On May 20, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that expanded tumor response data and overall survival data from the Phase 2a portion of 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 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 4-8 (Press release, VBI Vaccines, MAY 20, 2021, View Source [SID1234580391]).

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The e-poster presentation will highlight patient-specific tumor response data and improvement in overall survival (OS) compared to historical controls across both study arms:

Study arm 1 : VBI-1901 + granulocyte-macrophage colony-stimulating factor (GM-CSF)
6-month and 12-month OS : 80% (n=8/10) and 60% (n=6/10), respectively
2 partial responses (≥ 50% tumor reduction) and 2 stable disease observations – 40% disease control rate
1 patient still on protocol
Study arm 2 : VBI-1901 + GSK’s AS01B adjuvant system
6-month OS : 89% (n=8/9) – 12-month OS not yet reached
5 stable disease observations – 50% disease control rate
1 patient still on protocol
With few options for recurrent GBM patients, historical control data have demonstrated overall survival to be ~60% at 6-months and ~30% at 12-months after treatment with a monotherapy.1

Presentation details and schedule are as follows:

Abstract #: 2047
Abstract Title: Evaluation of GM-CSF and AS01B adjuvants in a Phase 1/2a trial of a therapeutic CMV vaccine (VBI-1901) against recurrent glioblastoma (GBM)
Presenter: Patrick Y. Wen, M.D., Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, Professor of Neurology at Harvard Medical School, and investigator of VBI’s Phase 1/2a study of VBI-1901
Session: Poster Session: Central Nervous System Tumors
Poster Access: June 4-8, 2021

The e-poster presentation will include a 5-minute pre-recorded presentation from Dr. Wen, available On Demand to meeting attendees from 9 AM ET on Friday, June 4.

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 vaccinated group, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01 adjuvant system as immunomodulatory adjuvants.
Enrollment of the 10 patients in each adjuvant group is complete.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with GSK’s AS01 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 has a high mortality.