MacroGenics, Inc., a clinical-stage biopharmaceutical company, focuses on discovering and developing monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases. The company generates its pipeline of product candidates from its proprietary suite of next-generation antibody-based technology platforms. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the company to generate product candidates and enter into various strategic collaborations with global pharmaceutical and biotechnology companies. Its product candidates include Margetuximab, a monoclonal antibody that targets human ep...
9640 Medical Center Drive
Rockville, MD 20850
Founded in 2000
MacroGenics, Inc. Presents at Needham & Company's 14th Annual Healthcare Conference, Apr-14-2015 08:00 AM
Mar 25 15
MacroGenics, Inc. Presents at Needham & Company's 14th Annual Healthcare Conference, Apr-14-2015 08:00 AM. Venue: Westin Grand Central Hotel, New York, New York, United States. Speakers: Scott Koenig, Chief Executive Officer, President and Director.
MacroGenics Begins Phase 1 Study of MGD010 for Treatment of Autoimmune Disorders
Mar 16 15
MacroGenics has begun its Phase 1 study with MGD010, the company's first Dual-Affinity Re-Targeting molecule being developed for patients with autoimmune disorders. This Phase 1 clinical trial is a first-in-human, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MGD010 in healthy subjects. MGD010 is a bi-specific molecule that simultaneously targets CD32B and CD79B, two B-cell surface proteins, for the treatment of autoimmune disorders. MGD010 is designed to inhibit B-cell activation by exploiting the inhibitory function of CD32B, a checkpoint molecule expressed by B cells.
MacroGenics, Inc. Reports Consolidated Earnings Results for the Year Ended December 31, 2014; Provides Update on Corporate Progress
Mar 3 15
MacroGenics, Inc. reported consolidated earnings results for the year ended December 31, 2014. For the period, the company reported total revenue of $47,797,000, loss from operations of $38,315,000, net comprehensive loss of $38,313,000 or $1.40 per basic and diluted share compared to total revenue of $58,035,000, income from operations of $366,000, net comprehensive income of $261,000 or $0.04 per basic and diluted share a year ago.
The company provided update corporate progress. Phase 3 Metastatic Breast Cancer Study: The company expects to commence SOPHIA, a Phase 3 pivotal study in approximately 530 subjects, in the third quarter of 2015. This study is planned to evaluate margetuximab plus chemotherapy against trastuzumab plus chemotherapy in third-line metastatic breast cancer patients with HER2 expression at the 3+ level by immunohistochemistry (IHC) or 2+ level by IHC with gene amplification, subject to completion of further regulatory review. MacroGenics projects that it will take approximately three years to complete this study, which will include an interim futility analysis. Presentation of Phase 1 Data: In mid-2015, MacroGenics plans to present margetuximab Phase 1 clinical data for patients with breast cancer in expansion cohorts testing once-every-three-week dosing regimens. MGA271 is an Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of molecules involved in immune regulation. Presentation of Phase 1 MGA271 Data: In the second half of 2015, MacroGenics plans to present Phase 1 clinical data for MGA271. Combination Studies: MacroGenics plans to initiate studies of MGA271 in combination with other immuno-oncology agents in 2015, including a combination study with ipilimumab in B7-H3 positive melanoma, lung, and head and neck cancers. MGD006 is a humanized DART molecule that recognizes both CD123 and CD3. CD123, the Interleukin-3 receptor alpha chain, is expressed on leukemia and leukemic stem cells. The primary mechanism of action of MGD006 is its ability to redirect T cells, via their CD3 component, to kill CD123-expressing cells. MacroGenics continues to enroll patients in the dose escalation portion of a Phase 1 study of MGD006 for the treatment of acute myeloid leukemia. MGD007 is a humanized DART molecule that recognizes both the glycoprotein A33 antigen, or gpA33, and CD3. The primary mechanism of action of MGD007 is its ability to redirect T cells, via their CD3 component, to kill gpA33-expressing cells. MacroGenics continues to enroll patients in the dose escalation portion of a Phase 1 study of MGD007 for the treatment of colorectal cancer. MacroGenics' pipeline of earlier DART candidates continues to progress. In addition to MGD011, which was recently licensed to Janssen Biotech, Inc., the company expects that both MGD010 and MGD009 will start in Phase 1 clinical studies in 2015. Details of these programs include: MGD010 Nearing Phase 1 Clinical Initiation: MGD010 is a DART molecule for the treatment of autoimmune disorders that simultaneously targets CD32B and CD79B, which are two B-cell surface proteins. MGD010 is designed to inhibit B-cell activation by exploiting the inhibitory function of CD32B, a checkpoint molecule expressed by B cells. MacroGenics expects to initiate a Phase 1a study in normal healthy volunteers in the first half of 2015. This product candidate is subject to a global collaboration with Takeda. Introducing MGD009: In late 2015, MacroGenics anticipates initiating a Phase 1 clinical study of MGD009, a humanized DART molecule that recognizes both CD3 and an undisclosed antigen expressed on many solid tumor types. MacroGenics retains worldwide development and commercialization rights to this molecule.