VBI Vaccines Announces Dosing of First GBM Patient in Phase 1/2a Clinical Study of VBI-1901
January 17 2018 - 8:00AM
VBI Vaccines Inc. (Nasdaq:VBIV) (TSX:VBV) (VBI), a commercial-stage
biopharmaceutical company developing next-generation infectious
disease and immuno-oncology vaccines, today announced that the
first patient has been dosed in a Phase 1/2a clinical study of
VBI-1901 for the treatment of recurrent glioblastoma multiforme
(rGBM). The multi-center, open-label, two-part study will
enroll up to 28 patients and is designed to evaluate safety,
tolerability, and the optimal therapeutic dose level of VBI-1901.
“We are excited to announce that the first patient has been
dosed in this initial clinical study of VBI-1901, our first
clinical study in immuno-oncology,” said Jeff Baxter, President and
CEO of VBI. “Recurrent GBM is a devastating CMV-associated tumor
with few effective treatment options. We developed VBI-1901 to
target two highly immunogenic CMV antigens, and, based on
preclinical studies, we believe it has the potential to induce a
strong anti-tumor immune response in these patients.”
About the Phase I/IIa Study Design
This two-part Phase 1/2a study is a multi-center, open-label,
dose-escalation study of VBI-1901 in approximately 28 patients with
rGBM:
- Part A: Dose-escalation phase to define the safety,
tolerability, and optimal dose level of VBI-1901 in rGBM
patients. This phase is expected to enroll up to 18
patients.
- 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 will be administered intradermally and will be
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 continue to receive
vaccine every four weeks until tumor progression.
The study will take place at two leading sites in the U.S. –
NewYork Presbyterian-Columbia University Medical Center in New York
City, New York, and Inova Health System in Falls Church, Virginia.
Andrew Lassman, MD, the John Harris Associate Professor of
Neurology and Chief of Neuro-oncology at Columbia University, has
been named as the lead investigator.
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 multiforme (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/
- News and Insights: http://www.vbivaccines.com/wire/
- Investors: http://www.vbivaccines.com/investors/
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,
including patent protection. 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 March 20, 2017, and filed with the
Canadian security authorities at sedar.com on March 24, 2017, as
may be supplemented or amended by the Company’s Quarterly Reports
on Form 10-Q-. 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 Beattie, Chief Business OfficerPhone: (617) 830-3031
x128Email: IR@vbivaccines.com
VBI Media Contact
Matt Middleman, M.D.LifeSci Public RelationsPhone: (646)
627-8384Email: matt@lifescipublicrelations.com
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