1500 East Gude Drive
MacroGenics, Inc. is a product driven company with an experienced management team that is focused on developing immune-based products including monoclonal antibodies to treat patients with cancer, autoimmune/inflammatory disorders, and infectious diseases. Founded in 2000, MacroGenics is a private, venture-backed biotechnology company headquartered in Rockville, Maryland. MacroGenics has a spectrum of fully integrated capabilities in monoclonal antibody product development including:
- Preclinical in vitro and in vivo development
MacroGenics is well positioned to compete in the area of monoclonal antibody therapeutics. Furthermore, MacroGenics has developed proprietary technology platforms and a diverse product portfolio with several drugs currently in clinical testing and others to enter clinical trials in the near future.
- Monoclonal antibody development and humanization
- Monoclonal antibody lead optimization
- Assay development
- Manufacturing of monoclonal antibodies under cGMP
- Clinical/Regulatory development.
PRODUCT DEVELOPMENT PROGRAMS:
• TEPLIZUMAB ANTI-CD3 PROGRAM – CD3 is a key signaling receptor associated with the T cell receptor complex. In partnership with Eli Lilly, MacroGenics is developing teplizumab (hOKT3-ala-ala antibody; MGA031) for the treatment of autoimmune/inflammatory disease. Previous human clinical testing showed promising results in a variety of indications. A pivotal phase III trial in type I diabetes is ongoing and other autoimmune/inflammatory indications including multiple sclerosis, psoriatic arthritis, psoriasis, rheumatoid arthritis, lupus, and IBD are being considered for further clinical development.
• MGAWN1 WEST NILE VIRUS PROGRAM – MacroGenics is developing an anti-WNV monoclonal antibody for treatment of viral induced encephalitis. MGAWN1 is a humanized monoclonal antibody that specifically neutralizes the virus. In September 2006, MacroGenics was awarded a $50 million contract from the National Institute for Allergy and Infectious Diseases to support the development of MGAWN1 through manufacturing and Phase 2 clinical trials. A phase I trial in normal healthy volunteers is currently ongoing. If approved for marketing by the U.S. Food and Drug Administration, the antibody could be used for the treatment of individuals with confirmed diagnoses of West Nile Virus infection or individuals who have signs and symptoms consistent with West Nile Virus neuroinvasive disease.
• NEXT GENERATION, Fc-OPTIMIZED, BEST-IN-CLASS – MacroGenics has utilized its proprietary Fc engineering platform to develop a next generation Mab with superior anti-tumor activity. We have demonstrated it performs better in vivo and in vitro than the FDA-approved Mab. Clinical testing will begin in early 2009. Fc-optimized, best-in-class Mabs to other clinically validated targets also are in development.
• DUAL AFFINITY RETARGETING (DART) PROGRAM - MacroGenics has developed a platform technology that is focused on dual specificity "antibody-like" therapeutic proteins capable of targeting multiple different epitopes with a single molecule. The DART platform has been specifically engineered to accommodate virtually any variable region sequence in a "plug-and-play" fashion with predictable expression, folding, and antigen recognition. A key technological advancement and distinguishing feature is a proprietary covalent linkage which results in a product with superior stability. This is a flexible platform which yields an array of product possibilities including, but not limited to: 1) modulation of receptor signaling events, 2) redirected effector cell killing, 3) inactivating multiple cytokines/receptor ligands, and 4) targeting multiple epitopes on a pathogen for enhanced neutralization and/or clearance. MacroGenics has developed proof-of-concept data and is developing specific product candidates using this platform.
• Fc ENGINEERING PROGRAM – MacroGenics has created a panel of proprietary Fc Variants that preferentially bind the activating FcRs and enhance the anti-tumor activity of cancer Mabs. Animal tumor modeling studies in wild type and our proprietary human FcR transgenic mice have shown that Mabs containing our Fc variants have enhanced anti-tumor activity. Clinical testing of our first Mab that incorporates this Fc engineering technology will begin in early 2009.
• Cancer Stem Cell Technology – MacroGenics has acquired a portfolio of proprietary cancer stem cells from many types of primary tumors. These cancer stem cells are maintained in vitro, and small numbers of them can form both localized and metastatic tumors in vivo. Using these cancer stem cells, greater than 1,300 monoclonal antibodies, including many that target cancer stem cells and cancers of the lung, colon, pancreas, prostate, breast and ovary, have been generated.
Last Update: 07-17-2008