Abstract: The present invention includes compositions and methods of treating a pregnant female subject at risk of preterm birth, comprising administering to the pregnant female subject an effective amount of an exosome that comprises a nucleic acid that expresses IL-10 or that comprises IL-10, wherein the effective amount of the IL-10 is effective to reduce, prevent or delay preterm birth

Abstract: The present invention provides a means for preventing and/or treating a symptom of a viral infection in a subject affected by the viral infection without inducing any undesired serious side effect by optimizing the application method and the dose of a medicine containing AM or a derivative thereof as an active ingredient. One aspect of the present invention relates to a medicine for preventing or treating a symptom or disorder in a subject affected by a viral infection, the medicine containing adrenomedullin or a derivative thereof as an active ingredient.

Abstract: Insulin complexes are stabilized using a ligand that increases binding interactions between the insulin monomers, and particularly between the B-chains of two adjacent insulin monomers. Particularly preferred ligands are polyphenols, and insulin complexes are typically in the R-state and may therefore also include metal cations and a small phenolic compound in a binding site that is distinct from the polyphenol binding site.

Abstract: The present invention relates to a pharmaceutical composition comprising at least one controlled-release PTII compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, pharmaceutical composition comprising at least one controlled-release PTII compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, wherein said pharmaceutical composition is administered no more frequent than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTII 1-84 administered every 24 hours required to maintain serum calcium within normal levels over said 24 hour period in humans.

Abstract: Disclosed herein are PTHrP or analogues thereof, such as abaloparatide, for preventing or reducing bone fractures in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to prevent or reduce bone fractures. Also disclosed are PTHrP or analogues thereof, such as abaloparatide, for increasing BMD and/or TBS in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to increase BMD and/or TBS.

Abstract: Described are silk fibroin nanoparticles encapsulating oxygen carriers and compositions containing silk fibroin nanoparticles encapsulating oxygen carriers. Also described are methods of using the silk fibroin nanoparticles encapsulating oxygen carriers as artificial blood substitutes.

Abstract: A method of treating systemic lupus erythematosus in a subject is provided in which a therapeutically effective amount of PIC1 is administered to the subject. A method of treating transfusion-related acute lung injury is also provided where a therapeutically effective amount of PIC1 is administered to the subject. PIC1 can modulate immune complex activation of the complement system and NET formation in the subject. PIC1 can also inhibit myeloperoxidase (MPO) activity in the subject.

Abstract: The invention provides American chestnut leaf compositions comprising oxalate oxidase. The compositions reduce oxalate levels in dietary sources of oxalate and are useful in reducing oxalate levels and reducing stone disease in patients. The invention provides methods of extracting and purifying oxalate oxidase from American chestnut leaf. The invention provides methods of extracting oxalate from biological samples.

Abstract: Provided are soluble neutral active Hyaluronidase Glycoproteins (sHASEGP's), methods of manufacture, and their use to facilitate administration for in vitro fertilization, as well as administration of molecules, or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. Sialated and pegylated forms of the sHASEGPs also are provided. Methods of treatment by administering sHASEGPs and modified forms thereof also are provided.

Abstract: The present invention provides compositions comprising Trabectedin or a tTF-NGR protein for use in the treatment of cancer in an individual, wherein the treatment comprises the following steps: (a) administering to the individual an effective amount of a composition comprising Trabectedin, and (b) subsequently administering to the individual an effective amount of a composition comprising a tTF-NGR protein.

Abstract: The present disclosure provides T-cell modulatory multimeric polypeptides (TMMPs) comprising a type 1 diabetes (T1D)-associated peptide epitope, MHC class II polypeptides, and one or more immunomodulatory polypeptides. A TMMP of the present disclosure is useful for modulating activity of a T cell. Thus, the present disclosure provides compositions and methods for modulating the activity of T cells, as well as compositions and methods for treating persons who have T1D.

Abstract: The present description relates to T-cell receptors (TCRs) binding to tumor-associated antigens (TAAs) for targeting cancer cells, T-cells expressing same, methods for producing same, and methods for treating cancers using same. In particular, the present description relates to TCRs and their variants that bind to HLA class I or II molecules with a peptide, such as IGF2BP3-001 have the amino acid sequence of KIQEILTQV (SEQ ID NO: 1). The present description further relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present description relates to the immunotherapy of cancer. The present description furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T-cells ex vivo and transfer into patients.

