BiondVax’s Multimeric-001 Universal Influenza Vaccine successfully meets primary and secondary endpoints, demonstrating excellent safety and immunogenicity in 120 elderly (65+) participants
NES ZIONA, Israel, February 16, 2012, BiondVax Pharmaceuticals (TASE: BNDX) today announced positive results from its second Phase II clinical trial (BVX-005) of the Universal Influenza Vaccine (Multimeric-001) developed by Biondvax for improving existing flu vaccines in elderly. The vaccine was found to be safe and well tolerated, and induced robust cellular and humoral immune responses in elderly patients (65+), successfully meeting the primary safety and secondary immunogenicity endpoints. In addition, when given as a primer before boosting with a commercially available seasonal influenza vaccine (trivalent inactivated vaccine, or TIV), Multimeric-001 vaccine enhanced the performance of the TIV by increasing immunity to influenza strains contained in the TIV (“prime-boost” regimen). The Multimeric-001 vaccine improved immunity to influenza in the elderly without the need for any adjuvant. The effectiveness of priming with Multimeric-001 was determined by means of hemagglutination inhibition (HAI) assays. HAI-based immune measures are utilized by US and European regulatory authorities to approve and license existing influenza vaccines.
Dr. Ron Babecoff, BiondVax’s CEO, said, “We are delighted with these Phase II results. We have confirmed, in what is to our knowledge, the first Phase II study of a universal flu vaccine in elderly, that the Multimeric-001 vaccine is not only safe and immunogenic on its own but also enhances the performance of traditional strain-dependent flu vaccines in the elderly when given in a prime-boost regimen.”
Babecoff added, “We are excited to report that this prime-boost indication for our universal flu vaccine increased immunity to TIV flu strains by more than 10 % – that could translate into over 35 million extra elderly people that potentially avoid the slippery slope of flu illness leading to flu complications, hospitalization and death in this age group.”
The elderly are a growing population at high risk for influenza and currently under protected. For example in the US, elderly adults constitute 15% of the population but account for 65% of hospitalizations and 90% of deaths attributable to influenza and its complications. This reflects weakening immune systems and the limited immunity provided to the elderly by TIVs. Indeed, of the approximately 350 million elderly worldwide vaccinated with a seasonal TIV each year (about 70% of the total seasonal flu vaccine market), up to 210 million do not respond sufficiently and are not protected against the strains contained in the TIV. Innovative approaches are urgently required to improve protection against influenza among the elderly and hence, to reduce influenza-related morbidity and mortality and associated high economic burden.
This Phase II trial was a randomized, double-blind, placebo-controlled study in 120 elderly (65+) volunteers conducted at two clinical research centers in Israel – the Hadassah University Hospital in Jerusalem and the Tel Aviv Sourasky Medical Center. In light of the successful conclusion of this second Phase II clinical trial in the elderly in Israel, BiondVax is preparing to conduct a third Phase II trial in the elderly in Europe. This trial is expected to commence in the third quarter of 2012 and to be concluded in the first quarter of 2013.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, notes that, “the results of this second Phase II clinical trial are most gratifying. We have now shown, in four clinical trials involving 440 participants, that our Multimeric-001 vaccine is safe and effectively activates the immune system, both on its own as well as in conjunction with commercial flu vaccines. Our most recent trial affirms that Multimeric-001, originally conceived as a standalone universal flu vaccine, has a novel and significant new indication – a capacity to improve immunity to flu in the elderly when given in conjunction with TIV, irrespective of the flu strains contained in the TIV. We believe this new indication will facilitate the development and licensing of Multimeric-001”
Dr. Ben-Yedidia will report the results of this second Phase II clinical trial in April 2012 at the 2nd Annual Vaccines Congress inLondon, UK and at the World Vaccine Congress in Washington DC, USA, in a presentation entitled “Multimeric-001: Improving flu vaccines for elderly – new insights from a Phase II clinical trial”.
Biondvax`s estimates regarding the future development of the vaccine and expected trials with respect to the vaccine are forward looking information based on the information that Biondvax has in its possession today pertaining to the potential of the vaccine`s development. These estimates may not be realized, in whole or in part, and/or may be realized differently than estimated, as a result of different factors, including the failure to reach the objectives of the trials and/or schedules and/or to obtain the necessary funding for the continuation of development of the vaccine as well as other factors which are not within Biondvax’s control and the materialization of any of the risk factors detailed in Section 5.27 of Biondvax`s shelf prospectus published on January 17, 2012.