Abstract: The application describes a method of treating chronic obstructive pulmonary disease (COPD) in a patient comprising administering 476 mg of an ST2 antagonist to the patient on Day 1 of a treatment period. The application also describes methods of treating or preventing frequency of moderate to severe exacerbations in a patient having COPD comprising administering an effective amount of an ST2 antagonist to achieve a clinical improvement of at least 10%, at least 20%, at least 21%, at least 22%, at least 25%, at least 30%, at least 35%, at least 40% or at least 45% annualized exacerbation rate reduction than standard of care (SOC).

Abstract: The present invention relates to anti-FcRH5 antibodies, including anti-FcRH5 antibodies comprising an FcRH5 binding domain and a CD3 binding domain (e.g., FcRH5 T cell-dependent bispecific (TDB) antibodies), and methods of using the same.

Abstract: The present disclosure provides methods and kits for treating or preventing an allergic reaction to a food allergen consumed by a human subject with one or more food allergies. In particular, the present disclosure provides prophylactic therapies comprising administration of an anti-IgE antibody at a specific dose to a human subject who is allergic to one or more food allergens.

Abstract: Described herein are methods for the efficient production of antibodies and other multimeric protein complexes (collectively referred to herein as heteromultimeric proteins) capable of specifically binding to more than one target. The targets may be, for example, different epitopes located on a single molecule or located on different molecules.

Abstract: The present disclosure relates to techniques for segmenting objects within medical images using a deep learning network that is localized with object detection based on a derived contrast mechanism. Particularly, aspects are directed to localizing an object of interest within a first medical image having a first characteristic, projecting a bounding box or segmentation mask of the object of interest onto a second medical image having a second characteristic to define a portion of the second medical image, and inputting the portion of the second medical image into a deep learning model that is constructed as a detector using a weighted loss function capable of segmenting the portion of the second medical image and generating a segmentation boundary around the object of interest. The segmentation boundary may be used to calculate a volume of the object of interest for determining a diagnosis and/or a prognosis of a subject.

Abstract: Cysteine engineered antibodies comprising a free cysteine amino acid in the heavy chain or light chain are prepared by mutagenizing a nucleic acid sequence of a parent antibody and replacing one or more amino acid residues by cysteine to encode the cysteine engineered antibody; expressing the cysteine engineered antibody; and isolating the cysteine engineered antibody. Certain highly reactive cysteine engineered antibodies were identified by the PHESELECTOR assay. Isolated cysteine engineered antibodies may be covalently attached to a capture label, a detection label, a drug moiety, or a solid support.

Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

Abstract: The invention relates to compounds and methods of using said compounds, as well as pharmaceutical compositions containing such compounds, for treating diseases and conditions mediated by TEAD, such as cancer.

Abstract: Provided herein are methods of freezing mammalian cells for storage or improving thaw recovery of cell banks comprising freezing mammalian cells in a freezing medium having a pH of 6.7 to 8.5.

Abstract: Provided herein are methods of treating B-cell proliferative disorders in particular Follicular Lymphoma and/or Diffuse Large B-Cell Lymphoma using immunoconjugates comprising anti-CD79b antibodies in combination with additional therapeutic agents.

Abstract: Provided herein are combination therapies comprising a KRasG12C inhibitor (e.g. Compound 1 or a pharmaceutically acceptable salt thereof) and a VEGF antagonist (e.g., bevacizumab) and methods of using such combination therapies.

Abstract: Provided herein are methods for generating a solid antigen/carrier protein gel for immunohistochemistry (IHC) staining, as well as gels, kits and methods of use thereto. In particular, the methods, gels and kits provided herein include a purified antigen such as a polypeptide antigen, and a carrier protein such as a serum albumin protein, an egg white protein or mixture of egg white proteins, gelatin, or poly-lysine. Examples are provided in which the purified antigen is cross-linked to the carrier protein in the solid antigen/carrier protein gel.

Abstract: The present application discloses high-concentration monoclonal antibody formulations suitable for subcutaneous administration, e.g. via a pre-filled syringe. In particular, it discloses a formulation comprising a spray dried monoclonal antibody at a concentration of about 200 mg/mL or more suspended in a non-aqueous suspension vehicle where the viscosity of the suspension vehicle is less than about 20 centipoise. Also disclosed are: a subcutaneous administration device with the formulation therein, a method of making the formulation, a method of making an article of manufacture comprising the suspension formulation, use of the formulation in the preparation of a medicament, and a method of treating a patient with the formulation.

Abstract: Described herein are benzoxazepin oxazolidinone compounds with phosphoinositide-3 kinase (PI3K) modulation activity or function having the Formula I structure: or stereoisomers, tautomers, or pharmaceutically acceptable salts thereof, and with the substituents and structural features described herein. Also described are pharmaceutical compositions and medicaments that include the Formula I compounds, as well as methods of using such PI3K modulators, alone and in combination with other therapeutic agents, for treating diseases or conditions that are mediated or dependent upon PI3K dysregulation.

Abstract: The present disclosure relates to cells (e.g., Chinese Hamster Ovary (CHO) cells) that are modified to reduce or eliminate the expression of certain endogenous cellular proteins, and methods of using such cells in the production of a recombinant product of interest, e.g., a recombinant protein, a recombinant viral particle, or a recombinant viral vector. These modifications were specifically chosen to generate engineered cells with desired traits in several key areas, including improved cell culture performance (e.g., higher viability and product titers).

Abstract: The invention provides dual specific antibodies capable of binding interleukin 4 (IL4) and interleukin 5 (IL5) and methods of making and using such antibodies. In general, the dual specific antibodies capable of binding IL4 and IL5 are generated by identification of a monospecific antibody having light chain variable region VL residues that are electrostatic or hydrophobic and altering the nucleic acid sequence encoding one or more solvent accessible residues in the VH of the antibody either alone or in combination with alteration of the nucleic acid sequence encoding the VL of the antibody. The altered VH and the VL are expressed and dual specific antibodies, or antigen-binding fragments thereof, are selected.

Abstract: The invention provides a compound of formula (I): or a prodrug thereof, or a pharmaceutically acceptable salt thereof, wherein R1 and R2 have any of the values described in the specification, as well as compositions comprising a compound of formula (I) or a prodrug thereof, or a pharmaceutically acceptable salt thereof. The compounds are agonists of glycolytic enzyme phosphofructokinase-1 liver type and are useful for treating diseases associated with the activity of glycolytic enzyme phosphofructokinase-1 liver type, such as cancer, diabetes, sepsis, and septic shock.

Abstract: The present invention provides a cell-based assay for identifying and/or quantifying anti-CD3 homodimers in a composition comprising a T cell-dependent Bispecific antibody (TDB). In some aspects, the invention T cells comprising a T cell activation responsive reporter are contacted with the TDB to detect the presence of anti-CD3 homodimers. Compositions of reporter T cells and kits are also contemplated.

Abstract: The present disclosure relates to chimeric ABC transporter proteins and methods of screening for molecules that bind to the periplasmic, extracellular, and/or luminal face of an ABC transporter protein using the chimeric ABC transporters. For example, in some embodiments, screening methods involve providing a chimeric ABC transporter in which one or more regions of the periplasmic, extracellular, and/or luminal face of the ABC transporter are substituted with one or more equivalent regions of the periplasmic, extracellular, and/or luminal face of a different ABC transporter and selecting for molecules that bind to the ABC transporter but do not bind to the chimeric ABC transporter. The disclosure also relates to molecules that bind to the periplasmic, extracellular, and/or luminal face of an ABC transporter protein, for example, identified in such screens.