Development of a novel quadrivalent seasonal influenza vaccine using E.coli production technology

Abstract Vaccine mismatch and delay continue to hamper seasonal influenza vaccination effortsWe propose here to develop EC QIVa novel quadrivalent influenza vaccine based on the immunologically dominant globular domain of hemagglutinin produced in an E coli expression systemeHAThe proof of concept for production of biologically active and correctly folded eHAhas been demonstrated for the seasonal H NH Nand two B lineage influenza virusesas well as for several avian influenza viruses with pandemic potentialA key breakthrough of this technology is the successful production of the oligomeric form of eHAThe eHAoligomer retains the receptor binding activity and the antigenicity of the parental HA moleculeThe productivity of eHAis significantly higher than that of licensed vaccinesThe low production cost of the E coli system will allow EC QIV to be highly competitive in the current saturated influenza vaccine marketA short production cycle will allow eHAto be more efficient in responding to emergence of drifted and or shifted influenza virusesThe eHAis focused on the immunodominant protective region of HA and has been shown to be more effective than the licensed influenza vaccines in protection against virus challenge in the ferret animal modelThis unique technology has the potential to provide cheaperfasterand more effective influenza vaccinesThis Phase II SBIR proposal is centered on the development of a highly productive commercial manufacturing process that will provide significant surge capacity for prevention of seasonal and pandemic influenza Narrative Development of cheaperfasterand more effective influenza vaccineTo achieve this goalwe propose to develop seasonal influenza vaccines based on globular domain of HA in Ecoli systemWe will conduct key development activities leading toward the evaluation in humans