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Leading the pipeline is Fludase®, which has recently completed a First-In-Man clinical trial. Fludase is a novel broad-spectrum recombinant protein for the prophylaxis and treatment of Influenza-Like Illness caused by all influenza and parainfluenza viruses, as well as pandemic influenza caused by strains such as H5N1. It is a first-in-class fusion protein that works by a different mechanism from all anti-virals currently approved or in development, and non-clinical data suggest a superior efficacy, safety and resistance profile. In recognition of Fludase’s potential importance for public health, NIAID has awarded NexBio ~$60 million BAA Contract to support research and development of the program. SepcidinTM, at lead optimization stage is, directed to the treatment of viral hemorrhagic fever caused by viruses such as Ebola, as well as sepsis and septic shock. Like Fludase, its mechanism is distinctive in that it acts on the human host rather than on a particular pathogen, enabling it to have broad-spectrum activity. TOSAP®, the technology used to formulate Fludase into a dry powder for inhalation, was invented at NexBio. TOSAP is a differentiated, novel, efficient and scalable method to formulate and manufacture nanospheres and microspheres for inhaled, oral and parenteral administration. The platform is proving broadly applicable to a large variety of molecules, such as proteins (including peptides and antibodies), small molecules (soluble and insoluble), virus (enabling inhaled vaccine delivery) and DNA/RNA. The formulation of siRNA for delivery using TOSAP is an area of active pursuit. TOSAP® is offered as a service and technology licensing business to third parties, and a Pharma collaboration to reformulate a proprietary compound is ongoing. NexBio is also using TOSAP to grow its own pipeline by reformulating commercially-improved on-market drugs, including generic and biosimilar compounds. |
NexBio was incorporated in 2002 and started it's operations in 2003. It is biopharmaceutical company located in San Diego, California, founded to create and commercialize novel, broad-spectrum biopharmaceuticals to prevent and treat current and emerging life-threatening human disease. All funding to date has been from the National Institutes of Health in the form of grants and contracts, totaling ~$73 million.