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Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma
Mustang Bio (MBIO) has received Orphan Drug Designation from the FDA for MB-108, an HSV-1 oncolytic virus targeting malignant glioma. The designation provides tax credits, fee waivers, and seven years of market exclusivity upon approval. The company plans to combine MB-108 with MB-101 (IL13Rα2‐targeted CAR-T cell therapy) in a novel therapeutic approach. Preclinical datashows MB-108 can reshape the tumor microenvironment, potentially enhancing MB-101's efficacy. In previous trials, two patients treated with MB-101 achieved complete responses lasting 7.5 and 31+ months. Further development depends on securing additional funding or strategic partnerships.
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Nzm Nhr :
102539778 : waiting for that volume
Krystian 1983 : Fly baby fly
