NEW YORK – Mustang Bio on Monday said it has received a $2 million grant from the National Cancer Institute, which it will put toward studying MB-106, its autologous CD20-directed CAR T-cell therapy.
Worcester, Massachusetts-based Mustang will use the NCI grant to partly fund a Phase I/II trial of MB-106 in relapsed or refractory B-cell non-Hodgkin lymphoma patients or chronic lymphocytic leukemia patients. The company plans to enroll roughly 35 patients with CD20-positive B-cell NHL or CLL, as determined by immunohistochemistry or flow cytometry, and track the safety, tolerability, and preliminary efficacy of the autologous therapy.
Mustang Bio in-licensed MB-106, which was originally developed at the Fred Hutchinson Cancer Research Center, in 2017. In May, the US Food and Drug Administration accepted the firm's investigational new drug application to begin the leukemia and lymphoma trial.
In addition to MB-106, Mustang is evaluating an IL13Rα2-directed CAR T-cell therapy in brain cancer patients and a CD123-targeted CAR T-cell therapy for blastic plasmacytoid dendritic cell neoplasm, acute myeloid leukemia, and high-risk myelodysplastic syndrome.
In addition to announcing the NIH grant, Mustang said on Monday that the Office for Human Research Protections has approved Federalwide Assurance for Mustang's research, recognizing Mustang's compliance with US federal regulations for the protection of human subjects in research.