Mustang Bio's brain cancer-targeting gene therapy granted FDA Orphan Drug designation

A new gene therapy developed for the treatment of malignant glioma, a rare and fast-growing brain cancer, received Orphan Drug status from the FDA this week, New York City-based biopharmaceutical company Mustang Bio and Columbus, Ohio-based Nationwide Children's Hospital announced.

The therapy, called MB-108, infuses into cancer tumors an oncolytic virus that kills cancer cells while leaving healthy cells unharmed. Mustang and Nationwide plan to use MB-108 to treat glioblastoma multiforme, a type of malignant glioma that accounts for more than half of all primary brain tumors and carries a median survival rate of less than 18 months.

Mustang will combine MB-108 with another of its biopharmaceutical treatments, MB-101, a form of CAR T-cell therapy in which immune cells are modified and returned to the body to attack cancer cells. A clinical trial of the drug is already underway at the University of Alabama at Birmingham.

The FDA's Orphan Drug designation provides incentives such as tax credits for clinical trials and prescription drug user fee waivers for drugs and biologics that show promise in diagnosing, treating or preventing rare diseases and disorders that affect fewer than 200,000 people in the U.S. per year.

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