Profile: MacroGenics Inc (MGNX.OQ)
18 Apr 2019
MacroGenics, Inc., incorporated on August 14, 2000, is a clinical-stage biopharmaceutical company focused on discovering and developing monoclonal antibody-based therapeutics for the treatment of cancer, as well as various autoimmune disorders and infectious diseases. The Company develops therapeutic product candidates using its antibody-based technology platforms and also in collaboration with other biopharmaceutical companies. The Company has a pipeline of product candidates in human clinical testing, primarily as treatments for different types of cancers, which are created primarily using its technology platforms. Its clinical product candidate is margetuximab, a monoclonal antibody directed against human epidermal growth factor receptor 2 (HER2) that has been enhanced using its Fc Optimization platform. It is also developing several product candidates targeting B7-H3, a protein in the B7 family of immune regulator proteins.
The Company has two clinical product candidates directed against B7-H3, enoblituzumab and MGD009, and it also has ongoing research efforts underway to advance MGC018, an antibody-drug conjugate (ADC) directed against B7-H3. Its candidate in this franchise, enoblituzumab, is a monoclonal antibody that has also been enhanced using its Fc Optimization platform. Four additional DART molecules, MGD006 (flotetuzumab), MGD007, MGD011 (duvortuxizumab) and PF-06671008, are also in Phase I clinical testing and each uses the same approach of targeting luster of differentiation 3 (CD3) and a specific tumor antigen known to be expressed on certain cancers. Its clinical-stage DART molecule, MGD010, has a different mechanism of action than the other DART molecules in development.
The Company is conducting an exploratory Phase Ib/II clinical trial combining margetuximab with an anti-PD-1 antibody in patients with HER2-positive gastric or gastroesophageal junction cancer. The Company is evaluating enoblituzumab in an ongoing Phase I clinical trial as monotherapy in multiple solid tumor types, as well as in combination therapy with either an anti-programmed death (PD)-1 antibody or an anti-CTLA-4 antibody. It is enrolling patients in the United States and Europe in a Phase I clinical trial of flotetuzumab in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). MGD007 is a DART molecule that targets both the glycoprotein A33 (gpA33) and CD3. It is enrolling patients with colorectal cancer in a Phase I clinical trial of MGD007. Duvortuxizumab is a DART molecule that targets both CD19 and CD3 and is being developed for the treatment of B-cell hematological malignancies. Duvortuxizumab is designed to redirect T cells, through their CD3 component, to eliminate CD19-expressing cells found in many hematological malignancies.
MGD009 DART molecule recognizes B7-H3 and CD3, and has an Fc domain, which is designed to provide extended pharmacokinetic properties. It has demonstrated that this molecule is able to mediate T cell killing of cancer cells in preclinical experiments. It is enrolling patients in a Phase I clinical trial of MGD009 in patients across a range of different solid tumors. MGA012 is a monoclonal antibody targeting PD-1. It is enrolling patients in a Phase I clinical trial of MGA012 in patients across a range of different solid tumors. MGD013 is a DART molecule that is intended to enable the co-blockade with a single recombinant agent of two immune checkpoint molecules, PD-1 and LAG-3, which may be co-expressed on T cells. It is conducting investigational new drug application (IND)-enabling activities for MGC018. PF-06671008 is being studied in certain undisclosed solid tumors and is in Phase I clinical testing.
MGD010 is a DART molecule designed to address limitations of existing B cell-targeted therapies by binding to the CD32B and CD79B proteins found on human B cells. In preclinical studies, this DART molecule modulated the function of human B cells without B cell depletion. In normal conditions, B cells utilize CD32B as one of the key checkpoints or negative regulators to ensure that tolerance to self is maintained and autoimmune disease does not occur. It has completed a Phase Ia clinical study in healthy volunteers and observed acceptable safety and pharmacodynamic activity consistent with the expected mechanism of action of MGD010. Teplizumab is an anti-CD3 monoclonal antibody being developed for the treatment of type 1 diabetes. Teplizumab is being evaluated in a Phase II clinical trial for potential application to patients at risk of developing Type 1 diabetes. MGD014 is a DART molecule that targets the envelope protein of human immunodeficiency virus (HIV)-infected cells (Env) and CD3-expressing T cells.
The Company competes with F. Hoffmann-La Roche Ltd., Puma Biotechnology, Inc., Cascadian Therapeutics, Merck & Co., Inc., The Bristol Myers Squibb Company, Amgen Inc., Genmab A/S, Merus B.V., Abbvie Inc., Affimed Therapeutics AG Corporation, Eli Lilly and Company and Xencor, Inc.
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