BiondVax’s Phase IIb trial for flu vaccine meets primary endpoints


Israel-based BiondVax Pharmaceuticals and the UNISEC consortium have announced positive data from the Phase IIb clinical trial of universal flu vaccine candidate, M-001.

M-001 is currently being developed to provide multi-season protection from common seasonal and pandemic human influenza virus strains and features the firm’s technology that combines conserved and common peptides of proteins from the virus.

The combination is expected to stimulate both arms of the immune system to ensure cross-protection and long-lasting effect.

The results showed that the placebo-controlled double-blind trial met both the primary endpoints of safety and influenza-specific cellular immune response.

During the trial, 219 subjects aged 18-60 and older initially received 0.5mg and 1mg of M-001 or saline placebo, followed by immunisation with a partial dose of avian H5N1 pandemic vaccine.

"Along with the substantial funding recently brought to BiondVax, we can now concentrate on performing all activities needed to launch the pivotal Phase III clinical trial."

BiondVax chief scientific officer Dr Tamar Ben-Yedidia said: “These significant results confirm that the M-001 is a unique and innovative influenza vaccine that elicits strong T-cell responses and is expected to provide multi-strain and multi-season protection against influenza illness.

“Along with the substantial funding recently brought to BiondVax, we can now concentrate on performing all activities needed to launch the pivotal Phase III clinical trial.”

The data indicated a statistically significant increase in T-cell dependent immune responses with both dosages compared to placebo, as well as HAI elevation in relation to one of the four H5N1 strains assessed.

M-001 vaccine was further found to be well-tolerated with a favourable safety profile.

Based on the previous and latest findings, BiondVax plans to directly evaluate the clinical efficacy of M-001 monotherapy in a Phase III trial by determining flu illness rate and severity.