Fresh off a grant from the Israeli government to set up a manufacturing plant for its universal flu vaccine, BiondVax has secured a €20 million ($22 million) loan from the European Investment Bank to advance its work.
With the money, BiondVax has the resources to launch phase 3 trials on its universal flu vaccine M-001 and set up a mid-sized manufacturing plant, company CEO Ron Babecoff said in a release. The biotech received funding from the Israeli government in March to cover about 20% of the costs of building that $5.5 million facility in Jerusalem. Once complete, the plant will be capable of manufacturing tens of millions of doses of M-001 for clinical studies and commercial needs.
The loan comes through the infectious diseases project of “InnovFin—EU finance for Innovators,” a collaboration between the EIB and the European Commission under Horizon 2020, a funding program by the European Commission to support scientific research. It will be available in three annual batches for up to three years and is contingent on certain milestones.
Seasonal flu vaccine effectiveness currently hovers at around 40% to 50%, but can be as low as 9% in elderly people, according to the CDC. The type A influenza virus is notorious for its ability to mutate and to cause epidemics, which reduces vaccine effectiveness and forces scientists to update vaccines every season.
Different from common vaccines that use natural immunogen to elicit immune responses, M-001 uses the epitope-based approach and consists of nine widely conserved flu epitopes. The company designed it to protect against current and future seasonal and pandemic flu strains.
Previous studies have shown that the shot is safe and immunogenic, and that it can enhance and expand the benefits of current flu vaccines. In particular, a study published recently in the journal Vaccine reported that M-001, when used as primer to trivalent influenza vaccine (TIV), can protect against future flu strains not known at the time of vaccination. Blood plasma samples from elderly participants who received M-001 prior to TIV in 2011 during a phase 2 study showed improved antibodies against a flu strain in the 2014/15 season.
Currently, the Israeli biotech is developing its vaccine in a two-part strategy. First, the company is advancing its shot as a universal primer to be used before any hemagglutinin-based seasonal or pandemic vaccine. Several phase 2 trials are testing that approach, including one conducted by the NIH’s National Institute of Allergy and Infectious Diseases, which tests M-001 as a primer to the H7N9 avian flu vaccine. A readout from that study is expected later this year. Second, the company is also seeking to obtain approval for M-001 as a stand-alone universal flu vaccine.