Abstract: The invention relates to a complement factor H fragment for use in the treatment and/or prophylaxis of a disease involving neovascularization.

Abstract: The invention relates to methods and compositions for treating a neurodegenerative disease. More particularly, the present invention is directed to methods of treatment of neurodegenerative diseases using progranulin and progranulin polypeptides, and methods of treatment of neurodegenerative diseases using effectors, or combinations of effectors, that modify progranulin expression.

Abstract: About 5-10% of all fractures result in delayed or impaired healing. Impaired bone fracture is difficult for the patient, and is very expensive for the medical system. The present disclosure provides methods of treating impaired bone fracture healing comprising administration of an effective amount of progranulin or progranulin derivatives to a subject suffering from delayed or impaired bone fracture healing. The disclosure also provides medical compositions and formulations comprising progranulin or progranulin derivatives to be used in the treatment of impaired bone fracture healing.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: Provided herein are glucagon agonist peptides conjugated with thyroid hormone receptor ligands that are capable of acting at the thyroid hormone receptor. Also provided herein are pharmaceutical compositions and kits of the conjugates of the invention. Further provided herein are methods of treating a disease, e.g., a metabolic disorder, such as diabetes, obesity, metabolic syndrome and chronic cardiovascular disease, comprising administering the conjugates of the invention.

Abstract: The application relates to an aqueous pharmaceutical formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine.

Abstract: The invention relates to a novel administration regime useful in the treatment of diseases or conditions where administration of insulin will be of benefit. In particular, the invention relates to a long-acting or ultra-long acting insulin for use in treating a disease or condition where administration of insulin will be of benefit, wherein the administration of said insulin includes or consists of one or more of the following steps: (a) obtaining a first data set of the subject, (b) obtaining a second data set of the subject, (c) obtaining a first data structure of the subject, and (d) obtaining a second data structure of the subject. When a determination is made that the at least first data structure, second data structure, first data set, and second data set collectively do contain the set of evaluation information, the device further includes providing the long-acting or ultra-long-acting insulin dose guidance recommendation.

Abstract: The present invention is a delivery system for sublingual and/or buccal delivery comprising at least one functional oil (i.e. acting as an oil delivery base); at least one surfactant; and at least one pharmaceutically active agent. The invention also includes a method for treating diabetes, for regulating blood glucose levels and/or for treating hyperglycaemia by sublingual or buccal administration of the delivery system where the pharmaceutical agent is insulin and/or an insulin analogue or mimetic, and/or a glucagon-like peptide-1 agonist.

Abstract: A high-purity inhalable insulin material, used for preparing a pulmonary pharmaceutical product, includes insulin particles having a particle size at the micrometer level and having the following characteristics: (i) the purity of insulin is not less than 96% on the dried basis; (ii) the total amount of insulin-related impurities is not more than 2%; (iii) the total amount of solvent impurities, which is not a co-solvent formulation component for a pulmonary product, is not more than 0.03%; and (iv) the total amount of non-solvent impurities is not more than 0.3%. Up to 99% by volume of the insulin particles in the inhalable insulin have a particle size of less than 5 ?m, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable insulin material. The yield rate for the high-efficiency method is 75 to 85% or more.

Abstract: Described are physically stable compositions in the form of an injectable aqueous solution, the pH of which is from 6.0 to 8.0, comprising at least a basal insulin of which the isoelectric point (pI) is from 5.8 to 8.5, and a co-polyamino acid bearing carboxylate charges and at least one hydrophobic radical.

Abstract: A hemostatic product that includes a dry fibrinogen mixture, a dry thrombin mixture and a biologically tolerable liquid. The dry fibrinogen mixture includes fibrinogen and at least one fibrinogen stabilizer. The dry thrombin mixture includes thrombin and at least one thrombin stabilizer. The biologically tolerable liquid is mixed with the dry fibrinogen mixture and the dry thrombin mixture to form the hemostatic product.

Abstract: Devices for guided tissue regeneration (GTR) include a matrix of chitosan and mutable collagenous tissue (MCT) wherein the chitosan is electrostatically bonded to the MCT to form MCT-chitosan composite material. The MCT can be isolated from invertebrate marine organisms, such as sponges, jellyfish, mollusks and echinoderms. The MCT-chitosan composite material can be formulated as a biofilm, a 3D-sponge, a hydrogel, or as an electrospun nanofiber, or the MCT-chitosan composite material can coat a biomaterial surface. The devices can include wound dressings and tissue sponges, including 3D sponges. Applications include tissue engineering and wound healing, as well as burns and other related guided tissue regeneration applications. MCT and MCT-chitosan composite material, contained in a pharmaceutically acceptable topical carrier, also has cosmeceutical applications, for treating scars, as well as skin discoloration and various pigmentation issues, including melasma/chloasma.

