The Food and Drug Administration (FDA) has granted Orphan Drug designation to VBI-1901 for the treatment of glioblastoma.

Glioblastoma is a rare, aggressive, malignant grade IV brain tumor that develops from the glial cells. VBI-1901 is an investigational bivalent enveloped virus-like particle (eVLP) vaccine immunotherapeutic candidate designed to target 2 highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65.

The designation is supported by data from the ongoing phase 1/2a study (ClinicalTrials.gov Identifier: NCT03382977) that evaluated the safety and tolerability of VBI-1901 in patients with recurrent glioblastoma. Findings showed that VBI-1901 achieved improvements in median and 18-month overall survival. Moreover, 1 patient who received VBI-1901 remains on protocol progression-free beyond 2 years, with a sustained 93% tumor reduction from baseline.

The Company is also investigating VBI-1901 for the treatment of glioblastoma in the ongoing phase 2 INSIGhT trial (ClinicalTrials.gov Identifier: NCT02977780).

“As recently presented at ASCO, we continue to see strong tumor response data and improvements in overall survival data compared to historical controls in the Phase 2a study of VBI-1901. 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,” said Jeff Baxter, President and CEO of VBI.

The FDA grants orphan drug designation to investigational drugs and biologics intended to prevent, diagnose, or treat rare medical diseases or conditions that affect fewer than 200,000 people in the US.

References

  1. VBI Vaccines receives US FDA Orphan Drug designation for VBI-1901 for the treatment of glioblastoma. News release. VBI Vaccines Inc. Accessed June 22, 2022. https://www.businesswire.com/news/home/20220622005240/en/VBI-Vaccines-Receives-U.S.-FDA-Orphan-Drug-Designation-for-VBI-1901-for-the-Treatment-of-Glioblastoma
  2. VBI Vaccines presents updated phase 2a tumor response and overall survival data for VBI-1901 in recurrent GBM at the 2022 ASCO Annual Meeting. News release. VBI Vaccines Inc. June 6, 2022. Accessed June 22, 2022. https://www.vbivaccines.com/press-releases/gbm-asco-2022/