NESS ZIONA, Israel, July 20,
2017 /PRNewswire/ --
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV),
and the UNISEC consortium today reported statistically significant
positive results from the Phase 2b clinical trial of M-001,
BiondVax's universal flu vaccine candidate.
The study had two primary endpoints: Safety and
influenza-specific cellular immune responses. Both endpoints were
achieved.
Trial Design: The randomized placebo-controlled
double-blind trial consisted of 3 arms; The 219 participants, aged
18 to 60 years, twice received either 0.5mg M-001, 1.0mg M-001, or
saline placebo. All participants were then immunized with a partial
dose of avian H5N1 pandemic vaccine.
Primary Safety Results: The Company previously
reported[1] and today confirms
that M-001 has a good safety profile and is well-tolerated.
Primary Cellular Results: TH1 cytokines
including Il-2, Interferon-gamma, and TNF-alpha are biological
molecules with known anti-viral and anti-influenza virus activity.
These cytokines are produced by CD4 immune system cells when
activated as part of T-cell dependent immunity. In this trial,
T-cell (also known as cellular) immunity was measured at baseline
(prior to immunization), and after immunization with M-001.
Compared to the placebo group, statistically significant elevated
T-cell dependent immune responses were found in both dosage forms,
more notably in the 1.0mg dose group.
The study's secondary endpoint evaluated antibody (HAI) response
to avian H5N1 pandemic vaccination after M-001 or placebo
administration. In one of the four H5N1 strains tested, a
statistically significant HAI elevation was observed in
participants who had received M-001.
Immunological assays and statistical analysis were performed by
various UNISEC[2] consortium
partners. Dr. Ed Schmidt,
Executive Manager of the UNISEC consortium, commented, "The
development of universal influenza vaccines can be highly
successful when public health institutes and companies work
together, share expertise, technologies, and
networks. In the UNISEC consortium, we are very pleased to have
BiondVax with their M-001 vaccine as one of our partners. The cell
mediated immunity observed in our Phase IIB clinical
study with the M-001 vaccine is very impressive and of
high scientific interest. We are certainly looking forward to
continuing this collaboration with BiondVax."
In light of these encouraging clinical trial results that
confirm previous study results, the recent €20 million EIB
funding[3], the Israel Ministry of
Economy grant approval[4], and
following consultations with leading European and American
regulatory experts, BiondVax is considering taking the opportunity
to proceed directly to testing the clinical efficacy of vaccination
with M-001 alone in a pivotal Phase 3 clinical trial. Clinical
efficacy is planned to be assessed by measuring reduction of flu
illness rate and severity.
Dr. Tamar Ben-Yedidia,
BiondVax's Chief Science Officer (CSO), noted, "These
significant results confirm that the M-001 is a
unique and innovative influenza
vaccine that elicits strong T-cell
responses and is expected to provide multi-strain and
multi-season protection against
influenza illness. Along with
the substantial funding recently brought to
BiondVax we can now concentrate on
performing all activities needed to launch the
pivotal Phase 3 clinical trial."
About BiondVax Pharmaceuticals Ltd
BiondVax is a clinical phase biopharmaceutical company
developing a universal flu vaccine. The vaccine is designed to
provide multi-season protection against most seasonal and pandemic
human influenza virus strains. BiondVax's proprietary technology
utilizes a unique combination of conserved and common peptides from
influenza virus proteins, activating both arms of the immune system
for a cross-protecting and long-lasting effect. BiondVax is traded
on NASDAQ: BVXV and TASE: BVXV. Please visit
http://www.biondvax.com .
BiondVax 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 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, uncertainties and risks in the clinical
development process, including, among others, length, expense and
the ability to enroll trial patients, reliance on
third parties and that the results of earlier research and/or
preclinical or clinical trial results may not be predictive of
actual results, conclusions or interpretations of subsequent
research or trials, the results of the Phase 2 & 3
trials, delays or obstacles in launching and/or successfully
completing our clinical trials, the lengthy and
unpredictable nature of the FDA's approval
process, our ability to satisfy rigorous regulatory
requirements, the impact of the global economic environment
on the Company customer target base, 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, http://www.sec.gov,
and in the Company's periodic filings with the SEC
and the Tel-Aviv Stock Exchange.
[1]
http://www.biondvax.com/2016/11/biondvax-phase-2b-trial-preliminary-safety-results-the-universal-flu-vaccine-candidate-is-safe-and-well-tolerated/
[2] Research leading to these results received
funding from the European Union Seventh Framework Programme
(FP7/2007-2013) under grant agreement n°602012.
[3]
http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/
[4]
http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/
For further information, please contact:
BiondVax
Joshua Phillipson
Business Development Manager
+972-8-930-2529 ext.5105
j.phillipson@biondvax.com
SOURCE BiondVax Pharmaceuticals Ltd.