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BiondVax's Universal Influenza Vaccine: M-001
 
BiondVax’s Universal Flu Vaccine, M-001, represents a quantum leap in the flu vaccine arena, as it is based on a proprietary combination of conserved non-changing epitopes, or peptides, common to practically all existing and future flu virus strains, including both seasonal and pandemic flu strains such as the avian and swine flu, regardless of their antigenic drift and shifts.

This innovative concept is the result of over 15 years of intensive research by Prof. Ruth Arnon and her team at the Israeli Weizmann Institute of Science, and subsequent development at BiondVax.

The Universal Influenza Vaccine comprises a unique, proprietary combination of 9 conserved linear epitopes from influenza virus proteins, combined in triplicate into a single recombinant protein and produced by fermentation in E.coli. TheT- and B-cell epitopes were selected from Hemagglutinin (HA), Nucleoprotein (NP) and Matrix (M) proteins, therefore ensuring activation of both humoral and cellular immunity.


BiondVax’s
Multimeric-001 vaccine is innovative and unique in a number of respects:
  • Activates both humoral (antibody) and cellular immune responses
  • Contains epitopes that enable the human immune system to recognize both Type A and Type B influenza strains
  • The vaccine is a single recombinant protein that is manufactured by fermentation in E. coli, and as such can be produced on an industrial scale in a mere 6-8 weeks, enabling year-round production and vaccination
This Universal Flu Vaccine has the potential to revolutionize the entire flu vaccine industry. The vaccine is not strain- or season-dependent. It promises to provide long lasting (BiondVax anticipates 3-5 years) and broad protection against existing and future influenza strains including the highly pathogenic Avian flu and Swine flu. Moreover, a single formulation will, for the first time, enable year-round vaccination. With our vaccine, mass production planning will be possible as well as on-demand worldwide distribution.

BiondVax has been developing the Universal Influenza Vaccine since 2005, after having secured a worldwide exclusive license for the development, manufacturing and commercialization of this innovative flu vaccine from the Weizmann Institute.  In that time, we have improved the formulation of the vaccine, enhancing the safety profile, and are continually effecting improvements that allow for optimization of the industrial production process in a cGMP environment.

BiondVax has conducted pre-IND discussions with the FDA in which we presented our pre- and clinical plans for the universal flu vaccine.  The Company is progressing with its development plan based on the recommendations received from the FDA.


Current Status

The universal influenza vaccine has been the focus of multiple pre-clinical studies and 4 human clinical trials, two Phase 1/2 and two Phase 2, encompassing 440 adults and elderly (aged 65+).
  • BVX002: Phase 1/2 trial, in 63 participants 18-49 years old, successfully concluded in December 2009
  • BVX003: Phase 1/2 trial, in 60 participants 55-75 years old, successfully concluded in April 2010
  • BVX004: Phase 2 trial, in 200 participants 18-49 years old, successfully concluded in June 2011
  • BVX005: Phase 2 trial in 120 participants 65+ years old, successfully concluded in February 2012
The vaccine has a positive safety profile and induces both humoral (antibody) and cellular influenza-specific immune responses. The clinical grade universal vaccine is produced at the Company’s facility that successfully passed a European (EU) Qualified Person (QP) Good Manufacturing Practices (GMP) audit in 2012. To the best of our knowledge, BiondVax’s universal influenza vaccine is the most mature technology in the field of universal influenza vaccines with the largest set of pre- and clinical data.

In addition to its standalone action, the universal vaccine enhances the activity of commercial influenza vaccines (seasonal and pandemic) when administered in a prime-boost regimen: first the universal vaccine is administered (primer) and then the commercial influenza vaccine is administered (boost). This synergy enables the universal vaccine to serve as multiple products, each with a distinct regulatory pathway and market: seasonal primer for elderly (or young infants), universal pandemic primer and standalone universal influenza vaccine.

Pandemic Primer - Preparedness AHEAD of Outbreak

The fastest way to bring the universal vaccine to the market is as a pandemic primer. This strategic commercialization enables the universal vaccine to be evaluated using the HAI biomarker utilized by regulatory authorities to approve influenza vaccines today, resulting in a shorter regulatory pathway for a product complementary to existing vaccines. Specifically, we propose that national governments should stockpile the universal vaccine during inter-pandemic phases to enable preparedness AHEAD of pandemic outbreak, whatever the emerging strain. A priming immunization is expected to lower the burden of pandemic disease while the pandemic strain-specific vaccine is manufactured, and subsequently enhance responses to the pandemic vaccine and enable pandemic vaccine sparing.

 
 

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BiondVax Pharmaceuticals Ltd.
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Ness Ziona, 74140, Israel

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