Recent Updates
Recently added Catalysts
SCNI

Last of 12,400 Participants Completes Final Visit in BiondVax's M-001 Universal Flu Vaccine Pivotal Phase 3 Clinical Trial Jerusalem, Israel

Key Takeaway: Last of 12,400 Participants Completes Final Visit in BiondVax's M-001 Universal Flu Vaccine Pivotal Phase 3 Clinical Trial Jerusalem, Israel - July 1, 2020 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) today announced that all participants in the placebo-controlled, blinded,

Full Press Release Details

Last of 12,400 Participants Completes
Final Visit in BiondVax's M-001 Universal Flu Vaccine Pivotal Phase 3 Clinical Trial
Jerusalem, Israel - July 1, 2020
- 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
influenza annually infects approximately 10-20% of the world's population1
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 population3
and as low as 12% in older adults.4
M-001 is a single recombinant protein of highly conserved influenza epitopes. Consequently:
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."
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
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."
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.
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
Joshua E. Phillipson | +972 8 930
Forward Looking Statements
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.
Last updated: Jul 1, 2020