Abstract: A novel approach to the development of a personalized vaccine. This approach is based on: A) sequencing of the gag gene from an HIV-infected individual treated with antiretroviral therapy; B) sequencing of the HLA alleles of the same individual; C) selecting the epitopes recognized by the individual's own HLA Class I within the highly-conserved Gag256-377, Gag147-169 and/or Gag225-251 amino acid sequences. An original algorithm that designs the target peptide for the vaccine starting from viral and HLA sequences of an individual with HIV/AIDS, forms the core of the present invention. The original algorithm makes extensive use of existing open- source software for protein design. The peptides designed in this manner and accordingly synthesized may be exploited as a therapeutic vaccine against HIV/AIDS. Vehicles for such peptides may be an individual's own dendritic cells pulsed with the peptide combination or a specific viral or DNA vector leading to intracellular expression of the viral peptides.

Abstract: A pharmaceutical product for use as a vaccine against a viral disease in a human or animal subject, comprising three compositions comprising activated, autologous dendritic cells, loaded with three different SARS-CoV2 peptides, to be administered in three separate doses sequentially to the human or animal subject.

Abstract: The present disclosure is directed to compositions and methods useful for treating, as well as vaccinating against, viral infections, including coronavirus infections.

Abstract: Disclosed are immunogenic constructs including: a nanoparticle; a cationic polymer electrostatically bound to an exterior surface of the nanoparticle and a stabilizer bound to the cationic polymer or the exterior surface of the nanoparticle; and an antigen or antigen producing agent. Optionally, the constructs may include adjuvant and/or one or more functional oligonucleotide(s) (e.g., siRNA or pDNA). Also disclosed are methods of using the provided immunogenic constructs for co-delivering an adjuvant, antigen, and optionally siRNA to a cell, inducing immune response in a subject, and treating or preventing an infectious disease in a subject.

Abstract: Provided is a method for activating CD4+ T cells using a polymer-based antigen complex. The method comprises the steps of bringing the polymer-based antigen complex into contact with B cells so that B cells process and present the antigen complex, and of bringing the B cells into contact with CD4+ T cells to activate CD4+ T cells. Also provided are a method for promoting the differentiation of CD4+ T cells into Tfh cells and Thl cells using the antigen complex, and a method for treating diseases by activating CD4+ T cells and/or promoting the differentiation of CD4+ T cells.

Abstract: The invention provides a phagocytosable particle for use in the treatment or prophylaxis of cancer in a subject, wherein the phagocytosable particle comprises a core and a neoantigenic construct tightly associated to the core, and wherein the neoantigenic construct comprises a neoepitope peptide having an amino acid sequence corresponding to an amino acid sequence of a part of a protein or peptide known or suspected to be expressed by a cancer cell in the subject, wherein the part of the protein or peptide has at least one somatic mutated amino acid. The invention also relates to injectable pharmaceutical compositions for use in the treatment or prophylaxis of cancer.

Abstract: Methods and compositions for enhancing an immunological response by administering an immunogenic composition comprising an effective amount of a MANF family protein or fragment thereof and an antigen to a subject. Also, methods and compositions for decreasing an immune response by inhibiting or antagonizing the activity of a MANF family protein.

Abstract: The present invention relates to the field of immunology, more in particular to the field of binding moieties and/or immunoglobulins which bind to human CD1d, including antibodies and fragments thereof that modify CD1d-mediated biological functions such as enhanced activation and reduced activation of CD1d-restricted T cells, including the natural killer T-cells and gamma-delta T-cells, and modulation of the function of cells expressing CD1d. The invention also relates to bi-, tri- or multi-specific immunoglobulins that bind to CD1d and a gamma-delta TCR and/or a tumor target. The invention further relates to pharmaceutical preparations and use of such mono-, bi-, and tri- or multi-specific binding moieties and/or immunoglobulins in the treatment of diseases or disorders.

Abstract: Compositions and methods for the treatment of cancer are provided. Specifically, the disclosure provides a method for treating and/or inhibiting cancer or neoplasia in a subject, the method comprises contacting cancer cells obtained from the subject to be treated with an inhibitor of an immunity suppressing tumor protein; rendering the cancer cells proliferation-incompetent (e.g., by irradiation); and administering the treated cancer cells and a checkpoint inhibitor to the subject, wherein the inhibitor of an immunity suppressing tumor protein is an inhibitor of Inhibitor of differentiation protein 2 (Id2), Myc, and/or apolipoprotein E (ApoE).

