JERUSALEM, June 10, 2020 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV) today announced the
completion of the clinical study report (CSR) of a Phase 2 clinical
trial of the Company's M-001 universal influenza vaccine candidate.
The trial in 120 adult volunteers was supported by the U.S.
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health (NIH).
As indicated when the preliminary trial data was published
earlier this year, both primary objectives of the trial, to assess
the safety and T cell immune responses to M–001, were achieved. The
CSR concludes that "M-001 was safe in this study" and that
"M-001 induced significant polyfunctional T cell
responses."
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. We also are grateful to the
investigators and their teams, and to the 120 volunteers who
participated in this trial. It is exciting that data from this
Phase 2 trial conducted in the U.S. confirm safety and cellular
immune response results, as have six previously completed clinical
trials of M-001."
The NIAID-supported Phase 2 trial was conducted under an FDA
Investigational New Drug application (IND), and NIAID's Division of
Microbiology and Infectious Diseases (DMID) has submitted the final
CSR to the FDA. NIAID has communicated to BiondVax that the study's
lead investigator may prepare a manuscript for publication sometime
in the future.
The published data are available at
https://clinicaltrials.gov/ct2/show/NCT03058692. The trial was
supported through NIAID awards #HHSN272201300016I,
HHSN272201300015I, HHSN272201300020I, and HHSN272201300021I.
In parallel, BiondVax's pivotal, clinical efficacy, Phase 3
trial in Europe is ongoing. The
trial, which is assessing M-001's ability to provide clinical
protection from circulating influenza strains, is being conducted
in more than 12,400 volunteers aged 50+ (with half aged 65+) over
two flu seasons in seven countries. Results of the pivotal Phase 3
trial are expected by the end of 2020.
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.
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, 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.
Logo -
https://mma.prnewswire.com/media/615570/BiondVax_Pharmaceuticals_Logo.jpg
Contact Details
Joshua E.
Phillipson
+972-8-930-2529
j.phillipson@biondvax.com
View original
content:http://www.prnewswire.com/news-releases/nih-report-on-phase-2-clinical-trial-of-biondvaxs-m-001-universal-influenza-vaccine-candidate-concludes-both-primary-endpoints-achieved-301073580.html
SOURCE BiondVax Pharmaceuticals Ltd.