• Presentation will highlight expanded immunologic and tumor response data as well as potentially-predictive biomarker data from the VBI-1901 + GM-CSF study arm in Part B of the ongoing Phase 1/2a study
  • E-Poster and accompanying recorded narrative will be available on June 22, 2020

VBI Vaccines Inc. (NASDAQ: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that expanded immunologic and tumor response data from the ongoing Phase 1/2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients will be presented at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II, to be held June 22-24, 2020.

In his presentation of the e-poster via an accompanying audio narrative, David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will describe how the highest dose of VBI-1901 in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) boosted cytomegalovirus (CMV) immunity, even in highly immunosuppressed patients. Moreover, a baseline biomarker was identified in patients in the Part A dose-ranging phase of the study that may help predict patients most likely to respond to, and derive clinical benefit from, treatment with VBI-1901. The correlation observed between baseline biomarker data and tumor response data in Part A of the trial was strengthened by the inclusion of additional patients in the Part B extension phase of the study.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.

Poster Presentation/Session Details

  • Title: CMV-specific immuno-dysregulation in recurrent glioblastoma patients can be overcome with therapeutic vaccination which is associated with tumor response and overall survival benefits in a Phase I/IIA study
  • Abstract: 6538
  • Session: Therapeutic Antibodies 5 / Vaccines
  • Date: June 22 – 24, 2020
  • Event Website: https://www.aacr.org/meeting/aacr-annual-meeting-2020/

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 38 patients with recurrent GBM:

  • Phase 1 (Part A)
    • Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
    • This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
    • Enrollment completed in December 2018.
  • Phase 2a (Part B)
    • Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
    • This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01Badjuvant system as immunomodulatory adjuvants.
    • Enrollment of the 10 patients in the GM-CSF arm is complete. Enrollment of the 10 patients in the AS01B arm is ongoing.

VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal.