iBio, Inc. (OTCBB:IBPM) announced today that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application filed for a vaccine candidate made with the Company's proprietary transformative technology, the iBioLaunch™ technology platform. The candidate vaccine was manufactured by iBio's research collaborator, Fraunhofer Center for Molecular Biotechnology (FCMB), in its cGMP pilot manufacturing facility in Newark, Delaware. The Company expects human clinical trials based upon this IND to commence promptly. The primary endpoint of the study will be safety, and immunogenicity data will also be collected.
“While this trial focuses on a significant vaccine application, our technology is easily and rapidly transferable to virtually any protein-based vaccine or therapeutic product”
"While this trial focuses on a significant vaccine application, our technology is easily and rapidly transferable to virtually any protein-based vaccine or therapeutic product," said Robert Erwin, president of iBio. "We expect the iBioLaunch platform to be broadly adopted and to transform the way in which vaccines and therapeutic proteins - including biosimilars and biobetters - are made."
Boasting dramatic superiority in speed of expression, surge capacity, efficiency and cost savings, the iBioLaunch technology platform is a plant-based transient expression system for recombinant protein production. It transforms the creation of biologics by eliminating the use of animal cells or genetically altered plants which are much slower and more expensive.
The iBioLaunch technology was invented and refined by FCMB during the past eight years to overcome the inadequacies of existing technologies. During this period, the technology progressed from concept through technical innovations, process improvement, and scale-up for application to multiple products. iBio owns the IP/technology developed at the not-for-profit FCMB, and continues to sponsor development and refinement of the technology for broad biologics applications in human healthcare.
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