VBI-1901 is a new cancer vaccine immunotherapeutic candidate that uses cytomegalovirus (CMV) as a foreign viral antigen approach to treat cancer by expressing two highly immunogenic CMV antigens, pp65 and gB.
It has been developed using the company’s enveloped virus-like particle (eVLP) technology.
The therapy has also received Fast Track Designation from the US FDA to treat recurrent GBM in patients with first tumour recurrence, in June last year.
VBI Vaccines president and CEO Jeff Baxter said: “This orphan drug designation is another significant milestone for our VBI-1901 programme, and it underscores the urgency of our effort to develop meaningful new treatment options for patients with this devastating cancer.
“As recently presented at ASCO, we continue to see strong tumour 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.”
A randomised, controlled clinical study of VBI-1901 to treat recurrent GBM patients is expected to begin in the third quarter of this year.
The controlled evaluation of the therapy in primary GBM patients as part of INSIGhT adaptive platform trial is expected to commence in the fourth quarter.