Brain Cancer Vaccine Candidate Approaches Launch
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 VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens gB and pp65.
Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans.
“This Fast Track Designation provides additional medical validation and is a meaningful milestone for our development of VBI-1901 as we work to provide clinical benefit for patients who have few treatment options available today,” stated Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, in a press release issued on June 8, 2021.
“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.”
With few options for recurrent GBM patients, historical control data have demonstrated overall survival to be ~60% at 6-months and ~30% at 12-months after treatment with a monotherapy.
FDA Fast Track Designation facilitates the development and expedites the review of new therapies to treat severe conditions and fill an unmet medical need.
The FDA Fast Track program facilitates the expedited development and review of new drugs or biologics intended to: 1) treat severe or life-threatening conditions and 2) demonstrate the potential to address unmet medical needs.
A therapeutic that receives Fast Track Designation is eligible for some or all of the following: 1) more frequent meetings with FDA to discuss the development plan and data needed to support approval, 2) more frequent written communication from FDA relating to the design of the proposed clinical trials and use of biomarkers, 3) Accelerated Approval and Priority Review, if relevant criteria are met, and 4) Rolling Review, which means the company can submit completed sections of its Biologic License Application or New Drug Application for review by FDA, instead of waiting until all sections of the application are completed.
Fast Track Designation was granted to VBI-1901, adjuvanted with granulocyte-macrophage colony-stimulating factor, to treat first-recurrent GBM.
In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.
Cambridge, Massachusetts-based VBI Vaccines Inc. is a biopharmaceutical company driven by immunology to pursue powerful prevention and treatment of disease.
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