Mustang Bio gets FDA Orphan Drug Designation for MB-101 CAR T-cell therapy in astrocytomas and glioblastoma

MUSTANG BIO, INC.

• FDA granted Orphan Drug Designation to MB-101 for recurrent diffuse/anaplastic astrocytoma and glioblastoma.
• Designation provides tax credits, fee waivers, and potential 7-year market exclusivity upon approval.
• Phase 1 trial showed 50% stable disease or better; two complete responses lasting 7.5 and 66+ months.
• Preclinical data support combining MB-101 with oncolytic virus MB-108 to improve efficacy.
• Company notes development of MB-109 program is contingent on raising additional funding.