Abstract: The present invention relates to treatment methods for leukemia using bispecific antibody constructs that specifically bind to human CD33 and human CD3. In particular, the present invention relates to methods for treating myeloid leukemia, including relapsed/refractory myeloid leukemia, in a patient in need thereof comprising administering to the patient at least one initiation cycle and at least one maintenance cycle of an anti-CD33×anti-CD3 bispecific antibody construct, wherein each initiation cycle and maintenance cycle comprises administering the bispecific antibody construct according to specific dosage regimens. Pharmaceutical compositions comprising the bispecific antibody constructs for use in the methods are also disclosed.
Abstract: Provided herein are PD-1 antigen-binding proteins and related nucleic acids, vectors, host cells, kits and pharmaceutical compositions. Methods of making PD-1 antigen-binding proteins and methods of treating a subject are further provided.
Type:
Grant
Filed:
January 11, 2019
Date of Patent:
December 6, 2022
Assignee:
Amgen Inc.
Inventors:
Khaled M. K. Z. Ali, Neeraj Jagdish Agrawal, Gunasekaran Kannan, Ian Foltz, Zhulun Wang, Daren Bates, Marissa Mock, Shunsuke Takenaka
Abstract: A drug delivery device includes a housing with at least one pressure communication channel or aperture, which distributes a negative fluid pressure across its base to draw tissue against the device. The device can also include a porous, adhesive layer over the channel(s) or aperture(s), for attaching to tissue. The device can also include a pressure sensor for determining whether there is proper attachment. Further, a bladder may be used instead of the adhesive layer for attaching the device. The bladder, in a partially inflated state, can apply constant pressure across a contact surface causing a flexible adhesive layer attached to the bladder to confirm and adhere to the tissue. Subsequent evacuation of the bladder causes it to deflate and collapse or retract, thereby causing the flexible adhesive layer to pull and stretch the tissue toward the base.
Abstract: An injector for delivering a therapeutic product may include a base having a flexible surface that conforms to various body contours of a patient and defines one or more an injection chambers. The injector may have a height that is substantially less than its width, thereby defining a low profile, which provides a larger more stable base that can pinch or stretch the skin in a controlled manner. The larger base can also accommodate larger volumes via multiple injection chambers and/or large combined primary containers.
Type:
Grant
Filed:
April 7, 2020
Date of Patent:
November 29, 2022
Assignee:
AMGEN INC.
Inventors:
Mark Ka Lai Lee, Stephanie Toy, Valerie M. Fenster
Abstract: The present disclosure provides compounds useful for the inhibition of Delta-5 Desaturase (“D5D”). The compounds have a general Formula I wherein the variables of Formula I are defined herein. This disclosure also provides pharmaceutical compositions comprising the compounds, uses of the compounds, and compositions for treatment of, for example, a metabolic or cardiovascular disorder. Further, the disclosure provides intermediates useful in the synthesis of compounds of Formula I.
Type:
Grant
Filed:
November 24, 2020
Date of Patent:
November 29, 2022
Assignee:
AMGEN INC.
Inventors:
Jennifer R. Allen, Michela Beltrani, Matthew P. Bourbeau, Teodora P. Damyanova, Iain Lingard, Ana E. Minatti, Paolo Vincetti
Abstract: The invention relates to methods for removal of low isoelectric point product-related impurities during cation exchange purification operations.
Type:
Application
Filed:
November 4, 2020
Publication date:
November 24, 2022
Applicant:
AMGEN INC.
Inventors:
Malhar R. AMBHAIKAR, Luis DIAZ, Natalia R. GOMEZ, Benjamin J. TILLOTSON
Abstract: The invention relates to high salt load conditioning during cation exchange chromatography for removal of low isoelectric point product-related impurities during manufacture of recombinant multispecific proteins.
Abstract: Amide compounds of formula (I): as defined herein, and synthetic intermediates thereof, which are capable of modulating KIF18A protein thereby influencing the process of cell cycle and cell proliferation to treat cancer and cancer-related diseases. The invention also includes pharmaceutical compositions, including the compounds, and methods of treating disease states related to the activity of KIF18A.
Type:
Application
Filed:
August 3, 2020
Publication date:
November 24, 2022
Applicant:
AMGEN INC.
Inventors:
Nuria A. TAMAYO, Abhisek BANERJEE, Jian Jeffrey CHEN, Matthew Richard KALLER, Thomas T. NGUYEN, Nobuko NISHIMURA, Qiufen May XUE, John Gordon ALLEN, Michael J. FROHN
Abstract: The present invention relates to antibodies that bind to soluble BCMA (sBCMA). Moreover, the invention relates to a detection system comprising such antibodies. The antibodies or the detection system may be used for detecting or quantifying sBCMA, for diagnosing a disease associated with sBCMA, for patient stratification, monitoring disease progression, and evaluating the therapeutic response.
Abstract: The present disclosure relates to AM-14 pharmaceutical formulations and therapeutic dosing regimens for the treatment of disease.
Type:
Grant
Filed:
September 8, 2020
Date of Patent:
November 22, 2022
Assignee:
AMGEN K-A, INC.
