VBIV - VBI Vaccines gets FDA orphan drug designation for brain cancer vaccine candidate VBI-1901

VBI Vaccines (NASDAQ:VBIV) on Wednesday said that the U.S. FDA had granted an orphan drug designation to its vaccine candidate VBI-1901 for the treatment of glioblastoma (GBM), an aggressive type of brain cancer. The FDA's orphan drug designation program expedites the development and evaluation of a drug or biological product to prevent a rare disease or condition. VBIV said it expects to initiate a clinical study in Q3 2022 in recurrent GBM patients, with potential to support an accelerated approval application. VBIV also expects to initiate evaluation of primary GBM patients as part of its INSIGhT adaptive platform trial. VBI-1901 had previously in June last year got the FDA's fast track designation for the treatment of recurrent GBM in patients with first tumor recurrence. VBIV stock +6.4% to $0.82 in morning trading.

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VBI Vaccines gets FDA orphan drug designation for brain cancer vaccine candidate VBI-1901