Abstract: Described are implantable devices having expandable reservoirs for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and includes a retention structure and a penetrable element coupled to and extending within at least a portion of the retention structure. A porous drug release mechanism is positioned in fluid communication with an outlet of the device; and a reservoir having a volume configured to contain one or more therapeutic agents is in fluid communication with the outlet through the porous drug release mechanism. The device is at least partially inserted along an axis of insertion. The reservoir enlarges from an insertion configuration having a first three-dimensional shape to an expanded configuration having a second three-dimensional shape, the second three-dimensional shape being eccentrically positioned relative to the axis of insertion.

Abstract: Proposed are a recombinant herpes simplex virus having a modified glycoprotein gH for retargeting and the use thereof. Particularly, the recombinant herpes simplex virus is capable of infecting a target cell having a target molecule to which a cell-targeting domain specifically recognizes and binds due to the presence of the cell-targeting domain in the glycoprotein gH thereof, and is thus useful for anticancer therapy or gene therapy.

Abstract: The present disclosure provides antibodies that bind complement C1s protein; and nucleic acid molecules that encode such antibodies. The present disclosure also provides compositions comprising such antibodies, and methods to produce and use such antibodies, nucleic acid molecules, and compositions.

Abstract: The present disclosure is directed to antibodies binding previously undefined epitopes on influenza A virus hemagglutinin and methods for use thereof.

Abstract: The invention relates to novel bispecific antibodies consisting of two fusion polypeptides comprising two antigen binding domains capable of specific binding to a first target and one antigen binding domain capable of specific binding to a second target, and to methods of producing these molecules and to methods of using the same.

Abstract: An isolated nucleic acid encoding a C-terminal fragment of paraspeckle component 1 (PSPC1) is disclosed. The C-terminal fragment of the PSPC1 comprises an extension of more than 10 but no greater than 131 amino acid residues with its C-terminal amino acid identical to the C-terminus of the PSPC1 sequence SEQ ID NO: 3 and exhibits a biological activity against tumor cells. The tumor cells are associated with either PSPC1 or protein tyrosine kinase 6 (PTK6), or both. The anti-tumor activity is at least one selected from the group consisting of: (a) suppressing tumor cell growth; (b) suppressing tumor cell progression; (c) suppressing tumor cell metastasis; (d) decreasing PSPC1 expression; and (e) decreasing oncogenic PTK6 expression in cytoplasm. Also disclosed is a peptide comprising a C-terminal fragment sequence of PSPC1. A reagent kit and method for predicting tumor progression, metastasis, and prognosis in a cancer patient are also disclosed.

Abstract: Provided herein are biparatopic antigen-binding constructs that specifically bind HER2. The biparatopic antigen-binding constructs comprise one antigen-binding moiety that binds to ECD2 of HER2, a second antigen-binding moiety that binds to ECD4 of HER2, and an Fc. At least one of the antigen-binding moieties is an scFv. The biparatopic antigen-binding constructs can be used in the treatment of cancer.

Abstract: The present invention relates to antibody molecules and functional fragments thereof, capable of binding to tumor necrosis factor alpha (TNF?), to processes for their production, and to their therapeutic uses.

Abstract: The present disclosure pertains to compositions comprising aflibercept and methods for producing such compositions in chemically defined media and using chromatography to reduce certain aflibercept variants.

Abstract: The present disclosure provides anti-TIM-3 antibodies or antigen-binding fragments thereof, isolated polynucleotides encoding the same, pharmaceutical compositions comprising the same, and the uses thereof.

Abstract: An antibody-drug conjugate, and an intermediate thereof, a preparation method therefor, and an application thereof. Provided is an antibody-drug conjugate as represented by formula I. The compound has good targetability, has a good inhibitory effect on HER3-positive tumor cells, and has good druggability and high safety. The antibody-drug conjugate has an inhibitory effect on HER3, has an inhibitory effect on SK-BR-3 and SW620 cells, and also has a good inhibitory effect on at least one of 22Rv1, LNCaP, NCI-H820, OVCAR-8, and HCC827 cells.

