Breakthrough Brain Cancer Treatment: FDA Backs Mustang Bio Therapy

Mustang Bio (NASDAQ:MBIO) has received Orphan Drug Designation from the FDA for MB-101, its IL13Ra2-targeted CAR T-cell therapy, for treating astrocytomas and glioblastoma. In an ongoing Phase 1 trial, MB-101 demonstrated promising results with 50% of patients achieving stable disease or better, including two partial responses and two complete responses lasting 7.5 and 66+ months.

The company plans to combine MB-101 with MB-108 (HSV-1 oncolytic virus), which previously received Orphan Drug Designation for malignant glioma treatment. The combination therapy aims to improve efficacy by using MB-108 to transform "cold" tumors into "hot" tumors, potentially enhancing MB-101's effectiveness. Phase 1 trials for both therapies continue at City of Hope and The University of Alabama at Birmingham, though further development requires additional funding or strategic partnership.

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