Abstract: Described here are methods and compositions for treating tumors and metastases that improve anti-angiogenesis therapy. By inhibiting these mechanisms in a biological system with an anti-beta one integrin composition in combination with an antiangiogenic composition, tumors and metastases may be deprived of an adequate blood supply, thereby resulting in tumor cell growth arrest and possibly regression, including tumor cell death. The present compositions comprise an anti-beta one integrin agent in combination with an anti-VEGF agent, in a pharmaceutical composition or compositions. Methods of treatment and of imaging are also described.

Abstract: An immunomodulator for use in the treatment, reduction, inhibition or control of a neoplastic disease in a patient intended to undergo checkpoint inhibition therapy, selected from a cell, protein, peptide, antibody or antigen binding fragment thereof, directed against CTLA-4, PD-1, PD-L1 and combinations thereof, simultaneously, separately or sequentially with administration of the immunomodulator. The immunomodulator comprises a whole cell Mycobacterium, for example, M. vaccae or M. obuense.

Abstract: The present disclosure relates to, inter alia, stable formulations comprising an antibody that binds human CD137 or antigen binding fragments thereof, and to use of the formulations in methods for treating, or ameliorating various diseases and conditions, including cancer, that are amenable to treatment with a CD137 antibody.

Abstract: High concentration antibody formulations capable of stable long-term storage are disclosed.

Abstract: Antibodies, compositions and methods are provided for treatment and prophylaxis of influenza virus. Antibodies and antigen-binding fragments are provided that bind near the HA0 maturation cleavage site consensus sequence of influenza hemagglutinin A. Antibody compositions, combinations and methods for effective passive immunization across influenza A and B strains are also provided.

Abstract: The present document describes methods of using compositions for inhibiting biofilm formation, or disrupting existing or developing biofilms in a subject, which composition comprises at least one chromophore and a pharmacologically acceptable carrier.

Abstract: Various embodiments of bulking or cushioning agents or material and related medical devices and methods are disclosed. For example, a method of performing a medical procedure in a tract of a body may include injecting a material in a liquid phase proximate a target site between a first tissue layer and a second tissue layer, allowing the material to transition from the liquid phase to the gel phase in response to a raise in temperature of the material to approximately at or above the predetermined temperature, and performing a surgical procedure on the target site. The material may have the liquid phase at temperatures below a predetermined temperature and a gel phase at temperature approximately at or above the predetermined temperature.

Abstract: The present invention provides a novel method for the preparation of 18F-fluoride (18F) for use in radiofluorination reactions. The method of the invention finds use especially in the preparation of 18F-labelled positron emission tomography (PET) tracers. The method of the invention is particularly advantageous where bulk solutions are prepared and stored in prefilled vials rather than being freshly prepared on the day of synthesis. Also provided by the present invention is a radiofluorination reaction which comprises the method of the invention, as well as a cassette for use in carrying out the method of the invention and/or the radiofluorination method of the invention on an automated radiosynthesis apparatus.

Abstract: The present invention relates to a cationic lipid having one or more biodegradable groups located in a lipidic moiety (e.g., a hydrophobic chain) of the cationic lipid. These cationic lipids may be incorporated into a lipid particle for delivering an active agent, such as a nucleic acid. The invention also relates to lipid particles comprising a neutral lipid, a lipid capable of reducing aggregation, a cationic lipid of the present invention, and optionally, a sterol. The lipid particle may further include a therapeutic agent such as a nucleic acid.

Abstract: The present disclosure provides polysorbate 20 compositions with particular fatty acid ester concentrations. In some embodiments, they may be used in pharmaceutical formulations, for example, to improve stability.

Abstract: The present invention relates to a modified hydrophobic excipient having a molecular formula of: where R is a hydrophobic natural compound or a hydrophobic synthetic compound with one to three hydroxyl groups (n=1-3); and R1 is an ?-amino protecting group, and R2 is an amino acid side chain, wherein, when m=0, R is reacted with an amino acid derivative with a protecting group by esterification to form a hydrophobic excipient carrying the amino acid derivative with a protecting group; or when m=1, R is firstly introduced with an amino acid linking arm of different chain lengths (l=1, 2, 4, 6) via an ester group, and then introduced with an amino acid derivative with a protecting group.

