and/or STEAP1 polynucleotides, polypeptides, vectors, viruses, vaccines, and vaccine combinations, and their uses.

Abstract: An aspect of the present invention is related to nucleic acid constructs capable of expressing a Zika antigen that elicits an immune response in a mammal against Zika virus, and methods of use thereof. Additionally, there are DNA plasmid vaccines capable of generating in a mammal an immune response against a Zika virus, comprising a DNA plasmid and a pharmaceutically acceptable excipient, and methods of use thereof. The DNA plasmid is capable of expressing a Zika antigen in a cell of the mammal in a quantity effective to elicit an immune response in the mammal that is cross reactive against all Zika strains.

Abstract: Provided herein is a method for preventing a person from an infection by a Coronaviridae virus with a poliomyelitis vaccine. Also provided herein is a method of inducing a protective immune response against a Coronaviridae virus with a poliomyelitis vaccine.

Abstract: The instant disclosure relates generally to oral inoculation and specifically to methods to prepare nasopharyngeal and oral material for oral inoculation of COVID-19. Severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-2”) viral particles are collected from at least one of a nasopharyngeal specimen and an oral specimen each derived from a patient infected with SARS-CoV-2 or a SARS-CoV-2 variant. Mammalian cells (e.g., Vero-E6 and/or Vero-CCL81 cells) are infected with the SARS-CoV-2 viral particles to produce infected mammalian cells. The infected mammalian cells are cultured to produce a mammalian cell culture. SARS-CoV-2 viral particles are collected from the mammalian cell culture to produce isolated viral particles. The isolated viral particles are frozen to produce a frozen isolate. The frozen isolate is partitioned into a plurality of tablets each having a therapeutically effective amount of the SARS-CoV-2 viral particles. An enteric coating is applied to each tablet.

Abstract: Methods and devices are provided for treating a food allergy in a subject in need thereof. The method entails delivering an effective amount of an allergen associated with the food allergy into the subject's cutis skin layer. Delivering the allergen is carried out by inserting one or more allergen-coated solid microneedles into the subject's skin. The one or more solid microneedles each has a base, shaft and tip, and when inserted in the subject, do not extend beyond the cutis. The allergen is allowed to dissociate from the one or more microneedles while inserted in the subject's cutis. Once the allergen disassociates, the one or more microneedles is removed from the subject's skin.

Abstract: The present disclosure describes combination therapies for breast cancer comprising an oligonucleotide toll-like receptor 9 agonist and a PD-1 antagonist. In particular, the present disclosure describes combinations of a CpG-C type oligonucleotide and an anti-PD-1 antibody for the treatment of breast cancer. The combination may further comprise a taxane chemotherapeutic agent, in the presence or absence of a corticosteroid.

Abstract: A potent human and mouse Toll-like receptor (TLR)1/TLR2 agonist was identified and optimized, Diprovocim, which exhibited an EC50 of 110 pM in human THP-1 cells and 1.3 nM in primary mouse peritoneal macrophages. In mice, Diprovocim-adjuvanted ovalbumin immunization promoted antigen-specific humoral and CTL responses, and synergized with anti-PD-L1 treatment to inhibit tumor growth, generating long-term anti-tumor memory, curing or prolonging survival of mice engrafted with the murine melanoma B16-OVA. Diprovocim induced greater frequencies of tumor infiltrating leukocytes than alum, of which CD8 T cells were necessary for the antitumor effect of immunization plus anti-PD-L1 treatment.

Abstract: The present invention relates to a composition comprising a photosensitizer use in prevention or treatment of dermatological disease in a patient, wherein the composition is used in the following order of steps: (a) topical application or subcutaneous injection of said composition to an area of the skin of said patient, (b) exposure of at least said area of the skin to light with a wavelength spectrum similar or identical to sun light for a duration of 30 min to 5 hours, and (c) exposure of at least said area of the skin to light of a wavelength spectrum comprising only one maximum in the absorbance spectrum of said photosensitizer as well as to methods of treating dermatological disease using the outlined steps and kits of parts comprising such compositions and light sources suitable to apply the respectively indicated light.