The Multimeric Universal Influenza Vaccine: BVX-M001
BiondVax’s Universal Flu Vaccine, the Multimeric-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.
These epitopes activate both arms of the immune system (humoral and cellular), providing the broadest possible protection against infection by triggering fast and effective clearance of existing and future influenza strains from the body.
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 Multimeric-001 Universal Influenza Vaccine consists of a unique, proprietary combination of 9 conserved linear epitopes from influenza virus proteins, taken in triplicate, combined into a single formulation recombinant protein and produced by fermentation in E.coli. The epitopes selected are taken from Hemagglutinin (HA), Nucleoprotein (NP) and Matrix (M) proteins, therefore ensuring high antigen content, activating both humoral and cellular immunity, delivering a cross-protecting and long-lasting effect.
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 believes for 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 commercializing of this innovative flu vaccine from the Weizmann Institute. In that time, we have improved the formulation of the vaccine, enhancing the safety profile, broadening the protection offered by the vaccine, and are continually effecting improvements that allow for the optimizing of the industrial production process in a cGMP environment.
BiondVax has had pre-IND discussions with the FDA in which we presented our pre- and clinical plans for the Multimeric-001 universal flu vaccine. The Company is progressing with its development plan based on the recommendations received from the FDA.
Current Status
The Multimeric-001 vaccine has been tested in one Phase II clinical trial and two Phase I/II clinical trials:
BVX002: Phase I/II trial, in 63 participants 18-49 years old, successfully concluded in December 2009
BVX003: Phase I/II trial, in 60 participants 55-75 years old, successfully concluded in April 2010
BVX004: Phase II trial, in 200 participants 18-49 years old, successfully concluded in June 2011
In all three trials, the Multimeric-001 vaccine was shown to be safe and well tolerated, and to successfully activate both humoral and cellular immunity, stimulating responses against the vaccine itself as well as against both Influenza Type A and Type B strains.
BiondVax initiated the first of a series of Phase II clinical trials in August 2010. This Phase IIa study was a randomized, double-blind, placebo-controlled, multi-center, safety and immunogenicity study in 200 healthy volunteers. The study was conducted at two clinical research centers in Israel, the Hadassah Clinical Research Center at Hadassah University Hospital in Jerusalem and the Tel Aviv Sourasky Medical Center (Ichilov).
In this trial, the vaccine was found to be safe and well tolerated, and induced robust immune responses, successfully meeting both the primary safety and immunogenicity endpoints, as well as additional secondary immunogenicity endpoints. It was also found that the Multimeric-001, when used in conjunction with a commercially available strain-dependant seasonal influenza vaccine (trivalent inactivated vaccine, or TIV), enhances the performance of the TIV by increasing the rates of Hemagglutination Inhibition (HI) seroconversion to influenza strains both included, and not-included, in the TIV itself.
The Road Ahead BiondVax is currently preparing to conduct its next Phase II trial, scheduled to commence in the fourth quarter of 2011, and expected to be completed by the second quarter of 2012.
Phase III trials are scheduled for 2013.
BiondVax is currently planning the expansion of its laboratory and production facilities located at the existing premises in Ness-Ziona, so as to enable the Company to produce the required clinical-grade material for the advanced clinical trials. This will provide BiondVax with significant potential to maximize our contribution to potential future collaborations with large pharma companies.
