BiondVax Meets with the US Biomedical Advanced Research and Development Authority (BARDA) to Present the Use of its Universal Flu Vaccine

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BiondVax Pharmaceuticals Ltd, developer of a universal flu vaccine, announced today that the Company has just returned from a meeting with officials at the Biomedical Advanced Research and Development Authority/Health and Human Services (BARDA/HHS) at which clinical trial results for BiondVax’s universal flu vaccine, the Multimeric 001, was presented. BiondVax was invited to give this seminar to the Influenza Division at BARDA, during which the Company’s solution for global pandemic flu outbreaks was discussed. At the meeting the Company was informed that BARDA will consider proposals to provide pandemic vaccines and funding of clinical trials examining the usage of BiondVax’s universal flu vaccine as a primer that provides preparedness ahead of pandemic flu outbreaks. In addition, at the seminar the Company discussed the use of its vaccine as a standalone
universal flu vaccine.

The Influenza Division at BARDA is considered world expert on pandemic preparedness and the deliberations of national governments when evaluating medical counter measures.

“The US is a key market for influenza vaccines and so it is critical to BiondVax’s success that our development strategy reflects the needs of US stakeholders, such as BARDA. The US health authorities have a major impact on the global health system and sets the agenda and the level
of global preparedness for pandemic outbreaks… We continue to work in parallel with regulatory bodies and health authorities around the world to promote agreements with governments for licensing the universal flu vaccine”Dr. Ron Babecoff, BiondVax’s CEO

About Biomedical Advanced Research and Development Authority/Health and Human Services (BARDA/HHS)
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. Since its inception in 2006, BARDA has supported more than 70 chemical, biological, radiological, and nuclear (CBRN) medical countermeasure product candidates. In 2014, $140 million was allocated specifically to continue efforts to prepare for and respond to a pandemic influenza outbreak.

About BiondVax Pharmaceuticals Ltd
BiondVax is a publicly traded (TASE: BNDX), advanced clinical stage biotech company dedicated to improving global protection against influenza, with its lead product a universal influenza (flu) vaccine called M-001. Influenza (flu) is the most common infectious disease, caused by countless flu strains as the virus mutates unpredictably and frequently. Current seasonal and pandemic/pre-pandemic flu vaccines rely predominantly on triggering immunity to variable viral regions and accordingly are strain-specific. The vaccines are manufactured based on global
surveillance each season or to prepare for a predicted pandemic threat and are often mismatched to the emerging flu strains. Therefore there is an urgent need for broadly protective flu vaccines especially in the case of pandemics and this is being addressed by BiondVax.

At this point in time, BiondVax’s universal flu vaccine (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 (conventional flu 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 conventional strain-specific seasonal/pandemic flu vaccines. Of note, this second indication provides a shorter and cost-effective pathway for clinical development, regulatory approval and commercialization of M-001 and provides a new approach to pandemic preparedness AHEAD of flu outbreak.

See the press release here.

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