Full Press Release Details
Begins NIH-Sponsored Phase 2 Clinical Trial
its Universal Flu Vaccine in the United States
Ziona, Israel - April 11, 2018
Pharmaceuticals Ltd. (Nasdaq: BVXV) reported today the first participant enrollment in the United States in a Phase 2 clinical
trial of the company's universal flu vaccine candidate, M-001. The trial is sponsored by the US National Institute of Allergy
and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Conducted under an FDA Investigational New Drug
(IND), the trial marks M-001's clinical debut in the United States.
developed in Professor Ruth Arnon's lab at the Weizmann Institute of Science in Israel, M-001 is comprised of nine
epitopes common to influenza virus strains including both influenza Type A and B. In six completed clinical trials in Israel
and Europe (two Phase 1/2 and four Phase 2), BiondVax's universal flu vaccine candidate has been shown to be safe, well-tolerated,
and immunogenic to a broad range of influenza strains.
previously announced, a pivotal clinical efficacy Phase 3 trial is planned in Europe
later this year. Co-funded by the European Union's European Investment Bank (EIB), the trial will enroll 9,630 participants
aged 50 years and older across four to six countries over a period of two flu seasons.1
Ron Babecoff, BiondVax's CEO, commented, "We are honored to be merging the world-renowned clinical and biomedical
expertise of NIAID-supported researchers with BiondVax's universal flu vaccine development efforts. We are pleased to participate
in NIAID's focus on development of novel flu vaccines to improve protection against current strains and protect against
emerging seasonal and pandemic threats."
NIAID-sponsored study, titled "A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess
the Safety, Reactogenicity and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Quadrivalent Influenza
Vaccine" is being conducted at three sites (University of Iowa, Cincinnati Children's Hospital Medical Center in Ohio,
and Baylor College of Medicine in Houston, Texas), with laboratory support by St. Louis University in St. Louis, Missouri. These
sites are part of the NIAID-funded network of Vaccine and Treatment Evaluation Units (VTEUs).
total of 120 participants aged 18 to 49 years will be randomly assigned to receive either two doses of M-001 or two doses of a
placebo, with the doses spaced several weeks apart. A few months following the second injection, all participants will receive
a currently marketed unadjuvanted quadrivalent seasonal influenza vaccine. Safety and immunogenicity will be assessed and compared
between the groups receiving M-001 and placebo.
information regarding both the NIAID-sponsored Phase 2 trial and the pivotal clinical efficacy Phase 3 trial are published on
the clinicaltrials.gov website at https://clinicaltrials.gov/ct2/show/NCT03058692, and www.clinicaltrials.gov/ct2/show/NCT03450915,
BiondVax Pharmaceuticals Ltd
is an advanced 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. BiondVax is traded
on NASDAQ: BVXV. Please visit www.biondvax.com.
further information, please contact:
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 Phase 2 and Phase 3 trials, 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, 2016 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