Abstract: Drug delivery systems and methods of use thereof for recording administration of a drug dose to a subject are provided. Aspects of the invention include a syringe stopper rod comprising a sensor component that is configured to detect a delivery signature, and to transmit a report comprising a drug dose completion signal to a data management component, e.g., a mobile computing device.

Abstract: Disclosed are compounds which inhibit the activity of anti-apoptotic Bcl-2 proteins, compositions containing the compounds and methods of treating diseases during which is expressed anti-apoptotic Bcl-2 protein.

Abstract: The present disclosure relates to techniques for obtaining a synthetic immunohistochemistry (IHC) image from a histochemically stained image. Particularly, aspects of the present disclosure are directed to accessing an input image that depicts a tissue section that has been stained with at least one histochemical stain; generating a synthetic image by processing the input image using a trained generator network; and outputting the synthetic image. The synthetic image depicts a tissue section that has been stained with at least one IHC stain that targets a first antigen, and techniques may also include receiving an input that is based on a level of expression of a first antigen from the synthetic image and/or generating, from the synthetic image, a value that is based on a level of expression of the first antigen.

Abstract: Disclosed are compounds which inhibit the activity of anti-apoptotic Bcl-2 proteins, compositions containing the compounds and methods of treating diseases during which is expressed anti-apoptotic Bcl-2 protein.

Abstract: Methods and systems may be provided to predict functional response based on a set of predictors for therapeutic proteins. For example, a method can comprise receiving input data comprising first input data related to a set of predictors and corresponding measured functional response associated with the set of predictors obtained from a first set of therapeutic protein samples and second input data related to the set of predictors and a second set of therapeutic protein samples for prediction of a functional response, wherein the set of predictors were selected as a combination of related biophysical attributes of therapeutic proteins based on a pre-determined criterion; training a machine learning model with the first input data; and using the machine learning model and the set of predictors to predict a functional response of the second set of therapeutic protein samples based on the second input data.

Abstract: The present disclosure provides methods for treating lupus nephritis in an individual that is greater than or equal to 12 years of age and less than 18 years of age. In some embodiments, the methods comprise administering to the individual an effective amount of a type II anti-CD20 antibody.

Abstract: The present invention provides antibody conjugates that include antibodies (e.g., anti-VEGF antibodies) covalently linked to polymers (e.g., hyaluronic acid (HA) polymers), cysteine engineered antibodies, pharmaceutical compositions thereof, and uses thereof, for example for treatment of disorders associated with pathological angiogenesis (e.g., ocular disorders).

Abstract: Processes are provided herein for the preparation of a bicyclic ketone compound of formula (I), or a stereoisomer thereof: or a pharmaceutically acceptable salt thereof, wherein R1, R2, R3 and n are as defined herein; and compounds prepared by these processes.

Abstract: The invention provides methods for treating or delaying progression of lupus nephritis in an individual that has lupus. In some embodiments, the methods comprise administering to the individual an effective amount of a type II anti-CD20 antibody. The invention also provides methods for treating or delaying progression of rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE) in an individual. In some embodiments, the methods comprise administering an effective amount of an anti-CD20 antibody.

Abstract: The invention provides anti-Jagged antibodies and methods of using the same.

Abstract: In some embodiments, a current state of a medical condition or a progression of the medical condition is predicted by processing one or more digital pathology images and expression levels of genes using a machine-learning model. In some embodiments, one or more predicted gene-expression levels are generated by processing a data set corresponding to one or more digital pathology images using a machine-learning model. In some embodiments, one or more predicted digital pathology metrics are generated by processing a data set that corresponds to expression levels of a set of genes using a machine-learning model.

Abstract: The application describes a method of treating pneumonia (e.g. COVID-19 pneumonia) in a patient comprising administering a weight-based intravenous dose of tocilizumab to the patient, wherein the weight-based dose is 8 mg/kg of tocilizumab. It also describes a method of treating pneumonia in a patient comprising administering an IL6 antagonist (e.g. an IL6 receptor antibody such as tocilizumab) to the patient in an amount effective to achieve a greater improvement in clinical outcome than standard of care (SOC) as measured on an ordinal scale of clinical status.

Abstract: The presently disclosed subject matter provides antibodies that bind KLB and FGFR1, and methods of using the same. In certain embodiments, an antibody of the present disclosure includes a bispecific antibody that binds to an epitope present on FGFR1 and binds to an epitope present on KLB.

Abstract: A machine-learning model (e.g., a clustering model) may be used to predict a phenotype of a tumor based on expression levels of a set of genes. The set of genes may have been identified using a same or different machine-learning model. The phenotype may include an immune-excluded, immune-desert or an inflamed/infiltrated phenotype. A treatment strategy and/or treatment recommendation may be identified based on the predicted phenotype.

Abstract: Provided are anti-CD8 antibodies that bind human CD8 and do not stimulate or inhibit the activation of CD8+ T cells. Also provided are nucleic acids encoding such anti-CD8 antibodies, vectors comprising such nucleic acids, host cells comprising same, and methods of making such anti-CD8 antibodies. Also provided are anti-CD8 antibodies conjugated to a detectable label. Provided are methods of using such anti-CD8 antibodies to detect CD8+ T cells in a subject, monitor disease progress in a subject having cancer, and monitor treatment progress in a subject having cancer.

Abstract: The invention comprises a process for the preparation of a chiral triol of formula I wherein, R1 is hydrogen or halogen by way of an asymmetric hydrogenation of a ketone compound of formula IIa wherein, R1 is hydrogen or halogen and R2 is C1-6-alkyl; with hydrogen in the presence of an iridium spiro-pyridylamidophosphine catalyst (Ir-SpiroPAP catalyst). The chiral triols of formula I are versatile building blocks for the preparation of various pharmaceutically active drug substances such as for instance for statins.

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: Provided herein are processes for the preparation of indolyl intermediates using Wenker Synthesis for the total synthesis of SERD compounds useful in the treatment of cancer.

Abstract: The invention provides stable aqueous pharmaceutical formulations comprising an anti-PDL1 antibody. The invention also provides methods for making such formulations and methods of using such formulations.

Abstract: Methods are disclosed to detect, characterize, measure, and quantify human and humanized antibodies, and their conjugates, that may be present in pre-clinical animal biological samples, or human biological samples, including plasma/serum and tissue samples.