On July 19, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a Fortress Biotech (NASDAQ: FBIO)
Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor
engineered T cell (CAR T) technology, reported that it has completed a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for MB-102 (CD123 CAR T) (Press release, Mustang Bio, JUL 19, 2018, View Source [SID1234527786]). MB-102 is a CAR T therapy in development for the treatment of acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk myelodysplastic syndrome (MDS). Mustang will continue its efforts on its IND filing to the FDA for MB-102.
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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are pleased with the FDA’s feedback on our development plan and expect to submit an IND filing for MB-102 in the fourth quarter as planned. We anticipate that our manufacturing facility will be ready to process patient cells in the next few months, which will help enable initiation of our Phase 1/2 clinical trial of MB-102 in AML, BPDCN and MDS to begin in 2019, after approval of Mustang’s first IND."
About MB-102 (CD123 CAR T)
MB-102 (CD123 CAR T) is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with MDS, as well as in hematologic malignancies including AML, B cell acute lymphoblastic leukemia, hairy cell leukemia, BPDCN, chronic myeloid leukemia and Hodgkin’s lymphoma.
In the first-in-human clinical trial at City of Hope (NCT02159495), MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities, as reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2017. Dose escalation continues at City of Hope in both indications.