Abstract: The invention concerns a modified bacteria; a pharmaceutical composition comprising same; and a method of preventing or treating disease particularly, but not exclusively, cancer or an infectious disease using same.

Abstract: A genetically engineered live bacterium comprising at least one effector gene that encodes a medical effector and at least one gene modification that shortens the bacterium's lifespan. After being administered to a subject, the bacterium survives within a time sufficient to allow the medical effector to exert at least one medical action and dies within a time sufficient to minimize pathogenesis to the subject. The bacterium provides an effective treatment of diseases or improving conditions while ensuring the biosafety for medical use.

Abstract: The invention relates to immunogenic polysaccharide-protein conjugates comprising a capsular polysaccharide (CP) from Streptococcus agalactiae, commonly referred to as group B streptococcus (GBS), and a carrier protein, wherein the CP is selected from the group consisting of serotypes Ia, Ib, II, III, IV, V, VI, VII, VIII, and IX, and wherein the CP has a sialic acid level of greater than about 60%. The invention also relates to methods of making the conjugates and immunogenic compositions comprising the conjugates. 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 present invention relates to the field of neisserial vaccine compositions (particularly gonococcal vaccine compositions) and the use of such compositions in medicine. More particularly, the present invention relates to genetically modified gonococci of strain FA1090 and outer membrane vesicles obtained therefrom. The invention also provides a process for preparing the genetically modified gonococci of the invention as well as immunogenic compositions and vaccines comprising the outer membrane vesicles of the invention.

Abstract: The present disclosure provides for systems and methods for targeted mass inoculation. A transmission system for targeted mass inoculation may comprise a first pathogen, wherein first pathogen may comprise a vaccination for an infectious disease. The transmission system may comprise a host that receives the first pathogen. The transmission system may comprise a vector that receives a second pathogen from the host. The second pathogen may inoculate a secondary host when the secondary host receives the second pathogen from the vector. The vector may comprise a mechanical device. When the vector comprises a mechanical device, the vector may comprise a computing device. The computing device may identify a suitable secondary host. The computing device may comprise an algorithm for secondary host recognition and differentiation. The computing device may retain a database comprising indicators of which secondary host candidates have already received the pathogen.

Abstract: The disclosure relates to avian influenza vaccines produced through reverse genetics to protect from A/Turkey/Indiana/22-like virus, methods for producing such vaccines, and method for using such vaccines to protect poultry. The disclosure also relates to methods of producing influenza viruses comprising chimeric polynucleotides having an HA non-coding sequence from an apathogenic high growth influenza virus and a polynucleotide encoding an HA protein from a highly pathogenic avian influenza virus or variant thereof, and/or having a chimeric polynucleotide having an NA non-coding sequence from an apathogenic high growth influenza virus and a polynucleotide encoding an NA protein from a highly pathogenic avian influenza virus or variant thereof.

Abstract: A nanoparticle that displays a coronavirus spike protein or a portion thereof on its surface, and methods of making and using the nanoparticle, are provided.

Abstract: The present invention relates to vaccines and therapeutic compositions targeted at coronaviruses, specifically, the Severe Acute Respiratory Syndrome coronavirus 2 (SARS CoV2). More specifically, the invention provides reconstituted Receptor Binding Motif (RBM) of a Spike protein of the SARS CoV2, Receptor Binding domains (RBDs), and spike proteins comprising the reconstituted RBMs or ?-linkers, compositions, vaccines, therapeutic and diagnostic methods and uses thereof.

Abstract: The present application relates to SARS-CoV-2 virus-like particles (VLP) and related plasmids, compositions, and methods. The VLP can comprise a modified spike glycoprotein, a matrix protein, a nucleoprotein N and an envelope protein of SARS-CoV-2, where the modified spike glycoprotein comprises an S1 domain and an S2 domain, and includes one or more modifications. These modifications can include: linking the S1 and S2 domains via generation of disulfides bonds between the S1 and S2 domains; linking intra-polypeptide and inter-polypeptide S2 helices of the S2 domain; and substitution of one or more non-cysteine residues with a cysteine residue to generate one or more disulfide bonds. The modifications can stabilize a prefusion conformation of the spike glycoprotein and prohibit a transition to a post-fusion structure.

