- Independent Data and Safety Monitoring Board (DSMB) unanimously recommends continuation of the study without modification
- Enrollment is complete in the high-dose study arm of Part A
- Expanded immunologic data and 6-month survival data from all three dose cohorts in Part A expected in the first half of 2019
VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI” or the “Company”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the independent Data and Safety Monitoring Board (DSMB) completed its third and final safety assessment of Part A of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent glioblastoma (GBM) patients. After reviewing the complete safety data from the fully enrolled, high-dose patient cohort, the DSMB unanimously recommended the continuation of the Phase 1/2a study without modification.
Part B of the study, which is expected to enroll a cohort of up to 10 additional patients, will be an extension of the optimal therapeutic dose level from Part A of the study. The Company will define the optimal dose following availability of expanded immunologic data and survival data from all three dose cohorts in Part A, which are expected later in the first half of 2019.
About the Phase 1/2a Study Design
VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 28 patients with recurrent GBM:
- Part A: Dose-escalation phase to define the safety, tolerability, and optimal therapeutic dose level of VBI-1901 in recurrent GBM patients. This phase enrolled 18 patients across three dose cohorts.
- Part B: A subsequent extension of the optimal therapeutic dose level, as defined in the dose escalation phase. This phase is expected to enroll an expanded cohort of approximately 10 additional patients.
VBI-1901 is administered intradermally and is adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent adjuvant that mobilizes dendritic cell function. Patients in both phases of the study will receive vaccine every four weeks until tumor progression.
Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.