Abstract: The present invention relates to an isolated specific binding member capable of binding sialyl-di-Lewisa, and associated treatments and pharmaceutical compositions for treatment of cancer.

Abstract: A composition comprising at least one AAV vector formulated for central nervous system delivery is described. The composition comprises at least one expression cassette which contains sequences encoding an anti-neoplastic immunoglobulin construct for delivery to the brain operably linked to expression control sequences therefor and a pharmaceutically acceptable carrier. The anti-neoplastic immunoglobulin construct may be an immunoglobulin modified to have decreased or no measurable affinity for neonatal Fc receptor (FcRn). Also provided are methods of using these constructs in preparing pharmaceutical compositions and uses thereof in anti-neoplastic regimens, particularly for primary and/or metastatic cancers of the brain.

Abstract: The present invention is directed to antibodies and fragments thereof having binding specificity for FZD7, which preferably do not substantially interact with (bind to) other FZD family members, and methods of making said anti-FZD7 antibodies and binding fragments thereof. Another embodiment relates to antibodies and binding fragments comprising sequences of VH, VL and/or CDR polypeptides described herein. The invention also contemplates conjugates of anti-FZD7 antibodies and binding fragments. The invention further contemplates use of anti-FZD7 antibodies and binding fragments for tissue engineering. This invention also relates to a transgenic mouse expressing the epitope of anti-FZD7 antibodies and binding fragments thereof. Embodiments also pertain to use of anti-FZD7 antibodies and binding fragments (as well as the identified FZD7 epitope) for diagnosis, assessment, prevention and/or treatment of diseases and disorders associated with aberrant FZD7 expression, such as cancer.

Abstract: Described herein are compositions, methods, and systems for modulating Notch receptor activation. Aspects of the invention relate to synthetic proteins comprising at least a Notch NRR (Negative Regulatory Region)-binding scFV fused to a transmembrane domain. Another aspect of the invention relates to drug-dependent synthetic proteins. Constructs and engineered cells comprising the synthetic proteins are additionally described herein.

Abstract: A method of determining the specific binding of ligand reversibly binding to a binding site in a sample using displacement competitive inhibition. The method comprising incubating the ligand (unlabeled) in the absence of a labeled ligand on a first tissue specimen, incubating the ligand (unlabeled) in the presence of a labeled ligand on a second tissue specimen, the first and the second tissue specimens being adjacent sections of specimen. MALDI imaging mass spectrometry is used to subsequently visualizing bound ligand localization, using in the first and second tissue specimen, respectively.

Abstract: Combinations of different chromatography modalities with particularly refined conditions significantly reduce acid charge variants in a preparation of monoclonal antibodies. The process for reducing acid charge variants utilizes a combination of anion exchange and hydrophobic interaction chromatography, followed by cation exchange chromatography polishing, whereby the levels of acidic or basic charge species of the monoclonal antibodies may be modulated to a desired level.

Abstract: This application provides antibodies and functional equivalents thereof which are capable of specifically binding RSV, as well as means and methods for producing them.

Abstract: This invention relates to a pharmaceutical composition for treatment of a bone disease comprising, as an active ingredient, a protein comprising an extracellular cysteine-rich domain, which is from the Frizzled receptor selected from the group consisting of mammalian animal-derived Frizzled 1, Frizzled 2, and Frizzled 7 and has activity of increasing bone mass, bone density, and/or bone strength, or a mutant of such domain having sequence identity of 85% or higher to the amino acid sequence of the domain and having activity of increasing bone mass, bone density, and/or bone strength, or a vector comprising a nucleic acid encoding the protein.

Abstract: The present invention relates to immune cell-based anti-cancer therapeutics and methods of using the therapeutics in the treatment of cancer.

Abstract: A bispecific antibody format, which comprises a) a Fab fragment comprising a first binding site for a first antigen; b) an scFv fragment comprising a second binding site for a second antigen; and c) a CH2 domain, wherein the Fab fragment and the scFv fragment are linked via the CH2 domain, wherein the first antigen is CD95 and the second antigen is CD20; or the first antigen is CD20 and the second antigen is CD95.

Abstract: The present invention relates to methods and compositions for modulating T cells. The modulation includes suppressing or inducing regulatory T cells or cytotoxic T cells.

Abstract: The present invention relates to methods for recellurization of blood vessels. This method is particularly useful for producing an allogeneic vein, wherein a donor vein is decellularized and then recellularized using whole blood or bone marrow stem cells. The allogeneic veins produced by the methods disclosed herein are particularly advantageous for implantation or transplantation into patients with vascular diseases.

