BiondVax Phase 2b European Trial: Last Patient Out

Top line results expected in the coming months

Ness Ziona, Israel – September 21, 2016 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) announced today that the last participant in a European Phase 2b clinical trial of M-001, its universal flu vaccine candidate, has completed their final visit. Conducted in collaboration with the EU-sponsored UNISEC consortium, the trial is designed to evaluate the safety and immunogenicity of M-001 when used ahead of a pandemic influenza vaccine.“This important milestone marks the conclusion of the patient facing part of our European trial. Laboratory analysis is now underway, and we look forward to the results in the coming months.  The conclusion of this trial, along with the upcoming start of our NIH-sponsored Phase 2 trial in the USA, means we are on track to be Phase 3 ready in the 2017/18 timeframe. We are excited to be one step closer to bringing our multi-strain and multi-season vaccine against seasonal and pandemic flu to the market,” explained BiondVax’s Chief Scientist, Dr. Tamar Ben-Yedidia.In 2009, following the official World Health Organization (WHO) declaration of a H1N1 swine flu pandemic, it took about 6 months until vaccines against the new strain could be administered. During those 6 months the pandemic proliferated, ultimately killing up to 575,000 people globally¹.  The long delay is attributable to current egg-based manufacturing processes and the need for the new vaccine to be highly specific to the new pandemic flu strain.To mitigate against the 6-month delay some authorities currently stockpile pandemic flu vaccines. For example, under the U.S. Department of Health and Human Services (HHS) Pandemic Influenza Plan, one of the key goals for vaccine preparedness is to “stockpile vaccines against influenza viruses with pandemic potential to cover 20 million persons.”²However, given current flu vaccine technology, each different flu strain requires its own specific vaccine. As well, there is an unlimited number of potential future flu strains. BiondVax’s flu vaccine, M-001, is advantageous in that it is designed to provide protection against a broad range of current and future potential flu strains.The current trial in Europe is designed to compare humoral and cellular immune response between two groups. These are (1) a control group receiving the standard avian pandemic vaccine alone, and (2) a group receiving BiondVax’s M-001 as a primer prior to receiving the pandemic vaccine.The goal following its approval for use as a pandemic primer would be to administer stockpiled M-001 immediately upon declaration of any new pandemic, thereby providing broad flu protection until a virus-specific vaccine is produced a few months later. BiondVax’s long-term intent is to license M-001 as a standalone universal flu vaccine, replacing both the current seasonal and pandemic vaccine technology.

1. http://www.cdc.gov/flu/spotlights/pandemic-global-estimates.htm, retrieved 19 Sept 2016.
2. https://www.medicalcountermeasures.gov/barda/pandemic-influenza.aspx, retrieved 19 Sept 2016.

About BiondVax Pharmaceuticals LtdBiondVax 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 www.biondvax.com.For further information, please contact:Joshua E PhillipsonBusiness Development+972-8-930-2529 x5105j.phillipson@biondvax.comForward Looking StatementsThis 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, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the current Phase 2 & contemplated phase 3 trials, the adequacy of available cash resources to fund product development and commercialization and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements. 

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BiondVax Presents BVX-006 Preliminary Phase II Results: The Universal Flu Vaccine at Higher Doses is Safe and Improves Immunogenicity in Older Adults

Preliminary results of BVX-006 show that M-001 is well tolerated and provides improved flu immunity by enhancing antibody responses to multiple strains when administered as a primer in a 1 mg dose

Ness Ziona, Israel – June 29, 2015 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) today announced positive preliminary results from its BVX-006 Phase II clinical trial of M-001, BiondVax's candidate for a universal influenza vaccine. In this trial, M-001 was injected intramuscularly to volunteers between the ages of 50 to 65, followed by an administration of the 2014/15 season trivalent influenza vaccine (TIV) 3 weeks later. M-001 was found to be safe and well tolerated and induced humoral immune responses, successfully meeting the primary safety and secondary immunogenicity endpoints.M-001 in a 1mg dose, primed for immune responses in a manner consistent with previous data in this age group, confirming BiondVax’s approach to the development of a universal influenza vaccine. Furthermore, as demonstrated in previous tests, a broadening of the immune response to elicit responses against strains not included in the standard influenza vaccine was detected.M-001 also elevated the immune response to other strains which were not included in the current influenza seasonal vaccine including against the drifted H3N2 strain of influenza that has caused this year’s epidemic in the United States. These results support BiondVax’s claim that M-001 provides a broaden and improved coverage against multiple influenza type A and B virus strains.In addition, the excellent safety profile demonstrated for the 1 mg dose of M-001 will enable BiondVax to safely administer this dose in upcoming trials (such as BVX-007 in Europe). The increased dose is expected to further improve the immune responses against multiple influenza strains when given as a primer or as a standalone product without an adjuvant. Furthermore, the 1mg dose can be particularly beneficial to a population with weakened immunity, such as the elderly.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, noted that, “We are very pleased with the results of this trial, which provide us with additional supporting data that our M-001 increases the immune response against multiple flu strains. The results indicating that the 1mg dosage level was well tolerated is very important and these positive results support our continued research and ongoing trials.”Added Dr. Ron Babecoff, BiondVax’s President and CEO, “We are very happy with these results, as they demonstrate the importance and value to society of developing M-001. This successful trial brings us one step further towards the phase 3 clinical trial.”