Abstract: Described herein is a method of preventing or treating a neurodegenerative disease including administering an agent to a person in which the agent causes increase in outflow of cerebrospinal fluid through nasopharyngeal lymphatic plexus (NPLP), or an agent that causes contraction and relaxation of the circular smooth muscles covering the deep cervical lymphatic vessels (dcLVs).

Abstract: Methods and compositions are provided for extending the half-life of a therapeutic agent. A modified therapeutic agent (mTA) comprises a therapeutic agent, a staple, and a half-life extending molecule. The mTAs disclosed herein may be used to treat a disease or a condition in a subject in need thereof.

Abstract: The present invention relates to improved medical therapies for all forms and stages of dementia involving administration of (i) GLP-1 receptor agonists to subjects with metabolic syndrome or (ii) semaglutide.

Abstract: Certain embodiments are directed to a formulation of a therapeutic agent, as well as a method of making such a formulation, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.

Abstract: The present invention relates to a composition for preventing, alleviating or treating sarcopenia, containing a low-molecular-weight collagen as an active ingredient, and the low-molecular-weight collagen of the present invention inhibits muscle protein breakdown and can exhibit a muscle-strengthening effect through an increase in muscle mass, and thus is expected to be effectively usable for preventing, alleviating or treating sarcopenia.

Abstract: A polypeptide, a composition containing the polypeptide, and a use thereof in preparing a drug for preventing and/or treating neuroblastoma.

Abstract: Presented herein are compositions that can be administered to a subject having damaged tissue, for example a wound. The compositions are often administered in combination with administration of energy (e.g., laser energy, light from a light emitting diode, radiofrequency (RF) energy, audio frequency energy, etc.) from an energy generating device and/or system to the affected site. The compositions, systems, devices, and methods herein were found to induce wound healing and tissue regeneration.

Abstract: An object of the invention is a process for the preparation of a pharmaceutical, wherein a prodrug with bioactivation by cytochrome P450 enzymes is mixed with at least one peroxygenase, and the product obtained is isolated. Furthermore, the invention relates thereto to selected prodrugs, such as thienopyridines and the products obtained according to the invention and their use.

Abstract: In some aspects the disclosure provides compositions and methods for promoting expression of functional BCKDHA protein, which is the E1-alpha subunit of the branched-chain alpha-keto acid (BCAA) dehydrogenase complex, and/or BCKDHB, which is the E1-beta subunit of the branched-chain alpha-keto acid (BCAA) dehydrogenase complex in a subject. In some embodiments, the disclosure provides methods of treating a subject having Maple Syrup Urine Disease (MSUD).

Abstract: The present disclosure is drawn to superoxide dismutase (SOD) compositions and methods thereof. A topical composition can comprise a combination of a therapeutically effective amount of superoxide dismutase (SOD) with a stabilizing carrier that is suitable for topical administration. A method of treating a condition in a subject that is responsive to treatment with superoxide dismutase (SOD) can comprise administering a therapeutically effective amount of the topical composition. A method of stabilizing a superoxide dismutase (SOD) composition can comprise combining an amount of SOD with deoxygenated water to form an SOD solution, and minimizing exposure of the SOD solution to reactive oxygen species (ROS).

Abstract: The present disclosure relates to pharmaceutical compositions comprising a non-naturally occurring fusion molecule and one or more pharmaceutically acceptable carriers, formulated for oral delivery to a subject, and designed to provide for improved, effective therapies for treatment of, e.g., inflammatory diseases, autoimmune diseases, cancer, metabolic disorders, and growth deficiency disorders. The present disclosure relates to a non-toxic mutant form of the Vibrio cholera Cholix gene (ntCholix), a variant of Cholix truncated at amino acid A386 (Cholix386) and the use of other various Cholix-derived polypeptide sequences to enhance intestinal delivery of biologically-active therapeutics.

Abstract: The invention relates to skin, and to novel compositions, therapies and methods for treating, preventing or ameliorating a variety of skin conditions. The invention also extends to cosmetics and pharmaceutical compositions, and methods of using them on skin to treat various conditions.

