AGC Biologics has entered into a commercial supply agreement with MacroGenics for the manufacture of margetuximab, a clinical-stage, novel immune-optimized monoclonal antibody. MacroGenics is a clinical-stage biopharma company developing monoclonal antibody-based therapeutics for the treatment of cancer.
 
AGC Biologics has provided development and validation services for margetuximab since 2014, and plans to implement a transition to commercial supply services.
 
Margetuximab is an investigational product that targets the human epidermal growth factor receptor 2, or HER2. HER2 is expressed by tumor cells in breast, gastroesophageal, bladder and other forms of solid tumor cancers, making it a key marker for biologic therapy. Margetuximab has an Fc domain, which was engineered to enhance engagement and activation of the immune system.
 
“Patients with late-stage cancer, such as metastatic breast cancer, often have limited choices and greater uncertainty regarding what drug will be most effective as the next step in their treatment path,” said Gustavo Mahler, Ph.D., president and chief executive officer of AGC Biologics. “We’re thrilled to work alongside MacroGenics in potentially bringing margetuximab to the market — filling a critical need, and delivering a promising new treatment option, if approved, with the chance to meaningfully impact patients’ lives.”
 
“We’re pleased to have worked with AGC Biologics to bring the development of margetuximab to this point, getting MacroGenics closer to our goal of providing a possibly meaningful advance to patients in need,” said Tom Spitznagel, Ph.D., senior vice president, Biopharmaceutical Development & Manufacturing at MacroGenics. “AGC Biologics has been an important partner throughout the development and validation process, providing the expertise, technology and customized flexibility to facilitate the exciting path of margetuximab from development to pre-commercialization.”