36 results about "Protein therapeutics" patented technology

The invention provides an organic molecule cytoplasm delivery carrier as well as a preparation method and application thereof, the compound for cytoplasm delivery has the characteristic of fat-soluble aggregation, and can form electrostatic adsorption with small molecule protein goods such as RNase A (13.7 KDa), Trypsin (24KDa) and Saporin (32.8 KDa), medium molecule protein goods such as HRP (40KDa) and macromolecular protein goods such as beta-Gal (430KDa), so that the compound for cytoplasm delivery can be used for preparing a lipid-soluble protein carrier. And furthermore, transmembrane transportation is formed through the strong fat solubility property, so that the protection and intracellular delivery of carried protein molecules are realized. According to the delivery mechanism, cargo molecules can quickly penetrate through cell membranes, and carried protein molecules can enter cytoplasm to exert functions without release operation. Development of the organic molecule cytoplasm delivery carrier is expected to assist potential protein therapies with low bioavailability and off-target toxicity to complete clinical transformation, which is crucial to tumor therapy, gene therapy and the like requiring precise local administration.

Methods and systems for monitoring and / or controlling production units used at various stages of biological product development and manufacturing are presented herein. In particular, in certain embodiments, the biological production monitoring and control techniques described herein utilize a mid-infrared (mid-IR) analyzer that is capable of obtaining mid-infrared spectral data from an aqueous sample in substantially real time. The techniques described herein can utilize this mid-infrared spectroscopic data to measure sample quality metrics, such as protein content, titer, secondary structure, aggregation, and the like, as well as viral and / or nucleic acid characteristics. Thus, sample quality metrics can be measured substantially in real time and / or continuously to assess, for example, the production quality of protein and gene therapeutic agents, and can be used by a control system to adjust and / or control process parameters to improve product quality, etc.

The present invention relates to a novel regulatory element. The regulatory element according to one embodiment is capable of increasing RNA stability or mRNA translation of a transcription product of a target gene, thereby being capable of increasing the expression level of the target protein, and can be effectively used in systems requiring precise control of gene expression, such as gene therapy, vaccine development, and production of protein therapeutics. Furthermore, the regulatory element of the present application exhibits excellent stability-increasing ability and translation-regulating ability not only in unmodified RNA but also in RNA containing a modified base, and thus can be effectively used in therapeutic mRNA or vaccine platforms requiring base modification.

Compositions are described, e.g., compositions comprising cell therapeutic agents and / or protein therapeutic agents, and methods of using these compositions to treat cancer.

The present application relates to natural ferritin, and particularly relates to an intracellular delivery system and application thereof. The system can effectively deliver various proteins into cells and maintain the biological activity thereof, and provides important technical support for the development of protein therapy with intracellular target as core. The method exhibits significant advantages in promoting intracellular protein transport, intracellular protein interaction research and protein level regulation. The delivery system has wide applicability, is simple to operate and safe and reliable, and becomes an important tool for future intracellular protein research and application.

The present application relates to a kind of preparation method and application of HPV recombinant protein therapeutic vaccine, belong to biological medicine technical field, the preparation method of the HPV recombinant protein therapeutic vaccine described includes: a plurality of complex lipid nanoparticles prepared by lipid are simultaneously wrapped and delivered HPV16HPV E6E7 recombinant protein antigen and nucleic acid TLR agonist adjuvant molecule.This application is beneficial to the recombinant protein therapeutic vaccine prepared to induce strong T cell immune response to HPV16E6E7 antigen, kill the cervical cancer cell infected by HPV.In addition, unlike the lipid nanoparticle (LNP) of mRNA vaccine delivery, there is no cation or ionizable lipid in the formula, significantly higher than mRNA vaccine in safety, with greater advantage than mRNA therapeutic vaccine, and low toxicity and side effects, vaccine effect is stable.

Proteins, nucleic acids encoding the proteins, compositions comprising the proteins, and methods are provided. The proteins have the ability to be self-targeted to ICAM-1 and, if desired, enzymatically-released at acidic pH. The ICAM-1-targeting peptides are provided as single copies or multiples repeats, and can be separated by linkers from the enzyme segment, from which the ICAM-1 targeting peptides can be released, if desired, at acidic pH. These fusion proteins enhance the activity of the enzyme segment within or liberated from the fusion protein, and provide increased recognition and targeting of diseased organs, transport from the bloodstream across the endothelium into said diseased organ, and intracellular uptake and lysosomal trafficking by cells in them, both in peripheral tissues and the central nervous system. Representative nucleotide and amino acid sequences of these fusion proteins, as well as in vitro, cellular, and in vivo animal data are provided. The described proteins can be used as a protein therapy, a gene therapy, or an implanted cell therapy.