Abstract: This disclosure relates to ionizable amino lipid-based lipid nanoparticles for delivery of mRNA encoding glucose-6-phosphatase. Lipid nanoparticle/mRNA therapies of the invention increase and/or restore deficient levels of glucose-6-phosphatase expression and/or activity in subjects and are useful for the treatment of glycogen storage disease type 1a (GSD-Ia). Lipid nanoparticle/mRNA therapies of the invention increase glucose production and reduce the abnormal accumulation of glycogen and glucose-6-phosphate associated with GSD-Ia.

Abstract: In one aspect, the present disclosure provides a formulation comprising a hyaluronidase enzyme and a therapeutically effective amount of an active ingredient. In another aspect, the present disclosure provides a method of administering a high volume of the formulation in a single administration to treat a disease or disorder in a subject.

Abstract: The invention provides compositions and methods for treating celiac sprue.

Abstract: The invention relates to a composition comprising a therapeutically effective amount of an alpha1-antitrypsin (AAT) protein, a variant, an isoform and/or a fragment thereof or a vector or a genetically modified cell comprising a sequence encoding AAT for use in the treatment and/or prevention of a disease or disorder of the nervous system or a symptom thereof.

Abstract: The invention provides isolated primate cells preferably human cells that comprise a genetically engineered disruption in a beta-2 microglobulin (B2M) gene, which results in deficiency in MHC class I expression and function. Also provided are the method of using the cells for transplantation and treating a disease condition.

Abstract: The present invention relates to the use of immunogenic peptides comprising a T-cell epitope derived from a soluble allofactor and a redox motif such as C-(X)2-[CST] or [CST]-(X)2-C in the prevention and/or suppression of immune responses to said soluble allofactor and in the manufacture of medicaments therefore.

Abstract: The present invention relates to a novel peptide targeting dendritic cells in the body, and a composition which is for treating cancer, and comprises the peptide. Specifically, the present invention relates to a composition for treating or preventing cancer, the composition comprising: a novel peptide targeting dendritic cells in the body; a tumor antigen; and flagellin. In addition, the novel peptide targeting dendritic cells in the body, the tumor antigen, and the flagellin according to the present invention may be linked by a single peptide or included in respective peptides.

Abstract: In some embodiments. methods of treating cervical cancer, including cervical cancers that are resistant to immune checkpoint inhibitor therapy. and cervical cancers that do not respond to immune checkpoint inhibitor therapy or have acquired resistance to immune checkpoint inhibitor therapy are disclosed.

Abstract: Provided is an immunogenic composition including a peptide, wherein consecutive amino acids of the peptide include at least amino acids 186-193 of SEQ ID NO:1 and one or more adjuvants. In an example, the peptide is covalently linked to an amino acid sequence including SEQ ID NO:2.

Abstract: Provided herein are short ComP glycosylation fragments (sequons) and glycoconjugates containing ComP glycosylation fragments, and methods of making and using, for example, for use in the production of glycoconjugate vaccines.

Abstract: The present invention provides an immunogenic composition comprising a Streptococcus pneumoniae polysaccharide-protein conjugate, comprising a capsular polysaccharide derived from one or more selected from the group consisting of serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F, derived from Streptococcus pneumoniae; and one or 2 or more of carrier proteins conjugated to the respective capsular polysaccharide, and method of preparation thereof. Through one example of the present invention, an immunogenic composition for preventing or treating pneumococcal infection can be provided.

Abstract: The disclosure generally relates to compositions comprising self-assembling vaccines and methods of using the same. The disclosure provides compositions comprising an expressible nucleic acid sequence comprising a first nucleic acid sequence encoding a self-assembling polypeptide or a pharmaceutically acceptable salt thereof and a second nucleic acid sequence encoding a viral antigen or a pharmaceutically acceptable salt thereof. The disclosure further provides compositions comprising an expressible nucleic acid sequence comprising a first nucleic acid sequence encoding a self-assembling polypeptide or a pharmaceutically acceptable salt thereof and a second nucleic acid sequence encoding a CD40 ligand polypeptide. Methods of using any of the disclosed compositions are also provided.

Abstract: Provided herein are universal prophylactic compositions for preventing infection with influenza viruses by directing the immune response to highly conserved regions of the virus. Also provided are universal therapeutic compositions for treating influenza infection by targeting the highly conserved regions. Methods for using the prophylactic and therapeutic compositions are also provided.

