Mustang Bio Inc. (NASDAQ:MBIO) has announced the dosing of the first patient in its multicentre, Open-label phase 1/2 study evaluating efficacy and safety of its CD123-targeted CAR T Cell therapy, MB-102.
Mustang commences dosing of patients in Phase 1/2 study of MB-102
The company is evaluating MB-102 in treating refractory/relapsed blastic plasmacytoid dendritic cell neoplasm (BPDCN), high-risk myelodysplastic syndrome (hrMDS), and acute myeloid leukemia. Phase 1 part of the study will determine the optimal MB-102 dose for the second phase trial. The trial will assess the safety of every dose level prior to progressing to the next phase.
Phase 2 part of the study will be divided into three cohorts evaluating the efficacy of MB-102 in refractory/relapsed AML, refractory/relapsed BPDCN, and demethylation resistant hrMDS. The study’s primary endpoint will be the response rate after 28 days following infusion in the arms. The secondary outcomes for the study will include progression-free survival, duration of response, overall survival, as well as the incidence of treatment-emergent adverse events that will be followed for three years.
Mustang Bio enters collaboration with SIRION to use LentiBOOST™ technology
The company has also announced the signing of a license agreement with SIRION Biotech GmbH under which it has acquired rights to SIRION’s LentiBoost™ technology. Mustang obtained the tech for the development of MB-207, the company’s lentiviral gene therapy for treating a patient with X-linked severe combined immunodeficiency (XSCID) referred to as bubble boy disease. The treatment is for patients that have been treated previously with hematopoietic stem cell transplantation (HSCT) with indicated treatment.
According to the terms of the agreement, Mustang will pay SIRION an undisclosed upfront payment with SIRION also legible to benefit from development and product sales milestones as well as royalties. Manuel Litchman, the CEO of Mustang, said that they are delighted to sign the agreement to use their LentiBOOST™ technology to develop MB-207. Litchman added that transduction was added to the lentiviral gene therapy cell processing in 2019, which has led to more benefits.