Abstract: This invention provides a method of reducing viral load in an HIV-1-infected human subject which comprises administering to the subject an effective HIV-1 viral load reducing dose of a CCR5 receptor antagonist, such as a humanized antibody designated PRO 140 or an anti-CCR5 receptor monoclonal antibody, wherein the viral load reducing dose achieves an average maximum decrease of viral load in the subject of at least 1.83 log10 to 2.5 log10 at about ten days following administration of the CCR5 receptor antagonist and wherein the viral load reducing dose further achieves a mean viral load reduction of 1.7 log10 at about nine days following administration of the CCR5 receptor antagonist.

Abstract: As described below, the present invention features methods for enhancing the efficacy of a tumor antigen in inducing an anti-cancer immune response in a subject by administering an OX40 agonist and an Indoleamine 2,3-dioxygenase (IDO) inhibitor with the tumor antigen.

Abstract: AnnexinA2 (ANXA2), a member of the Annexin family of calcium-dependent, phospholipid binding proteins, is one of a panel of identified antigens recognized by the post-vaccination sera of patients who demonstrated prolonged disease-free survival following multiple vaccinations. AnnexinA2 is abundantly expressed in pancreatic adenocarcinomas and cell surface/membrane AnnexinA2 increases with the progression from premalignant lesions to invasive pancreatic adenocarcinomas. The cytoplasmic to cell surface translocation of AnnexinA2 expression is critical for pancreatic cancer cell invasion. In addition, phosphorylation of AnnexinA2 at Tyrosine 23 is important for its localization to the cell surface and for the invasion of pancreatic cancer cells. Finally, loss of AnnexinA2 leads to the loss of the Epithelial-Mesenchymal Transition.

Abstract: The present invention provides methods for treating, preventing or ameliorating skin infections, including bacterial and viral infections. In certain embodiments, the invention provides methods to reduce skin infection in a patient with atopic dermatitis (AD). Also provided are methods for improving skin barrier function, and methods for reducing the risk of inflammation due to microbial infection in a patient in need thereof. The methods of the present invention comprise administering to a patient in need thereof a pharmaceutical composition comprising an interleukin-4 receptor (IL-4R) antagonist such as an anti-IL-4R antibody.

Abstract: The present invention relates to the use of endocytosis inhibitors, including clathrin-dependent endocytosis inhibitors such as inhibitors of dynamin and antibodies, for enhancing the immune response to cancer, and thereby treating cancers including cancer associated receptor positive cancers.

Abstract: The present invention provides methods of obtaining information relevant to monitoring and diagnosing cancer, particularly monitoring the progression or development of cancer, monitoring the response of cancer to treatment, diagnosing cancer, making a cancer prognosis, predicting the likelihood of a cancer responding to treatment and stratifying subjects having cancer. The methods involve determining the ratio of circulating CCL17 to circulating CCL22 in a sample from a subject.

Abstract: Disclosed herein are methods for counteracting age-related decrease in gene expression or treating age-related diseases, for example cancers and autoimmune diseases, caused by decreased expression levels of a gene associated with the apoptosis pathway, using a nitroxide. Further disclosed are methods for treating a human subject in need of an increased expression level of a gene associated with the apoptosis pathway using a nitroxide.

Abstract: The present invention is directed to improved therapeutics against receptors within the EGFR/ErbB/HER family that more broadly interfere with multiple members of the HER family (pan-HER inhibition). More particularly, the invention is directed to the use of antibody compositions for human cancer therapy. In vitro studies have shown that the antibody compositions of the invention targeting multiple HER family receptors are superior to antibody compositions targeting only one HER family receptor.

Abstract: The present invention relates to compositions and methods for the prevention, treatment, and diagnosis of cancer, especially carcinomas, such as pancreatic carcinoma. The invention discloses peptides, polypeptides, and polynucleotides that can be used to stimulate a CTL response against pancreatic and other cancers.

Abstract: The present invention provides novel antibodies and methods for using recombinant antigen-binding regions and antibodies and functional fragments containing such antigen-binding regions that are specific for CD38, which plays an integral role in various disorders or conditions. These methods take advantage of newly discovered antibodies and surprising properties of such antibodies, such as the ability to bind CD38 of minipig origin and the ability to induce, by cross-linking, specific killing of cells that express CD38. These antibodies as well as the novel methods for using those antibodies can be used to treat, for example, hematological malignancies such as multiple myeloma.

Abstract: The present invention relates to a stable, low viscosity antibody formulation, wherein the formulation comprises a high concentration of anti-INFAR1 antibody. In some embodiments, the invention relates in general to a stable antibody formulation comprising about 100 mg/mL to about 200 mg/mL of an antibody or fragment thereof that specifically binds human interferon alpha 1 (INFAR1); about 20 mM to about 80 mM of a lysine or a salt thereof; about 0.02% to about 0.06% of a surfactant; an uncharged excipient; and a formulation buffer. In some embodiments, the invention is directed to a container, dosage form and/or kit. In some embodiments, the invention is directed to a method of making and using the stable antibody formulation.

