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Mustang Bio's CAR-T cell therapy gets orphan drug nod for rare blood cancer

Mustang Bio Inc.'s medicine for a rare and incurable type of blood cancer has been granted orphan drug designation by the U.S. Food and Drug Administration.

MB-102 is under development for the treatment of blastic plasmacytoid dendritic cell neoplasm, a blood cancer that has a median survival of less than 18 months and no standard of care. The drug is a chimeric antigen receptor T cell therapy, which is a complex form of treatment that involve taking a person's own immune cells and modifying them to fight cancer cells when infused back into the body.

New York-based Mustang is evaluating MB-102 for treating blastic plasmacytoid dendritic cell neoplasm as well as acute myeloid leukemia in a phase 1 clinical trial. So far, the therapy has demonstrated complete responses at low doses in both indications.

MB-102 will now be eligible for certain incentives including tax credits for covering clinical trial expenses and prescription drug user fee waivers. Orphan drug designation is granted to medicines that are being developed to treat rare diseases or disorders that affect fewer than 200,000 people in the U.S.

Mustang focuses on the acquisition and development of novel cancer immunotherapy products based on CAR-T cell technology.