BiondVax Announces Positive Phase IIa Results for Universal Flu Vaccine

By Biondvax Pharmaceuticals Ltd, PRNE
Wednesday, June 15, 2011

NESS ZIONDA, Israel, June 16, 2011 -

BiondVax’s Multimeric-001 Universal Influenza Vaccine
Successfully Meets Primary and Secondary Endpoints With Strong
Safety and Immunogenicity Data in 200 Participants

BiondVax Pharmaceuticals Ltd.
(TASE: BNDX) today announced positive results from its first
Phase II clinical trial of the Multimeric-001 Universal Influenza
Vaccine.  The vaccine was found to be safe and well tolerated,
and induced robust immune responses, successfully meeting both the
primary safety and immunogenicity endpoints, as well as additional
secondary immunogenicity endpoints.  It was also found that
the Multimeric-001, when used in conjunction with a commercially
available strain-dependant seasonal influenza vaccine (trivalent
inactivated vaccine, or TIV), enhances the performance of the TIV
by increasing the rates of Hemagglutination Inhibition (HI)
seroconversion to influenza strains both included, and
not-included, in the TIV itself.  

Ron Babecoff, BiondVax’s CEO, said “We are very excited with
these positive Phase IIa results.  We have confirmed, in what
is to our knowledge the first Phase II study of a universal
influenza vaccine ever conducted in the world, that the
Multimeric-001 vaccine is not only safe and immunogenic on its own,
but it also has the potential to enhance the performance of
traditional strain-dependant flu vaccines.  We are more
convinced than ever that this product will provide real benefit to
people all over the world, bringing the ultimate goal of a
universal influenza vaccine closer than ever before.”

This Phase IIa trial was a randomized, double-blind,
placebo-controlled study in 200 healthy volunteers conducted at two
clinical research centers in Israel - the Hadassah University
Hospital in Jerusalem and the Tel Aviv Sourasky Medical Center.

The Multimeric-001 vaccine was safe and well tolerated, thus
meeting the first primary endpoint of the study.  No
vaccine-related severe adverse events were found in any of the
participants, nor were there any significant differences between
treatment and control groups.  These findings further
reinforce the positive safety profile of the Multimeric-001 vaccine
reported in the Company’s Phase I/II trials.

The vaccine also induced both humoral (antibody) and
cell-mediated immune responses, further confirming previous results
from the Phase I/II clinical trials.  Participants who
received two doses of the Multimeric-001 vaccine, in an adjuvanted
500mcg formulation, showed a statistically significant increase in
the level of IgG antibodies against the Multimeric-001 vaccine,
thus meeting the second primary endpoint of the study.  It was
also found that the Multimeric-001 vaccine caused a statistically
significant elevation in the secretion of Interferon-gamma (a known
anti-viral agent) to the Multimeric-001, meeting one of the
secondary endpoints.  

In addition, the Multimeric-001 vaccine, when administered once
concomitantly with a 50% dose of a seasonal TIV, also induced
higher rates of hemagglutination inhibition (HI) antibody responses
(a surrogate marker of protection against influenza infection which
is accepted by the regulatory authorities), when compared with the
TIV alone.  These results confirm the findings from the Phase
I/II trial in older adults completed in April 2010, and again show
that the combination of the Multimeric-001 vaccine with the TIV has
the potential to increase the number of people who reach the HI
seroconversion levels required by the US and European regulatory
authorities for licensure of influenza vaccines, than when compared
with the TIV alone.  Importantly, this increase in HI
seroconversion rates has been observed not only against strains
that were included in the TIV, but also against additional Type A
(H1N1 and H3N2) and Type B influenza strains that were not included
in the TIV.

These results suggest that the Multimeric-001 has the potential,
when administered in advance of future seasonal or pandemic
influenza outbreaks, to raise the general level of preparedness of
the population and thereby significantly improve the protection and
broaden the cross-strain coverage offered by the strain-dependant
influenza vaccines.

In light of the successful conclusion of this Phase IIa clinical
trial, BiondVax is preparing to conduct the next Phase II trial, in
the elderly - the population group most at risk for influenza
infections, and for whom current influenza vaccines are least
effective.  It is expected that this trial will be conducted
in two centers in Israel, in around 110 male and female
participants aged 65 and over.  This trial is expected to
commence in the fourth quarter of 2011 and to be concluded in the
first quarter of 2012.

Tamar Ben Yedidia, BiondVax’s Chief Scientific Officer, notes
that, “the results of this Phase IIa trial are most gratifying.
 We have now shown, in three clinical trials in over 320
participants, that the Multimeric-001 vaccine is safe and
effectively activates the immune system, both on its own as well as
in conjunction with the traditional flu vaccines.  This gives
us much confidence as we proceed with further Phase II and Phase
III studies.”

Dr. Ben Yedidia will be presenting the results of this Phase IIa
clinical trial at the BIO
International Convention in Washington DC, USA, on 29 June 2011, in
a presentation entitled “Clinical Progress Towards the Development
of a Universal Influenza Vaccine”.

About BiondVax Pharmaceuticals

BiondVax Pharmaceuticals (”the Company”), a publicly-traded
company (TASE: BNDX) based in Ness Ziona, Israel, is developing a
proprietary, innovative Universal Influenza (”flu”) Vaccine, the
Multimeric-001 vaccine, designed to provide multi-season and
multi-strain protection against all human influenza virus strains,
including both seasonal influenza strains as well as pandemic
influenza strains, such as Swine flu and Avian flu.

BiondVax’s innovative technology utilizes a unique, proprietary
combination of conserved epitopes from influenza virus proteins to
activate the immune system for a cross-protecting and long-lasting

BiondVax has successfully concluded a Phase IIa clinical trial,
as well as two Phase I/II trials, in which the Multimeric-001
Universal Flu Vaccine was shown to be safe and immunogenic.
 The Company is now preparing for further Phase II clinical
trials to be conducted in 2011 and 2012.

For further information on BiondVax, please visit href="">

    For further information, please contact:
    Danny Aronovic                           Tel: +972-9-899-5813
    Public Relations Consultant              Mob: +972-50-799-1121
    shapira marketing              


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