FDA Clears Mustang Bio’s IND for MB-102 (CD123-CAR T)

FDA Clears Mustang Bio’s IND for MB-102 (CD123-CAR T)

Mustang Bio, Inc (MBIO) reports that the U.S. Food and Drug Administration (FDA) has approved the Company’s investigational new dug application (IND) in acute myeloid leukemia (AML) blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk myelodysplastic syndrome (MDS).
The Problem
The American Cancer Society reports there were an estimated 19,520 new U.S. cases of AML in 2018 and the disease has an estimated five year survival rate of 25%. In 2016, an American Society of Hematology Education Program article reported that there were about 700 new BPCN cases in the U.S. and 1,000 in Europe per year, with median survival of 12 to 14 months.
The Drug
MB-102 is a CAR T cell therapy that is produced by engineering T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with myelodysplastic syndrome and hematologic malignancies, including 75%-89% of AML patients and over 90% in BPDCN patients. MB-102 has shown promising response rates in early small populations of these patients in an investigator-sponsored Phase I clinical trial being conducted by City of Hope, where the CAR T cell therapy was also developed. C...

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