Abstract: Provided herein is a vaccine adjuvant containing an N-terminal domain of osteopontin or a fragment thereof. Also provided are conjugates and fusion proteins containing the N-terminal domain of osteopontin conjugated to a pathogen or a protein derived therefrom. A method for potentiating an immune response to an immunizing antigen is also provided, the method including administering to a subject an effective amount of a vaccine adjuvant containing an N-terminal domain of osteopontin. Also provided is a method of vaccinating a subject against SARS-CoV-2, the method including administering to a subject a fusion protein containing the N-terminal domain of osteopontin and the receptor binding domain of SARS-CoV-2 spike glycoprotein. Cellular vaccines and methods of vaccinating a subject with a cellular vaccine are also provided herein.

Abstract: Methods for producing and providing a vaccine for immunizing an individual against an illness caused by a virus are provided, including viruses from the family of coronaviruses. The method includes obtaining a sample of the virus; inactivating the virus by destroying or removing nucleic acids carrying genetic information for the virus; and preparing the inactivated virus in order to obtain an administrable vaccine to be administered. Vaccines provided in such a manner and the use thereof are also provided.

Abstract: The present disclosure provides an improved vaccine compositions and methods for eliciting an immune response against SARS-COV-2 and providing broader protection against SARS-COV-2 variants.

Abstract: The invention pertains to the technical fields of genetic engineering and cell engineering, and in particular relates to a rhabdovirus-negative Spodoptera frugiperda insect cell line, and screening, identification and application thereof. According to the invention, the rhabdovirus-negative Spodoptera frugiperda insect cell line WSK-Sf9, with a CCTCC accession number C202246, is obtained through screening and identification. The cell line is verified through various high-sensitivity test methods such as nested PCR, transcriptome next-generation sequencing, real-time fluorescence quantitative PCR and TAQMAN probe-based real-time PCR, and finally obtained the Sf-rhabdovirus-negative Spodoptera frugiperda insect cell line WSK-Sf9.

Abstract: The present invention provides engineered polynucleotides encoding both the receptor binding domain (RBD) of a SARS-CoV-2 spike protein and an influenza hemagglutinin (HA) protein. Also provided are influenza viruses that comprise the engineered polynucleotides and express both the RBD and HA protein on their surface and methods for using these influenza viruses to generate an immune response to both influenza and SARS-CoV-2 in a subject.

Abstract: The disclosure relates to Epstein-Barr virus ribonucleic acid vaccines as well as methods of using the vaccines and compositions comprising the vaccines.

Abstract: Provided herein are, inter alia, methods and compositions including T cells expressing (i) a recombinant CAR protein which includes a peptide binding site and is capable of specifically binding cancer-specific antigens and (ii) a T cell receptor specific for a viral antigen (e.g., a CMV pp65 protein). The engineered T cells provided herein may be used in combination with a viral vaccine (e.g. cytomegalovirus (CMV) Triplex Vaccine) to treat a variety of cancers. The methods described herein also permit in vivo expansion of CMV-specific CAR T cells, instead of or in addition to ex vivo expansion, avoiding excessive T cell exhaustion that results in some cases from ex vivo manufacturing.

Abstract: Compositions and methods are provided relating to TLR agonist nanoparticle vaccine adjuvant formulations.

Abstract: An adjuvant activity enhancer for a CpG-ODN or squalene-comprising emulsion, containing as an active ingredient a peptide nucleic acid to which a cell-penetrating peptide is bound. A method for enhancing an adjuvant activity of a CpG-ODN or squalene-comprising emulsion, including combining a peptide nucleic acid to which a cell-penetrating peptide is bound with the CpG-ODN or squalene-comprising emulsion.

Abstract: An oligosaccharide vaccine for specific prevention of fungal infections and a method for preparing the same are provided. The vaccine is formed by conjugating a sulfhydrylated protein with oligosaccharide. The sulfhydrylated protein is formed by introducing a sulfhydryl group (—SH) to a carrier protein containing a primary amino group (—NH2), and then is conjugated with the oligosaccharide to form the oligosaccharide vaccine under the binding action of a bridging agent. The carrier protein is a non-humanized protein, and the oligosaccharide is a chitosan oligosaccharide mixture and/or chitin oligosaccharide mixture. The vaccine has strong immunogenicity, can activate Th17 cell immunity, and can recognize and protect infections caused by fungi.