Abstract: Provided herein are LILRB4-binding antibodies and methods of treating cancer by administering the LILRB4-binding antibodies alone or in combination with other therapies. Recombinant polypeptides comprising the CDRs of LILRB4-binding antibodies are also provided.

Abstract: The invention provides compositions and methods for suppressing autoimmune components of neurodegenerative diseases and thereby providing therapeutic effects to patients suffering from such diseases. Compositions and methods include immunosuppressive moieties such as regulatory T cells (Tregs) and proteins expressed by Tregs coupled to a chimeric antigen receptor or protein that specifically binds one or more glial cell markers. Therapeutically effective doses of said compounds for treating neurodegenerative diseases including progressive supranuclear palsy (PSP), Parkinson's disease (PD), Alzheimer's, Huntington's disease, amyotrophic lateral sclerosis (ALS), chronic traumatic encephalopathy (CTE), and prion diseases are disclosed.

Abstract: Provided herein is a heavy chain constant region comprising a CH1 domain, a hinge region, a CH2 domain and a CH3 domain, wherein the sequences of said CH1 domain and hinge region derive from the sequences of CH1 domain and hinge region in human IgG2, the sequences of said CH2 domain and CH3 domain derive from the sequences of CH2 domain and CH3 domain in human IgGs; and wherein, said antibody heavy chain constant region has an affinity to human Fc?RIIB equal to or higher than the affinity of human IgG1 to human Fc?RIIB, said antibody heavy chain constant region has an I/A ratio equal to or higher than human IgG1 has. Also provided are antibodies or fusion proteins based on a heavy chain constant region according to the above, wherein the antibody heavy chain constant region significantly enhances agonistic activity of the antibodies or fusion proteins and improves efficacy of the antibodies or fusion proteins in treating diseases like tumors and autoimmune diseases.

Abstract: The present invention is directed to a novel targeted heterodimeric Fc fusion proteins comprising an IL-15/IL-15R? Fc fusion protein and an antigen binding domain Fc fusion proteins. In some instances, the antigen binding domain binds to CD8, NKG2A, or NKG2D.

Abstract: The present invention provides T-cells modified to express at least two chimeric antigen receptors, wherein one of the CARs binds specifically to an antigen selected from CD138, HER2 and CD24 and another CAR binds specifically a different antigen selected from CD 138, HER2 and CD24. Further, the invention provides pharmaceutical compositions comprising these CAR T-cells and their use in treatment of cancer, in particular, ovarian cancer, DNA constructs encoding said CARs and methods for preparation of T-cells expressing said CARs.

Abstract: The present invention relates to multi-specific antibodies comprising fine tuned combination of low affinity single binding domain fragments to selectively target double targets on cancer cell, and use thereof for therapy, such as for guided immunotherapy.

Abstract: The present invention provides an antibody for detecting mesothelioma and an antibody having high specificity to mesothelioma and high sensitivity thereto. The present invention also provides a method of diagnosis of mesothelioma by using the antibody, a reagent containing the antibody for use in diagnosis of mesothelioma, and a kit comprising the antibody for use in diagnosis of mesothelioma. Further, the present invention provides a marker for use in diagnosis of mesothelioma. Furthermore, the present invention provides a pharmaceutical composition containing the antibody according to the present invention or an antigen-binding fragment thereof for use in treatment of mesothelioma. An antibody that binds to a glycosylated HEG1 protein obtained from mesothelioma.

Abstract: The present disclosure relates to TM4SF5-specific humanized antibodies and uses thereof.

