VBI Vaccines Announces Second Positive DSMB Review in Phase 1/2a Study of VBI-1901 in Recurrent Glioblastoma (GBM) Patients
September 25 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 the
independent Data and Safety Monitoring Board (DSMB) completed its
second safety assessment of the ongoing Phase 1/2a clinical study
of VBI-1901 in recurrent GBM. The DSMB reviewed the complete safety
data from the fully enrolled, intermediate-dose patient cohort, and
unanimously recommended the continuation of the study without
modification.
Following this recommendation, VBI has initiated enrollment in
the high-dose arm of the study. One final, pre-specified DSMB
review is expected to occur after completion of enrollment in the
high-dose cohort, concluding the dose-escalation phase of the
study.
“We are encouraged by the sustained clean safety profile of
VBI-1901 as concluded by this second DSMB assessment,” said Jeff
Baxter, VBI’s President and CEO. “These positive safety reviews are
critical milestones for the program and for patients diagnosed with
this extremely aggressive tumor who currently have no effective
treatment options. With active clinical study sites at the
Columbia University Medical Center, Dana-Farber Cancer Institute,
and Massachusetts General Hospital, we hope to complete enrollment
in this high-dose cohort quickly and look forward to announcing
initial immunologic data from the low- and intermediate-dose
cohorts expected later this year.”
About the Phase 1/2a Study DesignVBI’s two-part
Phase 1/2a study is a multi-center, open-label, dose-escalation
study of VBI-1901 in up to 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 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 10
other countries. VBI’s eVLP Platform technology enables 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 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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Cautionary Statement on Forward-looking
Information
Certain statements in this press release that are
forward-looking and not statements of historical fact are
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995
and are forward-looking information within the meaning of Canadian
securities laws (collectively, “forward-looking statements”). The
company cautions that such statements involve risks and
uncertainties that may materially affect the company's results of
operations. Such forward-looking statements are based on the
beliefs of management as well as assumptions made by and
information currently available to management. Actual results could
differ materially from those contemplated by the forward-looking
statements as a result of certain factors, including but not
limited to the ability to establish that potential products are
efficacious or safe in preclinical or clinical trials; the ability
to establish or maintain collaborations on the development of
therapeutic candidates; the ability to obtain appropriate or
necessary governmental approvals to market potential products; the
ability to obtain future funding for developmental products and
working capital and to obtain such funding on commercially
reasonable terms; the company's ability to manufacture product
candidates on a commercial scale or in collaborations with third
parties; changes in the size and nature of competitors; the ability
to retain key executives and scientists; and the ability to secure
and enforce legal rights related to the company's products. A
discussion of these and other factors, including risks and
uncertainties with respect to the company, is set forth in the
Company's filings with the Securities and Exchange Commission and
the Canadian securities authorities, including its Annual Report on
Form 10-K filed with the Securities and Exchange Commission on
February 26, 2018, and filed with the Canadian security authorities
at sedar.com on February 26, 2018, as may be supplemented or
amended by the Company's Quarterly Reports on Form 10-Q. Given
these risks, uncertainties and factors, you are cautioned not to
place undue reliance on such forward-looking statements, which are
qualified in their entirety by this cautionary statement. All such
forward-looking statements made herein are based on our current
expectations and we undertake no duty or obligation to update or
revise any forward-looking statements for any reason, except as
required by law.
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
Burns McClellan, Inc. Robert Flamm, Ph.D. Phone: (212)
213-0006Email: rflamm@burnsmc.com
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