Full Press Release Details
Preliminary Data from NIH/NIAID-sponsored
Phase 2 Clinical Trial of BiondVax's M-001
Universal Influenza Vaccine Candidate Validates Results of Previous Clinical Trials
Data published on Clinicaltrials.gov
Jerusalem, Israel - February
5, 2020 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today that preliminary data from the Phase 2 clinical
trial of BiondVax's M-001 universal influenza vaccine candidate have been published. The trial was supported by the U.S.
National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The primary objectives
of the trial were to assess safety and T-cell responses to M-001. The data, which are consistent with results of previous clinical
trials of M-001, indicate that both primary objectives were achieved. Analysis of the data is ongoing, and the clinical study report
(CSR) is expected in Q2 2020.
Dr. Tamar Ben-Yedidia, BiondVax's
Chief Scientific Officer, commented, "We are grateful for the opportunity to collaborate with NIAID and thank them for
their professionalism and partnership. This was M-001's first clinical trial in the US under the FDA's Investigational
New Drug program (IND). Data from this Phase 2 trial confirm results from six previously completed clinical trials of M-001. BiondVax's
universal flu vaccine candidate was found to be safe, well tolerated and induce statistically significant cellular immune responses."
Phase 2 clinical trial was conducted by NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). The trial enrolled
120 participants aged 18 to 49 years at the following VTEU sites: Baylor College of Medicine
in Houston, Texas; the University of Iowa in Iowa City, Iowa; and Cincinnati Children's Hospital Medical Center in Cincinnati,
Ohio. Individuals were randomly assigned to receive either two doses of M-001 or two doses of a placebo, with the doses spaced
three weeks apart. Later, near the beginning of the 2018/19 flu season, all participants were immunized with a currently marketed
quadrivalent seasonal influenza vaccine. Laboratory analyses of vaccine immunogenicity were performed at the Baylor College of
Medicine and Saint Louis University (St. Louis, Missouri) VTEU sites and at BiondVax Pharmaceuticals.
published data are available at https://clinicaltrials.gov/ct2/show/NCT03058692. The trial was supported through NIAID awards #HHSN272201300016I,
HHSN272201300015I, HHSN272201300020I, and HHSN272201300021I.
parallel, BiondVax's pivotal, clinical efficacy, Phase 3 trial in Europe, involving 12,463 older adults, is ongoing. Results
of that trial are expected by the end of 2020.
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 7 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
Joshua E. Phillipson | +972 8 930 2529
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, 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, 2018 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.