MacroGenics, Inc., a privately held biotechnology company that develops immunotherapeutics to treat autoimmune disorders, cancer and infectious diseases, has announced that it had administered drug to the first cohort of patients in a Phase I clinical trial of MGAH22.
MGAH22 is an Fc-optimized monoclonal antibody developed by MacroGenics which has been shown, in pre-clinical studies, to reduce tumor growth significantly in a broad panel of HER2-expressing tumors.
"We are excited to have begun clinical testing of MGAH22, a next generation antibody that may have wide application in cancer treatment," stated Dr. Scott Koenig, President and CEO of MacroGenics. "MGAH22 is the first Fc-engineered antibody therapeutic from our oncology pipeline to enter clinical development and represents a major milestone for MacroGenics. Our pre-clinical studies suggest that MGAH22 may provide significant differentiation from the other HER2-targeted immunotherapeutics, including the ability to treat tumors with relatively low levels of HER2 expression."
This open-label, multi-dose, single-arm, multi-center Phase I, dose-escalation study is being conducted to define the toxicity profile, maximum tolerated dose, pharmacokinetics, immunogenicity, and potential antitumor activity of MGAH22 in patients with refractory HER2-positive breast cancer and patients with other carcinomas that overexpress HER2 for whom no standard therapy is available. Additional information on the clinical trial can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01148849.