The present invention relates to a novel regulatory element for increasing gene expression, a screening method therefor, and a use thereof. A regulatory element according to one embodiment can increase RNA stability or mRNA translation, which is a transcription product of a target gene, and thus can increase the expression level of a target protein, and can be effectively used in systems requiring a high level of gene expression, such as gene therapy, vaccine development, protein therapeutic agent production, etc.

Disclosed are methods of producing conditionally active proteins that target senescent cells and are conditionally active in the extracellular environment of senescent cells. The methods include methods of using an evolved protein library and testing using physiological concentrations of bodily fluid components. Also disclosed are conditionally active proteins, antibodies, and antibody fragments for killing or removing senescent cells, conjugates and pharmaceutical compositions using these conditionally active proteins, and methods of treating age-related diseases, conditions, or disorders using the pharmaceutical compositions. Conditionally active proteins can be further evolved, conjugated to other molecules, masked, and reduced in activity by linking cleavable moieties.

The present disclosure provides recombinantly manufactured fusion proteins comprising a GLP-1 protein fragment or an analog thereof linked to a feline Fc fragment. Embodiments include the administration of the fusion proteins to patients and their use as an appetite suppressant, for treatment of obesity, for prevention of obesity, or for treatment of other conditions associated with excess weight in cats. Exemplary Fc fusion proteins and pharmaceutical formulations of exemplary Fc fusion proteins are provided, in addition to methods of use and preparation.

Core annular flow is used to enable the subcutaneous delivery of a viscous fluid such as a protein therapeutic formulation. The high-viscosity fluid is surrounded by a low-viscosity fluid, and the low-viscosity fluid lubricates the passage of the high-viscosity fluid. This allows the use of protein formulations that have a higher concentration and a higher viscosity at comparatively reduced injection forces and reduced injection times. Several different embodiments of injection devices that provide core annular flow are described herein.

The present invention relates to a novel injectable protein delivery system and a method for delivering one or more therapeutic agents to the central nervous system (CNS) to promote axonal regeneration. The system is based on the use of a recombinant spider silk protein, referred to as spiroin-SpyTag, which undergoes a rapid transition from a sol state to a gel state when exposed to ultrasonic treatment and incubated at body temperature. This unique characteristic allows the material to be easily injected into a specific target tissue. The methods disclosed herein can deliver a protein therapeutic agent covalently conjugated to spiroin-SpyTag to a subject affected by a CNS disorder or injury. In addition, methods of making such injectable protein delivery systems are fast, convenient, and economical and effective.

This disclosure relates to compositions and uses of caged proteins substituted with a photon decomposing chemical structure wherein the photon decomposing chemical structure is substituted through a linking group to a hydrophilic polymer. In certain embodiments, the caged protein is a proteinaceous agent such as an anticancer agent, cytokine, interleukin, fragment, or fusion thereof.

Described herein are flash nanoprecipitation methods capable of encapsulating hydrophobic molecules, hydrophilic molecules, bioactive protein therapeutics, or other target molecules in amphiphilic copolymer nanocarriers.

The subject invention pertains to a novel injectable protein delivery system and methods for delivering one or more therapeutic agents in the central nervous system (CNS) for promoting axon regeneration. This system is based on the use of a recombinant spider silk protein called spidroin-SpyTag, which undergoes a rapid transition from a sol state to a gel state when exposed to ultrasound treatment and incubated at body temperature. This unique characteristic allows the easy injection of the material into a specific target tissue. The methods herein disclosed allow the delivery of protein therapeutics covalently conjugated to the spidroin-SpyTag to a subject affected by a CNS disorder of injury. Additionally, the method for fabricating this injectable protein delivery system is rapid, convenient, and cost-efficient.

Described are new biodegradable nanoparticle platforms for encapsulation and sustained release of protein therapeutics through a scalable and reproducible method. Specifically nanoparticles comprising a complex comprising a protein, or peptide, and a counter ion polymer are described.

The present document describes compounds, or pharmaceutically acceptable salt thereof, of a core formula (I) where R1 features an amine group, particularly useful in the formulation of lipid particles including nucleic acid therapeutic agents, or proteins, or both, and for delivery of nucleic acid and protein therapeutics to cells in vivo or ex vivo, including anticancer and vaccine applications.

The present invention relates to the use of glutamine synthetase as a protein therapy (such as enzyme replacement protein therapy) for the treatment of hyperammonemia. In particular the invention relates to the systemic administration of glutamine synthetase. The glutamine synthetase may be provided in conjugated or fusion form, to increase its half-life in the circulation. Also provided is a pharmaceutical composition comprising glutamine synthetase. The invention also relates to the uses, methods, and compositions involving a combination of the glutamine synthetase protein and an ammonia lowering agent, such as a nitrogen scavenger.

This application pertains to methods of characterizing therapeutic proteins involving the use of size exclusion chromatography, ion exchange chromatography, and native mass spectrometry analysis, as well as methods of determining the stability of therapeutic proteins.

