VBI Vaccines Announces Biomarker Data From VBI-1901 Phase 1/2a Study in Recurrent GBM Presented at ESMO Virtual Congress 2020
September 17 2020 - 8:00AM
Business Wire
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage
biopharmaceutical company developing next-generation infectious
disease and immuno-oncology vaccines, today announced additional
biomarker data from its ongoing Phase 1/2a study evaluating
VBI-1901, the company’s cancer vaccine immunotherapeutic candidate
in recurrent glioblastoma (GBM) patients presented in an e-poster
at The European Society for Medical Oncology (ESMO) Virtual
Congress 2020.
Expanding the biomarker analysis of the six tumor responders
seen to-date in the study, including a confirmed durable partial
response, the e-poster highlighted data that further assessed
correlates of tumor response and clinical benefit. Specifically,
human leukocyte antigen (HLA) restriction and T cell receptor (TCR)
repertoires were evaluated.
“We continue to broaden the analysis around tumor responders in
our ongoing Phase 1/2a study of VBI-1901 to enable us to identify
GBM patients most likely to benefit from the vaccine
immunotherapeutic in the next phase of clinical development,” said
Dr. David E. Anderson, VBI’s Chief Scientific Officer. “This
analysis suggests that VBI-1901 is able to induce a CMV
antigen-specific immune response to target a broader set of CMV
antigens beyond what is expressed in VBI-1901, evident by HLA
analysis and functional T cell assays. As with the previously
announced CD4+/CD8+ ratio, a biomarker which may reflect the
immunologic fitness of CD4+ T cells in recurrent GBM patients,
these biomarkers will continue to be evaluated throughout the
study.”
In parallel to the ongoing biomarker analysis, enrollment in the
Phase 1/2a Part B study arm of VBI-1901 in combination with GSK’s
AS01B adjuvant system continues, with initial immunologic and tumor
data expected in Q4 2020.
The e-poster is available on the “Events/Presentations” page in
the “Investors” section of the VBI Vaccines website.
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 arm, assessing 10.0 µg of VBI-1901 in combination
with either GM-CSF or GSK’s proprietary AS01B adjuvant system as
immunomodulatory adjuvants.
- Enrollment of the 10 patients in the GM-CSF arm is complete.
Enrollment of the 10 patients in the AS01B arm is ongoing.
VBI-1901 is administered intradermally when adjuvanted with
GM-CSF and intramuscularly when adjuvanted with the AS01B 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 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:
(1) the only tri-antigenic hepatitis B vaccine, Sci-B-Vac®, which
is approved for use and commercially available in Israel and
recently completed its Phase 3 program in the U.S., Europe, and
Canada; and (2) an immunotherapeutic in development for a
functional cure for chronic hepatitis B. VBI’s enveloped virus-like
particle (eVLP) platform technology enables development of eVLPs
that closely mimic the target virus to elicit a potent immune
response. VBI’s lead eVLP programs include a vaccine
immunotherapeutic candidate targeting glioblastoma (GBM), a
prophylactic cytomegalovirus (CMV) vaccine candidate, and a
prophylactic pan-coronavirus vaccine 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:
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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 impact of general economic, industry or political
conditions in the United States or internationally; the impact of
the ongoing COVID-19 pandemic on our clinical studies,
manufacturing, business plan, and the global economy; 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 SEC and the Canadian securities authorities, including its
Annual Report on Form 10-K filed with the SEC on March 5, 2020, and
filed with the Canadian security authorities at sedar.com on March
5, 2020, 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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VBI Contact Nicole Anderson Director, Corporate
Communications & IR Phone: (617) 830-3031 x124 Email:
IR@vbivaccines.com
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