Abstract: The present invention relates to a drug-loaded emulsion, comprising a modified hydrophobic excipient having the following formula, a hydrophobic drug and a surfactant: where R is a hydrophobic natural compound or a hydrophobic synthetic compound with one to three hydroxyl groups (n=1-3); and R1 is an ?-amino protecting group, and R2 is an amino acid side chain, wherein, when m=0, R is reacted with an amino acid derivative with a protecting group by esterification to form a hydrophobic excipient carrying the amino acid derivative with a protecting group; or when m=1, R is firstly introduced with an amino acid linking arm of different chain lengths (l=1, 2, 4, 6) via an ester group, and then introduced with an amino acid derivative with a protecting group.

Abstract: The present document describes a pharmaceutical excipient composition comprising a functionalized anionic polysaccharide having carboxyl groups complexed with an amino acid-divalent cation complex, monolithic solid dosage forms for dual rate release of an active pharmaceutical ingredient, comprising the pharmaceutical excipient composition and active pharmaceutical ingredients, as well as processes for preparing the pharmaceutical excipient composition.

Abstract: The invention provides a composition including a succulent extract and an alginic acid component consisting of alginic acid and/or one or more salts thereof, wherein the succulent extract is present in an amount in a range from 0.1 wt % to 1000 wt % relative to the alginic acid component, both on a dry basis.

Abstract: The present invention relates to an effective component delivery system using self-assembly and self-disassembly of a self-assembled complex, and the effective component delivery system uses a self-assembled complex which is composed of substances existing in the body, thereby being less toxic and harmless to the human body, and the effective component delivery system is capable of controlling a self-disassembly rate and an effective component release rate by using various kinds of metal ions and ligands including phosphate or phosphonate.

Abstract: The present invention relates to compounds which function as antibody mimetic compounds. These compounds are bifuinctional/multifuinctional compounds which contain at least one cancer cell binding moiety which selectively binds to prostate specific membrane antigen (PSMA) and a FC receptor binding moiety which modulates an FC immune receptor, preferably a Fc?RI receptor. Compounds according to the present invention bind selectively to cancer cells which upregulate PSMA and through that interaction, place the Fc receptor binding moiety of the compound in proximity to a Fc receptor, preferably a Fc?RI receptor, which can modulate (preferably, upregulate) a humoral response in a patient to cancer cells. Through this biological action of the compounds according to the present invention, cancer cells, including metastatic cancer cells, especially prostate cancer cells can be immune regulated, resulting in the favorable therapy of cancer in a patient.

Abstract: An object is to provide a technique of forming CpG oligonucleotides and hydrophobized polysaccharides into complexes. This object is achieved by a complex comprising a modified CpG oligonucleotide containing a hydrophobic group A having a sterol skeleton, and a modified polysaccharide containing a hydrophobic group B.

Abstract: The present disclosure is related to a conjugate of an active drug and a glycosaminoglycan, such as hyaluronic acid (HA). For example, the active drug can be lenalidomide, nimesulide, or gemcitabine. The conjugate of the present disclosure is useful in the treatment of certain cancers.

Abstract: One purpose of the present invention aims to provide a novel drug delivery means for targeting neovascularity. Another purpose of the invention is to provide a novel drug delivery means for targeting hyperpermeable vasculature. Still another purpose of the invention is to provide a method and a detection reagent for treatment or diagnosis of various diseases including malignant tumors. The present conjugate of a drug and an anti-HMGB1 antibody or an antigen-binding fragment thereof is administered to a subject and incorporated into proangiogenic or hyperpermeable vascular endothelial cells to deliver the drug to the cells. In addition, the conjugate is used to provide a method and a detection reagent for treatment or diagnosis of various diseases including malignant tumors.

Abstract: A heterodimeric bispecific immunoglobulin molecule includes a first Fab or scFv fragment which specifically binds to EGFR, and a second Fab or scFv fragment which specifically binds to c-MET, and an antibody hinge region, an antibody CH2 domain and an antibody CH3 domain including a hybrid protein-protein interaction interface domain. Each of the interaction interface domains is formed by an amino acid segment of the CH3 domain of a first member and an amino acid segment of the CH3 domain of a second member. The hybrid protein-protein interface domain of the first chain is interacting with the protein-protein-interface of the second chain by homodimerization of a corresponding amino acid segment of the same member of the immunoglobulin superfamily within interaction domains.