Abstract: The present application relates to the fields of biotechnology, immunology, virology, genetics, and molecular biology. More specifically, the present invention relates to an isolated recombinant receptor-binding domain of the S glycoprotein (RBD-S) of SARS-CoV-2 (severe acute respiratory syndrome-related coronavirus 2), to a nucleic acid that encodes RBD-S of SARS-CoV-2, to an expression cassette and a vector based thereon, as well as to a recombinant AAV5 (adeno-associated vims serotype 5)-based virus for the induction of specific immunity to SARS-CoV-2 and/or prevention of the SARS-CoV-2-related coronavirus infection, to an AAV5-based vaccine for the induction of specific immunity to SARS-CoV-2 and/or prevention of the SARS-CoV-2-related coronavirus infection, and to their use for the induction of specific immunity to SARS-CoV-2 and/or prevention of the SARS-CoV-2-related coronavirus infection.

Abstract: Provided is an immune adjuvant including a polypeptide consisting of an amino acid sequence of SEQ ID NO: 2. The polypeptide is a hepatitis B virus-derived polypeptide, is effective in enhancing immunity through co-administration with vaccines as a single immune adjuvant, and in particular, when coadministered with another immune adjuvant, may exhibit a more remarkable immunity enhancement effect. Furthermore, the polypeptide is a single molecule having only 6 amino acids, is not cytotoxic, and has excellent in vivo stability.

Abstract: Disclosed are synthetic nanocarrier compositions, and related methods, comprising MHC Class II-restricted epitopes and immunosuppressants that provide tolerogenic immune responses, such as a reduction in CD4+ T cell help specific to an antigen.

Abstract: Disclosed are synthetic nanocarrier compositions, and related methods, comprising therapeutic protein APC presentable antigens and immunosuppressants that provide tolerogenic immune responses specific to therapeutic proteins.

Abstract: Disclosed are new synthetic compounds that includes a lipid diether to which a sugar group is grafted via a PEG spacer, and to now liposomes including at least one of the compounds. In particular, new synthetic compounds of general formula (I) and to new liposomes including at least one of the compounds is disclosed, as well as new liposomes for use as vectors and/or adjuvants, especially for use in vaccines.

Abstract: The present invention relates to filamentous, i.e. thread-like nanoparticles comprising sterol and a component derived from Quillaja saponaria Molina selected from quillaja acid and quillaja saponin. More particularly, the invention relates to the use of said thread-like nanoparticles in vaccines and drug delivery or adsorption systems systems, methods for their production and uses thereof, such as for use as a vaccine adjuvant and in cancer therapy.

Abstract: The disclosure provides compounds useful as adjuvants in vaccines, as well as methods of synthesizing such compounds and methods of using such compounds in the formulation of a vaccine. The disclosure also features methods of administering such vaccines to a subject (e.g., a mammalian subject, such as a human) in order to treat or prevent one or more diseases, such as a disease caused by a viral or bacterial infection.

Abstract: The present invention provides vaccine kits and a method for vaccination using such vaccination kits.

Abstract: Provided herein are, in various embodiments, methods and compositions comprising polynucleotides (e.g., mRNA) for eliciting an immune response. In certain embodiments, the disclosure provides for methods and compositions for enhancing efficacy of infectious disease treatment (e.g., mRNA vaccines). In still further embodiments, the disclosure provides methods and compositions for enhancing one or more vaccines, such as SARS-CoV-2 mRNA vaccines.

Abstract: The disclosure relates to novel regimens for treating psoriasis, which employ a therapeutically effective amount of an IL-17 antagonist, e.g., an IL-17 binding molecule, e.g., an IL-17 antibody, such as the secukinumab antibody, or an IL-17 receptor binding molecule, e.g., an IL-17 receptor antibody.