Inventors:
Dingjiang Liu, Holly Zhuohong Huang, David Andrew Martin, Christopher Boyd Russell, David H. Salinger, Scott Walter Baumgartner, Christopher Endres
Abstract: The present invention provides a compound of formula (I) or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising a compound of the invention, a method for manufacturing compounds of the invention and therapeutic uses thereof.
Type:
Application
Filed:
August 13, 2019
Publication date:
November 17, 2022
Applicants:
Amgen Inc., Carmot Therapeutics, Inc.
Inventors:
John R. BUTLER, Daniel ERLANSON, Russell GRACEFFA, Jeffrey IWIG, Joon Won JEONG, Ryan D. WHITE, Yongwei WU, Shuyan YI, Xiao Mei ZHENG, Jesse M. MCFARLAND, Abhisek BANERJEE
Abstract: The present invention relates to methods for purifying nucleic acids. In particular, the present invention relates to methods for purifying carbohydrate-conjugated oligonucleotides using a mixed-mode stationary phase and a mobile phase comprising a dual salt/organic solvent gradient. Methods for purifying carbohydrate-conjugated oligonucleotides using an anion exchange stationary phase and a mobile phase comprising a dual pH/salt gradient are also described.
Abstract: The present invention relates to methods of upregulating the high mannose glycoform content of a recombinant protein during a mammalian cell culture by manipulating the mannose to total hexose ratio in the cell culture media formulation.
Abstract: The present invention relates to antagonist antibodies of the human calcitonin gene-related peptide (CGRP) receptor as well as bispecific antigen binding proteins derived from the anti-CGRP antibodies that bind to and inhibit both the human CGRP receptor and another target, such as the human pituitary adenylate cyclase activating polypeptide type I receptor (PAC1) receptor. Pharmaceutical compositions comprising the anti-CGRP receptor antibodies and bispecific antigen binding proteins as well as methods for producing them are also disclosed. Methods of using the anti-CGRP receptor antibodies and bispecific antigen binding proteins to ameliorate, treat, or prevent conditions associated with the CGRP and PAC1 receptors, such as chronic pain, migraine, and cluster headache, are also described.
Type:
Application
Filed:
June 26, 2020
Publication date:
November 17, 2022
Applicant:
AMGEN INC.
Inventors:
Irwin CHEN, Su CHONG, Fernando GARCES, Mark Leo MICHAELS, Christopher MOHR, Kenneth William WALKER, Zhulun WANG, Neeraj Jagdish AGRAWAL, Bryna FUCHSLOCHER, Kevin GRAHAM, Agnes Eva HAMBURGER, Derek E. PIPER, Cen XU
Abstract: An inspection system for a drug container is provided to identify foreign matter, such as particles or fibers, within the drug container prior to filling with a drug. The system includes a camera device aligned with an axis of the drug container and captures a series of images of an interior surface of a sidewall of the drug container while the robot causes relative movement between the drug container and the camera device along a linear path. Atypical lighting, which improves contrast between particles and the background in images is employed to aid detection. A control circuit then processes the series of images to identify foreign matter within the drug container.
Type:
Grant
Filed:
February 12, 2019
Date of Patent:
November 15, 2022
Assignee:
AMGEN INC.
Inventors:
Thomas C. Pearson, Neelima Chavali, Dmitry Fradkin, Graham F. Milne, Erwin Freund
Abstract: The invention provides a bispecific antibody construct comprising a first human binding domain capable of binding to human CDH19 on the surface of a target cell and a second domain capable of binding to human CD3 on the surface of a T cell. Moreover, the invention provides a nucleic acid encoding the antibody construct, a vector comprising the nucleic acid and a host cell transformed or transfected with the vector. Furthermore, the invention provides a process for the production of the bispecific antibody construct, a medical use of the antibody construct and a kit comprising the antibody construct. The bispecific antibody construct may be useful in the treatment of melanoma.
Type:
Grant
Filed:
July 20, 2018
Date of Patent:
November 15, 2022
Assignees:
AMGEN RESEARCH (MUNICH) GMBH, AMGEN INC.
Inventors:
Shouhua Xiao, Zheng Pan, Dineli Wickramasinghe, M. Shawn Jeffries, Chadwick Terence King, Brian Mingtung Chan, Peter Kufer, Ralf Lutterbüse, Tobias Raum, Patrick Hoffmann, Doris Rau, Roman Kischel, Bryan Lemon, Holger Wesche
Abstract: The apparati, methods, and computer program products disclosed herein can be used to nondestructively detect undissolved particles, such as glass flakes and/or protein aggregates, in a fluid in a vessel, such as, but not limited to, a fluid that contains a drug.
Type:
Grant
Filed:
October 5, 2020
Date of Patent:
November 15, 2022
Assignee:
AMGEN INC.
Inventors:
Graham F. Milne, Erwin Freund, Ryan L. Smith
Abstract: The invention provides for the removal of a large fraction of contaminants from protein preparations while maintaining a high level of recovery using tentacle anion exchange matrix chromatography medium. Using the methods of the invention, leached affinity chromatography contaminants can be removed from recombinant protein preparations.