FDA Confirms IND Application From VBI Vaccines

VBI Vaccines (NASDAQ:VBIV; TSX:VBV) announced the US Food and Drug Administration accepted their Investigational New Drug Application (IND) for VBI-1901, an immunotherapy against brain tumor Glioblastoma Multiforme.
As quoted in the press release:

The IND enables VBI to initiate a multi-center Phase I/2a clinical study evaluating VBI-1901 in patients with recurrent GBM in the second half of this year.
VBI has leveraged its enveloped virus-like particle (eVLP) platform and expertise in immunology to develop a broadly active therapeutic vaccine that targets two highly immunogenic CMV antigens, gB and pp65, to direct a potent immune response against CMV infection. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including GBM. The vaccine candidate is combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), an adjuvant that mobilizes dendritic cell function and seeks to enhance productive immunity against tumors.
“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.”

Click here to read the full press release.

Source: www.marketwired.com