Nes Ziona, Israel – January 15 2013 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX) today confirmed that the Company is presenting at “The first World Health Organization’s (WHO) integrated meeting on development and clinical trials of influenza vaccines that induce broadly protective and long-lasting immune responses” to be held in Hong Kong January 24-26th 2013.
Dr. Tanya Gottlieb, Head of Business Development at BiondVax will present a lecture titled “Development and evaluation of a universal recombinant M-001 vaccine comprising epitopes from NP, HA and M1 proteins”.
The WHO is responsible for global surveillance of influenza (flu) and provides guidance to governments about preparing for and controlling influenza. This month there were the first reports in the media about a seasonal influenza outbreak. BiondVax’s invitation to present at this conference reflects the Company’s global recognition and success in advancing clinical development of its universal flu vaccine candidate M-001. In 2012 BiondVax completed successfully a Phase II trial in elderly, which confirms the results of three previous human trials demonstrating M-001’s safety and activity against multiple influenza strains. In addition, the Company successfully passed a European qualified person (QP) good manufacturing practices (GMP) audit, the green light to perform human trials in Europe. Of note, M-001 has demonstrated two uses, as a universal flu vaccine and as an enhancer (primer) of current flu vaccines. This second indication is particularly relevant for the elderly, who do not respond well to current flu vaccines, and in the event of a pandemic, when stockpiled M-001 could be given to prime the population’s immune responses during the several months it takes to produce a pandemic-specific vaccine. Indeed, BiondVax recently reported results supporting that M-001 enhances the efficacy of the bird flu H5N1 pandemic vaccine.
Dr. Tanya Gottlieb comments, “The upcoming WHO meeting highlights the growing body of evidence that a game-changing influenza vaccine is an urgent unmet need requiring the attention of public health authorities worldwide. BiondVax’s invitation to present at this WHO meeting reflects the promise of our universal flu vaccine candidate M-001. In particular, the distinctively advanced clinical stage of M-001’s development - 4 clinical trials with 440 participants aged 18 to 91 years - and M-001’s established capability to synergize with current seasonal and pandemic flu vaccines. Indeed, administration of M-001 before the H5N1 bird flu pandemic vaccine improved the performance of the pandemic vaccine such that one instead of two doses of the H5N1 pandemic vaccine was sufficient.”
About BiondVax Pharmaceuticals Ltd.
BiondVax is a publicly traded (TASE: BNDX), advanced clinical stage biotech company dedicated to improving protection against influenza, with its lead product a universal influenza (flu) vaccine called M-001. Flu is the most common infectious disease, caused by countless flu strains, as the virus mutates unpredictably and frequently. Currently, seasonal flu vaccines are re-formulated each year as they only protect against 3-4 strains (those predicted to be in circulation) and pre-pandemic flu vaccines (in stockpiles) are designed to protect against 1 strain that is considered the most likely public health threat. BiondVax’s universal flu vaccine is designed to protect against all A and B flu strains, present and future, seasonal and pandemic, as it triggers our immune defenses to recognize conserved and common parts of the virus.
At this point in time, BiondVax’s M-001 has several unique competitive advantages: the universal flu vaccine at the most advanced stage of clinical development (4 clinical trials with 440 people); an excellent safety profile; triggers both arms of our immune defenses, cellular and humoral (antibodies); active without the need for an adjuvant; easily, quickly and cheaply manufactured in only 6-8 weeks (current vaccines take 6-8 months); can be produced year-round and stockpiled as its composition does not change; and finally, M-001 has two indications, as a universal flu vaccine and as an enhancer of current seasonal/pandemic flu vaccines. Of note, this second indication provides an alternative pathway for clinical development, regulatory approval and commercialization of M-001 and is a new approach to improving pandemic preparedness.
For further information, please contact:
Dana Harel
Gelbert- Kahana
Tel: +972 3 607 4717
Mob: +972 54 4227715
dana@gk-biz.com
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.