Abstract: The disclosure is directed to methods, treatment regimens, uses, kits and therapies for treating Generalized Pustular Psoriasis (GPP). These methods, treatment regimens, uses, kits and therapies utilize, inter alia, administration of an IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab. Additionally disclosed are improved methods for treating plaque-type psoriasis that utilize up-titration and down-titration of the IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab, as well as modification of dose frequency. Further disclosed are methods of treating palmoplantar pustular psoriasis using the disclosed IL-17 antagonists, e.g., IL-17 antibodies, such as secukinumab.

Abstract: The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof. In some embodiments the formulations of the invention comprise between 5-200 mg/mL anti- PD-1 antibody, or antigen binding fragment thereof. The invention further provides methods for treating various cancers with stable formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by intravenous or subcutaneous administration.

Abstract: A method of generating a population of genetically modified veto cells is disclosed. The method comprising: (a) providing a population of cells comprising T cells, the T cells comprising at least 40% memory CD8+ T cells; (b) culturing the population of cells comprising T cells with an antigen or antigens under conditions which allow enrichment of tolerance-inducing antigen-specific cells having a central memory T-lymphocyte (Tcm) phenotype, the cells being depleted of graft versus host (GVH) reactivity; and (c) transducing the cells with a polynucleotide encoding a heterologous cell surface receptor comprising a T cell receptor signaling module, thereby generating the population of genetically modified veto cells.

Abstract: The present is directed to compositions comprising regulatory T cell epitopes, wherein said epitopes comprise a polypeptide comprising at least a portion of SEQ NOS: 1-73, fragments and/or variants thereof, as well as methods of producing and using the same.

Abstract: Provided are therapeutic agent including nucleic acid and CAR-modified immune cell and the use thereof. The therapeutic agent comprises first composition and second composition, the first composition comprises a nucleic acid having a labeling polypeptide coding sequence for being introduced into a tumor cell and/or a cancer cell; the labeling polypeptide has an extracellular antigen determining region, a spacer portion, and a transmembrane portion that are operatively linked, which can be expressed to form modification on the surface of the tumor cell and/or cancer cell; the extracellular antigen determining region comprises one or more epitope polypeptides; wherein, amino acid sequences of proteins on cell membrane or secreted proteins of mammal do not comprise the epitope polypeptide amino acid sequence in the natural state; the second composition comprises chimeric antigen receptor modified immune cell which specifically recognize and bind to the extracellular antigen determining region.

Abstract: Disclosed are compositions and methods for treating autoimmune diseases such as lupus, including immune cells expressing at least a chimeric antigen receptor (CAR) polypeptides that binds CD83 and uses thereof for suppressing and/or killing autoreactive cells in a subject having an autoimmune disease.

Abstract: Disclosed are isolated or purified T cell receptors (TCRs) having antigenic specificity for human p53R273C or human p53Y220C. Related polypeptides and proteins, as well as related nucleic acids, recombinant expression vectors, host cells, populations of cells, and pharmaceutical compositions are also provided. Also disclosed are methods of detecting the presence of cancer in a mammal and methods of treating or preventing cancer in a mammal.

Abstract: The present disclosure comprises a cancer peptide vaccine comprising a peptide of Asn-Val-Leu-His-Phe-Phe-Asn-Ala-Pro-Leu (SEQ ID NO: 1), a peptide of Ala-Ser-Leu-Asp-Ser-Asp-Pro-Trp-Val (SEQ ID NO: 2), a peptide of Lys-Leu-Lys-His-Tyr-Gly-Pro-Gly-Trp-Val (SEQ ID NO: 3), and a peptide of Leu-Leu-Gln-Ala-Glu-Ala-Pro-Arg-Leu (SEQ ID NO: 4), and a method of preparing the same.

Abstract: Genetically modified cells, including a recombinant nucleic acid expression construct including a first nucleic acid sequence region encoding a chimeric antigen receptor (CAR) that includes an extracellular antigen-binding domain recognizing a carcinoembryonic antigen (CEA) protein, a second nucleic acid sequence region encoding a checkpoint inhibitory molecule, and a third nucleic acid sequence region encoding an immune stimulatory cytokine. In some aspects, the genetically modified cells are T cells or NK cells, preferably cytotoxic T lymphocytes. Anti-CEA CAR-T cells or anti-CEA CAR-NK cells preferentially recognize a membrane-bound CEA protein and express a checkpoint inhibitory molecule and/or an immune stimulatory interleukin in proximity to tumor tissue. Medical use of the cells may relate to treatment of a medical disorder associated with the presence of pathogenic cells expressing CEA, preferably cancer cells, more preferably cancer cells of solid malignancies.

