VBI Vaccines Announces Second Positive DSMB Review in Phase 1/2a Study of VBI-1901 in Recurrent Glioblastoma Patients

VBI Vaccines (NASDAQ:VBIV) 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 second safety assessment of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM.

As quoted in the press release:

The DSMB reviewed the complete safety data from the fully enrolled, intermediate-dose patient cohort, and unanimously recommended the continuation of the study without modification.

Following this recommendation, VBI has initiated enrollment in the high-dose arm of the study. One final, pre-specified DSMB review is expected to occur after completion of enrollment in the high-dose cohort, concluding the dose-escalation phase of the study.

“We are encouraged by the sustained clean safety profile of VBI-1901 as concluded by this second DSMB assessment,” said Jeff Baxter, VBI’s President and CEO. “These positive safety reviews are critical milestones for the program and for patients diagnosed with this extremely aggressive tumor who currently have no effective treatment options.  With active clinical study sites at the Columbia University Medical Center, Dana-Farber Cancer Institute, and Massachusetts General Hospital, we hope to complete enrollment in this high-dose cohort quickly and look forward to announcing initial immunologic data from the low- and intermediate-dose cohorts expected later this year.”

Click here to read the full press release.