Abstract: The present disclosure relates to therapies for the treatment of a disorders characterized by a disorder-associated antigen (DAA); vaccination methods are disclosed. In particular, the disclosure describes anti-CD25 ADC molecular adjuvants for use in inducing or enhancing a subject's immune response against a DAA, allowing for treatment of the disorder characterized by the DAA. Also disclosed are dosage regiments for the treatment of solid tumours with an AThe present disclosure relates to the treatment of pathological conditions, such as cancer, with anti-CD25 ADCs.

Abstract: The invention relates to a therapeutic combination, comprising a first proteinaceous molecule comprising a first binding site for binding to a first epitope of a first cell-surface molecule, the first proteinaceous molecule provided with at least one saponin covalently bound to an amino-acid residue of said first proteinaceous molecule, and comprising a second pharmaceutical composition comprising a second proteinaceous molecule different from the first proteinaceous molecule, the second proteinaceous molecule comprising a second binding site for binding to a second epitope of a second cell-surface molecule different from the first cell-surface molecule, and comprising an effector moiety, wherein the second epitope is different from the first epitope. An aspect of the invention is a composition comprising the first proteinaceous molecule and the second proteinaceous molecule of the invention.

Abstract: The invention relates to novel cell-binding agent-maytansinoid conjugate having a self-immolative peptide linker and more specifically to conjugates of formula (I). The invention also provides novel maytansinoid compounds of formula (II), (III), (IV) or (V). The invention further provides compositions and methods useful for inhibiting abnormal cell growth or treating a proliferative disorder in a mammal using the compounds or conjugates of the invention.

Abstract: Disclosed are recombinant extracellular vesicles (EVs), compositions including modified EVs encapsulated in a matrix, methods for controlling the release of EVs from an encapsulating matrix, and methods of using the same in the treatment of disease.

Abstract: The presently disclosed subject matter relates to immunoswitch particles that switch off immunosuppressive pathways on tumor cells or immunosuppressive molecules induced by tumor cells in the tumor microenvironment, or virus infected cells or immunosuppressive molecules induced by virus infected cells in the microenvironment surrounding the virus infected cells, while simultaneously switching on co-stimulatory or co-inhibitory pathways on T cells, as well as method for converting immunosuppressive signals in cells, tissues, and subjects into stimulatory signals, and immunotherapy-based methods for treating cancer and chronic viral infections.

Abstract: Disclosed herein are compositions and methods for modulating the production of a protein in a target cell. The compositions and methods disclosed herein are capable of ameliorating diseases associated with protein or enzyme deficiencies.

Abstract: Disclosed herein are compositions and methods for modulating the production of a protein in a target cell. The compositions and methods disclosed herein are capable of ameliorating diseases associated with protein or enzyme deficiencies.

Abstract: Disclosed herein are compositions and methods for modulating the production of a protein in a target cell. The compositions and methods disclosed herein are capable of ameliorating diseases associated with protein or enzyme deficiencies.

Abstract: This invention provides nanoparticles containing protein-polynucleotide complexes and methods of manufacture and methods of their use. These particles, when administered to a subject in need, are capable of delivering these complexes to target cells and target intracellular locations where they can perform a therapeutic function. In some embodiments, this therapeutic function includes gene editing, induction of gene skipping, and regulation of gene expression. The instant nanoparticles are generally formed by designing and synthesizing the polynucleotide to according to its intended function, combining it with a protein selected for its substrate specificity and enzymatic function in a manner to form a polynucleotide-protein complex, encapsulating the complexes by dispersion into a water-insoluble surfactant system, optionally adding a targeting ligand, and stabilizing the nanoparticles by crystallization of the ligand to the surface of the nanoparticles.

Abstract: Disclosed herein are compositions and methods of modulating the expression of gene or the production of a protein by transfecting target cells with nucleic acids. The compositions disclosed herein demonstrate a high transfection efficacy and are capable of ameliorating diseases associated with protein or enzyme deficiencies.

