VBI-1901 is a polyvalent therapeutic vaccine candidate designed to direct an immune response against gB and pp65, two CMV antigens that are highly immunogenic targets during natural infection.
VBI-1901 includes granulocyte-macrophage colony-stimulating factor (“GM-CSF”), an adjuvant that mobilizes dendritic function and enhances Th1-type immunity.
VBI-1901 is an immunotherapy cancer vaccine that will stimulate the patient’s own immune system to identify and kill GBM cancer cells.
VBI-1901 is co-administered with GM-CSF via intradermal route.
Clinical Trial NCT03382977: Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
- This is a two-part, dose-escalation study to define the safety, tolerability, and optimal dose level of candidate GBM vaccine VBI-1901 with subsequent extension of optimal dose level in recurrent GBM subjects.
- Part A: Dose-escalation phase to define the safety, tolerability, and optimal dose level of VBI-1901 in recurrent GBM patients. This phase is expected to enroll up to 18 patients in three dose cohorts.
- Part B: A subsequent extension of the optimal dose level, as defined in the dose-escalation phase. This phase is expected to enroll an expanded cohort of approximately 10 additional patients.