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Mustang Bio Completes Pre-IND Meeting with FDA for MB-102
Jul. 19, 2018 08:48AM PST
Biotech InvestingMustang Bio (NASDAQ:MBIO) has announced it has completed a pre-Investigational New Drug (pre_IND) meeting with the US Food and Drug Administration (FDA) for MB-102. As quoted in the press release: 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 …
Mustang Bio (NASDAQ:MBIO) has announced it has completed a pre-Investigational New Drug (pre_IND) meeting with the US Food and Drug Administration (FDA) for MB-102.
As quoted in the press release:
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.
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.”