On March 3, 2020 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported an update on Part A of the ongoing Phase 1/2a study of VBI-1901, the company’s cancer vaccine immunotherapeutic candidate, for the treatment of patients with recurrent glioblastoma (GBM) (Press release, VBI Vaccines, MAR 3, 2020, View Source [SID1234555138]). For patients who had an immunologic response to the vaccine, considered to be vaccine responders, the 12-month overall survival (OS) rate was 83% (n=5/6), compared to 33% for vaccine non-responders (n=3/9). Similarly, among patients evaluable for response and survival in Part A, vaccine responders saw a 6.25-month improvement in median OS (14.0 months) compared to vaccine non-responders (7.75 months). VBI-1901 continues to be safe and well-tolerated at all doses tested, with no safety signals observed.

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"We remain encouraged by the data from this ongoing Phase 1/2a study of VBI-1901 in the recurrent GBM setting, a setting in which it has historically been incredibly difficult to show any benefit, especially with a monotherapy," said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. "The standard of care treatment in the recurrent GBM setting is not well defined, however, commonly-used regimens, including chemotherapy and VEGF-A inhibitors as monotherapy and in combination, have demonstrated 12-month OS rates below 50% with median OS around 8 to 12 months1. Moreover, these regimens often cause significant toxicity, poorly affecting quality of life for the individual. While the data generated for VBI-1901 is early, we continue to be optimistic as we work hard to provide any meaningful benefit to patients who currently have few treatment options."

Expanded immunologic, tumor imaging, and clinical data from the Phase 2a part of the study are expected in Q2 2020 – data from the VBI-1901 + GM-CSF arm – and Q4 2020 – data from the VBI-1901 + AS01B arm. Additionally, efforts are underway to define biomarkers that may help identify patients more likely to respond to VBI-1901.

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 AS01B adjuvant system as immunomodulatory adjuvants.
Enrollment in both study arms is ongoing.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and will be administered intramuscularly when adjuvanted with AS01B adjuvant system. Patients will receive the vaccine immunotherapeutic every four weeks until tumor progression.

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