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MacroGenics Provides Update on Corporate Progress and Third Quarter 2021 Financial Results
Investigational New Drug (IND) application submitted for MGD024, a next generation DART® molecule targeting CD123 and CD3 for AMLU.S. Food & Drug
About this update from Macrogenics, Inc.
[{"type":"text","content":"Investigational New Drug (IND) application submitted for MGD024, a next generation DART® molecule targeting CD123 and CD3 for AMLU.S. Food & Drug Administration (FDA) approves MacroGenics’ GMP manufacturing facility to produce MARGENZA® drug substance Discontinuing enrollment of Cohort A of Phase 2/3 MAHOGANY study of margetuximab Conference call scheduled for today at 4:30 p.m. ET. ROCKVILLE, Md., Nov. 02, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing 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 quarter ended September 30, 2021. “In September, we were pleased to present encouraging preliminary results from our ongoing Phase 1 cohort expansion study of MGC018 at the European Society for Medical Oncology (ESMO) Annual Meeting. We look forward to providing additional clinical data updates on this study next year as well as sharing our future development plans for this molecule in the first quarter of next year, after continued engagement with Key Opinion Leaders and regulatory agencies,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Beyond MGC018, we continue to advance our growing pipeline of investigational product candidates for the potential treatment of cancer. Finally, the recent FDA approval to manufacture MARGENZA drug substance at our GMP manufacturing facility is an important achievement for the Company.” Updates on Proprietary Programs The recent progress and key events related to MacroGenics’ investigational product candidates in clinical development and its approved product, MARGENZA, are highlighted below: MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. At ESMO, MacroGenics presented encouraging preliminary clinical results from the ongoing Phase 1 study of MGC018 in patients with solid tumors. The Phase 1 study cohort expansions are ongoing for metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of the head and neck (SCCHN) and triple negative breast cancer (TNBC). The Company expects to present additional data from the ongoing Phase 1 study of MGC018 in the first half of next year. In addition, Mac...