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July 06, 2015 1:19 AM ET

Biotechnology

Company Overview of MacroGenics, Inc.

Company Overview

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

United States

Founded in 2000

211 Employees

Phone:

301-251-5172

Fax:

301-251-5321

Key Executives for MacroGenics, Inc.

Chief Executive Officer, President and Director
Age: 63
Total Annual Compensation: $466.5K
Chief Financial Officer, Senior Vice President and Corporate Secretary
Age: 48
Total Annual Compensation: $313.8K
Senior Vice President of Research
Age: 61
Total Annual Compensation: $328.0K
Senior Vice President and General Counsel
Age: 42
Total Annual Compensation: $228.9K
Senior Vice President of Clinical Development
Age: 53
Total Annual Compensation: $148.6K
Compensation as of Fiscal Year 2014.

MacroGenics, Inc. Key Developments

MacroGenics, Inc. Announces Updated Results of Phase 1 Study of Margetuximab

MacroGenics, Inc. announced that updated results of the Phase 1 study of margetuximab were reported during a poster session at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO). Howard A. Burris III, M.D., FACP, Chief Medical Officer of Sarah Cannon Research Institute, and first author presented "Updated findings of a first-in-human, phase 1 study of margetuximab, an Fc-optimized chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors," during the Breast Cancer HER2/ER poster session. The primary objective of the study was to evaluate safety of margetuximab using two dosing regimens. Margetuximab was found to be well-tolerated at all doses. This open-label, multi-dose, single-arm, multi-center Phase 1, dose-escalation study was conducted in 60 patients with HER2-positive (2+ or 3+ by immunohistochemistry, or IHC) neoplasms, including 23 with breast cancer, and was aimed at defining the toxicity profile, maximum tolerated dose, pharmacokinetics, immunogenicity and potential anti-tumor activity of margetuximab (MGAH22). Margetuximab was administered by IV infusion once per week for 4 weeks in the following dose escalation cohorts: 0.1, 0.3, 1.0, 3.0, and 6.0 mg/kg; and once every 3 weeks in the following dose escalation cohorts: 10.0, 15.0, and 18.0 mg/kg. Study results showed that margetuximab was well-tolerated at all explored doses, including the high dose tested. Infusion reactions were generally mild overall and were well controlled with pre-medication. The most common adverse events (AEs) were Grade 1-2 constitutional symptoms and infusion-related reactions. No cardiac dysfunction was observed. Monotherapy anti-tumor activity was observed across several tumor types, including patients with gastric, colorectal and head and neck cancer as well as patients with breast cancer who had received extensive prior therapy and progressed on prior HER2-directed therapy. Tumor reductions were observed in 13 of 19 evaluable patients with breast cancer, including 4 of 19 patients with confirmed partial responses. In this population, a median progression-free survival (PFS) of approximately 5.5 months was observed. MacroGenics will commence SOPHIA, a pivotal Phase 3 study in approximately 530 patients, 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 IHC or 2+ level by IHC with gene amplification. MacroGenics projects that it will take approximately three years to complete this study.

MacroGenics, Inc. Reports Consolidated Earnings Results for the First Quarter Ended March 31, 2015; Announces the Clearance for Clinical Testing of MGD011

MacroGenics, Inc. reported consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported total revenue of $71,279,000, income from operations of $45,132,000, net comprehensive income of $45,129,000 or $1.42 per diluted share compared to total revenue of $14,719,000, loss from operations of $3,108,000, net comprehensive loss of $3,108,000 or $0.12 per basic and diluted share a year ago. Non-GAAP total revenues were $8,971,000, loss from operations was $17,176,000 and net comprehensive loss was $17,179,000 or $0.58 per basic and diluted share. The company announced the clearance for clinical testing of MGD011, following recent IND submission to the FDA. With the anticipated clinical initiation of this molecule by collaboration partner, Janssen Biotech, Inc., and recent Phase 1 initiation of MGD010, MGD011 will represent the fourth Dual-Affinity Re-Targeting molecule, or DART, to enter the clinic.

MacroGenics, Inc. to Report Q1, 2015 Results on May 06, 2015

MacroGenics, Inc. announced that they will report Q1, 2015 results at 4:30 PM, US Eastern Standard Time on May 06, 2015

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