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Learn more: teplizumab
Learn more: ClinicalTrials.gov
Since its founding in 2000, MacroGenics has focused on applying its world-class antibody capabilities to discover, develop and deliver to patients novel biologics for the treatment of autoimmune disorders, cancer and infectious diseases.
Our team of over 170 dedicated individuals is committed to apply breakthrough science to create life-changing medicines. As an example, our lead clinical product, teplizumab, is thought to reprogram the immune system to re-establish the lost immune balance that occurs in autoimmune diseases such as type 1 diabetes. This approach represents a paradigm-shift in the management of a disease for which there has been no new treatment since the introduction of insulin in the 1920’s.
Research & Development Process at MacroGenics
The illustration below provides a simple overview of the research and development process at MacroGenics. By maintaining in-house capabilities across the entire product development spectrum, we reduce our reliance on external contractors and better anticipate downstream development requirements. Furthermore, our highly collaborative approach to product development facilitates the rapid transition of programs through the development process.

Product Pipeline Summary
MacroGenics has a diverse portfolio of product candidates focused in three therapeutic areas: autoimmune disorders, oncology and infectious diseases.
The company’s lead program, teplizumab, is an anti-CD3 antibody being developed for the treatment of autoimmune diseases, including type 1 diabetes. In October 2007, MacroGenics and Eli Lilly and Company announced a global strategic alliance to develop and commercialize teplizumab as well as other potential next-generation anti-CD3 molecules. In June 2009, MacroGenics and Lilly announced that Protégé, their pivotal Phase 2/3 clinical study evaluating teplizumab in individuals with recent-onset type 1 diabetes, had achieved its targeted patient enrollment. The companies also announced that they had initiated the Protégé Encore trial, a second Phase 3 global study of teplizumab designed to capture patient-reported outcome measures in addition to safety and efficacy data. Learn more: Protégé Studies
In addition to its relationship with Lilly, MacroGenics is also pursuing development of its own proprietary molecules for the treatment of inflammatory disease.
In oncology, MacroGenics plans to initiate clinical development of MGAH22 in 2010. This product candidate is the first Fc-modified anti-cancer mAb produced from the company’s proprietary Fc optimization technology. MacroGenics’ earlier stage oncology pipeline includes multiple programs for which the company expects to select clinical development candidates over the next several years.
MacroGenics’ infectious disease portfolio includes MGAWN1, a humanized mAb that targets West Nile Virus. In July 2009, MacroGenics initiated the PARADIGM study, a Phase 2 clinical trial evaluating MGAWN1 for the potential treatment of individuals with neurological complications associated with West Nile Virus. MacroGenics was awarded a $50 million contract in September 2006 from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to support the development of MGAWN1. MacroGenics and its academic collaborators are also investigating antibody-based therapeutics for the treatment of infectious diseases from other pathogens, including Dengue, smallpox and H5N1.
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