Mustang Bio announces FDA acceptance of IND application for MB-109

Mustang Bio announced that the U.S. Food and Drug Administration, FDA, has accepted the Company’s Investigational New Drug, IND, application of MB-109 for the treatment of recurrent glioblastoma, GBM, and high-grade astrocytoma. Mustang is planning to initiate a Phase 1 multicenter clinical trial at City of Hope, COH, and the University of Alabama at Birmingham, UAB, to assess the safety, tolerability and efficacy of MB-109, a novel combination of MB-101 and MB-108 in adult patients with recurrent GBM and high-grade astrocytomas that express IL13Ralpha2 on the surface of the tumor cells. Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We are very pleased with the FDA’s acceptance of our IND application for MB-109, which allows Mustang to initiate a Phase 1 clinical trial to further evaluate combining MB-108 and MB-101, an attractive strategy for improving outcomes for patients with recurrent GBM and high-grade astrocytomas. Recurrent GBM remains a major challenge to treat, with a median overall survival rate of 6 months. We are committed to finding better treatment options for patients living with difficult-to-treat cancers and look forward to initiating our MB-109 Phase 1 clinical trial in 2024. The fact that this will be the first ever industry-sponsored trial to combine a CAR-T cell therapy with an oncolytic virus underscores Mustang’s commitment to innovation in the oncology and cell therapy space. Furthermore, FDA acceptance of our IND within 30 days of initial submission – despite the innovative aspect of the combination therapy and the complexity of the trial design – is testimony to the talent and resourcefulness of our team.”