Abstract: The present disclosure relates generally to methods for preparing a graft with at least two implants of biocompatible materials, the graft being folded a plurality of times prior to being used in reconstructing a treatment site. Methods of this disclosure are contemplated for preparing a graft at a site outside of a hospital setting, storing offsite, and/or later transporting to the hospital for use with a patient.

Abstract: The present disclosure relates to a method of generating an antibody library, not limiting to a human naïve antibody gene expression library encompassing a pool of nucleic acid sequences derived from a natural antibody repertoire comprising humoral immunity from healthy and genetically diverse human populations. More specifically, the method employs a combination of phage and/or yeast antibody surface display concept which allows to screen large antibody library size and facilitates better folding of antibody structure. The present disclosure also relates to a human naïve antibody library generated by employing the process of the present disclosure, a set of primers employed in the method and application(s) of said antibody library.

Abstract: The present technology is directed to modulators of nuclear receptor activity, specifically to the modulation of NR2F6 activity and NR2F6 utilizing compounds, and the immune modulation and modulation of cancer stem cell activity through administration of compounds described herein.

Abstract: The present disclosure relates to nanoemulsion compositions with certain surfactant blend ratios that impart enhanced permeability. Such compositions are useful for topical, mucosal and intranasal applications and allow for the greater delivery of one or more active agents to the application site to prevent infection by a microorganism.

Abstract: The present invention relates to a targeted cardiac therapy device that can precisely deliver therapeutic compounds to desired locations on, around or within the heart of a patient, and methods of treating conduction system disease, sinus node dysfunction, atrial fibrillation, myocardial infarction, and heart failure, using the described devices to deliver genetically engineered vectors or cells, proteins, stem cells, small molecule pharmaceuticals and biologics.

Abstract: The present invention relates to a targeted cardiac therapy device that can precisely deliver therapeutic compounds to desired locations on, around or within the heart of a patient, and methods of treating conduction system disease, sinus node dysfunction, atrial fibrillation, myocardial infarction, heart failure, and muscular diseases with cardiac involvement, using the described devices to deliver genetically engineered vectors or cells, proteins, stem cells, small molecule pharmaceuticals and biologics.

Abstract: Recombinant expression vectors are disclosed that include a control sequence for recombinant expression of proteins of interest; the control sequence combines a mCMV enhancer sequence with a rat EF-1alpha intron sequence. Some of the vectors are useful for tetracycline-inducible expression. Some of the vectors contain a 5? PiggyBac ITR and a 3? PiggyBac ITR to promote genomic integration into a host cell chromosome. A method of selecting a stable production cell line for manufacturing a protein of interest is also disclosed. Also disclosed are mammalian host cells comprising the inventive recombinant expression vectors and a method of producing a protein of interest, in vitro, involving the mammalian host cell.

Abstract: This invention relates to NPC-1 antigen on the MUC5AC protein and 16C3 antigen on CEACAM5 and CEACAM6 proteins, and 31.1 epitope on the A33 protein are differentially expressed in cancers including, lung cancer, ovarian cancer, pancreas cancer, breast cancer, and colon cancer, and diagnostic and therapeutic usages. Further, NPC-1, 16C3, and/or 31.1 epitope specific antibodies and diagnostic and therapeutic methods of use.

Abstract: In one aspect, provided herein is a heterologous boost method for inducing an immune response to at least one neoantigen, the method comprising administering to a subject a first boost and subsequently administering to the subject a second boost, wherein the first boost comprises a first oncolytic virus comprising a genome that expresses, in the subject, a first peptide, or the first boost comprises a first oncolytic virus and a second peptide, wherein the second boost comprises a second oncolytic virus comprising a genome that expresses, in the subject, a third peptide, or the second boost comprises a second oncolytic virus and a fourth peptide, wherein the first peptide, the second peptide, the third peptide, and the fourth peptide are each capable of inducing an immune response to at least one neoantigen, and wherein the second oncolytic virus is immunologically distinct from the first oncolytic virus. The subject may have pre-existing immunity to the at least one neoantigen.

