- BI-2601 (BRII-179) and BRII-835 combination was generally
well-tolerated with no new safety signals observed
- Initial data suggest VBI-2601 (BRII-179) and BRII-835
combination induced meaningfully stronger anti-hepatitis B surface
antigen (HBsAg)-specific T-cell and antibody responses compared to
BRII-835 alone
- Data to be featured in oral presentation, given by Dr. Man Fung
Yuen, M.D., Ph.D., D.Sc., at the 32nd Conference of the Asian
Pacific Association for the Study of the Liver (APASL) 2023 in
Taipei, Taiwan on February 18, 2023
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical
company driven by immunology in the pursuit of powerful prevention
and treatment of disease, today announced interim data from the
Phase 2 study evaluating the combination of VBI-2601 (BRII-179),
VBI’s HBV immunotherapeutic candidate, and BRII-835 (VIR-2218), an
HBV-targeting siRNA candidate, in chronically infected HBV
patients. The data, which will be featured in an oral presentation
at APASL on February 18, 2023, demonstrated that the combination
therapy was generally well-tolerated, restored strong anti-HBsAg
antibody responses, and led to improved HBsAg-specific T-cell
responses, when compared to BRII-835 alone. Notably, in two
participants who received the combination therapy, maximum
reductions in HBsAg to an undetectable level or to the lower limit
of quantification (LLOQ) were achieved by Week 40, which were
associated with robust HBV-specific antibody and T-cell
responses.
Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical
Officer, commented: “Numerous studies have assessed the potential
of siRNA candidates in hundreds of chronically infected HBV
patients, but this is the first time we’ve seen data from the
combination of an HBV siRNA with an HBV-specific immunomodulator.
Consistent with the known mechanism of action of VBI-2601 and its
inclusion of the pre-S1 and pre-S2 antigens in addition to the S
antigen, these interim data indicate that VBI-2601 may be able to
break tolerance to the S antigen, achieving immune restoration.
Additionally, the reduction of S antigen to at or below the LLOQ,
as seen in the two patients, is a noteworthy achievement in this
population. We are very encouraged by these interim data, which
suggest that the combination of VBI-2601 and an HBV siRNA has the
potential to be a meaningful part of a functional cure regimen. We
look forward to additional data from this study, as well as data
from the ongoing Phase 2 study of VBI-2601 as an ‘add-on’ to
existing pegylated interferon (PEG-IFN-α) and nucleos(t)ide reverse
transcriptase inhibitor (Nrtl) therapy in non-cirrhotic chronic HBV
patients, both of which are expected later this year.”
An abstract summarizing the interim data is available at the
following link:
https://www.apasl2023.tw/#/page/ABSTRACT%20BOOK.
The interim data will be shared in an oral presentation, titled
Preliminary Safety and Efficacy of the Combination Therapy of
BRII-835 and BRII-179 Treating Chronic HBV Infection, at the 32nd
Annual Conference of the Asian Pacific Association for the Study of
the Liver (APASL) taking place in Taipei, Taiwan, on Saturday,
February 18, 2023, at 14:10 local time.
About the Phase 2 Study
The randomized, multi-center Phase 2 study is being conducted at
clinical sites in Australia, Taiwan, Hong Kong Special
Administrative Region of China, South Korea, New Zealand,
Singapore, and Thailand. VBI’s partner, Brii Biosciences (Brii
Bio), is the study sponsor. The interim data were generated from a
total of 50 adult, non-cirrhotic patients who received
nucleos(t)ide reverse transcriptase inhibitor (NRTI) therapy for at
least 12 months and who were randomized and dosed across three
cohorts:
Cohort A:
BRII-835 Alone Regimen – Nine subcutaneous
100mg doses of BRII-835, dosed every four (4) weeks through Week
32
Cohort B:
BRII-835 Alone Regimen + nine 40µg
intramuscular doses of VBI-2601 admixed with interferon-alpha
(IFN-α) as co-adjuvant every four weeks from Week 8 through Week
40
Cohort C:
BRII-835 Alone Regimen + nine 40µg
intramuscular doses of VBI-2601 without IFN-α every four weeks from
Week 8 through Week 40
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious
disease threats with more than 290 million people infected
globally. HBV infection is the leading cause of liver disease and,
with current treatments, is very difficult to cure, with many
patients going on to develop liver cancers. An estimated 900,000
people die each year from complications of chronic HBV such as
liver decompensation, cirrhosis, and hepatocellular carcinoma.
About VBI-2601 (BRII-179)
VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV
immunotherapeutic candidate that builds upon the 3-antigen
conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate
and is designed to target enhanced B-cell and T-cell immunity.
VBI-2601 (BRII-179) is being developed in collaboration with Brii
Biosciences in the licensed territory of China, Hong Kong, Macau,
and Taiwan as part of a potential functional cure for chronic
hepatitis B infection.
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; 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; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230215005229/en/
Nicole Anderson Director, Corporate Communications & IR
Phone: (617) 830-3031 x124 Email: IR@vbivaccines.com
VBI Vaccines (NASDAQ:VBIV)
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