Advancing toward a universal flu vaccine: BiondVax reports positive phase 2 data

Results from a phase 2b study shows that BiondVax's universal flu vaccine candidate M-001 can elicit significant immune responses as a primer.

With financial backing from the Israeli government and the European Investment Bank, BiondVax is pushing forward in its quest for a universal flu vaccine. The company’s candidate showed positive T-cell and antibody responses in a phase 2b trial.

For the study, investigators divided 219 adult participants into three groups who received either a high dose or a low dose of the flu vaccine, M-001, or a dummy. All groups then received a partial dose of an H5N1 pandemic vaccine. Researchers found significantly elevated T-cell responses in those who received M-001 as a primer, more notably in the 1.0 mg higher dosage group, while a statistically significant antibody responses was observed in one of the four H5N1 strains.

By combining nine flu epitopes that aren't vulnerable to regular changes, BiondVax aims to provide multiseason protection against both seasonal and pandemic flu virus strains. Traditional flu shots are tailored to fight a few flu strains and need to be altered every year to fight against the strains health authorities predict will circulate in a given season.

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With the results in hand, BiondVax said in a statement it’s considering testing the candidate as a standalone vaccine in a succeeding phase 3 clinical trial that will assess its efficacy by measuring actual reduction of flu in terms of both rate and severity. With a recent €20 million commitment by the European Investment Bank, plus a grant from the Israeli government that covers about one-fifth of the $5.5 million needed to secure a facility in Jerusalem, the company has all the resources it needs to launch the pivotal study, BiondVax CSO Tamar Ben-Yedidia said in the statement.

Just days ago, the biotech signed a 10-year lease for a 1,800-square-meter site in the Jerusalem BioPark. Once finished, the facility will have capacity to produce tens of millions of doses of M-001 annually, either in single-dose syringes or in bulk. Construction will begin soon, and BiondVax expects it will “optimize production timelines and significantly reduce production costs.”

Johnson & Johnson, Sanofi Pasteur and FluGen are also working on their versions of universal flu vaccines.

UNISEC, a European consortium of three academic partners and five national health institutes, cosponsored the phase 2b study. In a statement, the group's executive manager Ed Schmidt said the responses seen were "very impressive and of high scientific interest."