– New combination trial of an RNA-targeted
therapeutic candidate and an HBV immunotherapeutic candidate aimed
at delivering a functional cure for chronic hepatitis B infection
–
Brii Biosciences (Brii Bio), Vir Biotechnology, Inc. (Nasdaq:
VIR), and VBI Vaccines Inc. (Nasdaq: VBIV) today announced that the
first patient has been dosed in a Phase 2 clinical trial evaluating
BRII-835 (VIR-2218), an investigational small interfering
ribonucleic acid (siRNA) targeting hepatitis B virus (HBV), in
combination with BRII-179 (VBI-2601), an investigational HBV
immunotherapeutic, for the treatment of chronic HBV infection. This
is the first clinical trial in the field to evaluate the
combination of these two HBV mechanisms of action.
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The multi-center, randomized, open-label study is designed to
evaluate the safety and efficacy of BRII-835 (VIR-2218) compared to
the combination of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with
and without interferon-alpha as a co-adjuvant. Both agents have
demonstrated proof of mechanism in HBV patients (NCT04507269
BRII-835 China study and ACTRN12619001210167 BRII-179 APEC study).
Brii Bio has led the design and implementation of this functional
cure proof-of-concept study with the support of VIR and VBI, and is
the sponsor of the Phase 2 study (NCT04749368). It will be
conducted at sites in Australia, China, Taiwan, Hong Kong Special
Administrative Region of China, South Korea, New Zealand,
Singapore, and Thailand.
Li Yan, M.D., Ph.D., chief medical officer of Brii Bio, said:
“Sustained seroclearance of HBV surface antigen, also known as a
functional cure, occurs rarely in the natural history of HBV
infection or during the current standard of care treatment. We
believe that both viral antigen knockdown with BRII-835 (VIR-2218)
and sustained induction of HBV-specific host immune responses by
BRII-179 (VBI-2601) are required to remove viral immunosuppression
and subsequently break immune tolerance. The combination of these
two agents is a step toward developing a functional cure for
HBV.”
Phil Pang, M.D., Ph.D., chief medical officer of Vir, said:
“This new combination trial represents an important addition to our
HBV portfolio approach of combining VIR-2218 with various
immunomodulators, including pegylated interferon alpha, VIR-3434
and with a TLR8 agonist, via our previously announced collaboration
with Gilead. We look forward to determining if such combinations
can stimulate an effective immune response that may result in a
finite duration of treatment.”
Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s chief medical officer,
said: “We believe that a functional cure for HBV is possible, and
will require restoration of HBV-specific immunologic control in
addition to viral suppression mechanisms. Data from our previous
study suggest BRII-179 (VBI-2601) was able to restimulate both
antibody and T cell responses specific to HBV. This combination
study represents the first combination of a therapeutic HBV vaccine
to restore HBV-immunity with antivirals designed to reduce the
levels of HBV surface antigens. We look forward to seeing the
outcome of the trial, a milestone that will be meaningful in our
collective efforts to provide an effective solution for patients
with such a complex and highly infectious virus.”
About BRII-835 (VIR-2218)
BRII-835 (VIR-2218) is an investigational subcutaneously
administered HBV-targeting siRNA that has the potential to
stimulate an effective immune response and have direct antiviral
activity against HBV. It is the first siRNA in the clinic to
include Enhanced Stabilization Chemistry Plus (ESC+) technology to
enhance stability and minimize off-target activity, which
potentially can result in an increased therapeutic index. VIR-2218
is the first asset in the Company’s collaboration with Alnylam
Pharmaceuticals, Inc. to enter clinical trials. Brii Bio licensed
exclusive rights to develop and commercialize VIR-2218 for the
greater China territory from Vir in 2020.
In addition to the Phase 2 combination trial with BRII-179
(VBI-2601), VIR-2218 is being evaluated in two ongoing trials: as a
monotherapy for HBV, and in combination with pegylated
interferon-alpha (PEG-IFN-α). Two additional Phase 2 trials of
VIR-2218 are expected to start in 2021.
About BRII-179 (VBI-2601)
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 Brii Biosciences
Brii Biosciences (Brii Bio) is a multi-national company
committed to serving patients’ needs and improving public health by
accelerating the development and delivery of breakthrough medicines
through partnerships, best-in-class research and development, and
the disruptive application of digital and data insight. With
operations in the People’s Republic of China and the United States,
Brii Bio is poised to serve as a bridge to carry transformative
medicines to patients, help create significant growth for our
partners and establish an innovation engine to help improve the
public health and wellbeing of patients around the world. Brii Bio
is developing treatments for illnesses with significant public
health burdens, including infectious diseases, liver diseases, and
CNS diseases. For more information, visit www.briibio.com.
About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused
on combining immunologic insights with cutting-edge technologies to
treat and prevent serious infectious diseases. Vir has assembled
four technology platforms that are designed to stimulate and
enhance the immune system by exploiting critical observations of
natural immune processes. Its current development pipeline consists
of product candidates targeting COVID-19, hepatitis B virus,
influenza A and human immunodeficiency virus. For more information,
please visit www.vir.bio.
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, please visit www.vbivaccines.com.
Vir Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “may,” “will,” “potential,” “aim,” “could” and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. These
forward-looking statements are based on Vir’s expectations and
assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties. Actual
results may differ materially from these forward-looking
statements. Forward-looking statements contained in this press
release include statements regarding the potential benefits of
VIR-2218, BRII-179, pegylated interferon-alpha, and VIR-3434
(individually or in combination), the expected timing of
commencement of clinical trials and availability of clinical data,
our goals with respect to the prophylaxis and/or treatment of HBV,
the potential ability of our product candidates (individually or in
combination with other agents) to functionally cure HBV and change
the standard of care, the potential of ESC+ technology to enhance
the therapeutic index of VIR-2218, and the potential benefits of
Vir’s collaboration with Brii Biosciences and other partners. Many
factors may cause differences between current expectations and
actual results, including unexpected safety or efficacy data or
results observed during clinical trials, difficulties in obtaining
regulatory approval, difficulties in collaborating with other
companies, challenges in accessing manufacturing capacity, clinical
site activation rates or clinical trial enrollment rates that are
lower than expected, successful development and/or
commercialization of alternative product candidates by our
competitors, changes in expected or existing competition, delays in
or disruptions to Vir’s business or clinical trials due to the
COVID-19 pandemic, geopolitical changes or other external factors,
and unexpected litigation or other disputes. Other factors that may
cause actual results to differ from those expressed or implied in
the forward-looking statements in this press release are discussed
in Vir’s filings with the U.S. Securities and Exchange Commission,
including the section titled “Risk Factors” contained therein.
Except as required by law, Vir assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
VBI 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 2, 2021, and
filed with the Canadian security authorities at sedar.com on March
2, 2021, 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/20210421005339/en/
Lisa Beck Brii Biosciences media@briibio.com
Cara Miller VP, Corporate Communications cmiller@vir.bio
+1-415-941-6746
Nicole Anderson Director, Corporate Communication & IR
IR@vbivaccines.com (617) 830-3031 x124
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