In the news release, BiondVax Announces Topline Results from
Phase 3 Clinical Trial of the M-001 Universal Influenza Vaccine
Candidate, issued Oct. 23, 2020 by
BiondVax Pharmaceuticals Ltd. over PR Newswire, we are advised by
the company that the Forward Looking Statements were not included.
The complete, corrected release follows:
BiondVax Announces Topline Results from Phase 3 Clinical Trial of
the M-001 Universal Influenza Vaccine Candidate
JERUSALEM, Oct. 23, 2020 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV), a pioneer in the
development of a universal flu vaccine designed to provide
protection against current, future, seasonal and pandemic
influenza, today announced topline data from the Company's pivotal,
phase 3 clinical trial of M-001 as a standalone universal flu
vaccine candidate.
Results did not demonstrate a statistically significant
difference between the vaccinated and placebo groups in reduction
of flu illness and severity, and therefore failed to meet both the
primary and secondary efficacy endpoints. The study's primary
safety endpoint was met.
"We are disappointed with these results, and I wish to thank the
BiondVax team for their efforts, dedication, and passion over the
past 15 years. Together we have endeavored to develop an innovative
approach to a persistent global problem. I am especially grateful
to each of the clinical trial participants, as well as the
investigators in all our trials for their efforts, and to our
stakeholders for their support," said Dr. Ron Babecoff, Founder,
President, and Chief Executive Officer. "The significant need
for better, more proactive flu protection is well-understood by
clinicians and public health experts around the world, and we have
devoted many years in pursuit of this worthy goal. Unfortunately,
this study did not have the efficacy outcomes that we anticipated
for M-001 on a standalone basis. We have observed in seven previous
studies that M-001 safely provoked an immune response to a broad
range of flu strains, but ultimately this was not sufficient on a
standalone basis to show protection."
Dr. Babecoff continued, "We have developed expertise
and IP in pursuit of our goals, and we retain a state-of-the-art
manufacturing facility. Going forward, we will examine options to
maximize the value of these assets."
About the pivotal Phase 3 trial: The randomized, modified
double-blind, placebo-controlled, pivotal Phase 3 trial assessed
safety and efficacy of the M–001 vaccine candidate alone in
reducing flu illness and severity in 12,463 adults aged 50 years
and older, including 6,291 (50.5%) aged 65 and older. 4,042
participants were enrolled and randomized in the trial's first
cohort prior to the 2018/19 flu season, and an additional 8,421
participants were enrolled across seven Eastern European countries
in the trial's second cohort (2019/20 flu season). Each participant
was monitored for one flu season.
The trial commenced in 2018, after the European Medicines Agency
(EMA)'s Committee for Medicinal Products for Human Use (CHMP)
reviewed the trial design and provided feedback. The CHMP response
included comments regarding various aspects of the trial design,
and also stated that, "It is agreed that a single pivotal
efficacy trial that provides a robust demonstration of efficacy
against laboratory-proven influenza like illness (ILI) could
suffice for an approval."
About BiondVax:
BiondVax (NASDAQ: BVXV) is a biopharmaceutical company that has
been developing M-001, a novel flu vaccine candidate. The vaccine
candidate was designed to provide multi-strain and multi-season
protection against current and future, seasonal and pandemic
influenza. An NIH/NIAID Phase 2 study completed in 2020 showed a
significant increase in polyfunctional CD4+ cells in the M-001
group. In a total of seven previously completed Phase 1/2 and Phase
2 clinical trials, the M-001 vaccine candidate was well-tolerated
and immunogenic. For more information, please
visit www.biondvax.com.
Company Contact: Joshua E. Phillipson | +972 8 930
2529 | j.phillipson@biondvax.com
Investor Relations: Joseph Green | +1 646 653 7030 |
jgreen@edisongroup.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, risks relating to the COVID-19 (coronavirus) pandemic;
timing of receipt of regulatory approval of our manufacturing
facility in Jerusalem; ability to
demonstrate the efficacy and safety of the vaccine; 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 prospectus filed today and our Annual Report on Form 20-F
for the year ended December 31, 2019
and other filings filed with the U.S. Securities and Exchange
Commission, or SEC, which is available on the SEC's website,
www.sec.gov. The Company undertakes no obligation to revise or
update any forward-looking statement for any reason.
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SOURCE BiondVax Pharmaceuticals Ltd.