Bivalent Immunotherapeutic Vaccine Candidate Granted FDA Orphan Drug Designation for Glioblastoma
Massachusetts-based VBI Vaccines Inc. announced yesterday that the U.S. FDA granted Orphan Drug Designation for VBI-1901, a bivalent vaccine candidate for the treatment of glioblastoma (GBM).
VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens gB and pp65.
“This orphan drug designation is another significant milestone for our VBI-1901 program, and it underscores the urgency of our effort to develop meaningful new treatment options for patients with this devastating cancer,” said Jeff Baxter, President, and CEO of VBI, in a press release issued on June 22, 2022.
“With this orphan drug status, we look forward to working closely with the FDA and clinical investigators to build on that data, advancing the potential of this program to be a valuable part of the fight against GBM.”
GBM is among the most common and aggressive malignant primary brain tumors in humans.
In the U.S. alone, 14,000 new cases are diagnosed each year.
The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy.
Unfortunately, even with aggressive treatment, GBM progresses rapidly and has a high mortality.
In June 2021, the FDA also granted Fast Track Designation for VBI-1901 to treat recurrent GBM in patients with first tumor recurrence.
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