Mustang Bio (NASDAQ:MBIO) announced that the FDA has granted orphan drug designation (ODD) to MB-108, an HSV-1 oncolytic virus and a component of MB-109, for the treatment of malignant glioma.
MB-109 combines MB-101, a chimeric antigen receptor (CAR)-T-cell therapy targeting interleukin 13 receptor alpha 2, with MB-108, an HSV-1 oncolytic virus licensed from Nationwide Children’s Hospital.
Manual Litchman, MD, president and CEO of Mustang, said, “The orphan drug designation for MB-108 is significant for Mustang, as it could provide additional market exclusivity and we hope to advance MB-108, in combination with MB-101, as a potential treatment option for patients living with malignant glioma, including patients with recurrent glioblastoma and high-grade astrocytomas, where there is historically a median overall survival of six months.”
Dr. Litchman added, “Our novel therapeutic strategy, combining our MB-108 oncolytic virus with MB-101 CAR-T-cell therapy, could be the first-ever industry-sponsored trial of its kind for the treatment of malignant glioma.”
