Abstract: In one embodiment, a method includes receiving one or more querying images associated with a container of a pharmaceutical product, each of the one or more querying images being based on a particular angle of the container of the pharmaceutical product, calculating one or more confidence scores associated with one or more defect indications, respectively for the container of the pharmaceutical product, by processing the one or more querying images using a target machine-learning model, and determining a defect indication for the container of the pharmaceutical product from the one or more defect indications based on a comparison between the one or more confidence scores and one or more predefined threshold scores, respectively.
Abstract: The present disclosure provides compositions, methods, and kits for detecting lipolytic activity. In some embodiments, the composition comprises an aqueous assay sample and an organic solvent, wherein the organic solvent comprises 4-methylumbellif-erryl caprylate (MU-C8). Also provided herein are methods for determining the stability of a protein preparation.
Type:
Application
Filed:
August 31, 2021
Publication date:
November 2, 2023
Applicant:
GENENTECH, INC.
Inventors:
Li YI, Adithi Chandrasekhara BHARGAVA, Inn Huam YUK
Abstract: The present disclosure provides methods and systems for high throughput assays for testing immune cell engager molecules and potential immune cell engager molecules. In some embodiments, multiple parameters, for example, in connection with engagement of tumor cells by immune cells such as T cells and in connection with tumor cell death, may be analyzed from the same samples in the assays, and, in some cases, may be analyzed simultaneously. In some embodiments, the methods and systems allow for determining the kinetics of various parameters.
Abstract: The invention relates generally crystalline mesylate salts, crystalline chloride salts and crystalline sulfate salts of the compound (S)-2-(3?-(hydroxymethyl)-1-methyl-5-((5-(2-methyl-4-(oxetan-3-yl)piperazin-1-yl)pyridin-2-yl)amino)-6-oxo-1,6-dihydro- [3,4?-bipyridin]-2?-yl)-7,7-dimethyl-2,3,4,6,7,8-hexahydro-1H-cyclopenta[4,5]pyrrolo[1,2-a]pyrazin-1-one that is an inhibitor of Bruton’s tyrosine kinase. In some aspects, the crystalline salts are single polymorphs.
Abstract: Provided herein are high throughput methods for optimizing and manufacturing various lipid nanoparticle (LNP) compositions and uses thereof. For example, in some embodiments, the present disclosure provides a high-throughput screening method for manufacturing a LNP composition comprising, obtaining at least two intermixable solutions comprising a payload and a plurality of molecules capable of self-assembly and mixing said at least two solutions under a set of controlled conditions, by which injection sequence, speed, volume, phase ratio and mixing duration are varied. In various embodiments, the present disclosure enables optimal encapsulation efficiency, particle size distribution, purification and particle recovery rate, and formulation stability to be determined. The methods disclosed herein enable efficient optimization of manufacturing conditions for preparation of LNP-based therapeutics.
Abstract: The subject matter described herein is directed to antibody-CIDE conjugates (Ab-CIDEs) that target BRM for degradation, to pharmaceutical compositions containing them, and to their use in treating diseases and conditions where BRM degradation is beneficial.
Type:
Application
Filed:
January 19, 2023
Publication date:
October 19, 2023
Applicant:
Genentech, Inc.
Inventors:
Peter Scott DRAGOVICH, Summer A. BAKER DOCKREY, Thomas Harden PILLOW, Donglu ZHANG
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 combination therapies comprising a KRasG12C inhibitor (e.g. GDC-6036) and an PI3K-inhibitor (e.g. inavolisib) and methods of using such combination therapies.
Type:
Application
Filed:
April 4, 2023
Publication date:
October 12, 2023
Applicant:
Genentech, Inc.
Inventors:
Mark Andrew MERCHANT, Jennifer Lee SCHUTZMAN, Zhen SHI, Chunyan SONG, Neekesh Vijay DHARIA, Stephanie Royer JOO
Abstract: The present invention relates to complement C1r subcomponent (C1R) inhibitors for use in treatment of neurological diseases. The invention in particular relates to the use of C1R inhibitors for down-regulation of C1R expression. The invention also relates to nucleic acid molecules, which are complementary to C1R and capable of reducing the level of an C1R mRNA. Also comprised in the present invention is a pharmaceutical composition and its use in the treatment of neurological diseases.
Type:
Application
Filed:
November 9, 2022
Publication date:
October 12, 2023
Applicant:
Genentech, Inc.
Inventors:
Alexander MUNK, Helene M. GYLLING, Jesse Eric HANSON, Lukasz J. KIELPINSKI
Abstract: Provided herein are solid forms, salts, and formulations of 3-((1R,3R)-1-(2,6-difluoro-4-((1-(3-fluoropropyl)azetidin-3-yl)amino)phenyl)-3-methyl-1,3,4,9-tetrahydro-2H-pyrido[3,4-b]indol-2-yl)-2,2-difluoropropan-1-ol, processes and synthesis thereof, and methods of their use in the treatment of cancer.