Abstract: This disclosure provides anti-CXCR5 antibodies and their use in the amelioration, treatment, or prevention of lupus. The disclosure also provides prophylactic, immunotherapeutic, and diagnostic compositions comprising an anti-CXCR5 antibody, and the use of such anti-CXCR5 antibodies in methods of preventing or treating lupus in mammals, including humans.

Abstract: The invention provides methods and compositions for use in treating cancer, e.g., gastric cancer (e.g., a gastric carcinoma (GC) or a gastroesophageal junction carcinoma (GEJC) (e.g., inoperable, locally advanced, metastatic, or advanced GC or GEJC)) or rectal cancer (e.g., locally advanced rectal cancer (LARC)) in a subject, for example, by administering to the subject a treatment regimen that includes an anti-TIGIT antagonist antibody (e.g., tiragolumab) in combination with a PD-1 axis binding antagonist (e.g., atezolizumab). The treatment regimen may be administered with chemotherapy or following a neoadjuvant chemotherapy regimen. Also provided are compositions (e.g., compositions comprising a PD-1 axis binding antagonist (e.g., atezolizumab) and/or an anti-TIGIT antagonist antibody (e.g., tiragolumab), including pharmaceutical compositions thereof, kits thereof, and articles of manufacture thereof) for use in treating cancer, e.g., gastric cancer (e.g., a GC or a GEJC (e.g.

Abstract: Provided herein are PD-L1 binding molecules comprising or conjugated to a toxin, e.g. a Shiga toxin A Subunit derived polypeptide. In some embodiments, the PD-L1 binding molecules are cytotoxic. In some embodiments, the PD-L1 binding molecules are capable of delivering a CD8+ T-cell epitope to an MHC class molecule inside a PD-L1 positive cell. The PD-L1 binding molecules described herein have uses for selectively killing specific cells (e.g., PD-L1 positive tumor cells and/or immune cells); for selectively delivering cargos to specific cells (e.g., PD-L1 positive tumor cells or immune cells), and as therapeutic and/or diagnostic molecules for treating and diagnosing a variety of conditions, including cancers and tumors involving PD-L1 expressing cells (e.g., PD-L1 positive tumor cells or immune cells).

Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

Abstract: An antibody or antigen-binding fragment thereof is described which binds to the spike protein S2 domain of severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome-related coronavirus (MERS-CoV) and/or severe acute respiratory syndrome coronavirus 2 (SARS CoV-2). The antibodies can be used in the diagnosis and treatment of coronavirus infection. The invention extends to compositions comprising the antibodies, including pharmaceutical compositions, diagnostic compositions, and kits. The invention also extends to methods of making and using the antibodies, for example in the diagnosis and therapy of coronavirus infections.

Abstract: The present invention concerns the field of gene transfer. More specifically, the present invention relates to method for enhancing receptor-targeted gene transfer into a primary T-cell as a host cell said method comprising contacting a host cell comprised in a sample with a gene transfer vehicle comprising a targeting agent which specifically binds to CD3 and a nucleic acid of interest to be transferred into the host cell in the presence of a tyrosine kinase inhibitor which is capable of inhibiting the LCK tyrosine kinase in said host cell and cultivating said host cell culture obtained for a time and under conditions which allow for receptor-targeted gene transfer.

Abstract: Disclosed is a T cell polarizing composition comprising a plurality of metabolites selected from metabolites enriched in non-dysbiotic feces, preferably including one or more of acetate, lactate, indole 3 lactate, 3-(4-hydroxyphenyl)lactate, or phenyllactate, bile acids (cholate, chenodeoxycholate, cholate sulfate), or IFNbeta. Further disclosed is a method of producing the T cell polarizing composition comprising mixing interferon beta (IFNbeta), acetate, lactate, and/or ILA.

