Business
MacroGenics Provides Update on Corporate Progress and 2019 Financial Results
Margetuximab: BLA for metastatic HER2-positive breast cancer accepted for review by the FDA; Phase 2/3 MAHOGANY study ongoing in front-line advanced
About this update from Macrogenics, Inc.
[{"type":"text","content":"Margetuximab: BLA for metastatic HER2-positive breast cancer accepted for review by the FDA; Phase 2/3 MAHOGANY study ongoing in front-line advanced HER2-positive gastric cancerFirst clinical data from Phase 1/2 studies of MGD013, MGC018 and MGD019 anticipated in 2020Conference call scheduled for today at 4:30 p.m. ET. ROCKVILLE, Md., Feb. 25, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2019.\n “2019 was an important year for MacroGenics, with the submission of our BLA for margetuximab for HER2-positive breast cancer. We also initiated a registration directed clinical study with margetuximab in combination with checkpoint blockade in advanced HER2-positive gastric cancer,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “During 2020, we anticipate additional key events. Following promising data presented at ASH in 2019, we plan to define a registration path for flotetuzumab in refractory AML, pending further discussions with FDA. We also look forward to presenting initial clinical data from several of our programs currently in Phase 1, potentially including our two bispecific DART molecules that provide dual checkpoint blockade, MGD013 and MGD019, as well as MGC018, our ADC targeting B7-H3. We look forward to a productive year for MacroGenics in 2020.” Key Pipeline Updates Recent progress and anticipated events in 2020 related to MacroGenics’ investigational product candidates in clinical development are highlighted below. Margetuximab is an Fc-engineered, anti-HER2 monoclonal antibody being evaluated for the treatment of patients with advanced HER2-positive cancers. Metastatic Breast Cancer. In December 2019, MacroGenics submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The safety and efficacy results provided in the BLA are primarily from the pivotal Phase 3 SOPHIA study, which is evaluating margetuximab plus chemotherapy compared to trastuzumab plus c...