Mustang Bio Inc (NASDAQ:MBIO) announced Thursday that the US Food and Drug Administration has granted orphan drug status to therapy MB-108 (oncolytic virus C134) for the treatment of malignant glioma, a type of brain cancer with a median survival rate of less than 18 months.
Nationwide Children’s Hospital in Columbus, Ohio has exclusively licensed oncolytic virus C134 to the New York City-based clinical-stage biopharmaceutical company.
“We are very pleased to receive orphan drug designation for MB-108, as it provides Mustang with additional market exclusivity and financial incentives to advance the oncolytic virus,” said Martina Sersch, Mustang’s chief medical officer, in a statement.
“MB-108 has demonstrated the potential to address an area of high unmet medical need, and we believe it is an important new treatment for patients with malignant glioma.”
She added that Mustang intends to combine MB-108 with MB-101 (IL13Rα2-specific CAR) to potentially enhance efficacy in treating glioblastoma multiforme, the most aggressive form of brain cancer.
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The company said a Phase 1 clinical trial evaluating MB-108 in recurrent glioblastoma multiforme is being conducted at the University of Alabama at Birmingham. MB-108 (C134) is a second-generation attenuated herpes simplex virus type 1 (HSV-1) oncolytic virus that has improved replication in tumors in mice, but with the same toxicity profile as its first-generation predecessors.
In these preclinical studies, the therapy not only demonstrates direct anti-tumor activity, but also elicits an immune response that can reverse tumor-associated immunosuppression, the company said.
A subsidiary of Fotress Biotech (NASDAQ:FBIO), Mustang specializes in CAR-T cell therapies, whereby a patient’s T cells are changed in a lab so they will attack cancer cells.
Mustang’s stock recently traded up 0.25% to $4 a share.
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