Abstract: The present invention refers to a bispecific in tandem receptor CAR, named RfuCAR, which includes a scFv that recognizes and ligates surface molecules on tumoral cells (CD33, CD123 or another tumoral target) and the IL-1 receptor type 2 (IL-1R2). According to this, the IL1-R2 was chosen as the ideal receptor to compose the RfuCAR construction, being able to capture the IL-103 with high affinity and specificity. These proprieties indicate it as a good candidate to reduce the neurotoxicity and CRS effects of CAR-T therapies. Additionally, the present invention deals with a method for modulating the tumoral microenvironment, for example, in case of acute myeloid leukemia, or other cancer type like but not restricted to acute lymbloblastic leukemia, pancreatic, lung and ovarian cancer.

Abstract: Described herein are immune cells (e.g., natural killer (NK), T cells) expressing a chimeric protein comprising IL2 and IL2R? (e.g., CIRB), a chimeric protein comprising IL2, IL2R? and IL21R (e.g., CIRB21), a chimera protein comprising IL2, IL2R?, and CD28 (e.g., CIRB28), or a combination thereof, and comprising a nucleic acid encoding a pore-forming protein, and methods of using such immune cells for treating a subject (e.g., a subject having cancer, graft-versus-host disease (GVHD), or an autoimmune disease. Expression of the pore-forming protein can be induced to promote destruction of immune cells expressing CIRB, CIRB21, CIRB28, or a combination thereof.

Abstract: The current disclosure fulfills a need in the art by providing methods and compositions for treating and vaccinating individuals against cancer. Accordingly, aspects of the disclosure relate to an isolated peptide comprising at least 70% sequence identity to a peptide of SEQ ID NO: 1 or 2. In some embodiments, the peptide comprises at least 6 contiguous amino acids of a peptide of SEQ ID NO:1 or 2. Further aspects relate to pharmaceutical compositions comprising the isolated peptide, nucleic acids encoding the peptide, and expression vectors and host cells comprising the nucleic acids of the disclosure. Also provided is an in vitro isolated dendritic cell comprising a peptide, nucleic acid, or expression vector of the disclosure.

Abstract: The present invention relates generally to proteins which bind to human epidermal growth factor receptor variant III (EGFRvIII). The present invention also relates to chimeric antigen receptors (CARs) comprising the EGFRvIII binding proteins, nucleic acids and vectors encoding the CARs, as well as cells comprising the CARs. The present invention also relates to methods of treating and diagnosing diseases such as cancer.

Abstract: The present specification discloses pharmaceutical compositions, methods of preparing such pharmaceutical compositions, and methods and uses of treating a severe pain in an individual using such pharmaceutical compositions.

Abstract: The present disclosure provides oligonucleotide compositions comprising (1) an oligonucleotide of the present disclosure, e.g., an ASO, siRNA, shRNA, DNA or RNA aptamer, gene therapy vector, miRNA, miRNA mimic, antimiR, DNA or RNA decoy, CpG oligonucleotide, or any therapeutic or diagnostic oligonucleotide known in the art, and (ii) a caprylic acid derivative, e.g., 5-CNAC. In some aspects, the oligonucleotide composition is formulated for delivery to the gastrointestinal tract. Thus, some aspects, the present disclosure provides oligonucleotide compositions for oral delivery comprising a therapeutic or diagnostic oligonucleotide (e.g., an ASO) and a caprylic acid derivative (e.g., 5-CNAC or de derivative thereof).

Abstract: Disclosed herein are levodopa prodrug compounds and methods for their use. Further disclosed herein are liquid pharmaceutical formulations comprising a levodopa-tyrosine conjugate and a stabilizer, wherein the liquid pharmaceutical formulations may further comprise a decarboxylase inhibitor, such as carbidopa, an antioxidant, a solvent, or any other pharmaceutically acceptable excipient. Further disclosed are methods of treating generative conditions and/or conditions characterized by reduced levels of dopamine in the brain, such as Parkinson's disease, comprising administering the disclosed prodrugs and/or liquid pharmaceutical formulations.

Abstract: The present invention provides lymphatic system-directing lipid prodrugs, pharmaceutical compositions thereof, methods of producing such prodrugs and compositions, as well as methods of improving the bioavailability or other properties of a therapeutic agent that comprises part of the lipid prodrug. The present invention also provides methods of treating a disease, disorder, or condition such as those disclosed herein, comprising administering to a patient in need thereof a provided lipid prodrug or a pharmaceutical composition thereof.