Abstract: A method of enhancing penetration of a topical composition of 5-aminolevulinic acid (ALA) into tissue for photodynamic therapy includes topically applying ALA to a treatment area to be treated with photodynamic therapy. The method further includes, after the ALA is applied to the treatment area, covering the treatment area with a low density polyethylene barrier. The treatment area is covered with the low density polyethylene barrier prior to light treatment to minimize transepidermal water loss from the treatment area.

Abstract: Physiological saline solutions (PSS) and methods for making and using same are disclosed relating to extracorporeal fetal care. In one aspect, disclosed herein is a PSS comprising: an aqueous solvent; from about 1.0 mM to about 2.0 mM calcium chloride; from about 3.0 mM to about 5.0 mM potassium chloride; from about 15.0 mM to about 20 mM sodium bicarbonate; from about 90 mM to about 110 mM sodium chloride; and from about 9 to about 13 mM sodium acetate; and optionally at least one buffering agent wherein the solution has a pH ranging from about 7.0 to about 7.4. In this or other aspects the solution has an osmolarity ranging from about 250 to about 270 mOsm.

Abstract: The present invention provides a pharmaceutical composition comprising: a multi-branched copolymer comprising at least three polyester arms, wherein the polyester is poly(?-caprolactone-co-lactic acid), attached to a central core which comprises a polyether, and wherein the multi-branched copolymer is substantially insoluble in aqueous solution, further comprising at least one pharmaceutically active ingredient, and a pharmaceutically acceptable organic solvent in an amount of at least 20% (w/w %) of the total composition.

Abstract: Methods for improving bioavailability and solubility of taxanes provided as solids in compressed tablet form are described. Compressed tablets containing a high proportion of a taxane are prepared using an amorphous solid dispersion in combination with a polymer carrier and a surfactant. Oral bioavailability of taxanes following ingestion is high, and supersaturating concentrations of the taxane are maintained in gastric fluids for an extended period of time.

Abstract: Described is an aqueous composition comprising: (a) at least one non-ionic cellulose ether, and (b) benzoic acid within the range of from 0.2 wt % to 0.3 wt % based on the total weight of the composition, wherein said composition has a viscosity equal to or above 24 000 cP, an osmolality of from 100 to 400 mOsmol/kg, and a pH of from 3 to 5. The aqueous composition may be used in the treatment and/or prevention of a human fungal infection such as a vaginal fungal infection.

Abstract: A stable pharmaceutical formulation or suspension has acetaminophen, a suspension agent, and a diluent. The formulation or suspension has viscosity suitable for drinking.

Abstract: According to one embodiment of the present invention, provided is a drug-clay mineral complex, in which the complex comprises a phospholipid, and the drug has an amine group.

Abstract: Disclosed are cancer cell- and proliferative cell-selective small molecule compounds that modulate certain cancer cell- or proliferative cell-specific metabolic enzymes or receptors, and methods of their use to treat cancer and other proliferative disorders.

Abstract: By administering a liposome formulation in which an antibacterial agent is bound to a liposome, in particular, a lipid-soluble side chain of the antibacterial agent is bound to a lipid of the liposome, and the antibacterial agent extends outward from a surface of the liposome, it is possible to provide a liposome formulation in which blood retention of an active ingredient is increased, an amount of the active ingredient taken by a reticuloendothelial system such as a liver is reduced, an amount of the active ingredient transferred into a kidney is reduced, and antibacterial activity can also be increased with little resistance.

Abstract: The disclosure relates to bifunctional KRAS-G12D-modulating compounds having the structure W-L-T, where W is a targeting group that binds specifically to KRAS-G12D protein, T is an E3-ligase binding group, and L is absent or is a bivalent linking group that connects W and T together via a covalent linkage. Compounds and pharmaceutical compositions thereof can promote degradation of the KRAS-G12D protein in a cell and are thus useful for treating, inhibiting, and preventing KRAS-G12D-associated diseases, disorders and conditions, including cancers.