JERUSALEM, July 1, 2020 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV) today announced that all
participants in the placebo-controlled, blinded, pivotal, clinical
efficacy, Phase 3 trial of BiondVax's M–001 universal influenza
vaccine candidate have now completed their site visits. In total,
over 12,400 volunteers aged 50+ (with half aged 65+) were enrolled
in the trial over the past two flu seasons in 83 sites across seven
European countries. The purpose of the study is to
assess M-001's ability as a standalone non-adjuvanted vaccine
to provide clinical protection from circulating influenza strains
as measured by reduction of influenza illness rate (as a primary
endpoint) and severity (as a secondary endpoint), as well as to
assess M-001's safety.
Seasonal influenza annually infects approximately 10-20% of the
world's population[1] resulting in up to about five
million cases of severe illness and 650,000 deaths[2].
In addition, pandemic influenza, such as the H1N1 Swine Flu
pandemic of 2009, is a constant global threat. However, current
influenza vaccines, which target frequently mutating parts of the
flu virus and therefore must be updated annually in the hope they
will match the next flu season's circulating strains, achieve on
average only about 40% vaccine effectiveness in the general
population[3] and as low as 12% in older
adults[4].
BiondVax's M-001 is a single recombinant protein of highly
conserved influenza epitopes. Consequently:
- M-001 does not need to be updated and therefore can be
manufactured and distributed year-round.
- M-001 is designed to provide protection to both existing and
future seasonal A and B strains, as well as emerging pandemic
strains.
Dr. Tamar Ben-Yedida,
BiondVax's Chief Scientist, commented, "We are pleased that
despite the ongoing COVID-19 pandemic, and the challenge of
conducting the trial across 83 sites and seven countries, thanks to
all the people involved – including the CRO, investigators, and
thousands of participants – we have maintained the planned
timelines of our pivotal Phase 3 trial. In light of the ongoing
COVID-19 pandemic, the need for improved influenza vaccines has
arguably never been clearer. To better protect lives and economies,
influenza vaccines must be more effective in reducing illness rates
and severity. Needless to say, we are eagerly anticipating results
of our trial by the end of this year."
Participants in the trial's second cohort were enrolled prior to
the 2019/20 flu season and monitored for influenza-like illness
(ILI) symptoms throughout the flu season. Swabs samples were
collected from those participants with ILI, and influenza
confirmation is currently being conducted by a qualified
laboratory. Analysis will continue in the coming months, and
results are expected by the end of 2020.
As part of this Phase 3 study, cell-mediated immunogenicity
markers of M-001 will be evaluated in a subset of participants. The
recently completed clinical study report (CSR) of a U.S. National
Institute of Allergy and Infectious Diseases (NIAID) supported
Phase 2 clinical trial of M-001 concluded that, "M-001 induced
significant polyfunctional T cell responses."
In addition to the ongoing pivotal, clinical efficacy, Phase 3
trial, equipment installation and manufacturing process scale-up in
BiondVax's pilot facility in Jerusalem are in progress. The facility has
planned annual capacity of up to between 10 and 20 million doses in
bulk.
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 seven 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.
Contact Details
Joshua E. Phillipson |
+972 8 930 2529 | j.phillipson@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, risks relating to the COVID-19 (coronavirus) pandemic,
including a risk of delay in the availability of the top line
results from our pivotal clinical efficacy Phase 3 trial for M-001,
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, 2019
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.
References
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5596521/
[2]
https://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal)
[3]
https://www.cdc.gov/flu/vaccines-work/effectiveness-studies.htm
[4] https://www.cdc.gov/flu/vaccines-work/2018-2019.html
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SOURCE BiondVax Pharmaceuticals Ltd.