Mustang Bio And FDA Complete Pre-IND Meeting For MB-102 (CD123 CAR-T)

Empire State Building, New York City. Source: ahundt, no changes made, CC0 Creative Commons.
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Mustang Bio, Inc., a Fortress Biotech Company, headquartered in the greater New York City area, is a clinical‐stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to leverage the patient’s own immune system to eliminate cancer cells. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to out-license or bring the technologies to market.

Mustang has partnered with the City of Hope National Medical Center and the Fred Hutchinson Cancer Research Center to develop proprietary chimeric antigen receptor (CAR) engineered T cell (CAR-T) therapies across many cancers, and with Harvard Medical School’s Beth Israel Deaconess Medical Center and the Harvard Stem Cell Institute for the development of CRISPR/Cas9-enhanced CAR-T therapies in hematologic malignancies and solid tumors.

The company 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). CD123 is widely expressed on bone marrow cells of patients with myelodysplastic syndrome (MDS), as well as in hematologic malignancies including acute myeloid leukemia (AML), B cell acute lymphoblastic leukemia, hairy cell leukemia, blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic myeloid leukemia and Hodgkin’s lymphoma. MB-102 is a CAR T therapy in development for the treatment of AML, BPDCN and high-risk MDS. Mustang will continue its efforts on its IND filing to the FDA for MB-102.

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“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.” – Manuel Litchman, M.D., President and Chief Executive Officer of Mustang