Abstract: The present invention provides compositions and methods for treating and preventing disease associated with ?v?5 integrin by blocking binding to ?v?5 integrin. In particular, antibodies specific for ?v?5 integrin are useful for preventing, treating, and reversing sepsis.

Abstract: Disclosed are a protein conjugate with improved in vivo duration and stability and the use thereof. The protein conjugate includes a physiologically active polypeptide, a non-peptide polymer and an immunoglobulin Fc fragment. Since the three components are covalently linked, the protein conjugate has extended in vivo duration and enhanced stability for the physiologically active polypeptide. The protein conjugate maintains the in vivo activity at relatively high levels and remarkably increases the serum half-life for the physiologically active polypeptide, with less risk of inducing undesirable immune responses. Thus, the protein conjugate is useful for developing long-acting formulations of various polypeptide drugs.

Abstract: The current invention relates to a new pharmaceutical formulation, in particular to a pharmaceutical formulation comprising a protein, more particularly an antibody as an active ingredient.

Abstract: The embodiments described herein include methods and formulations for treating lung and brain injury. The methods and formulations include, but are not limited to, methods and formulations for delivering effective concentrations of levocetirizine and montelukast to a patient in need. The methods and formulations can comprise conventional and/or modified-release elements, providing for drug delivery to the patient.

Abstract: Methods of determining cancer progression or cancer relapse in a subject at risk for cancer progression or cancer relapse, the methods comprising: obtaining a sample from said subject; measuring the level of VEGFR1+ hematopoietic progenitor cells (HPCs) and/or VEGFR2+ endothelial progenitor cells (EPCs) in said sample; and taking additional samples and conducting additional measurements of HPCs and/or EPCs at one or more later time points. From the measurements, it can be determined whether there is a surge in the level of HPCs and/or EPCs in at least one later measurement, relative to an earlier measurement. A surge in the level of HPCs and/or EPCs indicates increased risk of progression or relapse of said subject's cancer.

Abstract: The present invention provides methods of preparing active immunoconjugates, including anti-CD22 immunoconjugates. Suitably, the methods include a fed-batch refolding process and/or column stripping process that result in an increase in yield of the immunoconjugate over other processes that do not utilize the methods.

Abstract: The present invention provides compounds and methods for the treatment of an individual having or at risk of having a condition associated with alpha-1-antitrypsin by using a pharmacological chaperone. In particular, such methods are useful for the treatment and/or prevention of lung disorders associated with alpha-1-antitrypsin deficiency as well as liver disorders associated with an excess of alpha-1-antitrypsin. Suitable pharmacological chaperones include peptides and low-molecular weight compounds. The present invention also provides an assay for determining whether a test compound modulates alpha-1-antitrypsin activity.

Abstract: Methods and compositions are provided which comprise effective amounts of analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.

Abstract: Human recombinant antibodies or fragments thereof having specificity for the ?2-glycoprotein I (?2GPI), pharmaceutical compositions containing same and use thereof in a method for treating or preventing thrombus formation and fetal loss in a patient affected by antiphospholipid syndrome (APS).

Abstract: The present invention relates to the use of inhibitors of leukotriene B4 receptor BLT2 for treating asthma. More particularly, the present invention relates to a pharmaceutical composition for treating asthma comprising BLT2 inhibitors and a method for treating asthma using BLT2 inhibitors.

Abstract: Described herein is insulin, an insulin-like growth factor, parathyroid hormone, a fragment of parathyroid hormone, or a parathyroid hormone related protein that includes at least one bone targeting moiety, wherein the bone targeting moiety is covalently bonded to the peptide. Also described herein are the methods of making these compositions that prevent or treat conditions associated with bone loss and preventing bone fractures, and/or the inability to initiate de novo bone turnover and stimulate bone fracture repair.

Abstract: This invention relates to a pharmaceutical composition for treatment of a bone disease comprising, as an active ingredient, a protein comprising an extracellular cysteine-rich domain, which is from the Frizzled receptor selected from the group consisting of mammalian animal-derived Frizzled 1, Frizzled 2, and Frizzled 7 and has activity of increasing bone mass, bone density, and/or bone strength, or a mutant of such domain having sequence identity of 85% or higher to the amino acid sequence of the domain and having activity of increasing bone mass, bone density, and/or bone strength, or a vector comprising a nucleic acid encoding the protein.

Abstract: Use of an anti-NGF antibody capable of inhibiting the binding between NGF and TrkA, capable of blocking the biological activity of TrkA for the preparation of a medicament for treating and/or preventing chronic pain.

