FDA clears Mustang Bio IND for CAR T cell therapy

Mustang Bio (NASDAQ:MBIO) reported that the FDA approved its IND application for MB-102 for the treatment of acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk myelodysplastic syndrome (MDS).

MB-102 is a CAR T cell therapy that targets cancer cells expressing CD123, a receptor that is widely expressed on the bone marrow cells of patients with MDS and hematologic malignancies.

“We are excited to initiate our multi-center Phase 1/2 clinical trial later in 2019 and process patient cells in our manufacturing facility, which opened in June 2018,” Dr. Manuel Litchman, Mustang’s president and CEO, said in a statement.

The FDA previously granted MB-102 orphan drug designation for AML and BPDCN.


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