The third and final safety assessment of Part A of the ongoing Phase 1/2a clinical study of VBI-1901 was successful. This is according to the independent Data and Safety Monitoring Board (DSMB). The board says that there was a unanimous recommendation for continuity of VBI’s high-dose patient cohort. Meanwhile, VBI Vaccines Inc. (NASDAQ:VBIV) up 0.53% in the previous trading session and is trending upwards. This is the possible reason why the stock is gaining.
The company used recurrent glioblastoma (GBM) patients as the subjects of the clinical study. It is so excited about the latest development and especially the fact that Phase 1/2a study will go on without modification. It is worth noting that the administration of VBI-1901is is done intradermally.
What exactly will happen within the Phase 1/2a study?
The study, which is an extension of Part A of the study will engage 28 patients with recurrent GBM. The previous study had 18patients in the three dose cohorts. Nonetheless, the Phase 1/2a study is in two parts. Part A will have a dose-escalation phase and part B, which is a subsequent extension. All systems are in place for the continuation of the study. VBIV says it is expecting to report back the results of part A in the first half of 2019.
VBI is very keen on the prevention of hepatitis B, an infectious disease, whose treatment needs have remained unmet for decades. The only commercially-approved treatment is the trivalent hepatitis B vaccine, Sci-B-Vac. Sadly the approval is only in Israel and ten other countries, which clearly explains why a majority of those suffering from hepatitis B cannot access it. However, it is undergoing a Phase 3 study in the U.S., Europe, and Canada.
The enlargement of VBI’s management team
The biopharma has increased the members of its board by appointing Blaine McKee. The appointee has worked in the pharmaceutical and biotechnology industries for more than two decades. Hence he has built a track record of building successful biotech companies.
Dr. McKee will play a vital role in the transition of Sci-B-Vac from the clinical development to the commercial stage. This is according to VBI’s president and CEO, Jeff Baxter. On the other hand, McKee says he is excited to join VBI. He adds that he will do anything within his powers to achieve the company’s goals.