Orphan Drug Designation by US FDA for MB-108 (HSV-1 oncolytic virus) to Treat Malignant Glioma

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “The Orphan Drug Designation for MB-108 is significant for Mustang, as it could provide additional market exclusivity and we hope to advance MB-108, in combination with MB-101, as a potential treatment option for patients living with malignant glioma, including patients with recurrent glioblastoma (“GBM”) and high-grade astrocytomas, where there is historically a median overall survival of six months. Our novel therapeutic strategy, combining our MB-108 oncolytic virus with MB-101 CAR-T cell therapy, could be the first-ever industry-sponsored trial of its kind for the treatment of malignant glioma. As such, Mustang plans to also request Orphan Drug Designation from the FDA for MB-101 (IL13Rα2‐targeted CAR-T cell therapy) in malignant gliomas. These advancements highlight our dedication to potentially improving outcomes for patients battling difficult-to-treat cancers.”
Share:
More News
Elevation Oncology today announced that it has entered into a definitive merger agreement with Concentra Biosciences, LLC, whereby Concentra will acquire Elevation Oncology for $0.36 in cash per share of Elevation Oncology common stock, plus one non-tradeable contingent value right, which represents the right to receive: (i) 100% of the
“The AMPLITUDE study reinforces the power of a biomarker-driven approach and the potential of this novel combination regimen to shift the treatment paradigm in prostate cancer,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “By identifying patients most likely to benefit from
“We are gaining significant momentum on CHM CDH17 and look forward to our interactions with the FDA to get our advanced therapy to patients in need”, said Dr Rebecca McQualter CEO of Chimeric.
“Bringing VVD-214, the only clinical-stage covalent inhibitor of WRN in development worldwide, into our portfolio marks an incredibly exciting moment for Vividion,” said Aleksandra Rizo, M.D., Ph.D., Chief Executive Officer of Vividion. “We are eager to progress development of this compound, building on the encouraging clinical data we’ve seen to