FC-optimized HER2 single-fight Margetuximab treats stomach cancer, receives FDA award for orphan drug

MacroGenics announced that the U.SFood and Drug Administration (FDA) has awarded the Orphan Drug (ODD) to its single-resistant margetuximab, which targets HER2, to treat cancer in the stomach and gastroesophageal connectionsMargetuximab is a Fc engineering monoclonal antibody targeting HER2HER2 is expressed in tumor cells in breast cancer, gastroesophageal cancer, and other solid tumorsMargetuximab is designed to block the effects of HER2 and has a COMBINATION and anti-proliferation effect similar to qural monitusIn addition, Margetuximab has been modified to enhance its immune function through MacroGenics' Fc optimization technologyPhoto Source: Margetuximab is currently in a Phase 2/3 clinical trial maHOGANY (NCT04082364) to evaluate its potential as a first-line therapy for patients with HER2-positive gastric cancer (GC) or gastroesophageal connectivity (GEJ) in combination with immunocheckpoint inhibitors, with/without chemotherapyDrScott Koenig, President and CEO of MacroGenics, said, "We are pleased that the FDA has granted margetuximab orphan statusWe believe that immune-enhanced antibodies against HER2 have the potential to improve the clinical activity of existing standards of treatment in patients with gastric cancer or gastroesophageal connectivityGastric cancer or gastric esophagus connection cancer is collectively referred to as gastroesophageal adenocarcinomaAccording to the American Cancer Society, about 27,600 new cases of stomach cancer will be diagnosed in the United States by 2020, and more than 11,000 people will die from the diseaseGC and GEJ cancers are usually diagnosed as late at the time, so the prognosis is poor, with a 5-year survival rate of 5-20%Chemotherapy is the standard treatment for first-line treatment, and about 20% of patients with tumor HER2-positive can be used in combination with quralson