FDA Accepts VBI Vaccines’ IND to Treat Glioblastoma Multiforme

The company is leveraging a proprietary platform to develop its novel VBI-1901 immunotherapy.

Commercial-stage biopharmaceutical company VBI Vaccines announced recently the FDA has accepted the company’s Investigational New Drug Application (IND) for VBI-1901, a novel immunotherapy it developed to target Glioblastoma Multiforme (GBM), an aggressive brain tumor in humans. With the IND accepted, VBI said it will launch a multi-center Phase I-IIa clinical study in the second half of 2017, which will evaluate patients with GBM.

To develop VBI-1901, the company has announced that it will leverage its enveloped virus-like particle (eVLP) platform in combination with immunology to develop a “broadly active therapeutic vaccine.” According to VBI, the therapy targets two immunogenic CMV antigens, gB and pp65, which directs a potent immune response against CMV infection. VBI explained that the scientific literature suggests CMV infection is prevalent in many solid tumors, including GBM.

"A growing body of research has demonstrated that GBM tumors may be susceptible to infection by CMV, with over 90% of GBM tumors expressing CMV antigens,” said Jeff Baxter, President and CEO of VBI. “FDA clearance of this IND is a significant milestone for VBI as we expand our eVLP platform into immuno-oncology applications.” Glioblastoma, said VBI, is exceptionally aggressive with more than 12,000 new cases diagnosed each year and a median patient survival of less than 16%.

However, targeted immunotherapy may provide an alternative to surgery—one of the few treatment options for GBM patients. “While conventional therapies are non-specific and may damage surrounding normal tissues,” explains the program’s background, “targeted immunotherapy may offer a highly specific and potentially long-lasting treatment approach that leverages the immune system to protect against cancer.”


Guy Tiene

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