Brain Cancer Immunotherapeutic Granted Fast-Track Status

VBI Vaccines Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for VBI-1901, a cancer vaccine immunotherapeutic candidate for treating recurrent glioblastoma (GBM) patients with first tumor recurrence.

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using enveloped virus-like particle technology to target two highly immunogenic cytomegalovirus antigens, gB, and pp65.

An FDA Fast Track Designation expedites the review of new therapies to treat serious conditions and fill an unmet medical need. And underscores the significant need for new therapies for recurrent GBM patients. Glioblastoma is the most common malignant brain and other CNS tumors accounting for about 47% of all cases.

GBM also referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor. It invades the nearby brain tissue but generally does not spread to distant organs.

Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, stated in a press statement, “Building on the encouraging data seen to-date, including updated tumor responses and improvement in overall survival compared to historical controls ... we look forward to working closely with the FDA as we progress this cancer vaccine immunotherapeutic candidate with the hope of improving outcomes for adults with recurrent GBM.”

VBI Vaccines Inc. is a biopharmaceutical company based in Massachusetts, driven by immunology in the pursuit of powerful prevention and treatment of disease.