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Mustang Bio (NASDAQ:MBIO) announced it has received orphan drug designation from the US Food and Drug Administration (FDA) For its MB-102 product to treat acute myeloid leukemia (AML). As quoted in the press release: Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We are pleased that MB-102 has received Orphan Drug Designation …
Mustang Bio (NASDAQ:MBIO) announced it has received orphan drug designation from the US Food and Drug Administration (FDA) For its MB-102 product to treat acute myeloid leukemia (AML).
As quoted in the press release:
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We are pleased that MB-102 has received Orphan Drug Designation in two indications, AML and BPDCN. AML most commonly occurs in senior adults, many of whom have to forgo chemotherapy due to other health conditions. MB-102 has the potential to be an important new treatment for these and other patients, and to potentially address multiple areas of high unmet medical need. We expect to initiate a multicenter Phase 1/2 clinical trial in patients with AML, BPDCN and high-risk myelodysplastic syndrome in the coming months.”
MB-102 is currently being studied in a City of Hope, first-in-human Phase 1 dose-escalation clinical trial evaluating the safety and anti-tumor activity of escalating doses of MB-102 in patients with relapsed or refractory AML (cohort 1) and BPDCN (cohort 2). Patients receive a single dose of MB-102 with an option for a second infusion if they continue to meet safety and eligibility criteria and still have CD123+ disease. MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities. City of Hope developed CD123 CAR T.
Click here to read the full press release.