Abstract: Formulations having a protein component, in which the protein contains one or more digestion-aiding proteins, and one or more immunoprotective proteins. The ratio by weight of the one or digestion-aiding proteins to the one or more immunoprotective proteins may be about 12:1 to about 1:1. The formulations may also contain a fat component, a carbohydrate component, and vitamins and minerals. These formulations can be used to provide nutritional support to a subject, either as dietary supplements or as a primary source of nutrition, such as for an infant formula. The formulations may also be used to promote or induce proliferation of intestinal cells, promote or induce differentiation of intestinal cells, prevent or inhibit growth of enteropathogenic Escherichia coli in the digestive system of a subject, prevent or inhibit bacterial growth in the intestinal lumen, increase interleukin-18 secretion by intestinal cells, or increase intestinal immunity.

Abstract: The present invention relates to a method of treating or preventing a neurological condition mediated by a tau-dependent signalling complex in neurons of a subject, comprising treating the subject to: (a) promote phosphorylation of one or more amino acids residues of tau, wherein the phosphorylation of the amino acid residues causes disruption of the tau-dependent signalling complex in neurons of the subject; or (b) introduce a variant of tau that causes disruption of the tau-dependent signalling complex in neurons of the subject. The invention also relates to vectors, compositions and kits for treating or preventing a neurological condition mediated by a tau-dependent signalling complex in neurons of a subject.

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: In certain embodiments, the present invention provides a method of treating a subject having a tumor that expresses EGFR and/or uPAR, even if at low levels. In certain embodiments, the present invention provides a method of preventing hemangiosarcoma (HSA) in a dog predisposed to developing HSA or angiosarcoma in a human predisposed to developing angiosarcoma. In certain embodiments, the present invention provides a method of preventing a hemangiosarcoma (HSA) in a dog that is positive for HSA by means of a blood test but negative by tumor imaging.

Abstract: Provided herein are methods and compositions for the treatment of diseases associated with angiogenesis and neovascularization. In one aspect, the invention relates to a method for treating a condition in an eye of a patient in need thereof comprising administering to the patient in multiple dosing sessions, an effective amount of an immunoconjugate dimer, wherein the monomer subunits of the dimer each comprises a mutated human factor VIIa (fVIIa) protein conjugated to the human immunoglobulin G1 (IgG1) Fc domain and a VEGF inhibitor, wherein the administration results in an improved outcome compared to a patient having been administered the VEGF inhibitor alone.

Abstract: The invention relates to a new, more potent, coagulation Factor IX (FIX) expression cassette for gene therapy of Haemophilia B (HB). Disclosed is a vector for expressing factor IX protein, the vector comprising a promoter, a nucleotide sequence encoding for a functional factor IX protein, and an intron sequence, wherein the intron sequence is positioned between exon 1 and exon 2 of the nucleotide sequence encoding for a functional factor IX protein, and wherein the intron sequence has at least 80% identity to the sequence of SEQ ID NO. 1 as disclosed herein.

Abstract: The present invention relates to methods and compositions for preventing, treating and diagnosing infection by trypanosomes. The invention also relates to the use of excreted/secreted antigens (exoantigens, secretome) and specifically to the identification of a protein excreted/secreted by the trypanosomes, the inhibition of which makes it possible to provide effective protection, mainly by vaccination, against infection by trypanosomes or the development or spread thereof. The invention relates to use of the protein, the derivatives thereof, a nucleotide sequence derived from said protein, or an extract enriched with said protein, and to the use of antibodies directed against said trypanosomes for immunotherapy, diagnosis, and monitoring of infections by trypanosomes.

Abstract: The invention provides improved compositions for adoptive T cell therapies for B cell related conditions.

Abstract: The invention provides improved compositions for adoptive T cell therapies for B cell related conditions.

Abstract: The invention provides improved compositions for adoptive T cell therapies for B cell related conditions.

Abstract: The invention provides improved compositions for adoptive T cell therapies for B cell related conditions.

Abstract: A cancer vaccine composition for human leukocyte antigen (HLA)-A*0206-positive persons, comprising a protein product of the tumor suppressor gene WT1 or a partial peptide thereof.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention 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. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention 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. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: The invention relates to an immunogenic compound comprising an antigenic peptide having amino acid similarity with a tumor antigen, which antigenic peptide is selected in the group consisting of peptides having amino acid similarity with IL13RA2, the said antigenic peptide being selected in the group consisting of sequences described in the specification.

