Mustang Bio granted Orphan Drug Designation by U.S. FDA for MB-108

Mustang Bio (MBIO) announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation to Mustang for MB-108, a herpes simplex virus type 1 oncolytic virus, for the treatment of malignant glioma. Manuel Litchman, M.D., President and Chief Executive Officer 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. 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. As such, Mustang plans to also request Orphan Drug Designation from the FDA for MB-101 in malignant gliomas. These advancements highlight our dedication to potentially improving outcomes for patients battling difficult-to-treat cancers.”