The present invention relates generally to gene therapy for treating ailments that can affect vision such as retinal degeneration, retinal dystrophy, macular degeneration, macular dystrophy, ischemic retinopathies, and glaucoma. Embodiments include systems and treatments that use AAV-mediated gene therapy or non AAV-mediated DNA, mRNA, or protein therapy to target all retinal cells. An AAV virion can be introduced (e.g., via intravitreal or subretinal injection) into an eye of an individual, or systemically, to express a heterologous gene product such as BMI1 protein (B lymphoma Mo-MLV insertion region 1 homolog).

The present document describes compounds, or pharmaceutically acceptable salt thereof, of a core formula (I) Wherein R1 includes an amino group. These compounds are particularly useful in the formulation and in vivo and ex vivo delivery of nucleic acid and protein therapeutics for preparing and implementing T cell transfection, gene editing, cancer therapies, cancer prophylactics, and in the preparation of vaccines.

The present disclosure provides recombinantly manufactured fusion proteins comprising a GLP-1 protein fragment or an analog thereof linked to a feline Fc fragment. Embodiments include the administration of the fusion proteins to patients and their use as an appetite suppressant, for treatment of obesity, for prevention of obesity, or for treatment of other conditions associated with excess weight in cats. Exemplary Fc fusion proteins and pharmaceutical formulations of exemplary Fc fusion proteins are provided, in addition to methods of use and preparation.

Proteins, nucleic acids encoding the proteins, compositions comprising the proteins, and methods are provided. The proteins have the ability to be self-targeted to ICAM-1 and, if desired, enzymatically-released at acidic pH. The ICAM-1-targeting peptides are provided as single copies or multiples repeats, and can be separated by linkers from the enzyme segment, from which the ICAM-1 targeting peptides can be released, if desired, at acidic pH. These fusion proteins enhance the activity of the enzyme segment within or liberated from the fusion protein, and provide increased recognition and targeting of diseased organs, transport from the bloodstream across the endothelium into said diseased organ, and intracellular uptake and lysosomal trafficking by cells in them, both in peripheral tissues and the central nervous system. Representative nucleotide and amino acid sequences of these fusion proteins, as well as in vitro, cellular, and in vivo animal data are provided. The described proteins can be used as a protein therapy, a gene therapy, or an implanted cell therapy.

This disclosure relates to compositions and uses of caged proteins substituted with a photon decomposing chemical structure wherein the photon decomposing chemical structure is substituted through a linking group to a hydrophilic polymer. In certain embodiments, the caged protein is a proteinaccous agent such as an anticancer agent, cytokine, interleukin, fragment, or fusion thereof.

Methods for generating conditionally active proteins that target senescent cells and are conditionally active in the extracellular environment of senescent cells include heuristics using libraries of evolved proteins and assays using physiological concentrations of components of body fluids. Also disclosed are conditionally active proteins for killing or eliminating senescent cells, pharmaceutical compositions using these conditionally active proteins, and methods for treating age-related diseases, illnesses, or disorders using the same. The conditionally active proteins may be further evolved, conjugated to other molecules, masked, or have their activity reduced by the attachment of cleavable moieties. [Selection diagram] 18B

Provided herein are compounds and their pharmaceutically acceptable salts, lipid particles comprising such compounds or pharmaceutically acceptable salts thereof and compositions of the foregoing that can be used to reduce immune intolerance in a subject, for example, to treat autoimmune disorders, or in combination with an antigenic therapy, such as a protein or gene therapy, to improve the efficacy of the antigenic therapy. The compounds have the following structural formula:wherein values for the variables (e.g., Ring A, L, R1, R2, R3, m) are as described herein.

The present disclosure relates to the in vitro differentiation of memory B cells to plasmablasts or plasma cells and genetic modification of these cells to express a protein of interest, such as a specific antibody or other protein therapeutic.

Provided herein are protein therapeutics, such as antibodies and fusion proteins, for preventing, reducing, and / or treating SARS-CoV-2 infection in a subject. The methods provided herein include administering to a subject a therapeutically effective amount of an antigen-binding fragment (Fab fragment) or antibody that binds to a SARS-CoV-2 spike protein, an ACE2 decoy peptide that binds to a SARS-CoV-2 spike protein, and / or a DNA construct encoding an anti-spike Fab fragment or an ACE2 decoy peptide.

Provided herein are protein therapeutics, such as antibodies and fusion proteins, for preventing, reducing the occurrence of, and / or treating SARS-CoV-2 infection in a subject. The methods provided herein comprise administering to a subject a therapeutically effective amount of an antigen binding fragment (Fab fragment) or antibody that binds to SARS-CoV-2 spike protein, an ACE2 bait peptide that binds to SARS-CoV-2 spike protein, and / or a DNA construct encoding an anti-spike Fab fragment or ACE2 bait peptide.