Abstract: The present invention relates to an anti-CD19 antibody having a variant Fc region having some specific amino acid modifications relative to a wild-type Fc region which confer one or several useful effector functions. The present invention relates in particular to chimeric, humanized or full human anti-CD19 antibodies comprising such a variant Fc region. It relates advantageously to antibodies with an interesting and valuable glycosylation profile, especially a low fucose level and/or a high oligomannose level and low level of sialylated glycoform. The present invention also relates to the use of these antibodies in the treatment, prevention or management of disease or disorder, such as cancer, especially a B-cell malignancy, and auto-immune disease.

Abstract: In one aspect, the invention provides methods of inhibiting the effects of MASP-2-dependent complement activation in a living subject. The methods comprise the step of administering, to a subject in need thereof, an amount of a MASP-2 inhibitory agent effective to inhibit MASP-2-dependent complement activation. In some embodiments, the MASP-2 inhibitory agent inhibits cellular injury associated with MASP-2-mediated alternative complement pathway activation, while leaving the classical (Clq-dependent) pathway component of the immune system intact. In another aspect, the invention provides compositions for inhibiting the effects of lectin-dependent complement activation, comprising a therapeutically effective amount of a MASP-2 inhibitory agent and a pharmaceutically acceptable carrier.

Abstract: The present invention relates to CX3CR1-targeting imaging agents and their use in treatment and diagnosis of diseases. Single domain CX3CR1-targeting polypeptides linked to detection labels and their use in in vivo imaging of atherosclerotic plaques are described. The CX3CR1-targeting imaging agents are useful in the treatment and diagnosis of CX3CR1-mediated diseases including atherosclerosis.

Abstract: Heterocyclic compounds that modulate C3a receptors and their use in the treatment or prevention of inflammatory diseases, infectious diseases, cancers, metabolic disorders, obesity, type 2 diabetes, metabolic syndrome and associated cardiovascular diseases are described. The use of the compounds in stimulating or suppressing an immune response is also described together with pharmaceutical compositions comprising the compounds or their pharmaceutically acceptable salts.

Abstract: The present invention relates to monoclonal antibodies binding to human lectin-like oxidized LDL (low density lipoprotein) receptor 1 (hereinafter, sometimes referred to as “LOX-1”), and pharmaceutical compositions and methods of treatment comprising the same.

Abstract: The invention relates to anti-TNFR1 polypeptides and antibody single variable domains (dAbs) that are resistant to degradation by a protease, as well as antagonists comprising these. The polypeptides, dAbs and antagonists are useful for as therapeutics and/or prophylactics that are likely to encounter proteases when administered to a patient, for example for pulmonary administration, oral administration, delivery to the lung and delivery to the GI tract of a patient, as well as for treating inflammatory disease, such as arthritis or COPD.

Abstract: Compositions and methods are provided for the diagnosis and treatment of inflammation and autoimmune disorders, such as psoriasis. Compositions and methods for modulating IL-23 or IL-22 signaling are provided.

Abstract: The invention is directed to the treatment of prostate cancer by means of antibodies. Above all, the invention relates to the administration of an anti-alpha-v integrin (receptor) antibody to patients suffering from prostate cancer, especially castration-resistant prostate cancer (CRPC), optionally accompanied by lymph node and bone tissue metastases (mCRPC). In particular, the invention relates to the therapy of said patients by means of the anti-angiogenic antibody DI17E6 and structural mutants thereof.

Abstract: The invention provides methods for treating or preventing disorders associated with expression of BAFF comprising BAFF and fragments thereof, antibodies, agonists and antagonists.

Abstract: There are provided a composition for determining the efficacy of a c-Met antibody including marker genes and a method for determining the efficacy of a c-Met antibody using the marker genes.

Abstract: The present invention relates to monoclonal antibodies binding to human lectin-like oxidized LDL (low density lipoprotein) receptor 1 (hereinafter, sometimes referred to as “LOX-1”), and pharmaceutical compositions and methods of treatment comprising the same.

Abstract: The present invention relates to antibodies, immunoglobulin constructs or immunoglobulin IgG4 fusion proteins whose in vivo half-lives are increased by the combination of (i) a modified IgG4 Fc region or FcRn binding domain thereof and (ii) a modified IgG4 hinge region sequence.

Abstract: In an aspect, a method of augmenting an immune response in a subject in need thereof, comprising identifying the subject, and treating the subject to inhibit the immune suppressive effect of CD71+ cells is provided. Further provided is a method of preventing, treating or ameliorating an infection in a subject, comprising administering to the subject an agent that reduces the level of CD71+ cells in the subject.

Abstract: Methods and compositions for modulating blood-neural barrier (BNB) for the treatment of CNS conditions such as edema, and for increased drug delivery efficacy across the BNB. The present invention further relates to improved tPA treatment of ischemic cerebrovascular and related diseases in combination with antagonism of the PDGF signaling pathway. The inventive method and composition is particularly suitable for conjunctive therapy of ischemic stroke using tPA and an anti-PDGF-C antagonist or an anti-PDGFR-? antagonist.