MB-102 (CD123 CART) is a CAR T cell therapy that can manipulate the patient's T cells to identify and eliminate CD123-expressing tumor cells. CD123 is used for myelodysplastic syndrome and hematological malignancies (acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), hairy cell leukemia (HCL), BPDCN, chronic myeloid leukemia Etc.) It is widely expressed in patients' bone marrow cells. Cellular Leukemia (CML) and Hodgkin's Lymphoma (HL). CD123 is a very attractive target for T cell adoptive immunotherapy because it is expressed in 75-89% of AML and more than 90% of BPDCN patients. In a phase I clinical trial initiated by researchers in the City of Hope in the United States, MB-102 showed a satisfactory remission rate in the early population of these patients.
According to data from the American Cancer Society (ACS), there were an estimated 19,520 new cases of AML in the United States in 2018, with an estimated 5-year survival rate of 25%. According to an article from the American Society of Hematology (ASH) Education Project, in 2016, there were about 700 new BPDCNs in the United States each year, and about 1,000 new BPDCNs in Europe each year, with an average survival time of 12-14 months.
According to the report of the American Society of Hematology (ASH) Annual Meeting in December 2017 and the American Association for Cancer Research (AACR) Special Meeting on Tumor Immunity and Immunotherapy in December 2018, the meeting was held in Hope City. In the first human clinical trial (NCT02159495), MB-102 showed complete remission and no dose-limiting toxicity during the low-dose treatment of AML and BPDCN. Dose upgrades for the two indications in this study are currently underway.
Manuel Litchman, MD, President and CEO of MustangBio, said: "The FDA has approved the MB-102 IND application. This is an important milestone for the company because it is the first IND. We are very happy to be here in 2019. The Phase I/II clinical trials of the multifunctional plant in the second half of the year will begin, and patient cells will be processed in the production plant that opened in June 2018. We hope to meet the needs of patients with AML, BPDCN and MDS. We look forward to requesting further development of MB -102. To help solve this problem.