VBI Vaccines Announces Positive DSMB Review in Phase 1/2a Study of VBI-1901 in Recurrent Glioblastoma (GBM) Patients
April 17 2018 - 8:00AM
VBI Vaccines Inc. (Nasdaq:VBIV) (“VBI”), a commercial-stage
biopharmaceutical company developing next-generation infectious
disease and immuno-oncology vaccines, today announced that, upon
review of all safety data from the fully enrolled, low-dose patient
cohort of the ongoing Phase 1/2a clinical study of VBI-1901 in
recurrent Glioblastoma (GBM), the independent Data and Safety
Monitoring Board (DSMB) unanimously recommended the continuation of
the study without modification.
Following this recommendation, VBI has initiated enrollment in
the intermediate-dose arm of the dose-escalation phase of this
study. Two additional, pre-specified DSMB reviews will occur
after the completion of enrollment in the intermediate-dose study
arm and the high-dose study arm, respectively.
“We are encouraged by the safety profile of this candidate so
far and are excited to continue enrollment in the intermediate dose
cohort of this Phase 1/2a study, our first clinical study in
immuno-oncology,” said Jeff Baxter, VBI’s president and CEO. “In
recurrent GBM, a devastating CMV-associated tumor, patients have
few effective treatment options, and we believe that VBI-1901 has
the potential to stimulate immune responses critical to boosting
anti-tumor immunity.”
About the Phase I/2a Study
Design
VBI’s two-part Phase 1/2a study is a multi-center, open-label,
dose-escalation study of VBI-1901 in approximately 28 patients with
recurrent GBM:
- Part A: Dose-escalation phase to define the safety,
tolerability, and optimal dose level of VBI-1901 in recurrent GBM
patients. This phase is expected to enroll up to 18 patients in
three dose cohorts.
- Part B: A subsequent extension of the optimal dose level, as
defined in the dose escalation phase. This phase is expected to
enroll an expanded cohort of approximately 10 additional
patients.
VBI-1901 is administered intradermally and is adjuvanted with
granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent
adjuvant that mobilizes dendritic cell function. Patients in both
phases of the study will receive vaccine 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.
About VBI-1901 and GBM
VBI-1901 is a novel immunotherapy developed using VBI’s eVLP
technology to target two highly immunogenic cytomegalovirus (CMV)
antigens, gB and pp65. Scientific literature suggests CMV infection
is prevalent in multiple solid tumors, and recent research has
demonstrated that an anti-CMV dendritic cell vaccination regimen
may extend overall survival in patients with GBM. Additionally,
recent preclinical studies confirmed that VBI-1901 may be a potent,
“off-the-shelf” therapeutic vaccine.
Glioblastoma 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, with median patient survival of less than 16
months.
To learn more about VBI-1901,
visit: https://www.vbivaccines.com/gbm/
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a commercial-stage
biopharmaceutical company developing a next generation of vaccines
to address unmet needs in infectious disease and immuno-oncology.
VBI’s first marketed product is Sci-B-Vac®, a
hepatitis B (HBV) vaccine that mimics all three viral surface
antigens of the hepatitis B virus; Sci-B-Vac is approved for use in
Israel and 14 other countries. VBI’s eVLP Platform technology
allows for the development of enveloped virus-like particle (eVLP)
vaccines that closely mimic the target virus to elicit a potent
immune response. VBI is advancing a pipeline of eVLP vaccines, with
lead programs in cytomegalovirus (CMV) and glioblastoma (GBM). VBI
is also advancing its LPV™ Thermostability Platform, a proprietary
formulation and process that enables vaccines and biologics to
preserve stability, potency, and safety. VBI is headquartered in
Cambridge, MA with research operations in Ottawa, Canada and
research and manufacturing facilities in Rehovot, Israel.
- Website Home: http://www.vbivaccines.com/
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VBI Contact
Nicole Anderson, Communications ExecutivePhone: (617) 830-3031
x124Email: info@vbivaccines.com
VBI Investor Contact
Nell BeattieChief Business OfficerEmail: IR@vbivaccines.com
VBI Media Contact
Justin JacksonBurns McClellan Life Sciences Communications
Phone: (212) 213-0006Email: jjackson@burnsmc.com
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Company's filings with the Securities and Exchange Commission and
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February 26, 2018, and filed with the Canadian security authorities
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