On September 17, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported additional biomarker data from its ongoing Phase 1/2a study evaluating VBI-1901, the company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM) patients presented in an e-poster at The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, VBI Vaccines, SEP 17, 2020, View Source [SID1234565310]).

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Expanding the biomarker analysis of the six tumor responders seen to-date in the study, including a confirmed durable partial response, the e-poster highlighted data that further assessed correlates of tumor response and clinical benefit. Specifically, human leukocyte antigen (HLA) restriction and T cell receptor (TCR) repertoires were evaluated.

"We continue to broaden the analysis around tumor responders in our ongoing Phase 1/2a study of VBI-1901 to enable us to identify GBM patients most likely to benefit from the vaccine immunotherapeutic in the next phase of clinical development," said Dr. David E. Anderson, VBI’s Chief Scientific Officer. "This analysis suggests that VBI-1901 is able to induce a CMV antigen-specific immune response to target a broader set of CMV antigens beyond what is expressed in VBI-1901, evident by HLA analysis and functional T cell assays. As with the previously announced CD4+/CD8+ ratio, a biomarker which may reflect the immunologic fitness of CD4+ T cells in recurrent GBM patients, these biomarkers will continue to be evaluated throughout the study."

In parallel to the ongoing biomarker analysis, enrollment in the Phase 1/2a Part B study arm of VBI-1901 in combination with GSK’s AS01B adjuvant system continues, with initial immunologic and tumor data expected in Q4 2020.

The e-poster is available on the "Events/Presentations" page in the "Investors" section of the VBI Vaccines website.

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 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.