Mustang Bio, Inc. ("Mustang") (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that the U.S. Food and Drug Administration ("FDA") has accepted the Company's Investigational New Drug ("IND") application to initiate a Phase 1/2 multicenter study to assess the safety, tolerability and efficacy of MB-106, a CD20-targeted CAR T therapy for relapsed or refractory CD20+ B-cell non-Hodgkin lymphoma ("B-NHL") and chronic lymphocytic leukemia ("CLL").
MB-106 targets CD20, a commercially validated target on the surface of cancer cells that has lacked a strong CAR T-based clinical focus in the U.S. MB-106 cells express a third-generation CAR derived from a fully human antibody that originated in the Fred Hutchinson Cancer Research Center ("Fred Hutch") laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division. The CAR T therapy was exclusively licensed to Mustang in 2017, and Fred Hutch and Mustang collaborated to develop the cell processing that will be used in the Mustang IND Phase 1/2 clinical trial.
To date, the same vector planned for use in the manufacturing of MB-106 is currently being evaluated in the ongoing Phase 1/2 study sponsored by Fred Hutch, where Mazyar Shadman, M.D., M.P.H., Associate Professor in the Clinical Research Division, is the Principal investigator. Data from this ongoing study were presented by Dr. Shadman at the 62nd Annual American Society of Hematology meeting in 2020 and demonstrated a favorable safety profile, with an 89% overall response rate (ORR; 8/9 patients) and a 44% complete response rate (CR; 4/9 patients).
NHL is one of the most common cancers in the United States, accounting for about 4% of all cancers, and CLL accounts for about one-third of the new cases of leukemia. The American Cancer Society estimates that in the U.S. in 2021 about 81,560 people will be diagnosed NHL and 21,250 with CLL.
Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are pleased with the FDA's acceptance of our IND application for MB-106, which allows us to further advance this CAR T therapy as a potentially safe and effective treatment option for B-NHL and CLL. It is especially gratifying that we were able to achieve this milestone in just 28 days after our IND submission. We are committed to finding better treatment options for patients living with these cancers and look forward to initiating our multicenter, Phase 1/2 clinical trial later this year, with Dr. Shadman as the Study Chair."