Abstract: Compositions and methods, including therapeutic alkaline phosphatases that find use in the treatment or prevention of various neurodevelopmental diseases or disorders, are described.

Abstract: The present disclosure relates to a sequential boost oncolytic viral immunotherapy and compositions for use in the same. More particularly, the disclosure relates to oncolytic viruses that significantly increase antigen-specific T cell-mediated immune responses when combined in a sequential heterologous boost treatment regimen.

Abstract: The invention relates to balloon coatings and their use in delivering drugs via a drug-eluting balloon. The delivery can be, e.g., to a vessel wall.

Abstract: Disclosed are a process and an automated facility for manufacturing a purified protein of interest. The protein of interest can be a recombinant or naturally occurring protein and/or a therapeutic or other medically useful protein. For example, the disclosed process and automated facility are useful for manufacturing a purified protein drug substance.

Abstract: The present invention relates to an antibody against delta-like 1 homolog (Drosophila) (DLK1) or an antigen-binding fragment thereof, a nucleic acid encoding the same, a vector comprising the nucleic acid, a cell transformed with the vector, a method for producing the antibody or an antigen-binding fragment thereof, an antibody drug conjugate (ADC) comprising the same, a pharmaceutical composition for treating cancer, a composition for diagnosing cancer, and a chimeric antigen receptor (CAR) and a T-cell engager comprising the same.

Abstract: The present application relates to the field of human immunology, in particular, a herpes simplex virus (HSV) vaccine. The subunit vaccine composition comprises isolated surface glycoproteins from herpes simplex viruses, fusion proteins or fragments thereof mixed in varied combination with a nanoemulsion, which is a potent immune enhancer.

Abstract: This invention relates to antibodies to anti-cancer antibodies and uses thereof, including combination therapies and compositions. Combinations targeting the extrinsic, intrinsic, or common pro-apoptotic pathways are provided. Exemplary anti-cancer antibodies are differentially expressed in cancers, such as antibodies targeting the bind the antigens NPC-1, 16C3, or 31.1. Exemplary anti-cancer antibodies target lung cancer, ovarian cancer, cervical cancer, uterine cancer, pancreas cancer, breast cancer, and colon cancer.

Abstract: The present disclosure relates to methods of obtaining cell with disrupted fucosylation and obtaining afucosylated protein. The present disclosure employs the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology in a protein producing cell line to produce afucosylated protein. The resulting protein, specifically the resulting monoclonal antibody is completely afucosylated and reveals higher degree of antibody dependent cellular cytotoxicity.

Abstract: Recombinant expression vectors are disclosed that include a control sequence for recombinant expression of proteins of interest; the control sequence combines a mCMV enhancer sequence with a rat EF-1alpha intron sequence. Some of the vectors are useful for tetracycline-inducible expression. Some of the vectors contain a 5? PiggyBac ITR and a 3? PiggyBac ITR to promote genomic integration into a host cell chromosome. A method of selecting a stable production cell line for manufacturing a protein of interest is also disclosed. Also disclosed are mammalian host cells comprising the inventive recombinant expression vectors and a method of producing a protein of interest, in vitro, involving the mammalian host cell.

Abstract: The present invention relates to, inter alia, safe and effective doses of a beta-lactamase for, e.g. microbiome protection.

Abstract: Disclosed are an antibody to human programmed cell death 1 (PD-1) or an antigen-binding fragment thereof, a nucleic acid encoding the same, a vector including the nucleic acid, an isolated cell transformed with the vector, a method for producing the antibody or an antigen-binding fragment thereof, and a composition for preventing or treating cancer containing the same. The novel antibody binding to PD-1 or an antigen-binding fragment thereof can bind to PD-1 and inhibit the activity of PD-1, thus being useful for the development of immunotherapeutic agents for various diseases associated with PD-1.