VBI Vaccines to Present Interim Phase 2b Data on VBI-1901 at 2024 ASCO for Recurrent Glioblastoma

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), based in Cambridge, Massachusetts, has shared new interim results from its Phase 2b clinical trial for VBI-1901, a cancer vaccine candidate targeting recurrent glioblastoma (GBM). The company announced that these findings have been accepted for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

The presentation at ASCO will include updated data from previously assessed patients along with new data from additional patients who have been recently included in the Phase 2b study. This study continues to build on data initially presented at the World Vaccine Congress Washington in April, showing promising tumor response rates.

The Phase 2b trial is designed as a multi-center, randomized, controlled, open-label study involving up to 60 patients who have experienced their first recurrence of GBM. The participants are divided into two groups: one receiving the VBI-1901 vaccine in combination with GM-CSF, administered intradermally every four weeks, and the other receiving monotherapy standard-of-care treatments, either intravenous carmustine or oral lomustine, every six weeks until disease progression or intolerable toxicity.

Key endpoints of the study include safety and tolerability, overall survival (OS), tumor response rate (TRR), progression-free survival (PFS), immunologic responses, reduction in corticosteroid use compared to baseline, and changes in the quality of life of patients.

The U.S. Food and Drug Administration (FDA) has recognized a statistically significant improvement in overall survival as a critical indicator for the approval of new oncology drugs, underscoring the importance of this study's endpoints.

Glioblastoma is one of the most aggressive and common malignant primary brain tumors in humans, with over 12,000 new cases diagnosed annually in the United States. The standard treatment typically involves surgical resection followed by radiation and chemotherapy, but even with such aggressive treatments, the prognosis remains poor.

VBI-1901, the investigational cancer vaccine, leverages VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation, which facilitate more frequent interactions with the FDA and potential accelerated approval processes if certain criteria are met.

VBI Vaccines Inc. is dedicated to advancing immunology-based treatments and prevention strategies for a range of diseases. Utilizing their innovative virus-like particle (VLP) technologies, including proprietary enveloped VLP (eVLP) and mRNA-launched eVLP (MLE) platforms, VBI aims to produce vaccines that effectively mimic natural virus presentations to stimulate the human immune system. Their focus spans significant infectious diseases like hepatitis B, coronaviruses, and CMV, as well as aggressive cancers such as GBM. The company operates out of Cambridge, Massachusetts, with research facilities in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.