VBI Vaccines Announces Initiation of Phase 1 Study of Multivalent Coronavirus Vaccine Candidate, VBI-2901
29 September 2022 - 10:00PM
Business Wire
- Initiation of first clinical study of multivalent VBI-2901,
designed to increase breadth of protection against COVID-19 and
related coronaviruses
- Preclinical data support broadly reactive immunity of VBI-2901
against a panel of coronavirus variants in mice, which now also
includes circulating BA.4 and BA.5
- The study is expected to enroll approximately 100 adults in
Canada and is supported by the Government of Canada
- Interim data expected mid-year 2023, subject to speed of
enrollment
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical
company driven by immunology in the pursuit of powerful prevention
and treatment of disease, today announced the initiation of
enrollment in the Phase 1 clinical study of VBI-2901, a multivalent
enveloped virus-like particle (eVLP) coronavirus vaccine candidate
expressing the full-length spike proteins from the SARS-CoV-1
(SARS), SARS-CoV-2 (COVID-19), and MERS-CoV (MERS) viruses.
Jeff Baxter, VBI’s President and CEO commented, “We strive to
contribute to the long-term solution in the fight against
coronaviruses and remain committed to supporting our public health
partners. As we work to develop a vaccine capable of providing
broad protection against known, emerging, and as-yet-unknown
COVID-19 and coronavirus strains, we believe this study initiation
is a meaningful step toward that goal.”
Coronaviruses are enveloped viruses by nature, making them prime
targets for VBI’s flexible eVLP technology, which in a Phase 1a/1b
study of two monovalent, variant-specific vaccine candidates
generated human proof-of-concept data demonstrating the safety,
tolerability, and immunogenicity of the eVLP platform against
coronaviruses.
David Anderson, Ph.D., VBI’s Chief Scientific Officer added, “We
are excited to kick-off the first human study of VBI-2901, a
candidate that has consistently elicited a stronger response than
our variant-specific candidates against a broad panel of
coronavirus variants in mice. Our preclinical panels now include
BA.4 and BA.5 as well as the ancestral strain, Delta, Beta, Lambda,
Omicron, and pangolin and bat coronaviruses distantly related to
circulating human strains. These data seen to date demonstrated
that, generally, as the strains became more divergent from the
ancestral strain, VBI-2901 elicited a greater increase in antibody
responses compared to our other variant-specific COVID-19 vaccine
candidates.”
The Phase 1 randomized, open-label study will enroll three
cohorts of subjects, randomized 1:1:1, to compare either two
intramuscular doses of VBI-2901 at a low- (5µg) or high- (10µg)
dose level, or one dose of VBI-2901 at the high-dose level (10µg)
in approximately 100 healthy adults age 18-64 who have previously
received two or more immunizations with COVID-19 vaccines licensed
by Health Canada. Each participant must have received their
previous dose of a licensed COVID-19 vaccine at least six months
prior to study enrollment.
This study is supported by funding from the Government of
Canada’s Innovation, Science and Economic Development (ISED)
through the Strategic Innovation Fund.
About VBI’s Coronavirus Vaccine Program: VBI-2900
VBI-2900 consists of three enveloped virus-like particle (eVLP)
vaccine candidates: (1) VBI-2901, a multivalent coronavirus vaccine
expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins,
(2) VBI-2902, a monovalent COVID-19 vaccine expressing a modified
prefusion form of the SARS-CoV-2 ancestral spike protein, and (3)
VBI-2905, a monovalent COVID-19 vaccine expressing a modified
prefusion form of the spike protein from the Beta variant (also
known as B.1.351).
The vaccine program has been developed through collaborations
with the National Research Council of Canada (NRC), the Coalition
for Epidemic Preparedness Innovations (CEPI), and the Government of
Canada, through their Strategic Innovation Fund.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven
by immunology in the pursuit of powerful prevention and treatment
of disease. Through its innovative approach to virus-like particles
(“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform
technology, VBI develops vaccine candidates that mimic the natural
presentation of viruses, designed to elicit the innate power of the
human immune system. VBI is committed to targeting and overcoming
significant infectious diseases, including hepatitis B,
coronaviruses, and cytomegalovirus (CMV), as well as aggressive
cancers including glioblastoma (GBM). VBI is headquartered in
Cambridge, Massachusetts, with research operations in Ottawa,
Canada, and a research and manufacturing site in Rehovot,
Israel.
For more information, visit www.vbivaccines.com.
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 successfully manufacture and commercialize PreHevbrio/PreHevbri;
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 pipeline candidates
and the commercialization of PreHevbrio/PreHevbri; the ability to
obtain appropriate or necessary regulatory 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 7, 2022, and filed with the
Canadian security authorities at sedar.com on March 7, 2022, 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/20220929005213/en/
VBI: Nicole Anderson Director, Corporate Communications
& IR Phone: (617) 830-3031 x124 Email: IR@vbivaccines.com
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