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.
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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.
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.
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By GlobalData“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.