Abstract: Antibody drug conjugates (ADC's) comprising a drug conjugated to antibody or antigen binding fragments thereof that bind to Globo series antigen disclosed herein, as well as methods of use thereof. Methods of use include, without limitation, cancer therapies and diagnostics. The antibodies of the disclosure can bind to certain cancer cell surfaces. Exemplary targets of the antibodies disclosed herein can include carcinomas, such as sarcoma, skin cancer, leukemia, lymphoma, brain cancer, glioblastoma, lung cancer, breast cancer, oral cancer, head-and-neck cancer, nasopharyngeal cancer, esophagus cancer, stomach cancer, liver cancer, bile duct cancer, gallbladder cancer, bladder cancer, pancreatic cancer, intestinal cancer, colorectal cancer, kidney cancer, cervix cancer, endometrial cancer, ovarian cancer, testical cancer, buccal cancer, oropharyngeal cancer, laryngeal cancer and prostate cancer.

Abstract: The invention provides anti-C1s antibodies and methods of using the same. The affinities of the antibodies to C1s depend on pH and other conditions. The invention also provides pharmaceutical formulations comprising the antibodies, and methods of treating an individual having a complement-mediated disease or disorder comprising administering the antibody to the individual. In addition, the binding affinity of the antibody at high and low pH was measured, and mice PK study was conducted on the antibodies, and pharmacokinetics parameters of the antibodies were evaluated in this application.

Abstract: The present invention relates to C5 binding polypeptides, comprising a C5 binding motif, BM, which motif consists of an amino acid sequence selected from i) EX2X3X4A X6 X7EID X11LPNL X16X17X18QW X21AFIX25X26LX28D, and ii) an amino acid sequence which has at least 86% identity to the sequence defined in i), wherein the polypeptide binds to C5. The present invention moreover relates to C5 binding polypeptides for use in therapy, such as for use in treatment of a C5 related condition, and to methods of treatment.

Abstract: The present invention is a composition intended for consumption by animals containing antimicrobials and anti-inflammatory agents, which may include ovotransferrin, chitosan, and Curcumin. The composition may be provided as powder that is mixed into feeds, may be incorporated into pellets, or may be delivered through water, among other methods of dosage. The invention is intended as a health supplement for increased gain and improved general health in production animals affected by enteric diseases such as coccidiosis and as a general health supplement in humans and companion animals facing enteric diseases to maintain the gut microbiome.

Abstract: The present disclosure relates to antibodies and proteins comprising an antigen-binding portion thereof that specifically bind to the pro-inflammatory cytokine IL-17 A. The disclosure more specifically relates to specific antibodies and proteins that are IL-17 A antagonists (inhibit the activities of IL-17 A and IL-17 AF) and are capable of inhibiting IL-17 A induced cytokine production in in vitro assays, and having an inhibitory effect in an antigen-induced arthritis model in vivo. The disclosure further relates to compositions and methods of use for said antibodies and proteins to treat pathological disorders that can be treated by inhibiting IL-17A or IL 17AF mediated activity, such as rheumatoid arthritis, psoriasis, systemic lupus erythematosus (SLE), lupus nephritis, chronic obstructive pulmonary disease, asthma or cystic fibrosis or other autoimmune and inflammatory disorders.

Abstract: The present disclosure pertains to compositions comprising anti-VEGF proteins and methods for producing such compositions.

Abstract: The present disclosure pertains to methods for producing aflibercept from a host cell cultured in a chemically defined medium (CDM) including purification of aflibercept, wherein aflibercept following purification includes aflibercept variants that have at least one oxidized amino acid residue selected from the group consisting of tryptophan, histidine and a combination thereof.

Abstract: The present invention relates to the area of improved anti-IgE antibodies and antigen binding agents, and compositions thereof, which target IgE, for instance: for use in treating disorders caused by IgE (such as allergic responses, or certain autoimmune responses); and, in particular, disorders caused by the interaction of IgE with the Fc?RI receptor. In particular, this invention relates to improved anti-IgE antibodies and antigen binding agents related to novel mutants of omalizumab (Xolair®). The improved anti-IgE antibodies and antigen binding agents of the invention may have improved affinity for IgE and/or an improved interaction with the C?2 domain of IgE and/or an improved modified epitope on IgE (for instance further involving the C?2 domain of IgE) and/or the ability to disassociate IgE from the Fc?RI receptor for instance at pharmaceutically-relevant concentrations.