Abstract: The disclosure relates to a porcine circovirus type 3 virus strain, and a vaccine composition prepared from the immunogenic substance of the strain, the porcine circovirus type 3 virus strain has good immunogenicity, and the prepared vaccine composition can provide complete protection against varies of porcine circovirus type 3 viruses from different sources.

Abstract: The present invention relates to a composition comprising at least one ISCOM complex and at least one ectodomain from at least one hemagglutinin (HA) domain and at least one ectodomain from at least one neuraminidase (NA) domain from one or lore influenza virus, wherein the extodomains represent ectodomains isolated from the influenza virus. The invention also regards a kit. The composition may be used as an immune stimulating medicine, immune modulating pharmaceutical or a vaccine e.g. against influenza for vertebrates, e.g. birds and mammals.

Abstract: A baculovirus displaying a porcine epidemic diarrhea virus S protein or S1 domain thereof is provided for preventing porcine epidemic diarrhea virus infection.

Abstract: The present invention provides a human type 14 replication defective adenovirus vector, and a preparation method for the same, the method comprising: constructing an Ad14 genome into a plasmid, with knocking out E3 and E1 genes of the Ad14 genome, and replacing open reading frames 2, 3, 4, 6, and 6/7 of an E4 gene of the Ad14 genome with corresponding reading frames of an Ad5 genome. The human type 14 replication defective adenovirus vector according to the present invention is potentially applicable in the research and development of a vaccine and a drug against human type 14 adenovirus infection, applicable as a gene vector in the research and development of other pathogen vaccines, and applicable in a biological report and trace system, etc.

Abstract: An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) conjugated to a carrier protein. The immunogenic composition, formulated as a vaccine, increases coverage against pneumococcal disease in infants and young children globally, and provides coverage for serotypes 6A and 19A that is not dependent on the limitations of serogroup cross-protection.

Abstract: The present invention relates to compositions and methods for immunomodulation which are effective for increasing conception rate in cows.

Abstract: Formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided including a pre-lyophilized formulation, a reconstituted lyophilized formulation, and a stable liquid formulation. Preferably, the fusion protein has the sequence of SEQ ID NO:4.

Abstract: The present invention relates to the use of an inhibitor of HER-3 for the treatment of a hyperproliferative disease in combination with radiation treatment.

Abstract: Embodiments disclosed herein relate to magnetic nanoparticles having a non-narcotic analgesic, as well as methods of preparation and use thereof. A magnetically response pharmaceutical can include a core region having magnetic nanoparticles (MNPs) and a protein-based analgesic. Further, an exterior coating comprising a polymer can be formed around the core region. The magnetically responsive pharmaceutical can be administered to a recipient and directed to a target region using an external magnetic field.

Abstract: The present invention relates to the field of drug delivery, in particular the delivery of unmodified cargo molecules (such as doxorubicin and Taxol©) using iron oxide nanoparticles as therapeutic delivery agents. Specifically described are methods to entrap cargo (i.e. known therapeutics (drugs) and other types of molecules) into the exterior coating of iron oxide nanoparticles, including iron oxide nanoparticles approved for use in humans. Additionally, methods describe the use of such drug-loaded nanoparticles as therapeutic delivery agents. Further, methods include quantifying and visualizing the amount of cargo molecule loading levels when preparing these therapeutic agents and then quantifying and visualizing the amount of delivery (i.e. unloading) of these cargo molecules from these nanoparticles using compact magnetic relaxometers, common NMR instruments and magnetic resonance imaging (MRI) instruments.

Abstract: Formulations for topical compositions which may be used to deliver drugs. The formulations may be used with a wearable drug delivery device for transdermal delivery. The composition may comprise a clay carrier such as kaolin and/or halloysite, loaded with one or more target compositions. The composition may comprise about 5 to about 15 percent by weight kaolin; about 5 to about 15 percent by weight oil carrier; about 2 to about 3 percent by weight essential oil; about 6.5 to about 26 percent by weight emollient; about 15 to about 20 percent by weight aloe vera barbadensis juice gel; about 0.9 percent to about 5 percent by weight thickening agent; about 0.1 percent to about 5 percent by weight stabilizer; about 2 percent to about 8 percent by weight surfactant; about less than 1 percent by weight target compound; about 0.35 to about 1.8 percent by weight preservative; and about 1 percent to about 5 percent by weight water.

