of Amgen’s BiTE® Platform in Heavily Pre-Treated Patients With Multiple Myeloma and Acute Myeloid Leukemia
FDA Grants Fast Track Designation for AMG 420
Amgen (NASDAQ:AMGN) today announced the first clinical results from studies evaluating investigational novel bispecific T cell engager (BiTE®) immunotherapies AMG 420 and AMG 330. In two separate Phase 1 dose escalation studies, AMG 420, which targets B-cell maturation antigen (BCMA), and AMG 330, which targets CD33, provided early evidence of tolerability and anti-tumor activity in patients with relapsed and/or refractory multiple myeloma and relapsed or refractory acute myeloid leukemia (AML), respectively. These data were highlighted during oral presentations at the 60thAmerican Society of Hematology (ASH) Annual Meeting & Exposition in San Diego.
BiTE® antibody construct technology, pioneered by Amgen, is an innovative treatment approach that helps the body’s immune system attack cancer cells without the removal of immune cells from the patient. Amgen is studying a number of “off-the-shelf” investigational BiTE®immunotherapies, with distinct targets, across a range of hematologic and solid tumors.
“Building on our success with the only approved BiTE® immunotherapy available for patients, Amgen is emphasizing our commitment to the potential of this platform by advancing the development of approximately a dozen novel molecules across hematologic and solid tumor targets in hopes of continuing to offer meaningful advances to patients in need,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We’re encouraged by the early results of investigational BiTE® immunotherapies AMG 420 and AMG 330, especially when considered in the context of these heavily pre-treated patients, many of whom have run out of available options. We look forward to sharing more results from our BiTE® pipeline at future medical meetings.”
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