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MacroGenics Initiates Phase I Clinical Trial of MGAH22 for Patients With HER2-Expressing Solid Tumors
Date:1/6/2011

Green Cross Corp., a leading Korean pharmaceutical company, is collaborating with MacroGenics to support the Phase I clinical trial activities in Korea.  In June 2010, Green Cross entered into a collaboration agreement with MacroGenics for the exclusive development and commercialization of MGAH22 in Korea.  MacroGenics received an undisclosed upfront payment and is eligible for future milestones and double-digit royalties on net sales, and will receive future clinical development support for additional studies conducted in Korea.

Background on MGAH22

MGAH22, an Fc-modified monoclonal antibody, targets the HER2 oncoprotein, which is overexpressed on the surface of various cancer cells and plays an important role in tumorigenesis, tumor aggressiveness, and outcome in breast and other cancers.  HER2 has proven to be an excellent target for cancer therapeutics as shown by the clinical success of trastuzumab in both breast and gastric cancer.

The benefits of trastuzumab in metastatic breast and gastric cancer accrue exclusively to patients with the highest level of HER2 expression (HER2 3+ by immunohistochemistry) or those who have gene-amplified tumors. Thus, therapies are needed for patients whose tumors overexpress the HER2 oncoprotein at lower levels without gene amplification.  Furthermore, the benefits of trastuzumab in metastatic breast cancer accrue primarily to patients who are homozygous for the high affinity allele of the Fcγ receptor, CD16A (FγcRIIIA).  These patients represent only approximately 15% of the population.

MacroGenics has engineered MGAH22 for increased binding to the low affinity allele of CD16A, thus offering potentially increased effectiveness in the approximately 85% of patients who carry lower affinity FcγRs.  In addition, this engineering work has been shown in pre-clinical studies to enhance killing of tumors expressing low levels of HER2.

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SOURCE MacroGenics, Inc.
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