BiondVax Announces Positive Phase IIa Results for Universal Flu Vaccine

BiondVax's Multimeric-001 Universal Influenza Vaccine  successfully meets primary and secondary endpoints with strong safety and  immunogenicity data in 200 participants

Ness Ziona, Israel - 16 June 2011 - 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. 

Dr.  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.

Dr.  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 Ltd.

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 effect.

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.

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