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MGAH22: HER2+ Tumors (Breast, other)

Phase 1 clinical study in patients with HER2 positive solid tumors.
Learn more: MGAH22
Learn more: ClinicalTrials.gov

Company Highlights

  • Robust pipeline in oncology, autoimmunity and infectious diseases
  • Partners include Boehringer Ingelheim, Pfizer and Servier
  • Fully-integrated biologics capabilities across product development process 
  • Strong financial position and blue-chip investor base
  • Experienced management team and highly collaborative corporate culture 
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Corporate Timeline

2011
  • Entered MGA271 option deal with Servier
  • Initiated MGA271 Phase 1 trial
  • Published analysis of teplizumab Phase 3 data in The Lancet
  • Published DART data in Blood demonstrating potent activity vs. BiTE
2010
  • Entered strategic DART collaborations with BI, Pfizer
  • Initiated MGAH22 Phase 1 trial
2009
  • Completed PROTÉGÉ enrollment
  • Initiated MGAWN1 Phase 2 trial
2008
  • $25M Series D financing
  • Acquired Raven Biotech.
2007
  • Global strategic alliance with    Eli Lilly & Co. (anti-CD3)
    2006
  • Initiated teplizumab pivotal T1D study
  • Orphan drug designation for teplizumab in T1D
  • Gov't awards > $62M to advance infectious disease programs
  • $45M Series C financing
    2005
  • Opened cGMP manuf. facility
  • In-licensed teplizumab
    2004
  • $30.5M Series B financing
    2002
  • $12.6M Series A2 financing
    2001
  • $13.5M Series A financing
    2000
  • Founded by Scott Koenig and scientists from Rockefeller Univ. and Inst. for Systems Biology
Home»About Us

About Us

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 cancer, autoimmune disorders and infectious diseases.

Our team of 135 dedicated individuals is committed to apply breakthrough science to create life-changing medicines. As an example, our lead autoimmune product candidate, 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. If successful, this approach would represent 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.
    Our innovative product candidates leverage our fully-integrated capabilities around the discovery, development, and production of antibodies and incorporate three proprietary technology platforms:


Research & Development Process at MacroGenics

The illustration below provides an 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: oncology, autoimmune disorders and infectious diseases. 

In oncology, MacroGenics initiated clinical development of MGAH22 in August 2010.  MGAH22 is the first Fc-modified anti-cancer mAb produced from the company’s proprietary Fc optimization technology and targets tumors that over-express the HER2 oncoprotein, potentially including breast, bladder, gastric, prostate and pancreatic.  In mid-2011, MacroGenics began clinical development of its second anti-cancer mAb, MGA271, which recognizes a novel target (B7-H3), which is expressed on several solid tumor types.  MGA271 is a humanized, Fc-optimized mAb that is being studied for the treatment of multiple solid tumors, potentially including prostate, renal and pancreatic cancers as well as melanomas.  MacroGenics’ earlier stage oncology pipeline includes multiple programs for which the company expects to select clinical development candidates over the next several years.

The company’s lead autoimmune program, teplizumab, is an anti-CD3 antibody being developed for the prevention and treatment of early onset type 1 diabetes.  In June 2011, MacroGenics announced the publication in The Lancet of results from Protégé, a Phase 3 clinical study of teplizumab in type 1 diabetes. Exploratory, post-hoc analyses suggest that teplizumab, an anti-CD3 monoclonal antibody, when used in a full dose regimen may preserve C-peptide and increase the percentage of patients requiring very low doses of insulin compared to those on placebo. In addition, these analyses identified certain subpopulations to be studied in future trials.

MacroGenics is also pursuing development of its own proprietary molecules for the treatment of inflammatory disease.

MacroGenics’ infectious disease portfolio includes several antibody-based therapeutics for the treatment of infectious diseases from pathogens, including Dengue, smallpox and H5N1.


View full Product Pipeline