VBI Vaccines Expands on Data from Phase 1/2a Glioblastoma Study

• Well tolerated at all doses with no safety signals
• Three patients in high dose (10 µg) cohort showed evidence of stable disease by MRI
• 10 µg dose selected for Part B of the study, which is expected to initiate enrollment mid-year 2019

VBI Vaccines Inc. (NASDAQ: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, presented a poster on Sunday, June 2, 2019, at the American Society of Clinical Oncology (ASCO) Annual Meeting that exhibited expanded clinical data from Part A of the Phase 1/2a study of VBI-1901 in recurrent Glioblastoma (GBM) patients.

The poster presented data on a total of 18 patients enrolled in Part A of the study, which was a multi-center, open-label, dose-escalation study across three dose cohorts of VBI’s vaccine immunotherapeutic, VBI-1901 – 0.4 µg, 2.0 µg, and 10.0 µg.  Part A was designed to evaluate the safety and tolerability of VBI-1901, and to define the optimal immunogenic dose level to test in the Part B extension phase of the study, which is expected to initiate enrollment mid-year 2019.  Part B of the trial will further assess immunologic responses and potential correlations with tumor and clinical responses.

Andrew B. Lassman, M.D., Chief of Neuro-oncology at Columbia University Irving Medical Center and Associate Director for Clinical Infrastructure at Herbert Irving Comprehensive Cancer Center, and principal investigator of the study commented, “Though early, the data we’ve seen to-date in this Phase 1/2a study of VBI-1901 are intriguing, yet of course require confirmation in later phase and additional trials.  The patients in this study, and more generally in the recurrent GBM setting, are immunocompromised and have very few effective treatment options available to them. Any treatment that could demonstrate even some benefit would be incredibly meaningful for these patients and their families.  I look forward to seeing additional data from Part B of the study.”

https://www.globenewswire.com/news-release/2019/06/04/1863878/0/en/VBI-Vaccines-Reports-Data-from-Part-A-of-the-Ongoing-Phase-1-2a-Study-of-VBI-1901-in-Recurrent-Glioblastoma-GBM-Patients-at-ASCO-2019.html