Abstract: The object of the present invention is to provide a composition for a non-aqueous patch preparation with excellent adhesibility which can sustainedly release a drug. The patch preparation of the present invention can improve the adhesibility of the patch preparation and the release property of a drug by the addition of a powder ingredient (a filler or the like). As a result, the long-time sustention of the adhesibility of tape preparations enables an improvement of the transdermal absorbability and the sustained release of a drug. By the use of a composition for a patch preparation comprising this powder ingredient, a drug, regardless of the type of a drug is dissolved in an organic solvent or an ionic liquid to prepare a drug solution comprising the organic solvent, the drug solution is incorporated into the non-aqueous patch preparation of the present invention, and thereby a preparation with the improved transdermal absorbability and the improved sustained release can prepared.

Abstract: The compositions and methods described herein are topically applied to the skin with negligible or no skin irritation and can direct or prevent transport through the skin. The compositions contain neat ionic liquids, optionally in combination with a drug to be delivered. In a preferred embodiment, the compositions increase transdermal transport of the drug to be delivered. In some embodiments, the compositions disrupt bacterial biofilms. This is particularly beneficial in the treatment of antibiotic resistant skin infections. In other embodiments, the compositions direct delivery within the skin. In still other embodiments, the compositions prevent transfer of substances through the stratum corneum. The disclosed compositions and methods can be tuned and modified such that they can be used to treat or prevent a variety of different diseases and disorders.

Abstract: The present invention provides improved processes for the preparation of auristatin drug-linkers with a PEG unit, as well as intermediates thereof.

Abstract: The present disclosure relates to antisense oligonucleotides (AONs), such as phosphorodiamidate morpholino oligonucleotides (PMOs). The present disclosure further relates to the conjugation of multiple PMOs to cationic cell penetrating peptides (CPPs) to enhance the uptake of PMOs into skeletal and cardiac muscle cells.

Abstract: The present invention relates to a method for providing ocular neuroprotection or for preventing, treating or alleviating the effects of, an ocular disease associated with retinal ganglion cell death in a subject in need thereof, comprising administering to said subject an effective amount of a recombinant P-selectin immunoglobin G (P-sel-IgG) chimeric fusion protein, or a composition comprising the protein and a pharmaceutically acceptable adjuvant, vehicle, or carrier.

Abstract: This disclosure relates to targeted protease compositions and uses related thereto. In certain embodiments, the disclosure relates to nanoparticles wherein a targeting molecule is linked to the nanoparticle and wherein a catalytic domain of a protease is linked to the nanoparticle. In certain embodiments, the targeting molecule and the catalytic domain are within a single polypeptide sequence. In certain embodiments, the targeting molecule binds a molecule more highly expressed on cancer cells then non-cancerous cells, and the nanoparticles disclosed herein are used for the treatment of cancer by further attaching an anti-cancer agent to the nanoparticle or incorporating an anticancer agent within the nanoparticle.

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: Described herein are block copolymers, and methods of making and utilizing such copolymers. The described block copolymers are disruptive of a cellular membrane, including an extracellular membrane, an intracellular membrane, a vesicle, an organelle, an endosome, a liposome, or a red blood cell. Preferably, in certain instances, the block copolymer disrupts the membrane and enters the intracellular environment. In specific examples, the block copolymer is endosomolytic and capable of delivering an oligonucleotide (e.g., an mRNA) to a cell. Compositions comprising a block copolymer and an oligonucleotide (e.g., an mRNA) are also disclosed.

Abstract: The present invention relates to a process for the selective reduction of cysteine-engineered antibodies comprising reacting an antibody comprising one or more engineered cysteines at positions selected from HC40, HC41,HC42, HC89, HC152, HC153, HC155, HC171, LC40, LC41, LC165, and LC168 with a compound according to formula (I), (II), (III), (IV), (V), (VI) or (VII): (I) (II) (III) (IV) (V) (VI) (VII), and to a process for the preparation of antibody conjugates, including antibody-drug conjugates (ADCs).

Abstract: In antibody-drug conjugates having tubulysin analog as the warhead, according to formula (III) the acetate group in the Tuv subunit (dotted box) demonstrates improved stability against hydrolytic cleavage.

Abstract: A compound which is either A: or B: and salts and solvates thereof, as well as their conjugates with a cell-binding agent.

Abstract: Provided in the present invention are a di-substituted maleic amide linker conjugated to an antibody and a preparation method and use thereof. In particular, the present invention conjugates a strongly cytotoxic active substance to a biomacromolecule through a class of new linkers. The class of linkers can selectively act simultaneously with disulphide chains, so as to greatly improve the substance homogeneity of a conjugate. The conjugate prepared by the linker of the present invention has a high inhibitory activity on a cell strain expressing the corresponding antigen. Also provided is a method for preparing the above-mentioned conjugate and the use.