Type:
Grant
Filed:
December 3, 2020
Date of Patent:
October 10, 2023
Assignees:
Genentech, Inc., Hoffmann-La Roche Inc.
Inventors:
Cheol Keun Chung, Jie Xu, Hans Iding, Kyle Clagg, Michael Dalziel, Alec Fettes, Francis Gosselin, Ngiap-Kie Lim, Andrew McClory, Haiming Zhang, Paroma Chakravarty, Karthik Nagapudi, Sarah Robinson
Abstract: The present invention relates generally to the fields of molecular biology and growth factor regulation. More specifically, the invention relates to therapies for the treatment of pathological conditions, such as cancer.
Abstract: Provided are combination therapies comprising inavolisib (a.k.a. GDC-0077) and other HER2-targeted therapies (e.g., pertuzumab and trastuzumab) for the treatment of HER2-positive cancers; and methods of treating HER2 positive (HER2+) cancers in a patient (preferably a patient with a PIK3CA mutant breast cancer) comprising administering a therapeutically effective amount of inavolisib and a HER2-targeted therapy (e.g., trastuzumab, pertuzumab, or a combination of trastuzumab and pertuzumab).
Type:
Application
Filed:
June 9, 2023
Publication date:
October 5, 2023
Applicants:
Genentech, Inc., Hoffmann-La Roche Inc.
Inventors:
Jennifer Lee Schutzman, Chunyan Song, Kyung Wha Song, Eirini Thanopoulou, Simon Peter Warburton, Anwesha Dey, Stephanie Royer Joo
Abstract: The present disclosure relates to methods and compositions for determining the relative distribution of glucuronidation, iduronidation, and/or galacturonidation of polypeptides, including stereoselective liquid chromatography-mass spectrometry (LC-MS) methods capable of achieving the simultaneous separation and relative quantitation of glucuronidation, iduronidation, and/or galacturonidation of polypeptides.
Abstract: Processes for preparing biheteroaryl compounds are provided, including the biheteroaryl compound 3-(difluoromethoxy)-5-[2-(3,3-difluoropyrrolidin-1-yl)-6-[(1S,4S)-2-oxa-5-azabicyclo[2.2.1]heptan-5-yl]pyrimidin-4-yl]pyridin-2-amine. Among other advantages, the processes provide for: the use of solvents that are relatively non-toxic and inexpensive; reduced usage of expensive precious metal catalysts; reaction temperature reduction in certain steps; the use of relatively non-toxic oxidation agents; the use of inexpensive transition metal catalysts; a reduction of molar ratios of certain reactants thereby improving process efficiency while reducing cost and waste; significantly higher reactant concentrations in certain steps; elimination of the need for multiple chromatographic purification steps; elimination of the need for certain extraction steps using organic solvent; and provide for higher yield and improved purity.
Type:
Application
Filed:
March 31, 2023
Publication date:
October 5, 2023
Applicants:
Genentech, Inc., Hoffmann-La Roche Inc.
Inventors:
Fabienne HOFFMANN-EMERY, Manuel KONRATH, Christian LAUTZ, Katrin Monika NIEDERMANN, Jonathan Ugo ORCEL, Diane Elizabeth CARRERA
Abstract: The present invention relates to complement component 4 (C4) inhibitors for use in treatment of a neurological disease. The invention in particular relates to the use of C4 inhibitors for down-regulation of C4 expression. The invention also relates to nucleic acid molecules, which are complementary to C4A and/or C4B and capable of reducing the level of an C4A and/or C4B mRNA. Also comprised in the present invention is a pharmaceutical composition and its use in the treatment of a neurological disease.
Type:
Application
Filed:
November 9, 2022
Publication date:
October 5, 2023
Applicant:
Genentech, Inc.
Inventors:
Alexander MUNK, Helene M. GYLLING, Jesse Eric HANSON, Lukasz J. KIELPINSKI
Abstract: Assays to analyze quality and quantity attributes of fixed dose combinations are provided. In particular, assays for fixed dose combinations of two anti-HER2 antibodies, and for subcutaneous formulations comprising pertuzumab and trastuzumab are described herein.
Type:
Application
Filed:
January 11, 2023
Publication date:
October 5, 2023
Applicants:
Genentech, Inc., Hoffmann-La Roche Inc.
Inventors:
Cécile AVENAL, Nadine HOLZMANN, Michael NOAK, Tania RUCHTY, Gabriele Maria SCHAEFER, Franziska ZAEHRINGER