Abstract: The present disclosure relates to recombinant production reporter cells comprising a logic gate such that an expressible sequence (e.g., a reporter gene) is expressed after the occurrence of triggering event related to a stage of production or an environmental condition of a biological production system. Nucleic acids, kits, and methods for making and using the recombinant production reporter cells are also disclosed herein.

Abstract: Compositions, methods and therapeutic regimens of mutant Fibroblast Growth Factor-21 (FGF-21) peptide conjugates for the treatment of severe hypertriglyceridemia are provided.

Abstract: An object of the present invention is to provide a method for producing insulin-producing cells having sufficient glucose responsiveness from mesenchymal stem cells, an insulin-producing cell having sufficient glucose responsiveness, a cell structure containing the insulin-producing cell, and a pharmaceutical composition.

Abstract: The present invention relates to a novel peptide of a glucagon derivative and a composition for preventing or treating obesity comprising the peptide as an active ingredient. The glucagon derivative according to the present invention shows a more excellent activating effect with regard to both glucagon-like peptide-1 receptors and glucagon receptors compared to native glucagon, and thus can be widely used as an effective agent for treating obesity.

Abstract: Provided herein, in one aspect, is a method of preventing or delaying the onset of clinical type 1 diabetes (T1D), comprising: providing a non-diabetic subject who is at risk for T1D; administering a prophylactically effective amount of an anti-CD3 antibody to the non-diabetic subject; and determining, prior to or after the administering step, that the non-diabetic subject has more than about 5% to more than about 10% TIGIT+KLRG1+CD8+ T-cells in all CD3+ T cells, which is indicative of successful prevention or delay of the onset of clinical T1D.

Abstract: Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.

Abstract: An ultra-rapid acting insulin composition and method for treating hyperglycemia in patients with diabetes are disclose. The composition is an inhalable dry powder composition comprising fumaryl diketopiperazine and insulin for pulmonary delivery, which significantly reduces the rates of hypoglycemic events in patients in patients on mealtime insulin therapy.

Abstract: Stable liquid formulations of GLP-1 and GLP-1 analogues and method of using such formulations in the treatment of disorders or conditions are provided.

Abstract: The invention provides reagents, pharmaceutical compositions and methods for the treatment of prevention of disorders and diseases related to defects in trigeminal innervation of the cornea, stem cell deficiency, nonhealing epithelial wounds and particularly to diseases such as neurotrophic keratopathy.

Abstract: Methods and compositions using dnayzme-based GATA3 inhibitors for the treatment of insulin resistance and Type II diabetes, for the stimulation of adipogenesis in vivo, and for the promotion of fat redistribution are disclosed.

Abstract: The present invention discloses a polypeptide and application thereof. By modifying oxyntomodulin (OXM), hybridizing OXM with a peptide sequence of Exenatide, including enabling the polypeptide to be resistant to DPP-4 enzyme degradation through amino acid modification, and conjugating fatty acid chains at the same time, an OXM hybrid peptide having longer pharmacologic action time and better weight losing effects is obtained. Synthesis of a target polypeptide is fast realized by an orthogonal protection strategy solid-phase synthesis method, and a crude product is purified and freeze-dried to obtain the OXM hybrid peptide.

Abstract: The present disclosure provides methods for treating allergy comprising selecting a patient with an allergy and administering a therapeutically effective amount of an IL-4/IL-13 pathway inhibitor (e.g., an anti-IL-4 receptor antibody or antigen-binding fragment thereof) in combination with a therapeutically effective amount of an agent that depletes plasma cells (e.g., an anti-BCMA/anti-CD3 bispecific antibody). In certain embodiments, a plasma cell ablating agent such as an anti-BCMA/anti-CD3 bispecific antibody ablates the plasma cells, including IgE+ plasma cells, while the IL-4/IL-13 pathway inhibitor prevents the generation of new IgE+ plasma cells, thus eliminating allergen-specific IgE in the patient.

Abstract: Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.

Abstract: A method for treating or preventing one or more symptoms of severe inflammation in the lung of a subject in need thereof includes administering to the subject a composition comprising dendrimers complexed, covalently conjugated, or intra-molecularly dispersed or encapsulated with one or more therapeutic or prophylactic agents, in an amount effective to treat, alleviate or prevent one or more symptoms of severe inflammation. The compositions and methods are useful for treating disorders characterized by cytokine storm, for example, for treating or preventing acute lung injury (ALI) and/or acute respiratory distress syndrome (ARDS) results in from ventilator use or infection such as with COVID-19, sepsis, and systemic bacterial infections in a subject in need thereof have been established. Preferably, the dendrimers are generation 4, 5, 6, 7, or 8 poly(amidoamine) (PAMAM) dendrimers, and the therapeutic agents are one or more anti-inflammatory and/or anti-oxidant agents such as N-acetyl cysteine.

Abstract: The present disclosure provides recombinantly manufactured ultra-long acting insulin-Fc fusion proteins for use in treating canine diabetes. The insulin-Fc fusion proteins comprise an insulin polypeptide linked via a peptide linker to an Fc-fragment of canine origin. Based on the results obtained, creating a treatment that is amenable to low cost manufacturing, exhibits sufficient in vivo bioactivity, displays extended duration of bioactivity, does not induce anti-drug antibodies, and substantially retains is potency over multiple administrations, requires a non-obvious combination of insulin polypeptide, peptide linkers, and species-specific Fc fragment, in addition to selective mutations on one or more of these components. Exemplary ultra-long acting insulin-Fc fusion proteins, polynucleotides encoding these insulin-Fc fusion proteins, and pharmaceutical formulations of exemplary insulin-Fc fusion proteins are provided, in addition to methods of use and preparation.

Abstract: Disclosed herein are self-assembling protein nanoparticles comprising passenger molecules of interest.

Abstract: Disclosed herein is a glucose-responsive insulin delivery system based on the interaction between the glucose-modified insulin and glucose transporters (GLUTs) on erythrocytes (or red blood cells, RBCs). After being conjugated with glucose, insulin can efficiently bind to RBC membranes. The binding is reversible in the setting of hyperglycemia, resulting in fast release of insulin and subsequent drop of blood glucose (BG) level in vivo. In some embodiments, the delivery vehicle can include: 1) intravenously injectable polymeric nanoparticles (˜100 nm in diameter) coated with RBC membrane and loaded with glucose-modified insulin and/or 2) painless microneedle (MN) patches loaded with the complex of GLUT and glucose-modified insulin.

Abstract: The invention includes a thioamide-modified peptide, wherein the thioamide modification increases the in vivo half-life of the peptide. The invention further includes methods of treating or preventing a disease or disorder in a subject in need thereof, the method comprising administering to the subject a thioamide-modified peptide of the invention.

Abstract: Disclosed herein are a means to prevent and/or ameliorate age, disease and obesity associated metabolic diseases, such as diabetes and impaired glucose tolerance. Also disclosed are compositions and methods that relate to the findings that GDF11 prevents weight gain, improves glucose tolerance and reduces hepatosteatosis in aged mice administered a high fat diet. In particular, the methods and compositions described herein relate to increasing the level of GDF11 in a subject, thereby treating or preventing the development of obesity in the subject, reducing the metabolic consequences of obesity and improving the subject's metabolic health.

Abstract: The present invention relates to methods for reducing the risk of major adverse cardiovascular events in type 2 diabetes mellitus (T2DM) patients with multiple cardiovascular risk factors without established cardiovascular disease or with established cardiovascular disease comprising administering the glucagon like peptide-1 (GLP-1) receptor agonist dulaglutide.