Core Insights - Mustang Bio, Inc. announced that the FDA granted Orphan Drug Designation for MB-108, a herpes simplex virus type 1 (HSV-1) oncolytic virus, for the treatment of malignant glioma, which could provide additional market exclusivity [1][3] - The company is advancing a novel combination therapy of MB-108 and MB-101 (IL13Rα2-targeted CAR-T cell therapy) aimed at improving treatment outcomes for patients with recurrent glioblastoma and high-grade astrocytomas [1][3] - Preclinical data supports the combination therapy's potential to reshape the tumor microenvironment, making cold tumors "hot" and enhancing the efficacy of CAR-T cell therapy [3][5] Company Overview - Mustang Bio is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers, aiming to translate medical breakthroughs into potential cures [6] - The company has partnered with leading medical institutions to advance CAR-T therapies and is actively seeking to raise additional funding or form strategic partnerships to further develop its programs [4][6] Clinical Development - The ongoing Phase 1 clinical trials for MB-101 and MB-108 are enrolling patients, with previous data indicating that the therapies were well tolerated in patients with recurrent glioblastoma [3][5] - The combination therapy aims to leverage MB-108 to enhance the infiltration and activation of MB-101 CAR-T cells within the tumor mass, potentially leading to improved tumor cell killing [5]
Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma