- VBI is the first biopharma company to collaborate with GSK to
assess AS01B adjuvant system as part of a therapeutic cancer
vaccine candidate
- Combination will be tested in additional study arm in Part B
of VBI’s ongoing Phase 1/2a clinical study of VBI-1901 in recurrent
GBM patients
VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage
biopharmaceutical company developing next-generation infectious
disease and immuno-oncology vaccines, today announced a
collaboration with GlaxoSmithKline (GSK) to clinically evaluate the
combination of VBI-1901, VBI’s cancer vaccine immunotherapeutic,
with GSK’s proprietary AS01B adjuvant system. As part of the
collaboration, VBI plans to add an additional study arm to Part B
of the company’s ongoing, multi-center, open-label Phase 1/2a
clinical study targeting recurrent glioblastoma (GBM), a
cytomegalovirus (CMV)-associated tumor.
“VBI-1901 has shown encouraging results in Part A of the ongoing
Phase 1/2a clinical study in recurrent GBM patients and we are
excited to be able to expand the scope of Part B to assess the
candidate in combination with AS01B, a highly-innovative adjuvant
system that has contributed to positive results in combination with
the gE antigen in GSK’s shingles vaccine, Shingrix,” said David E.
Anderson, Ph.D., VBI’s Chief Scientific Officer. “VBI’s enveloped
virus-like particle (eVLP) technology, the basis for VBI-1901, is
highly versatile and has demonstrated clinical potency in both
preventative and therapeutic settings. We believe that these two
technologies may be an ideal match for next-generation vaccines,
and we look forward to seeing the results of this
collaboration.”
“This is the first time we have partnered with a biopharma
company to evaluate AS01B in such a clinical setting and the first
time this adjuvant will be assessed in oncology for GBM patients.
We have shown the ability of AS01B to boost T-cell mediated
immunity and believe the combination of AS01B and VBI-1901 could
have benefits for patients with glioblastoma, a rare but
devastating cancer,” said Emmanuel Hanon, Senior Vice President,
Head of R&D at GSK Vaccines.
In Part A of the study, VBI-1901 adjuvanted with
granulocyte-macrophage colony-stimulating factor (GM-CSF) was
well-tolerated at all doses. Further, three out of six patients in
the high-dose (10 µg) cohort demonstrated evidence of stable
disease by magnetic resonance imaging (MRI), which correlated with
vaccine-induced immune response. Based on this safety and
immunogenicity data, the high-dose was identified as the optimal
therapeutic dose to test in the Part B extension phase of the
study.
Part B of the ongoing Phase 1/2a clinical study is now planned
to be a two-arm, open-label study, enrolling 20 first-recurrent GBM
patients to receive VBI-1901 in combination with either GM-CSF or
AS01B as immunomodulatory adjuvants. Enrollment of the 10 patients
in the VBI-1901 with GM-CSF arm was initiated at the end of July
2019. Initiation of enrollment of the 10 patients in the VBI-1901
with AS01B arm is expected later in the second half of 2019,
subject to U.S. Food and Drug Administration (FDA) acceptance of
the amended protocol.
VBI’s ongoing two-part study is being conducted at The
Neurological Institute of New York Columbia University Medical
Center, Dana-Farber Cancer Institute, and Massachusetts General
Hospital.
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:
- Part A:
- Dose-escalation phase that defined the safety, tolerability,
and optimal dose level of VBI-1901 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
- Part B:
- Subsequent extension of the optimal dose level, 10.0 µg, as
defined in the Part A dose escalation phase
- This phase will be a two-arm study, enrolling 10 patients in
each arm, assessing VBI-1901 in combination with either GM-CSF or
AS01B as immunomodulatory adjuvants
- Part B will enroll first-recurrent GBM patients only
VBI-1901 is administered intradermally when adjuvanted with
granulocyte-macrophage colony-stimulating factor (GM-CSF), and will
be administered intramuscularly when adjuvanted with GSK's
proprietary AS01B adjuvant system. Patients in both phases of the
study will receive the vaccine immunotherapeutic every four weeks
until clinical 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 Glioblastoma (GBM)
Scientific literature suggests cytomegalovirus (CMV) infection
is prevalent in multiple solid tumors, including GBM, gliomas, and
breast cancer, among others. GBM is among the most common and
aggressive malignant primary brain tumors. 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.
About VBI Vaccines Inc.
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage
biopharmaceutical company developing a next generation of vaccines
to address unmet needs in infectious disease and immuno-oncology.
VBI is advancing the prevention and treatment of hepatitis B, with
the only commercially-approved trivalent hepatitis B vaccine,
Sci-B-Vac®, which is approved for use in Israel and 10 other
countries and is currently in a Phase 3 program in the U.S.,
Europe, and Canada, and with an immunotherapeutic in development
for a functional cure for chronic hepatitis B. 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. Integrating its cytomegalovirus
(CMV) expertise with the eVLP platform technology, VBI’s lead eVLP
program candidates include a prophylactic CMV vaccine candidate and
a glioblastoma (GBM) vaccine immunotherapeutic candidate. 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/
About GlaxoSmithKline (GSK) and AS01 Adjuvant System
GSK – one of the world’s leading research-based pharmaceutical
and healthcare companies – is committed to improving the quality of
human life by enabling people to do more, feel better, and live
longer. The GSK proprietary AS01 adjuvant system contains QS-21
Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned
subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes. For
further information please visit www.gsk.com/about-us/.
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 25, 2019, and filed with the Canadian security authorities
at sedar.com on February 25, 2019, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190910005273/en/
VBI Contact Nicole Anderson Associate, Corporate
Communications Phone: (617) 830-3031 x124 Email:
info@vbivaccines.com VBI Investor Contact Nell Beattie Chief
Business Officer Email: ir@vbivaccines.com VBI Media Contact
Burns McClellan, Inc. Robert Flamm, Ph.D. Phone: (212) 213-0006
Email: rflamm@burnsmc.com
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