Abstract: Disclosed herein are compositions and methods of modulating the expression of gene or the production of a protein by transfecting target cells with nucleic acids. The compositions disclosed herein demonstrate a high transfection efficacy and are capable of ameliorating diseases associated with protein or enzyme deficiencies.

Abstract: Disclosed herein are compositions and methods of modulating the expression of gene or the production of a protein by transfecting target cells with nucleic acids. The compositions disclosed herein demonstrate a high transfection efficacy and are capable of ameliorating diseases associated with protein or enzyme deficiencies.

Abstract: The present disclosure provides novel gene therapy constructs comprising a PARK2 gene or activating variant and methods of administering to treat Parkinson's Disease or symptoms thereof.

Abstract: The present invention relates to inducible regulatory elements, promoters and vectors, especially gene therapy vectors, and methods of their use.

Abstract: The present invention relates to compositions comprising and methods of using synthetic polynucleotides, e.g., modified mRNA, encoding CRISPR related proteins including dCAS9 and synthetic sgRNAs targeting a gene of interest.

Abstract: The invention provides compositions, kits and methods to treat a hyperproliferative disorder with an agent that increases expression of MCR1 and an MCR1 ligand. The invention also provides a method of treating drug-resistant melanoma, comprising administering an MCR1 ligand to a patient in need thereof. The present invention also provides in certain embodiments a melanoma-targeting conjugate comprising Formula I: T-L-X wherein T is a MCR1 ligand, L is a linker, and X an anti-cancer composition, for the therapeutic treatment of a hyperproliferative disorder. The present invention also provides methods, kits and uses of the conjugate of Formula I.

Abstract: Disclosed is a composition for targeting medullary thyroid cancer, the composition includes a diagnostic radionuclide-labeled ligand of the olfactory receptor OR51E2. The composition is internalized into parafollicular C cells by the olfactory receptor OR51E2 that is expressed on the parafollicular C cells of the thyroid gland and as such, can be advantageously used for diagnosing parafollicular C cell-derived medullary thyroid cancer and identifying whether or not parafollicular C cell-derived medullary thyroid cancer metastases are. In addition, a pharmaceutical composition includes an acetate-associated therapeutic radionuclide for treatment of medullary thyroid cancer can be used for treatment of medullary thyroid cancer because the composition is internalized into cancer cells through the binding of the acetate to the olfactory receptor OR51E2.

Abstract: The invention involves the use of supercritical or near supercritical fluids to inactivate pathogens in biologic materials which may or may not be contaminated by pathogens. The pathogen reduced material is then inserted into empty, sterile containment vessels. The apparatus can be used as a means to achieve terminal sterilization of the biologic materials. The preferred method of use for the apparatus includes operation of a conveyor belt to move and fill bottles, flasks, containers, or vials in an assembly line to create the finished product in an effective and timely fashion.

Abstract: The present invention discloses novel ultraviolet collapsible frameworks (UCF's) that, when housed in correspondingly expandable and collapsible containers, enable the design of UV disinfecting devices that are easy to use, safe, relatively lightweight, portable and easy to store, and that can effectively disinfect a wide range of objects. In some embodiments, replaceable UVC emitter pods are powered by pod stations disposed on the framework structure.

Abstract: A UV germicidal panel light for sterilization. The UV germicidal panel light includes a light body in a square shape and with four lateral faces provided with an accommodating groove; four gratings connecting to the light body respectively and provided in four the accommodating grooves respectively, including several light emitting grooves which extend from the end where the gratings are nearby the light body to the end where the gratings are far from the light body and whose inner wall is provided with a light absorption layer; and four UV germicidal modules connecting to the light body or the gratings, with the light emitting direction pointing to the corresponding the grating. The UV germicidal panel light can be applied in occasions with people, can prevent UV rays generated acting on human body and can guarantee the safety and high sterilization efficiency of the UV germicidal panel light.

Abstract: A multifunction UV disinfector includes a blower, a UV source, and a housing with a shield mechanism. The shield mechanism provides a closed configuration that directs an air flow created by the blower past the UV source for air disinfection and that shields a surroundings of the disinfector from the UV source. The shield mechanism further provides an open configuration in which the UV light from the UV source is directed out of the disinfector to surfaces for surface disinfection in the surroundings. The disinfector may further employ a filter or an ionizer.