Clinical Trial to Commence for Product Based Upon Transformative iBioLaunch Technology
NEWARK, Del., Sep 20, 2010 (BUSINESS WIRE) -- iBio, Inc. 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(TM) 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," 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.
About iBio, Inc.
iBio, Inc. is a biotech company commercializing its proprietary, transformative iBioLaunch(TM) technology platform for the production of biologics including therapeutic proteins -- orphan biologics, biosimilars and biobetters -- and vaccines. The iBioLaunch platform uses transient gene expression in plants for superior efficiency in protein production. Advantages include significantly lower capital and process costs, and the technology is ideally suited to infectious disease applications where speed, scalability, and surge capacity are important. iBio owns the IP/technology developed at the not-for-profit Fraunhofer USA Center for Molecular Biotechnology, and continues to sponsor development and refinement of the technology for broad applications in human healthcare. Further information is available at www.ibioinc.com.
About Fraunhofer USA Center for Molecular Biotechnology
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc., is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders. The technology CMB developed for iBio, Inc. provides a safe, rapid and economical alternative for both vaccine and therapeutic protein production. Further information is available at www.fraunhofer-cmb.org.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995:
Statements included in this release related to iBio, Inc. may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as competitive factors, technological development, market demand, and the Company's ability to obtain new contracts and accurately estimate net revenues due to variability in size, scope and duration of projects. Further information on potential risk factors that could affect the Company's financial results can be found in the company's Reports filed with the Securities and Exchange Commission.
SOURCE: iBio, Inc.