NEW YORK – Mustang Bio said on Thursday that the US Food and Drug Administration cleared it to begin a Phase I trial to evaluate MB-109, a combination of its CAR T-cell therapy MB-101 and its HSV-1 oncolytic virus MB-108, in IL13Rα2-expressing glioblastoma and astrocytoma.
The combination of these two candidates is designed to turn immunologically cold tumors into hot tumors, or those with more immune activity and inflammation, to potentially improve the efficacy of the MB-101 IL13Rα2-targeted CAR T-cell therapy, according to the company. The oncolytic virus treatment will be given first to inflame the tumor microenvironment, followed by the CAR T-cell therapy to kill the tumor cells.
Researchers will enroll patients with recurrent GBM and high-grade astrocytomas that express IL13Rα2 on the surface of the tumor cells into the study, which is expected to begin in 2024. The trial will evaluate safety, tolerability, and efficacy of MB-109.
The firm said in an announcement that in a previous Phase I study of MB-101 in glioblastoma patients, those with hot tumors, or high levels of intratumoral CD3-positive T cells prior to treatment, achieved complete responses to the therapy The two treatments have been found to be separately tolerable in different clinical trials with glioblastoma patients.
Earlier this year, Mustang decided to discontinue development of several pipeline candidates to focus on its lead CD20 CAR T-cell therapy MB-106, the glioblastoma treatment MB-109, and its in vivo CAR-T platform.