Full Press Release Details
Universal Flu Vaccine Phase 3 Clinical Trial Completes First Season's Enrollment of 4,098 Participants
Israel, October 24, 2018 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today the successful enrollment of the
last participant in the first season of a pivotal, clinical efficacy, Phase 3 trial of the M-001 universal flu vaccine candidate.
The 4,098 participants
enrolled in this year's cohort will be monitored for two flu seasons. A second cohort of approximately 6,000 participants
will be enrolled prior to the 2019/2020 flu season. Participants, aged 50 years and older, with half aged 65 plus, are randomly
divided into two equal groups, one receiving M-001 and the other receiving a placebo. Safety, as well as laboratory confirmed
influenza incidence will be assessed, with results expected in the second half of 2020.
Ben-Yedidia, BiondVax's Chief Science Officer and co-inventor of M-001, commented, "We are pleased with the
progress of our universal flu vaccine's pivotal Phase 3 trial. Our partners are doing a wonderful job conducting this challenging
study. The trial aims to show the extent to which M-001 protects people against influenza illness, regardless of flu strain."
To date, participants
were recruited in 55 clinical trial sites in four European countries. Some additional European countries and sites are expected
to participate in the Phase 3 trial's second season.
clinical trials in 698 young adult to elderly participants, M-001 has been shown to be safe, well-tolerated, and immunogenic to
a broad range of influenza strains. A recombinant protein consisting of nine common and conserved influenza virus epitopes, M-001
is a single, unchanging vaccine formulation. It is designed to induce T-cell immune responses and to serve as a common denominator
to current, future, seasonal, and pandemic influenza.
reported, the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) reviewed the trial
design and allowed BiondVax to proceed. Regulatory authorities in countries in which the trial is being conducted have also allowed
the trial to proceed. Participants are volunteers and have provided informed consent.
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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax's
proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating both arms of
the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 human clinical
trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit www.biondvax.com.
Joshua E. Phillipson
| +972 8 930 2529 | j.phillipson@biondvax.com
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 involve certain risks and uncertainties 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 and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of
receipt of regulatory approval of the new manufacturing facility and its products; 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 United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy
of available cash resource and the ability to raise 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, 2017 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's
website, www.sec.gov, and in the Company's periodic filings with the SEC and the Tel-Aviv Stock Exchange. We undertake no
obligation to revise or update any forward-looking statement for any reason.