Abstract: The invention provides methods of treating or preventing an ocular disease or disorder in a subject, methods of treating or preventing ocular pain or discomfort comprising, administering to the subject a composition comprising a pharmaceutically acceptable carrier and a pharmaceutically effective amount of a transient receptor potential melastatin 8 (TRPM8) antagonist. In certain preferred embodiments, the ocular disease or disorder is a dry eye disease.

Abstract: The present invention relates to a process for the enzymatic modification of a glycoprotein. The process comprises the step of contacting a glycoprotein comprising a glycan comprising a terminal GlcNAc-moiety, in the presence of glycosyltransferase that is, or is derived from, a ?-(1,4)-N-acetylgalactosaminyltransferase, with a non-natural sugar-derivative nucleotide. The non-natural sugar-derivative nucleotide is according to formula (3): wherein A is selected from the group consisting of —N3, —C(O)R3, —(CH2)iC?C—R4, —SH, —SC(O)R8, —SC(O)OR8, —SC(S)OR8, —F, —Cl, —Br —I, —OS(O)2R5, terminal C2-C24 alkenyl groups, C3-C5 cycloalkenyl groups, C4-C8 alkadienyl groups, terminal C3-C24 allenyl groups and amino groups.

Abstract: The present disclosure provides CD2 binding molecules that specifically bind to CD2, including monospecific, bispecific and trispecific binding molecules, conjugates comprising the CD2 binding molecules, and pharmaceutical compositions comprising the CD2 binding molecules and the conjugates. The disclosure further provides methods of using the CD2 binding molecules to modulate CD2 signaling in order to treat a variety of immune (e.g., autoimmune), inflammatory and proliferative disorders. The disclosure yet further provides recombinant host cells engineered to express the CD2 binding molecules and methods of producing the CD2 binding molecules by culturing the host cells under conditions in which the CD2 binding molecules are expressed.

Abstract: The present invention is directed to methods of inducing a phenotypic change in a population of monocytes and/or macrophages. The method includes administering to the population of monocytes and/or macrophages, a macrophage stimulating agent coupled to a carrier molecule, wherein the carrier molecule facilitates macropinocytic uptake of the agent by monocytes and macrophages in the population and is defective in neonatal Fc receptor binding, wherein the administering induces a phenotypic change in the monocytes and macrophages in the population.

Abstract: A method of operating a chromatography column is described for use in methods of manufacture for producing anti-TNF antibodies, e.g., the anti-TNF? antibody SIMPONI® (golimumab). This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value.

Abstract: The disclosure is directed to a histidine-mutated anti-HIV antibody having one or more mutations at the residue Y53a, D58, K96, D97, N98, or T100a in the heavy chain of ibalizumab, and at the residue S26, L30, L33, Q89, Y92, S93 or Y94 in the light chain of ibalizumab. In addition, the disclosure also is directed to two histidine mutated variants with two mutations, one with mutations at the residues Y53a and Y94, and the other with mutations at the residues D58 and L30 in the heavy and light chains of ibalizumab, respectively.

Abstract: The present disclosure pertains to compositions comprising anti-VEGF proteins.

Abstract: The present disclosure relates to monoclonal antibodies and antigen binding fragments thereof that bind to human Factor XI and activated Factor XI (“Factor XIa”), and pharmaceutical compositions and methods of treatment comprising the same.

Abstract: Provided are proteinaceous heterodimers, pharmaceutical compositions, medicaments and/or kits comprising the proteinaceous heterodimers, methods for producing the proteinaceous heterodimers, and uses thereof.

Abstract: The present invention relates to anti-HLA-G antibodies and methods of using the same.

Abstract: The present invention pertains to affinity chromatography isolation and purification of extracellular vesicles (EVs). The EVs of the present invention are engineered to enable highly specific binding to e.g. chromatography matrices, which is highly useful for affinity-based isolation and purification of EVs from complex biological fluids such as cell culture medium or biological fluids.

