• The two-arm Phase 2a study is expected to enroll 20 first-recurrent GBM patients to receive VBI’s cancer vaccine candidate, VBI-1901, in combination with either GM-CSF or AS01B
  • Initial immunologic data from the VBI-1901 with AS01B study arm expected Q4 2020
  • Expanded immunologic data, tumor and clinical responses from VBI-1901 with GM-CSF study arm expected Q2 2020
  • VBI is the first biopharma company to collaborate with GSK to assess the AS01B adjuvant system as part of a therapeutic cancer vaccine candidate

VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the first patient has been dosed in the second study arm in the ongoing Phase 2a clinical study of VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate. The Phase 2a study is a two-arm, open-label study, enrolling 20 first-recurrent GBM patients to receive VBI-1901 in combination with either GM-CSF or AS01B, GlaxoSmithKline’s (GSK) proprietary adjuvant system, as immunomodulatory adjuvants.

“We are excited to initiate enrollment in this study arm to evaluate VBI-1901 in combination with AS01B, GSK’s effective proprietary adjuvant system,” said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. “AS01B has been shown to boost T-cell mediated immunity and, building on the encouraging early immunologic and tumor response data we’ve seen to-date from the VBI-1901 with GM-CSF study arm, we look forward to evaluating the benefit this combination could have for patients with GBM, a devastating disease with few treatment options.”

“We are pleased that this study is now underway as this is the first time AS01B will be assessed in oncology for GBM patients in a clinical setting. We are looking forward to seeing initial results later this year and hope that this technology will be able to make a real difference for GBM patients. Applying our expertise in adjuvant technologies in new fields of vaccines research is a core part of our innovation strategy,” said Emmanuel Hanon, Senior Vice President, Head of R&D at GSK Vaccines.

VBI’s ongoing two-part study is being conducted at The Neurological Institute of New York Columbia University Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, and the Ronald Reagan UCLA Medical Center.

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:

  • 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
  • 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 AS01B adjuvant system as immunomodulatory adjuvants.
    • Enrollment in each study arm is ongoing

VBI-1901 is administered intradermally when adjuvanted with GM-CSF and will be administered intramuscularly when adjuvanted with AS01B adjuvant system. Patients in the study will receive the vaccine immunotherapeutic every four weeks until clinical disease progression.

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