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news.The US Food and Drug Administration (FDA) has accepted Israel-based BiondVax Pharmaceuticals' investigational new drug (IND) application for its Multimeric-001 vaccine (M-001).
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The company was also notified by FDA’s regulatory advisors to proceed with the clinical trial of its investigational universal flu vaccine.
The IND application will allow the company to conduct an FDA approved Phase II trial that will involve the administration of its product candidate M-001.
The company’s technology uses combination of conserved and common peptides from influenza virus proteins to activate both arms of the immune system for a cross-protecting and long-lasting effect.
BiondVax CSO Dr Tamar Ben-Yedidia said: "Influenza is a serious global concern – it spreads rapidly, leading to serious illness which can directly or indirectly lead to death, particularly among the elderly.
"Today’s vaccines are far from ideal – they mostly protect against the strains within them, but frequent mismatches between these strains and the circulating ones lead to low vaccine effectiveness.
"We believe our solution, whereby one vaccine protects against each and every flu strain, will save the lives and suffering of many millions around the world each year."