NEW YORK – Mustang Bio said on Wednesday it planned to discuss data in lymphomas from a Phase I/II trial of its CD20-targeted autologous CAR T-cell therapy, MB-106, with the US Food and Drug Administration.
The firm reported initial data on Wednesday from a multicenter Phase I/II trial in relapsed or refractory B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia. All four patients evaluable had responses to MB-106 with two patients with follicular lymphoma and one patient with Waldenstrom macroglobulinemia having a complete response.
In results from a separate, single-center study at Fred Hutchinson Cancer Center, MB-106 demonstrated a 95 percent response rate among 20 patients with follicular lymphoma with 80 percent of patients achieving a complete response. In a cohort of six patients with Waldenstrom macroglobulinemia, two patients achieved a complete response.
Mustang plans to have an end-of-Phase I meeting with the FDA by the end of 2023 to confirm its plan to begin treating patients in a pivotal Phase II trial of MB-106 in Waldenstrom macroglobulinemia next year. The firm also expects to request regenerative medicine advanced therapy (RMAT) designation for MB-106 in Waldenstrom macroglobulinemia from the FDA in 2024.
Earlier this year, Mustang discontinued several of its cell and gene therapy programs to focus on advancing MB-106, its glioblastoma treatment MB-109, and an in vivo CAR-T platform.