JERUSALEM, Feb. 5, 2020 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today that
preliminary data from the Phase 2 clinical trial of BiondVax's
M-001 universal influenza vaccine candidate have been published.
The trial was supported by the U.S. National Institute of Allergy
and Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH). The primary objectives of the trial were to assess
safety and T-cell responses to M‑001. The data, which are
consistent with results of previous clinical trials of M-001,
indicate that both primary objectives were achieved. Analysis of
the data is ongoing, and the clinical study report (CSR) is
expected in Q2 2020.
Dr. Tamar Ben-Yedidia,
BiondVax's Chief Scientific Officer, commented, "We are grateful
for the opportunity to collaborate with NIAID and thank them for
their professionalism and partnership. This was M-001's first
clinical trial in the US under the FDA's Investigational New Drug
program (IND). Data from this Phase 2 trial confirm results from
six previously completed clinical trials of M-001. BiondVax's
universal flu vaccine candidate was found to be safe, well
tolerated and induce statistically significant cellular immune
responses."
The Phase 2 clinical trial was conducted by NIAID-funded
Vaccine and Treatment Evaluation Units (VTEUs). The trial enrolled
120 participants aged 18 to 49 years at the following VTEU
sites: Baylor College of Medicine in
Houston, Texas; the University of Iowa in Iowa City, Iowa; and Cincinnati Children's
Hospital Medical Center in Cincinnati, Ohio. Individuals were
randomly assigned to receive either two doses of M-001 or two doses
of a placebo, with the doses spaced three weeks apart. Later, near
the beginning of the 2018/19 flu season, all participants were
immunized with a currently marketed quadrivalent seasonal influenza
vaccine. Laboratory analyses of vaccine immunogenicity were
performed at the Baylor College of
Medicine and Saint Louis
University (St. Louis,
Missouri) VTEU sites and at BiondVax
Pharmaceuticals.
The published data are available at
https://clinicaltrials.gov/ct2/show/NCT03058692. The trial was
supported through NIAID awards #HHSN272201300016I,
HHSN272201300015I, HHSN272201300020I, and HHSN272201300021I.
In parallel, BiondVax's pivotal, clinical efficacy, Phase 3
trial in Europe, involving 12,463
older adults, is ongoing. Results of that trial are expected by the
end of 2020.
About BiondVax
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage
biopharmaceutical company developing a universal flu vaccine. The
vaccine candidate, called M-001, is designed to provide
multi-strain and multi-season protection against current and
future, seasonal and pandemic influenza. BiondVax's proprietary
technology utilizes a unique combination of conserved and common
influenza virus peptides intended to stimulate both arms of the
immune system for a cross-protecting and long-lasting effect. In a
total of 7 completed Phase 1/2 and Phase 2 clinical trials
enrolling 818 participants, the vaccine has been shown to be safe,
well-tolerated, and immunogenic. The ongoing pivotal Phase 3
clinical trial aims to assess safety and effectiveness of M-001 in
reducing flu illness and severity. For more information, please
visit www.biondvax.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Litigation Reform Act of 1995. Words
such as "expect," "believe," "intend," "plan," "continue," "may,"
"will," "anticipate," and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements reflect the management's current views with respect to
certain current and future events and are subject to various risks,
uncertainties and assumptions that could cause the results to
differ materially from those expected by the management of BiondVax
Pharmaceuticals Ltd. Risks and uncertainties include, but are not
limited to, the prosecution, timing and results of the ongoing
Phase 2 and Phase 3 trials and any subsequent trials; timing of
receipt of regulatory approval of our manufacturing facility in
Jerusalem; ability to demonstrate
the efficacy and safety of the vaccine; the timing of clinical
trials and marketing approvals; the risk that drug development
involves a lengthy and expensive process with uncertain outcome;
the ability of the Company to maintain, preserve and defend its
intellectual property and patents granted; whether our
vaccine candidate will successfully advance through the clinical
trial process on a timely basis, or at all, and receive approval
from the U.S. Food and Drug Administration or equivalent foreign
regulatory agencies; the adequacy of available cash resources and
the ability to raise additional capital when needed. More detailed
information about the risks and uncertainties affecting the Company
is contained under the heading "Risk Factors" in our Annual Report
on Form 20-F for the year ended December 31,
2018 filed with the U.S. Securities and Exchange Commission,
or SEC, which is available on the SEC's website, www.sec.gov. We
undertake no obligation to revise or update any forward-looking
statement for any reason.
Contact Details:
Joshua E.
Phillipson | +972 8 930 2529 |
j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.