Abstract: The present disclosure is directed to methods of treating atopic dermatitis comprising administering to a subject in need thereof a therapeutically effective amount of an anti-IL-13 antibody, or antigen binding fragment thereof, thereby treating atopic dermatitis in the subject.

Abstract: The present disclosure pertains to compositions comprising anti-VEGF proteins and methods for producing such compositions.

Abstract: Provided is a universal method for quantitatively determining therapeutic tumor necrosis factor (TNF)-alpha inhibitors in patient samples that is sufficiently sensitive for being able to detect all therapeutic TNF-alpha inhibitors.

Abstract: The present invention relates to bispecific antibodies against ROR1 and CD3, their manufacture and use.

Abstract: The invention relates to a multivalent antibody which comprises: a base antibody portion which comprises two binding domains; and at least one additional binding domain, wherein the base antibody portion is connected by a linker to the at least one additional binding domain, wherein each binding domain of the base antibody portion and each of the at least one additional binding domains all have a common variable region, and wherein the linker comprises a hinge sequence or a sequence derived from a hinge sequence. The invention also relates to a multivalent antibody which comprises: a base antibody portion which comprises two binding domains; and at least one additional binding domain, wherein at least one additional binding domain comprises a CH1 region and is connected to the base antibody portion by said linker, linking a variable region of the base antibody portion and the CH1 region, and wherein the multivalent antibody binds to at least three different epitopes.

Abstract: The present invention is directed to novel heterodimeric antibodies.

Abstract: Some embodiments provided herein are chimeric costimulatory antigen receptor (CoStAR), useful in adoptive cell therapy (ACT), and cells comprising the CoStAR. In some embodiments, the CoStAR can act as a modulator of cellular activity enhancing responses to defined antigens. In some embodiments, CoStAR and/or fusion proteins, nucleic acids encoding the CoStAR and therapeutic uses thereof are also provided.

Abstract: Compositions and methods relating to epitopes of sclerostin protein, and sclerostin binding agents, such as antibodies capable of binding to sclerostin, are provided.

Abstract: The present disclosure relates to protein molecules that specifically bind to CD123, which may have at least one humanized or human CD123-binding domain. Such molecules are useful for the treatment of cancer. The protein molecule binding to CD123 may have a second binding domain that binds to another target. In one embodiment, multi-specific polypeptide molecules bind both CD123-expressing cells and the T-cell receptor complex on T-cells to induce target-dependent T-cell cytotoxicity, activation, and proliferation. The disclosure also provides pharmaceutical compositions comprising the CD123-binding polypeptide molecules, nucleic acid molecules encoding these polypeptides and methods of making these molecules.

Abstract: The present invention relates to compositions and methods of GDNF fusion polypeptides, wherein the GDNF fusion polypeptides include an Fc domain, an albumin-binding peptide, a fibronectin domain, or a human serum albumin, joined to a GDNF variant either directly or by the way of a linker. The GDNF fusion polypeptides may used to treat metabolic diseases, such as obesity and Type-1 and Type-2 diabetes, and neurological diseases, such as Amyotrophic lateral sclerosis (ALS) and Parkinson's disease.

Abstract: Embodiments of a recombinant Respiratory Syncytial Virus (RSV) G ectodomain are provided. Also disclosed are nucleic acids encoding the RSV G ectodomain and methods of producing the RSV G ectodomain. Methods for inducing an immune response in a subject are also disclosed. In some embodiments, the method can be a method for inhibiting a RSV infection in a subject by administering an effective amount of the recombinant RSV G ectodomain to the subject to produce a protective immune response.

Abstract: Described herein are anti-CD277 antibodies which: activates or inhibit the cytolytic function of V?9/V?2 T cells, and/or costimulates T cells together with CD3-TCR, and/or costimulates T cells in addition to CD28-B7 costimulation, and/or increases the activity and/or survival of monocytes and dendritic cells. The use of said antibodies in therapy is also described.